Authors' recommendations: Although proponents have advocated the use of prolotherapy for a range of indications, relatively few clinical uses have been studied systematically or published in the peer-reviewed literature. Results of the most recent systematic reviews are inconclusive for demonstrating the effectiveness of prolotherapy for treatment of musculoskeletal pain, and new evidence from case series would not alter these conclusions. The majority of published experimental studies have included conservative therapy with prolotherapy for relief of chronic low back pain, and to a lesser extent, osteoarthritis of the knee with varying results. Sample sizes have been insufficient on which to base national policy decisions.The existing evidence base shows wide variation in patient selection criteria. In case series, findings from physical examination by a prolotherapist are part of the inclusion criteria, whereas all RCT entry criteria were diagnosis-driven. The positive results seen in these case series may, in part, reflect careful selection criteria that a prolotherapist would employ in clinical practice using both diagnostic and examination findings.Greater attention needs to be paid to using an appropriate control group. RCTs to date have employed control therapies with injection, which may invoke a response irrespective of injectant used, resulting in similar clinical improvement observed across study arms, while other RCTs have used control groups with very different treatment regimens such that it is not possible to attribute improvement in outcomes to prolotherapy alone.Prolotherapy appears to have a safety profile comparable to that of other needling procedures, when performed by a skilled prolotherapist, but treatment protocols varied considerably across studies. Up to now, education and training for prolotherapists have relied on continuing education programs and mentoring and have not been standardized.Prolotherapy along with conservative interventions (eg. physiotherapy) appears to offer some pain relief when administered by a skilled prolotherapist in patients with low back pain who are refractory to other treatments, but its independent role in these patients remains to be determined. Given the increasing interest in this intervention, additional research and monitoring are warranted to clarify the safety profile and to determine the optimal proliferant, dosage and schedule, appropriate patient selection criteria, and the independent role of prolotherapy for a number of indications for which there are limited nonsurgical options for persons seeking chronic pain relief.Ongoing clinical trials of prolotherapy should help define its clinical use (source: www.clinicaltrials.gov) :• Joint Injections for Osteoarthritic Knee Pain. Sponsored by the National Center for Complementary and Alternative Medicine. Consists of 2 blinded injection arms and a non-binded physical therapy arm. Phase I and II. NCT00085722.• Efficacy Study of Prolotherapy vs Corticosteroid for Tennis Elbow. Conducted by Spaulding Rehab Hospital. Phase III. NCT00160303.Additional scientific study is needed in the area of chronic low back pain, which represents a substantial burden to veterans and to the general population at large and where the preponderance of evidence exists on which to build a sound foundation of knowledge.

Project Status: Completed

URL for project: http://www4.va.gov/VATAP/docs/ProlotherapyMusculoskeletalPain2008tagm.pdf

Year Published: 2008

URL for published report: n/a

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: United States

Organisation Name: VA Technology Assessment Program

Contact Address: Liz Adams, VA Technology Assessment Program, Office of Patient Care Services (11T), VA Boston Healthcare System Room 4D-142, 150 South Huntington Avenue, Boston, MA 02130 USA Tel: +1 617 278 4469; Fax: +1 617 264 6587;

Contact Name: elizabeth.adams@med.va.gov

Contact Email: elizabeth.adams@med.va.gov

Copyright: VA Technology Assessment Program (VATAP)