Changes in Pain Perception after Pelvis Manipulation in Women with Primary Dysmenorrhea: A Randomized Controlled Trial – Duke Center of Excellence in Manual and Manipulative Therapy

Author Names

Molins-Cubero, S., Rodríguez-Blanco, C., Oliva-Pascual-Vaca, A., Heredia-Rizo, A.M., Boscá-Gandía, J.J., Ricard, F.

Reviewer Name

Michelle Metzger, SPT

Reviewer Affiliation(s)

Duke University School of Medicine, Doctor of Physical Therapy Division

Paper Abstract

Objective: This study aims to evaluate the immediate effect of a global pelvic manipulation (GPM) technique, bilaterally applied, on low back pelvic pain in women with primary dysmenorrhea (PD). Design: A prospective, randomized, double-blind, controlled trial. Setting: Faculty of Nursing, Physiotherapy and Podiatry. University of Sevilla, Spain. Methods: The sample group included 40 women (30 ± 6.10 years) that were divided into an experimental group (EG) (N = 20) who underwent a bilateral GPM technique and a control group (CG) (N = 20) who underwent a sham (placebo) intervention. Evaluations were made of self-reported low back pelvic pain (visual analog scale), pressure pain threshold (PPT) in sacroiliac joints (SIJs), and the endogenous response of the organism to pain following catecholamines and serotonin release in blood levels. Results: The intragroup comparison showed a significant improvement in the EG in the self-perceived low back pelvic pain (P = 0.003) and in the mechanosensitivity in both SIJs (P = 0.001). In the between-group comparison, there was a decrease in pain perception (P = 0.004; F(1,38) = 9.62; R(2) = 0.20) and an increase in the PPT of both SIJs, in the right side (P = 0.001; F(1,38) = 21.29; R(2) = 0.35) and in the left side (P = 0.001; F(1,38) = 20.63; R(2) = 0.35). There were no intergroup differences for catecholamines plasma levels (adrenaline P = 0.123; noradrenaline P = 0.281; dopamine P = 0.173), but there were for serotonin levels (P = 0.045; F(1,38) = 4.296; R(2) = 0.10). Conclusion: The bilateral GPM technique improves in a short term the self-perceived low back pelvic pain, the PPT in both SIJs, and the serotonin levels in women with PD. It shows no significant differences with a sham intervention in catecholamines plasma levels.

NIH Risk of Bias Tool

Quality Assessment of Controlled Intervention Studies

Was the study described as randomized, a randomized trial, a randomized clinical trial, or an RCT?

Was the method of randomization adequate (i.e., use of randomly generated assignment)?

Was the treatment allocation concealed (so that assignments could not be predicted)?

Were study participants and providers blinded to treatment group assignment?

Were the people assessing the outcomes blinded to the participants’ group assignments?

Were the groups similar at baseline on important characteristics that could affect outcomes (e.g., demographics, risk factors, co-morbid conditions)?

Was the overall drop-out rate from the study at endpoint 20% or lower of the number allocated to treatment?

Was the differential drop-out rate (between treatment groups) at endpoint 15 percentage points or lower?

Was there high adherence to the intervention protocols for each treatment group?

Were other interventions avoided or similar in the groups (e.g., similar background treatments)?

Were outcomes assessed using valid and reliable measures, implemented consistently across all study participants?

Did the authors report that the sample size was sufficiently large to be able to detect a difference in the main outcome between groups with at least 80% power?

Were outcomes reported or subgroups analyzed prespecified (i.e., identified before analyses were conducted)?

Were all randomized participants analyzed in the group to which they were originally assigned, i.e., did they use an intention-to-treat analysis?

Key Finding #1

The global pelvic manipulation thrust technique applied bilaterally resulted in decreased short-term self-perceived low back pain compared to the control group for people experiencing primary dysmenorrhea.

Key Finding #2

Pain pressure threshold for both Sacroiliac Joints increased on both sides for those who received the thrust technique, while those in the control group showed a decrease in pain pressure threshold on the left side.

Key Finding #3

Those who received the thrust technique showed higher levels of adrenaline, serotonin, and dopamine and reduced levels of noradrenaline after receiving the intervention compared to the control group.

Key Finding #4

The global pelvic manipulation thrust technique resulted in positive changes related to pain compared to the control group when tested immediately after receiving the intervention suggesting short-term changes.

Please provide your summary of the paper

This study examined the efficacy of a global pelvic manipulation thrust technique applied bilaterally for the treatment of patients experiencing primary dysmenorrhea. The results demonstrated that participants who received the thrust technique had decreased short-term self-perceived low back pain (measured with VAS), increased pain pressure threshold for both sides of the Sacroiliac Joint (measured with a digital dynamometer), and higher levels of adrenaline, serotonin, and dopamine and reduced levels of noradrenaline (measured through blood extraction). These results suggest global pelvic manipulation thrusts may be a viable treatment option for the short-term in this population and are effective at modulating pain. However, it should be noted that the change in VAS score did not meet the VAS MDC value likely due to the low baseline VAS score for participants. This study examined only the immediate effects of the thrust manipulation and therefore no long-term effects can be described. While short-term effects are important to assess, long-term effects should be considered in future studies. This study was also limited by the lack of control of subject’s intake of NSAIDs and/or clyclo-oxygenase-2 specific inhibitors, as well as oral contraceptives (all of which can influence pelvic pain levels). Furthermore, patient’s comfortability and fear of spinal manipulation and blood extraction and their recent food intake, stress level, and circadian rhythm could have impacted catecholamines and serotonin plasma levels.

Please provide your clinical interpretation of this paper. Include how this study may impact clinical practice and how the results can be implemented.

This study supports the use of the global pelvic manipulation thrust technique applied bilaterally when treating patients with primary dysmennorhea for short-term results. This is important considering the most common therapeutic approach is medical management with NSAIDs and oral contraceptives, which may involve adverse side effects. While the long-term effects of this technique are not currently known, it is a quick and simple treatment with immediate effects that can help decrease pain during the current treatment session with a lower risk of adverse effects. This technique can be used for patients being treated for pelvic concerns and those experiencing primary dysmennorhea being treated for other conditions to benefit the treatment session.