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					Name: Christopher Branch                            Supervisor: Robin Lansman



                           Acknowledgements



Many special thanks to the following people for their time, guidance and

patience.

       Robin Lansman

       Paul Blanchard

       Hillary Abbey

       Philip Branch

       Jonathan Foxon




                                   1
Name: Christopher Branch                                   Supervisor: Robin Lansman



                                   Abstract



Objective: The aim of this study is to help the osteopath decide if cervical

spine manipulation is effective in the treatment of neck dysfunction by

producing an unbiased review of published randomized controlled trials

(RCTs) that test the effects of cervical spine manipulation.

Background: Research in the Netherlands in 1996 estimated that US $160

million was spent on the medical treatment of neck pain in the Netherlands

alone and the total number of sick days related to neck pain was estimated to

be 1.4 million with a total cost of $185.4 million. Research in Sweden has

shown that 43% of people had neck pain at a given time.

Design: This systematic review was based on the standards and format

recommended by the Cochrane Collaboration Back Review Group for Spinal

Disorders.

Methods: Ten RCTs were reviewed using a set of methodological quality

assessment criteria based upon van Tulder et al. (1997)

Results: There was diversity in the interventions, design and outcome

measures of the studies. Eight of the studies were deemed as high quality,

two low quality.

Conclusion: There is evidence to suggest that manipulation has positive

effects on pain and neck disability. However, there is not enough evidence to

say whether manipulation is the best choice of manual therapy. The best

quality evidence suggests manipulation in combination with exercise is better

than manipulation or exercise alone.

Keywords: Cervical Spine; Neck; Spinal Manipulation; Systematic Review.



                                       2
Name: Christopher Branch                                   Supervisor: Robin Lansman



                                      Contents



Acknowledgements                                                               1
Abstract                                                                       2
Contents                                                                       3
Introduction                                                                   4
Method                                                                         6
        Literature Search                                                      6
        Inclusion Criteria                                                     7
        Table 1: Criteria List for the Methodological Quality Assessment       8
        Assessment of Research Quality                                         9
        Table 2: Methodological Quality Assessment Form                        10
        Ethical Issues and Control of Bias                                     11
Results                                                                        12
        Table 3: Articles Reviewed – Interventions, Outcomes and Results 13
        Quality of Studies Reviewed                                            15
        Table 4: Methodological Quality Assessment Results                     16
        Table 5: Scores per Criterion                                          17
        Inter-rater and Intra-rater Reliability                                17
        Table 6: Inter-rater and Intra-rater Reliability                       19
Discussion                                                                     20
        Patient Perceived Pain and Disability                                  20
        Peak Flow in Vertebral Artery                                          21
        Pain Pressure Threshold (PPT) on Myofascial Trigger Point              21
        Somatosensory Evoked Potentials                                        22
        Potential Weaknesses and Limitations                                   22
Conclusion                                                                     25
References                                                                     26




                                           3
Name: Christopher Branch                                   Supervisor: Robin Lansman



                                 Introduction


Spinal manipulation has been used in manual therapy for more than 2000

years (Evans 2002). However, it is only in the last few decades that there has

been research investigating the effects of it. Manipulation is defined as a high-

velocity, low amplitude thrust directing forces at a specific point, area or

structure (Hartman 1998). It is believed that mechanical and neurophysiologic

changes occur after manipulation, yet it remains a poorly understood topic,

the benefits of which are still to be clearly established (Evans 2002, Pickar

2002, Refshauge et al. 2002).



Neck pain is a common occurrence and very costly. Research in the

Netherlands in 1996 estimated that US $160 million was spent on the medical

treatment of neck pain in the Netherlands alone and the total number of sick

days related to neck pain was estimated to be 1.4 million with a total cost of

$185.4 million (Borghouts et al. 1999). Research in Sweden has shown that

43% of people had neck pain at a given time; 48% of women and 38% of

men. Nineteen percent of the entire population suffered neck pain that was of

more than 6 months duration (Guez et al. 2002).



The use of complimentary medicine is growing worldwide but only a small

minority of it is evidence based and accepted by primary health care

professions (Stone 2000). There are conflicting beliefs on the benefits and

risks of cervical spine manipulation indicating the need for further research in

the area. It has been said that there is limited evidence of the efficacy of neck




                                       4
Name: Christopher Branch                                 Supervisor: Robin Lansman



manipulation, but even less evidence for the most likely alternative

intervention – mobilization (Rivet 2006).



The aim of this study is to help the osteopath decide if cervical spine

manipulation is effective in the treatment of neck dysfunction by producing an

unbiased review of published randomized controlled trials that test the effects

of cervical spine manipulation.




                                       5
Name: Christopher Branch                                  Supervisor: Robin Lansman



                                   Method



A systematic review is a review that has been prepared using a systematic

approach to minimising biases and random errors which is documented in a

materials and methods section (Egger et al. 2001). Systematic reviews of

multiple studies help establish whether scientific findings are consistent and

can be generalised across populations, settings and treatment variations or

whether findings vary by particular subsets (Mulrow et al. 1998).



This systematic review is based on the method guidelines in the Cochrane

Collaboration Back Review Group for Spinal Disorders by van Tulder et al.

(1997) as this is recognised to be the most reliable design in conducting

manual therapy systematic reviews.



Literature Search



                 Keywords                         Hits
Manipulation, Spinal AND Neck                     36
Manipulation, Spinal OR Manipulation,             37
Osteopathic, OR Manipulation Chiropractic
AND Neck
Manipulation, Spinal OR Manipulation,              53
Osteopathic, OR Manipulation Chiropractic
OR Manipulation, Orthopaedic OR
Manipulation OR Adjustment OR
Mobilisation AND Neck OR Neck Pain


Searches were performed in the Pubmed database with the above keywords.

Limits used were: English language, published in the last 10 years, studies on

humans, and Randomized Controlled Trials.



                                       6
Name: Christopher Branch                                       Supervisor: Robin Lansman




The Cochrane Library was searched for relevant systematic reviews.



The references of each paper were scanned for potentially relevant articles

not found in the literature search but this did not yield any other material of

value.



Inclusion Criteria:



The inclusion criteria are based upon van Tulder et al. (1997).



Study Design: Randomised Controlled Trials

Participants: Randomized controlled trials were included that reported on

subjects between 18 – 70 years of age with acute (<30 days), subacute (30-

90 days) or chronic (> 3 months) neck pain (Gross et al. 2004).

Interventions: Randomized controlled trials in which the experimental group

contains spinal manipulation of the cervical spine. Spinal manipulation is

defined as a high-velocity, low-amplitude thrust (Hartman 1998). Additional

interventions are allowed.

Outcomes: Randomized controlled trials were included that assess specific

effects of cervical manipulation. Outcome measures considered to be most

important are pain, a global measure of improvement (assessed with a neck

disability index), and mechanical function of neck (range of movement,

strength and endurance). Other measurements included are effects on

somatosensory        change   and   effects   on   vertebral    artery    flow    rate.



                                         7
Name: Christopher Branch                                                                 Supervisor: Robin Lansman



Table 1               Criteria List for the Methodological Quality Assessment



Criteria from van Tulder et al (1997) and van                    Requirement to score a “Yes”
Tulder et al (2000)
Patient Selection.
a.     Were the eligibility criteria specified?                  Cause, nature and duration of neck pain described
                                                                 with inclusion and exclusion criteria stated.

b1.    Was treatment allocation randomised?                      Assignment based on a truly random (unpredictable)
                                                                 generation method.
b2.    Was the treatment allocation concealed?                   Assignment generated by a person who is not
                                                                 otherwise involved in patient selection.

c.     Were the groups similar a baseline regarding the          Comparable in age / gender / type of symptoms /
       most important prognostic indicators?                     outcome measures / size of groups.

Interventions.

d.     Were the index and control interventions explicitly       Interventions clearly described.
       described?

e.     Care provider blinded to the intervention?                Not used – care provider cannot be blinded.

f.     Were co-interventions avoided or comparable?              Co-interventions either avoided or comparable
                                                                 between index and control groups.

g.     Compliance acceptable in all groups?                      Reported details of how compliance was measured
                                                                 and levels attained are satisfactory.

h.     Was the patient blinded to the intervention?              Blinding described or interventions between groups
                                                                 are equally credible and acceptable to patients.

Outcome Measurement.

i.     Outcome assessor blinded to the interventions?            Blinding explicitly described.

j.     Were the outcome measures relevant?                       Relevant outcomes showing effect of manipulation.

k.     Were adverse effects described?                           Described, or “no adverse effects” explicitly stated.

l.     Withdrawal/dropout rate described and acceptable?         Drop-out <20% in short-term follow-up, <30% in long-
                                                                 term follow-up.

m1.    Short-term follow-up measurement?                         Outcomes measured after intervention.

m2.    Long-term follow-up measurement?                          Outcomes measured >3months after intervention.

n.     Was the timing of the outcome assessment in both          Timing was the same for all groups.
       groups comparable?

Statistics.

o.     Was the sample size for each group described?             Described for each group and each outcome.

p.     Did the analysis include an intention to treat            All patients are included in analysis of outcome,
       analysis?                                                 regardless of non-compliance or co-interventions.
                                                                 Baseline values are used for missing measures.

q.     Were point estimates and measures of variability          Point estimates and measures of variability presented
       presented for the primary outcome measures?               for each outcome measure.




                                                             8
Name: Christopher Branch                                  Supervisor: Robin Lansman



Assessment of Research Quality:



Each randomized controlled trial was systematically reviewed using the

criteria described in the Methodological Quality Assessment in van Tulder et

al. (1997). Table 1 shows the Methodological Quality Assessment Criteria and

the requirement to score a “yes” for each criterion.



The methodological quality rating for each paper was recorded on a form

shown in Table 2. The requirement to score a “Yes” is described, a “No” was

given if the criterion was explicitly not met, and an “X” (unclear) if there was

no mention of the criterion requirements.



A brief summary of each article is given in Table 3. The details of

interventions and design, outcome measures and results are listed.



The results and rating of each study are shown in Table 4 and they are

ranked from highest to lowest quality. The total score for each paper reviewed

was the number of “yes” scores it achieved. An “X” score was rated as a “No”

for the purposes of quality rating. A score of 11 or higher was rated as “high

quality” and the rest as “low quality”.



An analysis of the scores of each criterion is given in Table 5 rated from

highest to lowest.




                                          9
Name: Christopher Branch                                                               Supervisor: Robin Lansman



Table 2              Methodological Quality Assessment Form

Paper:                                    Date:               Totals:
                                                              Yes:           No:            X (unclear):


Criteria                                            Requirement to score a “Yes”                            Score
                                                                                                            (Y/N/X)
Patient Selection.

a.     Were the eligibility criteria specified?     Cause, nature and duration of neck pain described
                                                    with inclusion and exclusion criteria stated.

b1.    Was treatment allocation randomised?         Assignment based on a truly random (unpredictable)
                                                    generation method.

b2.    Was the treatment allocation concealed?      Assignment generated by a person who is not
                                                    otherwise involved in patient selection.

c.     Were the groups similar a baseline           Comparable in age / gender / type of symptoms /
       regarding the most important prognostic      outcome measures / size of groups.
       indicators?

Interventions.

d.     Were the index and control interventions     Interventions clearly described.
       explicitly described?

e.     Care provider blinded to the intervention?   Not used – care provider cannot be blinded.

f.     Were co-interventions avoided or             Co-interventions either avoided or comparable
       comparable?                                  between index and control groups.

g.     Compliance acceptable in all groups?         Reported details of how compliance was measured
                                                    and levels attained are satisfactory.

h.     Was the patient blinded to the               Blinding described or interventions between groups
       intervention?                                are equally credible and acceptable to patients.

Outcome Measurement.

i.     Outcome assessor blinded to the              Blinding explicitly described.
       interventions?

j.     Were the outcome measures relevant?          Relevant outcomes showing effect of manipulation.

k.     Were adverse effects described?              Described, or “no adverse effects” explicitly stated.

l.     Withdrawal/dropout rate described and        Drop-out <20% in short-term follow-up, <30% in
       acceptable?                                  long-term follow-up.

m1.    Short-term follow-up measurement?            Outcomes measured after intervention.

m2.    Long-term follow-up measurement?             Outcomes measured >3months after intervention.

n.     Was the timing of the outcome                Timing was the same for all groups.
       assessment in both groups comparable?

Statistics.

o.     Was the sample size for each group           Described for each group and each outcome.
       described?

p.     Did the analysis include an intention to     All patients are included in analysis of outcome,
       treat analysis?                              regardless of non-compliance or co-interventions.

q.     Were point estimates and measures of         Point estimates and measures of variability
       variability presented for the primary        presented for each outcome measure.
       outcome measures?




                                                        10
Name: Christopher Branch                                 Supervisor: Robin Lansman



Ethical Issues and Control of Bias:



It is paramount that a systematic review takes an unbiased approach to

reviewing the literature and a few steps have been taken to ensure this. A

comparison of inter-rater and intra-rater consistency was made and the

results are shown in table 6. Three articles were randomly selected and on

different dates they were re-reviewed by the author (intra-rater rating) and

then by a separate individual (inter-rater rating). Any differences of opinion

were discussed.



Extensive literature searches were performed with a wide range of keywords.



The procedure of this investigation is ethically acceptable as there are no

human or animal subject populations (Ross 2007).




                                      11
Name: Christopher Branch                                 Supervisor: Robin Lansman



                                   Results



Ten articles fit the inclusion criteria and were deemed suitable for review.

There was diversity in their interventions, design and outcome measurements

although all used cervical spine manipulation in the experimental group (Table

3). Some studies compared manipulation (high-velocity, low-amplitude thrust

(HVLAT)) with mobilization (passive movement with no thrust) (Haavik-Taylor

1998, Licht 1998, Martinez-Segura 2006, Ruiz-Saez 2007), some compared

HVLAT with mobilization and exercises (Bronfort 2001, Evans 2002, Jordan

1998) and McReynolds et al (2005) used an intra-muscular injection of

Ketorolac in the control group. The latter study was conducted in an accident

and emergency room where spinal manipulation and Ketorolac injection are

the two most commonly used procedures in the treatment of acute neck pain.



The outcomes measured differed also. Most studies assessed pain, global

assessment of improvement and mechanical neck function but Haavik-Taylor

et al. (2006) measured somatosensory evoked potentials in the median nerve,

Licht et al. (1998) measured peak flow in the vertebral artery and Ruiz-Saez

et al. (2007) measured pain pressure threshold on a myofascial trigger point.




                                      12
Name: Christopher Branch                                               Supervisor: Robin Lansman




Table 3           Articles Reviewed – Interventions, outcomes and results.

  Reference                           Interventions                               Outcomes Measured                                    Results

Bronfort et al.   1. Spinal manipulation and Low Technology                 Pain. Neck Disability Index.          After 11 weeks, patient satisfaction with
2001              Exercise (SMT/Exx) – Chiropractic treatment, High-        Functional Health Status (Short-      SMT/Exx was the only statistically significant
                  velocity low-amplitude (HVLA) thrust and 45mins           Form 36). Use of over-the-counter     superior result. SMT/Exx showed greater gains
                  supervised exercise.                                      medications. Satisfaction with        in all measures or strength, endurance and
                  2. MedX Exercise – one on one with a physical             care. Neck strength, endurance        ROM. SMT/Exx showed more improvement in
                  therapist, stretching, stationary bike and resistance     and active range of movement          endurance than MedX however MedX showed
                  training.                                                 (ROM).                                more than SMT alone.
                  3. Spinal manipulation (SMT) – Chiropractic HVLA                                                There were no statistically significant differences
                  thrust and 45mins sham micro-current therapy.                                                   between groups in patient-rated outcomes after
                                                                                                                  11 weeks.

Evans et al.      1. Spinal manipulation and Low Technology                 Pain. Neck Disability Index.          A difference in patient-rated pain was observed
2002              Exercise (SMT/Exx) – Chiropractic treatment, High-        Functional Health Status (Short-      in favour of the two exercise groups.
                  velocity low-amplitude (HVLA) thrust and 45mins           Form 36). Use of over-the-counter
                  supervised exercise.                                      medications. Satisfaction with
                  2. MedX Exercise – one on one with a physical             care. Neck strength, endurance
                  therapist, stretching, stationary bike and resistance     and active range of movement
                  training.                                                 (ROM).
                  3. Spinal manipulation (SMT) – Chiropractic HVLA
                  thrust and 45mins sham micro-current therapy.

Haavik-Taylor     1. Spinal Manipulation – HVLA thrust administered         Spinal, brainstem and cortical        Significant decrease in amplitude of SEP’s
et al. 2006       by a chiropractor to dysfunctional segment.               somatosensory evoked potentials       following a single cervical HVLA thrust.
                  2. Passive head movement.                                 (SEP’s) to the median nerve.

Hurwitz et al.    1. HVLA thrust with or without heat. 2. HVLA thrust       Pain. Neck Disability Index. Short-   Mean reductions in pain were similar in the
2002              with or without electrical muscle stimulation. 3.         Form 36.                              manipulation and mobilization groups through
                  Mobilization with or without heat. 4. Mobilization with                                         the 6 months.
                  or without electrical muscle stimulation (EMS).




                                                                                 13
Name: Christopher Branch                                              Supervisor: Robin Lansman




Jordan et al.    1. Intensive training: stretching, stationary bike,     Primary: Patient perceived effect.     No significant difference between groups on all
1998             resistance training of neck.                            Blinded physician’s global             measures.
                 2. Physiotherapy treatment: individual treatment        assessment. Self-reporting             All groups had approximately 50% reduction in
                 plans, active and passive elements involved. No         disability scale. Self-reported        pain and reduced medication use.
                 HVLA thrust.                                            pain. Medication use.                  These improvements maintain statistical
                 3. Manipulative treatment: HVLA thrust administered     Secondary: Active ROM.                 significance at the 4 month and 12 month follow-
                 by chiropractor to dysfunctional segment.               Isometric contraction strength and     ups.
                                                                         endurance.
Licht et al.     1. HVLA thrust administered by chiropractor.            Peak flow in right vertebral artery.   No change in peak flow immediately after HVLA
1998             2. Passive examination of cervical spine but no                                                thrust.
                 HVLA thrust.                                                                                   No correlation between peak flow velocity and
                                                                                                                systolic blood pressure.
Martinez-        1. HVLA thrust to neck.                                 Active cervical ROM of flexion,        There was significant improvement in neck pain
Segura et al.    2. Mobilization – neck held in side-bending and         extension, side-bending and            at rest and ROM after manipulation. There was
2006             contralateral rotation for 30 seconds but no HVLA       rotation (using goniometer).           also significant improvement in pain and flexion,
                 thrust.                                                 Neck pain at rest – visual             extension and side-bending ROM (but not in
                                                                         analogue scale.                        rotation) after mobilization.
                                                                                                                Manipulation group obtained greater
                                                                                                                improvement than control group in all measures.
                                                                                                                Pre-post effect sizes were large in manipulation
                                                                                                                group but small-medium in control.
McReynolds et    1. Osteopathic manipulative techniques (OMT):           Patient perceived pain (11-point       Patients receiving OMT reported significantly
al. 2005         HVLA thrust, muscle-energy techniques, soft tissue      pain scale).                           greater decrease in pain intensity.
                 massage.
                 2. 30mg Ketorolac intramuscular injection.
Palmgren et      1. HVLA manipulation administered by chiropractor,      Pain – visual analogue scale.          At 5 weeks, the treatment group showed
al. 2006         myofascial techniques, spine stabilizing exercises.     Active cervical range of               significant reductions in pain and improvement
                 2. Passive neck examination, advice about               movement. Head repositioning           in all aspects of HRA whereas the control group
                 exercises.                                              accuracy (HRA).                        showed no decrease in pain and improvement in
                                                                                                                only one HRA aspect.
                                                                                                                No significant difference was detected in
                                                                                                                cervical range of movement.
Ruiz-Saez et     1. HVLA manipulation at C3/4.                           Pain pressure threshold (PPT) on       Experimental group showed trend toward an
al. 2007         2. Sham procedure: side flexion with contralateral      myofascial trigger point.              increase in PPT after manipulation. Control
                 rotation held for 30secs.                                                                      group showed trend toward decrease in PPT.




                                                                              14
Name: Christopher Branch                                  Supervisor: Robin Lansman



Quality of Studies Reviewed:


Eight of the articles were rated as high quality, and the other two as low

quality. The highest quality article was by Bronfort et al. (2002) with 17 “Yes”

scores and the lowest was by Haavik-Taylor et al. (2006) which scored 9

“Yes” ratings. The highest number of “X” scores was 3 in Ruiz-Saez et al.

(2007) (Table 4).



The results show that most of the evidence scored highly in explanation of

eligibility criteria, interventions, randomization, blinding and relevance of

outcomes measured. Poor scores were achieved in concealment of treatment

allocation, patient blinding, blinding of the assessor, long-term follow-up and

intention-to-treat analysis (Table 5).




                                         15
Name: Christopher Branch                                               Supervisor: Robin Lansman




Table 4               Methodological Quality Assessment Results

              Criteria                    Bronfort   Evans   Jordan   Martinez-    Palmgren    McReynolds   Hurwitz   Ruiz-   Licht   Haavik-
                                           2001       2002    1998     Segura        2006         2005       2002     Saez    1998    Taylor
                                                                        2006                                          2007             2006
a. Were eligibility criteria specified?      Y         Y       Y         Y              Y           Y         Y        Y       N         Y
b1. Treatment allocation                     Y         Y       Y         Y              Y           Y         Y        Y       Y         N
randomised?
b2. Was treatment allocation                 Y         Y       X         Y              Y           N         N        X       N         N
concealed?
c. Were groups homogenous?                   Y         Y       Y         Y              Y           Y         Y        Y       Y         Y
d. Index / control interventions             Y         Y       Y         Y              Y           Y         Y        Y       Y         Y
described?
f. Were co-interventions avoided or          Y         Y       Y         Y              Y           Y         N        Y       Y         Y
comparable?
g. Compliance acceptable in all              Y         Y       Y         Y              Y           Y         Y        X       Y         X
groups?
h. Patient blinded?                          N         N       N         N              N           N         N        N       N         N
i. Outcome assessor blinded?                 Y         Y       Y         Y              N           N         X        N       Y         N
j. Were the outcome measures                 Y         Y       Y         Y              Y           Y         N        Y       Y         Y
relevant?
k. Were adverse effects described?           Y         Y       Y         N              N           Y         Y        Y       N         N
l. Withdrawal/drop-out rate                  Y         Y       Y         N              Y           Y         Y        N       N         Y
acceptable?
m1. Short-term follow-up                     Y         Y       Y         Y              Y           Y         Y        Y       Y         Y
measurement?
m2. Long-term follow-up                      Y         Y       Y         N              N           N         Y        N       N         N
measurement?
n. Comparable timing of outcome              Y         Y       Y         Y              Y           Y         Y        Y       Y         Y
assessment?
o. Sample size for each group                Y         Y       Y         Y              Y           Y         Y        Y       Y         Y
described?
p. Intention-to-treat analysis               Y         X       X         N              N           N         Y        X       N         N
included?
q. Point estimates and measures of           Y         Y       Y         Y              Y           N         N        Y       N         N
variability presented for the primary
outcome measures?
Total Scores Y/N/X                          Y: 17    Y: 16    Y: 15     Y: 13          Y: 13       Y: 12     Y: 12    Y: 11   Y: 10     Y: 9
                                            N: 1     N: 1     N: 1      N: 5           N: 5        N: 6      N: 5     N: 4    N: 8      N: 8
                                            X: 0     X: 1     X: 2      X: 0           X: 0        X: 0      X: 1     X: 3    X: 0      X: 1

Quality rating:                             High      High    High      High           High        High      High     High    Low       Low




                                                                                  16
Name: Christopher Branch                                  Supervisor: Robin Lansman



Table 5         Scores per criterion


                       Criteria                   Total Y    Total N     Total X
c. Were groups homogenous?                          10          0          0
d. Index / control interventions described?         10          0          0
m1. Short-term follow-up measurement?               10          0          0
n. Comparable timing of outcome assessment?         10          0          0
o. Sample size for each group described?            10          0          0
a. Were eligibility criteria specified?              9          1          0
b1. Treatment allocation randomised?                 9          1          0
f. Were co-interventions avoided or                  9          1          0
comparable?
j. Were the outcome measures relevant?                9          1           0
g. Compliance acceptable in all groups?               8          0           2
l. Withdrawal/drop-out rate acceptable?               7          3           0
k. Were adverse effects described?                    6          4           0
q. Point estimates and measures of variability        6          4           0
presented for the primary outcome measures?
i. Outcome assessor blinded?                          5           4          1
b2. Was treatment allocation concealed?               4           4          2
m2. Long-term follow-up measurement?                  4           6          0
p. Intention-to-treat analysis included?              2           5          3
h. Patient blinded?                                   0          10          0




Inter-rater and Intra-rater Reliability:



Table 6 shows the results of the inter-rater and intra-rater reliability. The

randomly selected reviews (each article was given a number and numbers

were       chosen          by   a      random    number        generator         at

http://www.random.org/integers/) were rated twice on different dates by the

author (rater 1) and by a separate individual (rater 2). The results show a

good level of consistency. Opinions differed on criteria h (patient blinded) in

two of the articles. After a discussion, it was noted that although both papers

stated that the subjects were blinded to which group they were allocated to,



                                        17
Name: Christopher Branch                                   Supervisor: Robin Lansman



the author argues they were not blinded during the intervention. It is noted

that it is very hard to blind subjects in these trials as the researchers have to

gain consent for all interventions before they are aware which group the

subject will be allocated to. This makes the subject aware of the possibilities.



The inter-rater rating of Licht et al. (1998) changed the overall quality rating

from low to high so these results were debated in detail. One of the

differences was in criteria h and was discussed above. The other was criteria

k (were adverse effects described). After discussion, it was decided that

although the article states that there were adverse reactions to treatment,

there is not enough detail to warrant scoring a “Yes”.




                                       18
Name: Christopher Branch                                                    Supervisor: Robin Lansman




Table 6 Intra-rater and Inter-rater Reliability

            Criteria                       Evans                   Licht            Martinez-Segura
                                            2002                   1998                   1998
                         Rater>     1        1      2       1        1      2       1      1      2

a. Were eligibility criteria        Y       Y       Y       N       N       N       Y       Y       Y
specified?
b1. Treatment allocation            Y       Y       Y       Y       Y       Y       Y       Y       Y
randomised?
b2. Was treatment allocation        Y       Y       Y       N       N       N       Y       Y       Y
concealed?
c. Were groups homogenous?          Y       Y       Y       Y       Y       Y       Y       Y       Y
d. Index / control interventions    Y       Y       Y       Y       Y       Y       Y       Y       Y
described?
f. Were co-interventions            Y       Y       N       Y       Y       Y       Y       Y       Y
avoided or comparable?
g. Compliance acceptable in all     Y       Y       Y       Y       Y       Y       Y       Y       N
groups?
h. Patient blinded?                 N       N       Y       N       N       Y       N       N       N
i. Outcome assessor blinded?        Y       Y       Y       Y       Y       Y       Y       Y       Y
j. Were the outcome measures        Y       Y       Y       Y       Y       Y       Y       Y       Y
relevant?
k. Were adverse effects             Y       Y       Y       N       N       Y       N       N       N
described?
l. Withdrawal/drop-out rate         Y       Y       Y       N       N       N       N       N       N
acceptable?
m1. Short-term follow-up            Y       Y       Y       Y       Y       Y       Y       Y       Y
measurement?
m2. Long-term follow-up             Y       Y       Y       N       N       N       N       N       N
measurement?
n. Comparable timing of             Y       Y       Y       Y       Y       Y       Y       Y       Y
outcome assessment?
o. Sample size for each group       Y       Y       Y       Y       Y       Y       Y       Y       Y
described?
p. Intention-to-treat analysis      X       X       N       N       N       N       N       N       N
included?
q. Point estimates and              Y       Y       Y       N       N       N       Y       Y       X
measures of variability
presented for the primary
outcome measures?
Total Scores:                      Y: 16   Y: 16   Y: 16   Y: 10   Y: 10   Y: 12   Y: 13   Y: 13   Y: 11
                                   N: 1    N: 1    N: 2    N: 8    N: 8    N: 6    N: 5    N: 5    N: 6
                                   X: 1    X: 1    X: 0    X: 0    X: 0    X: 0    X: 0    X: 0    X: 1




                                                   19
Name: Christopher Branch                                  Supervisor: Robin Lansman



                                 Discussion


The main aim of this study was to decide if cervical spine manipulation is

effective in the treatment of neck dysfunction. Ten randomized controlled trials

were reviewed 8 of which were rated as high quality.



The discussion of the literature has been divided into topics relating to the

outcome measures of the studies.



Patient Perceived Pain and Disability:



Of the seven studies which measured pain and neck disability as their primary

outcomes, there is strong evidence that neck manipulation can reduce patient

perceived pain and related disability. However, there is not enough supporting

evidence to show that spinal manipulation alone is the best choice of

treatment. The two highest quality studies (Bronfort et al. 2001 and Evans et

al. 2002) showed that “MedX” exercise had more improvement than spinal

manipulation alone but manipulation and exercise had greater improvements

in all measures in the one and two year follow-up.



The evidence given by Hurwitz et al. (2002) and Jordan et al. (1998) states

that there is no significant difference between manipulation, mobilization and

exercise. Jordan et al.’s study was high quality (scoring 15 out of 18 on the

methodological quality assessment) and used high-velocity, low-amplitude

thrust (HVLAT), physiotherapy treatment (mobilization and exercise) and

intensive exercise as its interventions and showed that all groups had similar


                                      20
Name: Christopher Branch                                  Supervisor: Robin Lansman



reductions in patient perceived pain and disability. Hurwitz et al. stated that

mobilization is as effective as manipulation. This study was not as high quality

as Jordan et al. scoring 12 out of 18 and it had weaknesses in concealing

treatment allocation, avoiding co-interventions and relevance of outcome

measures, thus making the results less reliable.



Martinez-Segura et al. (2006) and Palmgren et al.’s (2006) evidence

contradicted this stating that manipulation obtained greater improvement than

mobilization in all measures and that mobilization did not reduce pain.



Peak Flow in Vertebral Artery:



Licht et al. (1998) observed no change in peak flow velocity immediately after

manipulation. This research may reduce concern over the cerebrovascular

complications after manipulation as major changes in peak flow velocity might

explain the pathophysiology of cerebrovascular accidents. Licht et al. state

that to their knowledge this is the only study comparing velocity in the

vertebral artery before and after spinal manipulation. More research is

necessary to make an informed conclusion.



Pain Pressure Threshold (PPT) on Myofascial Trigger Point:



Ruiz-Saez et al.’s results showed the manipulation group had increase in PPT

while mobilization showed a trend toward a decrease. This suggests that




                                      21
Name: Christopher Branch                                  Supervisor: Robin Lansman



spinal manipulation can directly influence muscle and decrease pain. The

neurophysiologic mechanisms are not discussed.



Somatosensory Evoked Potentials:



Haavik-Taylor et al.’s study is the only one in this review which gives insight

into the neurophysiologic effect of HVLAT. Their evidence suggests that a

single session of neck manipulation significantly decreased somatosensory

evoked potentials in the median nerve for at least half an hour where

mobilization caused no change. This implies that manipulation can change the

afferent neural traffic in a nerve and decrease the pain signals to the central

nervous system. The authors state that the exact mechanisms can only be

hypothesized. This study, however, is rated as low quality as it scored 9 out of

18 on the van Tulder et al. (1997) methodological quality assessment criteria

list. There was no randomization or concealment of treatment allocation,

patients and outcome assessors were not blinded, there was no long-term

follow-up and there were statistical downfalls in that an intention-to-treat

analysis and point estimates and measures of variability were not included.

This makes the results less reliable.



Potential Weaknesses and Limitations:



This review focused on the effects of neck manipulation but there are vast

topics such as adverse effects, risk and consent which must be considered

before choosing to use cervical spine manipulation.



                                        22
Name: Christopher Branch                                   Supervisor: Robin Lansman




An extensive search was performed but it is noted that some medical search

engines required a subscription fee and these were not used. Searches were

limited to the English language only. Some relevant research was potentially

missed.



Due to the lack of available randomized controlled trials, research with

different outcome measures had to be used. While the majority of the studies’

outcomes were comparable, one paper investigated change in vertebral artery

peak flow (Licht et al. 1998), Haavik-Taylor et al. (2006) measured

somatosensory evoked potentials and Ruiz-Saez et al. (2007) assessed

change in myofascial trigger point pain threshold. This diversity compromised

the ability to reach a clear conclusion and therefore more research in these

areas is necessary.



When rating the methodological quality, five of the studies were unclear on

one or more of the criteria. It is recommended by van Tulder et al. (1997) to

contact the authors of the study to ascertain more information so a score can

be given but this was outside the scope of this review.



There are some areas of this review that are open to subjectivity and bias.

The methodological quality assessment uses recognised criteria and

underwent inter-rater and intra-rater reliability tests but the results are still

based on a subjective view. The decision as to whether studies were high or




                                       23
Name: Christopher Branch                                 Supervisor: Robin Lansman



low quality was based upon an arbitrarily chosen number for the purposes of

this review and was not an absolute judgement of their quality.




                                      24
Name: Christopher Branch                                    Supervisor: Robin Lansman



Conclusion:



On the basis of this study, there is evidence to suggest that manipulation has

positive effects on pain, neck disability, neck function and can reduce neural

traffic in the afferent fibres of nerves. However, there is not enough evidence

to say whether manipulation alone is the best choice of manual therapy. The

best quality evidence suggests manipulation in combination with exercise is

better than manipulation or exercise alone, but there is conflicting evidence to

say if manipulation is better than mobilization.



In view of this conflicting evidence, and the diversity of studies in this review,

the author believes that more published randomized controlled trials are

required to reach definitive conclusions.




                                        25
Name: Christopher Branch                                   Supervisor: Robin Lansman



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Bronfort G, Evans R, Nelson B, Aker PD, Goldsmith CH, Vernon H. (2001)

A randomized clinical trial of exercise and spinal manipulation for patients with

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Egger M, Davey Smith G, Altman DG. (2001) Systematic Review in Health

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Evans DW. (2002). Mechanisms and effects of spinal high-velocity, low-

amplitude thrust manipulation: previous theories. Journal of Manipulative and

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                                       26
Name: Christopher Branch                                   Supervisor: Robin Lansman



Gross AR, Hoving JL, Haines TA, Goldsmith CH, Kay T, Aker P, Bronfort G,

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                                       27
Name: Christopher Branch                                      Supervisor: Robin Lansman



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                                       28
Name: Christopher Branch                                    Supervisor: Robin Lansman



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García-León R. (2007). Changes in pressure pain sensitivity in latent

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Complimentary Therapies in Medicine; 8: 207 - 213




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