Medical Policy: 02.01.18 
Original Effective Date: November 1996 
Reviewed: October 2016 
Revised: October 2016 


Benefit Application:

Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.


Description:

Prolotherapy, also referred to as regenerative injection therapy, joint sclerotherapy, and proliferation therapy, refers to a procedure performed to strengthen the lax or injured ligaments by injecting proliferating agents/sclerosing solutions directly into torn or stretched ligaments. The mild inflammatory response that is created by the injection promotes growth of new ligament or tendon fibers, resulting in a tightening of the weakened area.  It is proposed that additional treatments of prolotherapy, over a period of a few weeks, allow a gradual buildup of tissue to restore the original strength to the area and  may relieve pain. 

Prolotherapy may involve a single or a series of injections of the proliferating agent, which are often diluted with a local anesthetic.  Agents used for prolotherapy include zinc sulfate, psyllium seed oil, combinations of dextrose; glycerin; and phenol or dextrose alone. Polidocanol and sodium morrhuate, vascular sclerosants, have also been used to sclerose areas of high intratendinous blood flow associated with tendinopathies.

Various sclerosing agents are used for injection. These sclerosing agents include Asclera® (polidocanol), Varithena® (an injectable polidocanol foam), Sotradecol® (sodium tetradecyl sulfate), Ethamolin® (ethanolamine oleate), and Scleromate® (sodium morrhuate). These agents are not currently approved as joint and ligamentous sclerosing agents.

 

Practice Guidelines and Position Statements

American College of Occupational and Environmental Medicine

  • Guidelines on chronic pain from the American College of Occupational and Environmental Medicine (2008) have concluded that the use of prolotherapy for neuropathic or myofascial pain is not recommended.
  • Guidelines on low back pain from the American College of Occupational and Environmental Medicine (2007, updated in 2011) have concluded that the use of prolotherapy for acute, subacute, chronic or radicular pain syndromes is not recommended.
  • American College of Occupational and Environmental Medicine (2011) guidelines on hand, wrist, and forearm disorders were unable to make a recommendation about the use of prolotherapy because of insufficient evidence.

 

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.


Prior Approval:

 

Not applicable


Policy:

Prolotherapy is considered investigational for all applications, including but not limited to:

  • Achilles tendinosis
  • Back pain
  • Epicondylitis
  • Iliotibial band syndrome.
  • Knee ligament instability
  • Knee osteoarthritis
  • Myofascial pain
  • Neuropathic pain
  • Osteomyelitis pubis
  • Sacroiliac joint pain
  • Temporomandibular joint syndrome/Temporomandibular oint hypermobility
  • Tendinopathies
  • Groin pain
  • All lower limb tendinopathies
  • All musculoskeletal pain

The literature consists of small randomized trials on a variety of pain syndromes with inconsistent results. The body of scientific evidence does not permit conclusions concerning the effect of prolotherapy on health outcomes for chronic neck or back pain, tendinopathies of the upper or lower limbs, osteoarthritic pain, or other musculoskeletal pain conditions.  Systematic review of the literature found limited evidence that prolotherapy injections are a safe and effective treatment for Achilles tendinopathy, plantar fasciopathy and Osgood-Schlatter disease. More robust research using large, methodologically-sound randomized controlled trials is required. Therefore, prolotherapy is considered investigational for all indications.



Procedure Codes and Billing Guidelines:

  • To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
  • M0076 should be used for reporting prolotherapy. The code includes the charges for proliferatives.

Selected References:

  • Medicare Coverage Issue Manual, 35-13. Prolotherapy, joint sclerotherapy, and ligamentous injections with sclerosing agents- not covered.
  • Reeves, K.D., 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. The Journal of Alternative and Complementary Medicine 2000; vol 6, No 4: 311-320.
  • Reeves, K.D., Hassanein, K. Randomized prospective double-blind placebo-controlled study of dextrose prolotherapy for knee osteoarthritis with or without ACL laxity. The Journal of Alternative and Complementary Medicine 2000; vol 6, No.2: 68-7. 
  • Hauser, R.A. Punishing the pain - Treating chronic pain with prolotherapy. Rehab Management Feb/March 1999;26-30.
  • Dechow E, Davies RK, Carr AJ, Thompson PW. A randomized, double-blind, placebo-controlled trial of sclerosing injections in patients with chronic low back pain. Rheumatology (Oxford) 1999 Dec;38(12):1255-9. 
  • Tsatsos G, Mandal R. Prolotherapy in the treatment of foot problems. J Am Podiatr Med Assoc 2002 Jun;92(6):366-8.
  • ECRI. Prolotherapy for ligament or tendon pain. Plymouth meeting (PA): ECRI Health technology Information Service External Site2004 May 14. 8 p. (ECRI Hotline Response).
  • Linetsky, F. S., Miguel, R., and Torres, F. Treatment of cervicothoracic pain and cervicogenic headaches with regenerative injection therapy. Curr Pain Headache Rep. 2004;8(1):41-8.
  • Kim WM, Lee HG, Jeong CW et al. A randomized controlled trial of intra-articular prolotherapy versus steroid injection for sacroiliac joint pain. J Altern Complement Med 2010; 16(12):1285-90.
  • Scarpone M, Rabago DP, ZZgierska A et al. The efficacy of prolotherapy for lateral epicondylosis: a pilot study. Clin J Sport Med 2008; 18(3):248-54.
  • Rabago D, Best TM, Zgierska A et al. A systematic review of four injection therapies for lateral epicondylosis: prolotherapy, polidocanol, whole blood and platelet rich plasma. Br J Sports Med 2009; 43(7):471-81.
  • Robago D, Zgierska A, Fortney L, et al. Hypertonic dextrose injections (prolotherapy) for knee osteoarthritis: results of a single-arm uncontrolled study with 1-year follow-up. J Altern Complement Med. 2012 Apr;18(4):408-14.
  • Carayannopoulos A, Borg-Stein J, Sokolof J, et al. Prolotherapy versus corticosteroid injections for the treatment of lateral epicondylosis: a randomized controlled trial. PM R. 2011 Aug; 3(8): 706-15.
  • Refai H, Altahhan O, Elsharkawy R. The efficacy of dextrose prolotherapy for temporomandibular joint hypermobility: a preliminary prospective, randomized, double-blind, placebo-controlled clinical trial. J Oral Maxillofac Surg. 2011 Dec; 69(12): 2962-70.
  • CMS External SiteNational Coverage Determniation (NCD) for Prolotherapy, Joint Sclerotherapy and Ligamentous Injections with Scelorosing Agents (150.7).
  • UpToDate External SiteEpicondylitis (Tennis and Golf Elbow). Neeru Jayanthi M.D.. Topic last updated January 13, 2014.
  • UpToDate External SiteSubacute and Chronic Low Back Pain: Nonsurgical Interventional Treatment. Roger Chou M.D.. Topic last updated December 5, 2013.
  • UpToDate External SiteTreatment of Acute Low Back Pain. Christopher L. Knight M.D., Richard A. Deyo, M.D., MPH, Thomas O. Staiger, M.D., Joyce E. Wipf, M.D,, Topic last updated September 26, 2013.
  • UpToDate External SiteOverview of the Management of Overuse (Chronic) Tendinopathy. Karim Kahn, M.D., Alex Scott, PhD, RPT.
  • American Association of Orthopaedic Medicine External Site(AAOM). Position Statement. Prolotherapy for the Treatment of Back Pain.
  • American College of Occupational and Environmental Medicine External Site(ACOEM). NGC: 9327. Low back disorders. Occupational medicine practice guidelines: evaluation and management of common health problems and functional recovery in workers. 2nd ed. 2007.
  • European Commission Research Directorate General External Site(ECRDG) [website]. European Guidelines for Management of Non-specific Low Back Pain. 2004. Updated June 14, 2005.
  • Rabago D, Mundt M, Zgierska A, et al. Hypertonic dextrose injection (prolotherapy) for knee osteoarthritis: Long term outcomes. Complement Ther Med. Jun 2015;23(3):388-395. PMID 26051574
  • Jahangiri A, Moghaddam FR, Najafi S. Hypertonic dextrose versus corticosteroid local injection for the treatment of osteoarthritis in the first carpometacarpal joint: a double-blind randomized clinical trial. J Orthop Sci. Sep 2014;19(5):737-743. PMID 25158896
  • Sanderson, L. Bryant, A. Effectiveness and safety of prolotherapy injections for management of lower limb tendinopathy and fasciopathy: a systematic review. J Foot Ankle Res 2015 Oct (20);8:57. doi: 10.1186/s13047-015-0114-5
  • U.S. National Institutes of Health (NIH). Clinical trials: prolotherapy External Site
  • Bertrand H, Reeves KD, Bennett CJ, et al. Dextrose prolotherapy versus control injections in painful rotator cuff tendinopathy. Arch Phys Med Rehabil. 2016; 97(1):17-25.

Policy History:

  • October 2016 - Annual Review, Policy Revised
  • November 2015 - Annual Review, Policy Revised
  • December 2014 - Annual Review, Policy Revised
  • February 2014 - Annual Review, Policy Renewed
  • May 2013 - Annual Review, Policy Renewed
  • June 2012 - Annual Review, Policy Renewed
  • August 2011 - Annual Review, Policy Renewed

Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.