The effect of spinal manipulation on pain and prostaglandin levels in women with primary dysmenorrhea. Spinal manipulative therapy versus a low force mimic maneuver for women with primary dysmenorrhea: a randomized, observer-blinded, clinical trial.
The primary objectives of this study were to compare the effect of spinal manipulation vs. sham manipulation on a) circulating plasma levels of the prostaglandin F2a metabolite, 15-keto-13,14-dihydroprostaglandin (KDPGF2a), b) perceived abdominal and back pain and c) perceived menstrual distress in women with primary dysmenorrhea.
                This randomized clinical pilot study investigated the outcome measures before and after either a spinal manipulation treatment (SMT) or a sham manipulation.
                All subjects were treated at the National College Chiropractic clinic, a private chiropractic clinic in the suburban Chicago area.
                Forty-five women with a history of primary dysmenorrhea were recruited from the local community. The volunteers ranged in age from 20-49 (mean age = 30.3 yr), and were entered into the study between April 1990 and January 1991. Twenty-four were randomly assigned to the spinal manipulation group and 21 were assigned to the sham group.
                Subjects treated with spinal manipulation were placed in a side-lying position with the bottom leg straight and the top leg flexed at the knee and hip. They received a high-velocity, short lever, low-amplitude thrust to all clinically relevant vertebral levels within T10 and L5-S1 and the sacroiliac joints. In the sham manipulation, subjects were placed in a side-lying position with both hips and knees flexed. Their manipulation consisted of a similar thrust administered to the midline base of the sacrum.
                Perceived abdominal and back pain were measured with a visual analog scale, and menstrual distress was measured with the Menstrual Distress Questionnaire. Both were administered 15 min before and 60 min after treatment. Blood samples were collected by venipuncture for the determination of plasma levels of KDPGF2a at the same times. The plasma was then assayed for KDPGF2a by radioimmunoassay.
                Analysis of covariance and paired Student's t tests were used for the statistical evaluation. Immediately after treatment, the perception of pain and the level of menstrual distress were significantly reduced by SMT. This reduction was associated with a significant reduction in plasma levels of KDGPF2a in the SMT group. A significant and similar reduction in plasma KDPGF2a also occurred in the sham group, indicating that a placebo effect was associated with a single sham intervention.
                This randomized pilot study suggests that SMT may be an effective and safe nonpharmacological alternative for relieving the pain and distress of primary dysmenorrhea. However, the large change in KDPGF2a observed in both treatment groups clearly indicates that further studies with more subjects, studied over a longer time frame, are needed to resolve the question of a placebo effect. Non-drug therapies for women with primary dysmenorrhea are primarily based on anecdotal evidence and small-scale clinical studies. This randomized, observer-blinded, clinical trial evaluated the efficacy of spinal manipulative therapy (SMT) in the treatment of women with primary dysmenorrhea. Women were recruited from the Chicago metropolitan area and evaluated for inclusion through four screening levels. One hundred thirty eight women, ages 18-45, with primary dysmenorrhea diagnosed by participating gynecologists, were randomly assigned to either SMT or a low-force mimic (LFM) maneuver. No treatment occurred at menstrual cycle 1. Treatment for both groups took place on day 1 of cycles 2, 3 and 4, and prophylactic treatment of three visits took place during the 7 days before cycles 3 and 4. Main outcome measures were the Visual Analog Scale (VAS) and plasma concentration of the prostaglandin F2alpha metabolite, 15-keto-13,14-dihydro-prostaglandin F2alpha (KDPGF2alpha), measured 15 min before treatment and 60 min after treatment on day 1 of four consecutive menstrual cycles. The Moos' Menstrual Distress Questionnaire (MDQ) was also administered after treatment on day 1 of each cycle. At cycle 2, the post-treatment VAS scores decreased for both groups, with no statistically significant difference in pre- to post-treatment scores between the two groups (P = 0.44). The changes in pre- to post-treatment KDPGF2alpha levels were not statistically different between the SMT and LFM groups (P = 0.15). No treatment effects were detected over the three cycles for VAS, KDPGF2alpha or MDQ (P = 0.65, P = 0.61 and P = 0.78, respectively). However, there were statistically significant linear time effects for VAS (P = 0.008), MDQ (P < 0.001), and borderline significance for KDPGF2alpha (P = 0.054); these decreases were not considered clinically meaningful. The LFM maneuver used in this study was designed to act as a 'placebo-like' control treatment in comparison with SMT. Although it is possible that the trial did not continue long enough for any placebo effect of the LFM to wash out, it seems more likely that this maneuver was indistinguishable from SMT. Therefore, the postulated superior benefit of high-velocity, short-lever, low-amplitude, high-force spinal manipulation to a low-force maneuver is not supported by the results of this study. 1999 International Association for the Study of Pain.
There is no evidence to suggest that spinal manipulation is effective in the treatment of dysmenorrhoea. In the one trial reporting on adverse effects there was no greater risk of such events with spinal compared with sham manipulation.