Prolotherapy research studies

Ross Hauser, MDRoss Hauser, MD

In recent years an explosion into Prolotherapy research has occurred, both by supporters and those trying to disprove the treatment. In the days before double-blinded studies, doctors would ask patients if they felt better. If tens of thousands of patients told the doctors that they felt better, than it was presumed and accepted that the therapy was effective.

In 2011. I wrote in the Journal of Prolotherapy “scientific literature review shows there is level 1 and 2 evidence to support the use of dextrose Prolotherapy for osteoarthritic pain and function, tendinopathies, myofascial pain syndrome, sacroiliac pain, and myofascial pain syndrome. (These levels mean: Level I: Evidence obtained from at least one properly designed randomized controlled trial. Level II-1: Evidence obtained from well-designed controlled trials without randomization.)

There is level 3 evidence in support of the use of dextrose Prolotherapy for diffuse muscusloskeletal pain involving the spine, pelvis and peripheral joints. Dextrose Prolotherapy should be recommended for such musculoskeletal conditions as tendinopathy, ligament sprains, Osgood-Schlatter disease and degenerative joint disease, including osteoarthritis.” (Level 3 meaning: Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees.)

This article sought to evaluate, through a scientific review of the current literature, the efficacy of dextrose Prolotherapy in treating musculoskeletal pain.

Prolotherapy Research in the double-blind model

Modern research demands that treatments be proved by double-blinded methods. This means that neither the patient nor the physician knows which therapy is used. For medications this is easy because the pills can be made to look alike and a sugar pill used as the placebo is presumed to have no therapeutic value. Unfortunately for certain procedures, like Prolotherapy and most surgeries, there is no adequate placebo.

Prolotherapy involves multiple Prolotherapy injections into the ligament/bone interface and joints where a person is experiencing pain. Prolotherapy induces a mild inflammatory reaction that helps proliferate fibroblasts which make the collagen tissue which makes up ligaments, tendons, and most joint tissue.

Once enough collagen is made, that ligament, tendon, or joint structure will improve its strength enough to eliminate the person’s pain. Current researchers typically use saline solution as a placebo in Prolotherapy research studies instead of one of the ‘normal’ Prolotherapy solutions.

The technique of the Prolotherapy injections versus the placebo injections is exactly the same. The placebo injections involve piercing the skin and injecting the saline solution into the bone/ligament interface or into the respective joints. The problem with this method is that sticking needles into areas of pain as the placebo, is not a placebo, it is called acupuncture.

It has been shown that just dry needling an area of pain can help diminish or eliminate the pain.1 Acupuncture is an accepted medical treatment. On top of that, to diminish the pain of the Prolotherapy shots, researchers will often inject lidocaine or anesthetics into the skin, but this again is an active treatment for pain. Intradermal injection (injection into the skin) is another method practitioners can use to eliminate pain. Another fact is that saline injections into areas of pain is also an effective therapy to eliminate pain.2

Prolotherapy research

In my own published research I have discussed the effectiveness of various forms of Prolotherapy. Most recently at the time of this writing Stem Cell Prolotherapy. In this research Seven patients with hip, knee or ankle osteoarthritis received two to seven treatments over a period of two to twelve months. Patient-reported assessments were collected in interviews and by questionnaire. All patients reported improvements with respect to pain, as well as gains in functionality and quality of life. Three patients, including two whose progress under other therapy had plateaued or reversed, achieved complete or near-complete symptomatic relief, and two additional patients achieved resumption of vigorous exercise. These preliminary findings suggest that osteoarthyritis treatment with stem cell prolotherapy injection merits further investigation. 3

Recently we published in the The Open Rehabilitation Journal Prolotherapy research describing the effectiveness of Prolotherapy for hip labral tear and groin pain. This research supports my opinion that Prolotherapy should be a first line treatment in hip labrum tears.

There is a long list of past Prolotherapy research including that I have authored and co-authored including Prolotherapy research on the regeneration of articular cartilage.4

1. Garvey, T. A prospective, randomized, double-blind evaluation of trigger point injection therapy for low back pain. Spine. 1989; 14: 962-964.

2 Frost, F. A control, double-blind comparison of mepivicaine injection versus saline injection for myofascial pain. The Lancet. 1980; March 8, pp. 499-501.

3 Hauser RA, Orlofsky A. Regenerative injection therapy with whole bone marrow aspirate for degenerative joint disease: a case series. Clin Med Insights Arthritis Musculoskelet Disord. 2013 Sep 4;6:65-72. doi: 10.4137/CMAMD.S10951.

In this Prolotherapy research we discuss regenerative injection techniques for joint diseases including dextrose Prolotherapy,  bone marrow-derived stem cells or Stem Cell Therapy, and Platelet-rich plasma therapy.  We showed in seven patients that received dextrose prolotherapy and Stem Cell Therapy who had  hip, knee or ankle osteoarthritis reported significant improvements.

4. Hauser R, Hauser MA. A Retrospective Study on Dextrose Prolotherapy for Unresolved Knee Pain at an Outpatient Charity Clinic in Rural Illinois. Journal of Prolotherapy. 2009;1:11-21.

In this Prolotherapy research we  studied a sample of 80 patients, representing a total of 119 knees, that were treated quarterly with Prolotherapy. On average, 15 months following their last Prolotherapy session, patients were contacted and asked numerous questions in regard to their levels of pain and a variety of physical and psychological symptoms, as well as activities of daily living, before and after their last Prolotherapy treatment. The results of this study showed that patients had a statistically significant decline in their level of pain, stiffness, crunching sensation, and improvement in their range of motion with Prolotherapy. More than 82% showed improvements in walking ability, medication usage, athletic ability, anxiety, depression, and overall disability with Prolotherapy. Ninety-six percent of patients felt Prolotherapy improved their life overall.

Interested in learning more about Prolotherapy? Information for the new Prolotherapy patient

Prolotherapy Research citations