Some Studies Have Linked Prolotherapy to Low Back Pain Relief

More than 20 clinical studies have documented the effects of prolotherapy on low back pain. Like many other treatments used for low back pain, the results of these studies have been somewhat mixed.³ This is due to several factors including the type of study, the methods used, and the scientific rigor of the studies.

• Seventeen of the studies were cohort studies, where patients with low back pain were given prolotherapy and asked how they felt afterward. Since these studies did not have a control group where patients received only placebo injections, it’s impossible to know if the results are due to prolotherapy or something else.

  Article continues below

• Five studies were randomized clinical trials (RCTs), where patients with low back pain were given either prolotherapy or placebo injections but were not told which they received, and asked how they felt afterward. These studies make it easier for researchers to know if the results are due to prolotherapy or something else, and are given more weight than cohort studies by the medical community.

Positive cohort studies

The cohort studies, which involved over 3,000 patients, reported that patients receiving prolotherapy enjoyed relief from low back pain both in the short-term (e.g., two weeks) and long-term (e.g., four years). However, there are important weaknesses to many of these studies. Some are fairly dated and were conducted in the 1960s and 1970s when research methods were not as sophisticated. ⁴ Others are simply the personal experience of physicians who have been treating patients with prolotherapy for a long time, without independent verification of the data by a neutral third party.

Inconclusive randomized clinical trials

In the randomized clinical trials, the results were split as to whether patients got meaningful pain relief with prolotherapy compared to placebo injections: three studies reported generally negative results and two reported generally positive results⁵. Since the studies used very different treatment techniques and research methods, it’s very difficult to compare them or come to any conclusions. This often happens when researchers study treatments for low back pain because so many factors are involved in patients getting better.

In the three randomized with negative results, there were differences in the amount of solution injected and the number and location of injections. Some of the studies also admitted that some of the patients were not good candidates for prolotherapy, because their low back pain might not have been from ligament damage, they were in poor physical condition, or they had health problems other than low back pain. This makes it possible that the results are not valid or at least skewed against prolotherapy.

In the two randomized clinical studies with positive results, there were too many differences between the patients who received prolotherapy and patients who received placebo injections to know exactly what helped their low back pain. For example, in one study only the patients who received prolotherapy also got steroid injections and spinal manipulation, compared to patients in the control group who received only placebo injections.

More rigorous study is needed to evaluate efficacy of prolotherapy

Given the variety of treatment protocols and lack of controls in many of the previous studies, more research is necessary to demonstrate conclusively if and how prolotherapy works to provide relief from low back pain. Rigorous testing of the most widely used prolotherapy protocols would benefit both patients by providing more options and practitioners by building a firmer scientific footing for the therapy. Studies should also help to identify which patients with low back pain (if any) are most likely to benefit from prolotherapy. Until these studies are conducted, patients should consider prolotherapy as one of many treatment options available to them and discuss whether it may be appropriate with their spine care team.

References:

3. Dagenais, et al., Intraligamentous injection of sclerosing solutions (prolotherapy) for spinal pain: a critical review of the literature. Spine. 5, (2005) 310-328, p. 316.

4. Ibid., p. 317.

5. Ibid., p. 324.