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PROLOTHERAPY FOR MUSCULOSKELETAL INDICATIONS

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                PROLOTHERAPY FOR MUSCULOSKELETAL
                          INDICATIONS
Protocol: OTH024
Effective Date: July 2, 2010

Table of Contents                                                                                                                              Page

COMMERCIAL COVERAGE RATIONALE......................................................................................... 1
MEDICARE & MEDICAID COVERAGE RATIONALE...................................................................... 2
BACKGROUND ...................................................................................................................................... 2
CLINICAL EVIDENCE........................................................................................................................... 2
U.S. FOOD AND DRUG ADMINISTRATION (FDA) .......................................................................... 5
APPLICABLE CODES ............................................................................................................................ 5
REFERENCES ......................................................................................................................................... 5
PROTOCOL HISTORY/REVISION INFORMATION .......................................................................... 6


INSTRUCTIONS FOR USE
This protocol provides assistance in interpreting UnitedHealthcare benefit plans. When deciding
coverage, the enrollee specific document must be referenced. The terms of an enrollee's document
(e.g., Certificate of Coverage (COC) or Summary Plan Description (SPD)) may differ greatly. In the
event of a conflict, the enrollee's specific benefit document supersedes this protocol. All reviewers
must first identify enrollee eligibility, any federal or state regulatory requirements and the plan benefit
coverage prior to use of this Medical Policy. Other Protocols, Policies and Coverage Determination
Guidelines may apply. UnitedHealthcare reserves the right, in its sole discretion, to modify its
Protocols, Policies and Guidelines as necessary. This protocol is provided for informational purposes.
It does not constitute medical advice.


COMMERCIAL COVERAGE RATIONALE

The use of prolotherapy for any musculoskeletal indications such as chronic low back pain and
osteoarthritis of the knee, thumb, and finger joints is not medically necessary.

Although in available studies prolotherapy provided some limited benefit, the treatment effects were
very small and short-lived. Studies that included short to medium-term follow-up found that
prolotherapy provided no significant functional improvement compared with the placebo treatment.
Additional studies are needed to further define treatment parameters and to determine whether a
clinically significant improvement is achieved.




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MEDICARE & MEDICAID COVERAGE RATIONALE

Medicare has a National Coverage Determination for Prolotherapy, Joint Sclerotherapy, and
Ligamentous Injections with Sclerosing Agents.

The National Coverage Determination is as follows:

The medical effectiveness of the above therapies has not been verified by scientifically controlled
studies. Accordingly, reimbursement for these modalities should be denied on the ground that they are
not reasonable and necessary as required by §1862(a)(1) of the Act.

There is no Local Coverage Determination for Nevada for Proltherapy, Joint Sclerotherapy, and
Ligamentous Injections with Sclerosing Agents.

For Medicare and Medicaid Determinations Related to States Outside of Nevada:
Please review Local Coverage Determinations that apply to other states outside of Nevada.
http://www.cms.hhs.gov/mcd/search

Important Note: Please also review local carrier Web sites in addition to the Medicare Coverage
database on the Centers for Medicare and Medicaid Services’ Website.


BACKGROUND

Prolotherapy (also known as proliferant therapy or proliferation therapy) involves the injection of a
sclerosant or irritant solution at sites of pain or injury. According to proponents of this technique, the
injected solution induces an inflammatory process that mimics the natural healing process, inducing
fibrous tissue formation and promoting stability of joints and ligaments. The injected prolotherapy
solution usually contains a chemical irritant such as phenol and an osmotic shock agent such as glucose
or glycerine. Some protocols also include a chemotactic agent such as morrhuate sodium, which is
designed to promote infiltration of the site with inflammatory cells. In addition, solutions injected
during prolotherapy usually contain an anesthetic to minimize the pain associated with injection of the
irritant. (Foland et al., 2006)


CLINICAL EVIDENCE

Review of published, peer reviewed literature did not identify any additional studies since 2008.

Ongley et al. (1987) conducted a randomized controlled trial (RCT) of prolotherapy as an adjunct to
forceful physical manipulation versus placebo injection with non-forceful manipulation found that the
treatment regimen including prolotherapy provided statistically significant improvements in pain and
disability; however the results have not been replicated. Therefore, this study has been criticized for its
differences in treatment protocols other than the use of true versus placebo prolotherapy, raising
significant doubt concerning the efficacy of prolotherapy. (CMS)



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A systematic review by Rabogo et al. (2005) concluded that there are limited high-quality data
supporting the use of prolotherapy in the treatment of musculoskeletal pain or sport-related soft tissue
injuries. Their conclusion at that time did not support the use of prolotherapy in the treatment of
musculoskeletal pain or sport-related soft due to the limited high-quality data. Positive results
compared with controls have been reported in nonrandomized and randomized controlled trials.
Further investigation with high-quality randomized controlled trials with non-injection control arms in
studies specific to sport-related and musculoskeletal conditions would be necessary to determine the
efficacy of prolotherapy.

A systematic review by Dagenais et al. (2008) of articles on prolotherapy published from 1997 to 2007
concluded that that prolotherapy is one of a number of treatments recommended for the treatment of
chronic low-back pain. Prolotherapy has a prolonged history of use, a reasonable but not proven
theoretical basis, a low complication rate, and conflicting evidence of efficacy.

A possible dose-response effect or the combination with other interventions such as spinal
manipulation therapy may explain the conflicting results of RCTs. Two of the RCTs in which
prolotherapy was administered using six weekly injections of 20 to 30 ml
dextrose/glycerin/phenol/lidocaine with SMT and exercise had positive results, suggesting this
particular intervention protocol is worth considering for patients with chronic low-back pain who are
refractory to other approaches. At this time there is no evidence of efficacy for prolotherapy injections
alone without co-interventions. Future studies are needed to support or refute the positive results
obtained in some of the prior RCTs while addressing some of the methodological weaknesses by
minimizing differences between the intervention and control groups. Other studies are also needed to
establish the safety of common prolotherapy solutions, and determine the optimal dose and number of
injection sessions required.

Chronic Low Back Pain
The evidence from published studies indicates that prolotherapy may provide very limited, short-term
benefits for chronic back pain. While prolotherapy improved chronic low back pain in the short- term,
the benefit was not maintained for more than a few weeks and outcomes were similar for placebo and
treatment groups at 5 to 24 months. Multiple injections may be required to achieve long-term relief;
however, accelerated deterioration of bone and cartilage may occur when frequent injections are
administered over an extended period of time. The safety and efficacy of this approach has not been
investigated in the included studies.

The largest and most rigorous trial of prolotherapy for chronic back pain was conducted by Yelland et
al. (2004) who randomized 110 patients with nonspecific chronic low back pain to true or placebo
prolotherapy and re-randomized these patients to exercise treatment or no exercise treatment. At 1 and
2 year follow-up, there were no statistically significant differences between the true and placebo
prolotherapy groups in pain, disability, medication use, activity reduction due to back pain, or
assessments of physical and mental quality of life. Likewise, flexion and extension exercises were not
found to provide any significant benefit.




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Osteoarthritis
A limited short-term benefit of prolotherapy was observed for osteoarthritis in two randomized
controlled trials that evaluated prolotherapy versus placebo prolotherapy for osteoarthritis of the knee
or the thumb and finger joints. However, the improvements were small and the studies did not include
follow-up and it is therefore not known whether the treatment effect was maintained. The larger of
these studies enrolled 68 patients who had 111 osteoarthritic knees. Although this study found that
prolotherapy provided a statistically significant improvement in all of the pain, swelling, knee
buckling, and flexion outcome measures combined, most of the improvements were small and the
statistical significance of differences between the treatment and control groups in individual outcome
measures was not reported.

Reeves and Hassanein (2000) enrolled 27 patients with 150 osteoarthritic finger joints and found that,
compared with the control group, patients randomized to true prolotherapy had statistically significant
improvements in flexion and pain during movement; however, there were no significant improvements
in resting pain or grip pain.

Cochrane Review
Prolotherapy injections for chronic low-back pain (2006): The authors concluded that there is
conflicting evidence regarding the efficacy of prolotherapy injections for patients with chronic low-
back pain. When used alone, prolotherapy is not an effective treatment for chronic low-back pain.
When combined with spinal manipulation, exercise, and other co-interventions, prolotherapy may
improve chronic low-back pain and disability. Conclusions are confounded by clinical heterogeneity
amongst studies and by the presence of co-interventions. (Dagenais, 2006)

Professional Societies
European Commission Research Directorate General (ECRDG): A 2004 ECRDG Working Group
that developed guidelines for the treatment of chronic low back pain concluded that there was strong
evidence that prolotherapy is not an effective treatment for nonspecific chronic low back pain.
Therefore, the Working Group recommended against use of prolotherapy for this disorder.

American Association of Orthopaedic Medicine (AAOM): In a 2006 position statement on
Prolotherapy for the Treatment of Back Pain, the AAOM states that prolotherapy is a safe efficacious
therapy for the treatment of selected cases of low back pain and other chronic myofascial pain
syndromes. This is based upon basic science data showing the effects of prolotherapy in animal
models, clinical studies, a lengthy history of clinical use and efficacy, and increasingly widespread
acceptance within the medical community. While we recognize that further basic science and clinical
studies need to be done and are currently in process, we believe that prolotherapy is a safe, cost
effective and efficacious therapy that can provide pain relief and return of function for many patients.

Additional Search Terms
Injecting therapy, proliferative therapy, sclerosing solution, sclerosing therapy, sclerotherapy,
Scleromate (US)




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U.S. FOOD AND DRUG ADMINISTRATION (FDA)

Sclerosants used for prolotherapy contain mixtures of common agents such as glucose, phenol, and
glycerine. Although these agents are subject to various FDA regulations, there do not seem to be any
commercially available prolotherapy solutions that have undergone FDA approval. Consequently,
practitioners of this technique prepare their own sclerosants. (Wilkinson 2005)


APPLICABLE CODES


    HCPCS Code             Description
      M0076                Prolotherapy

Coding Clarification
ICD-9 Diagnoses: Non covered - all diagnoses


REFERENCES

American Association of Orthopaedic Medicine. Position Statement. Prolotherapy for the Treatment of
Back Pain. Available at: http://www.myctm.org/articles/q4-2006-oa-prolo-position-back-pain.pdf.
Accessed August 25, 2009.

Centers for Medicare & Medicaid Services (CMS) NCD for Prolotherapy, Joint Sclerotherapy, and
Ligamentous Injections with Sclerosing Agents. NCD 150.7 Effective September 27, 1999. Accessed
May 2010.

Dagenais S, Mayer J, Haldeman S, et al. Evidence-informed management of chronic low back pain
with prolotherapy. Spine J. 2008 Jan-Feb;8(1):203-12.

Dagenais S, Yelland MJ, Del Mar C, et al. Prolotherapy injections for chronic low-back pain.
Cochrane Database of Systematic Reviews 2006, Issue 4. Art. No.: CD004059. DOI:
10.1002/14651858.CD004059.pub3.

European Commission Research Directorate General (ECRDG) [website]. European Guidelines for
Management of Non-specific Low Back Pain. Updated June 14, 2005. Available at:
http://www.backpaineurope.org/web/files/WG2_Guidelines.pdf. Accessed August 25, 2009.

Foland JA. Pain management & rehabilitation. 2006. Irvine Orthopedics and Physical Medicine
[website]. Available at: http://www.kalindra.com/prolotherapy.htm. Accessed August 25, 2009.

Ongley MJ, Dorman TA, Klein RG, et al. Therapeutics: a new approach to the treatment of chronic
low back pain. Lancet. 1987;2(8551):143-146.




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Reeves KD, Hassanein K. Randomized, prospective, placebo-controlled double-blind study of dextrose
prolotherapy for osteoarthritic thumb and finger (DIP, PIP, and trapeziometacarpal) joints: evidence of
clinical efficacy. J Altern Complement Med. 2000;6(4):311-320.

Reeves KD, Hassanein K. Randomized prospective double-blind placebo-controlled study of dextrose
prolotherapy for knee osteoarthritis with or without ACL laxity. AlternTher Health Med. 2000;6(2):68-
74, 77-80.

Wilkinson HA. Injection therapy for enthesopathies causing axial spine pain and 'the failed back
syndrome' A single blinded, randomized and cross-over study. Pain Physician. 2005; 8(2):167-174.

Yelland MJ, Glasziou PP, Bogduk N, et al. Prolotherapy injections, saline injections, and exercises for
chronic low-back pain: a randomized trial. Spine. 2004;29(1):9-16.


PROTOCOL HISTORY/REVISION INFORMATION

         Date              Action/Description
      10/01/2009           Medical Technology Assessment Committee
      05/21/2010
                           Corporate Medical Affairs Committee
      05/22/2009




Prolotherapy for Musculoskeletal Indications                                                 Page 6 of 6

				
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