Author Names
Castro-Sánchez A.M., Aguilar-Ferrándiz M.E., Matarán-Peñarrocha G.A., Sánchez-Joya Mdel M., Arroyo-Morales M., Fernández-de-las-Peñas C.
Reviewer Name
Natalia Hanabergh, SPT
Reviewer Affiliation(s)
Duke University School of Medicine, Doctor of Physical Therapy Division
- Was the study described as randomized, a randomized trial, a randomized clinical trial, or an RCT?
- Yes
- Was the method of randomization adequate (i.e., use of randomly generated assignment)?
- Yes
- Was the treatment allocation concealed (so that assignments could not be predicted)?
- Yes
- Were study participants and providers blinded to treatment group assignment?
- Yes
- Were the people assessing the outcomes blinded to the participants’ group assignments?
- Yes
- Were the groups similar at baseline on important characteristics that could affect
outcomes (e.g., demographics, risk factors, co-morbid conditions)?
- Yes
- Was the overall drop-out rate from the study at endpoint 20% or lower of the number
allocated to treatment?
- Yes
- Was the differential drop-out rate (between treatment groups) at endpoint 15 percentage
points or lower?
- Yes
- Was there high adherence to the intervention protocols for each treatment group?
- Yes
- Were other interventions avoided or similar in the groups (e.g., similar background
treatments)?
- Yes
- Were outcomes assessed using valid and reliable measures, implemented consistently
across all study participants?
- Yes
- 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?
- No
- Were outcomes reported or subgroups analyzed prespecified (i.e., identified before
analyses were conducted)?
- Cannot Determine, Not Reported, or Not Applicable
- Were all randomized participants analyzed in the group to which they were originally
assigned, i.e., did they use an intention-to-treat analysis?
- Yes
Key Finding #1
Patients with FMS receiving the experimental protocol exhibited greater improvements in pain, tender point count, sleep quality, and depressive symptoms than those receiving the control condition.
Key Finding #2
Women and men get similar improvements in quality of sleep and tender point count after manual therapy.
Key Finding #3
Women showed a greater reduction in pain and impact of FMS symptoms than men
Key Finding #4
Men reported higher decreases in depressive symptoms and pressure hypersensitivity than women.
Please provide your summary of the paper
The purpose of this study was to determine the short-term therapeutic effects of a manual therapy (MT) protocol for improving pain unction, pressure pain thresholds (PPT), quality of sleep, and depressive symptoms in women and men with fibromyalgia syndrome (FMS). 89 patients, male and female, previously diagnosed with fibromyalgia syndrome were recruited. Inclusion criteria included being between the ages of 18-70 years, no regular physical activity limitations of activities due to pain in the recent 30 days, and agreement to evening therapy sessions. Patients were divided into either an experimental group or control group. The experimental group underwent manual therapy for 45-minutes/week for 5 weeks. Intervention protocol included Suboccipital release, Release of the pectoral region, Diaphragm release, Lumbosacral decompression, Release of the psoas fascia, and Thoracic spine extension manipulation in prone (high- velocity low-amplitude). The control group received not intervention. Patient reported outcome measures and tools included Pressure Pain Thresholds (digital pressure algometer), Impact of FMS Symptoms (FIQ-Spanish version), Pain (McGill Pain Questionnaire), Quality of Sleep (PSQI), and Depression (CES-D). These reported measures were recorded at baseline prior to intervention commencement and 48 ours following the final session at the 5-week mark. This RCT did find the application of a MT protocol to be a positive tool to improve pain intensity, widespread pressure pain sensitivity, impact of FMS symptoms, sleep quality, and depressive symptoms in individuals with FMS. Sex differences were also identified: both men and women get similar improvements in quality of sleep and tender point count with an MT protocol; however, women showed a greater reduction in pain and impact of FMS symptoms compared to men, but men reported higher decreased in depressive symptoms and pressure hypersensitivity compared to women.
Please provide your clinical interpretation of this paper. Include how this study may impact clinical practice and how the results can be implemented.
The application of a manual therapy protocol can be beneficial to a patient with fibromyalgia syndrome to improve quality of life. As noted in the study, both sexes with fibromyalgia syndrome found improvements in various aspects of their condition experience. Being a chronic pain condition, and one with no known cure, finding that adding manual therapy to treatment sessions may improve an individual’s experience, whether it be pain level, pressure sensitivity, impact of FMS symptoms, sleep quality and /or depressive symptoms is hopeful for symptom management. It is an additional tool that can assist with a treatment plan and one that offers various approaches and outcomes. Additional research is needed to identify the differences in responses towards interventions on sex-specific psychological and sociological circumstances.
