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Chronic Pain Canada

Effects of PEMM in Chronic Low Back Pain Women With Urinary Incontinence

RecruitingNot applicableNCT07351851
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

Urinary incontinence (UI), Chronic low back pain (CLBP) in women are prevalent and often coexist. Multiple conditions when coexist, it leads to reduced Quality of life in turn causing physical and mental impairment. Musculoskeletal structures and fascial restrictions is one of the attribute to the coexistence of urinary incontinence and chronic back pain in women. External myofascial mobilization (EMM) with core exercises have been proven beneficial for conditions in males that is caused by musculoskeletal and fascial structures. However there are limited research which proves the effect of EMM in conditions involving musculoskeletal and fascial structures . Therefore, the aim of the study is to find the effect of MFTs in reducing the disability in women with CLBP and UI PRIMARY OBJECTIVE To evaluate the effectiveness of PEMM treatment in reducing disability, pain and improving mental health in women with CLBP and UI Study design : Simple randomization Sampling method: Simple Random sampling Random numbers will be generated in Excel, then random numbers will be presented in a concealed envelope for the participants to choose Sample Size : 130 (Experimental 65, Control 65) Sample size was determined using expected effect size i.e., mean change in the primary outcome variable disability index reported in the recent research study . With effect size (change in the disability index score) 3.5 and standard deviation of the change in the outcome 6.45, statistical power 80% and level of significance 5%, the required sample size would be n=55 participants in each group. However, to accounts for multiple secondary outcome measures, possible dropouts and non-response it would be good to increase an additional 20% in calculated sample size i.e., a total of 130 participants (65 participants in each group) will be included in this study. The following sample size equation was used to determine adequate sample size:n = \[2 (Z?/2 + Z?)2 \* ?2\] / (m1-m2)2 Where Z? and Z? are the v…

Study details

Official title
Effects of PEMM in Chronic Low Back Pain Women With Urinary Incontinence A Randomised Controlled Trial
Conditions
Interventions
  • Other: PEMM with Theragun
  • Other: Active Comparator: Control
Sponsor
Hamad Medical Corporation
Start date
2025-09-29
Primary completion
2027-12
Sex
Female
Age range
from 18 Years to 65 Years
Results posted
No results posted in this snapshot
Countries
Qatar
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Age group of 18 - 65 years * Has child/children \<5 parity * CLBP patients with UI referred for physiotherapy for CLBP * Patient with low back pain for more than 3 months * NRS more than 5/10 * Patient with complain of urinary incontinence since past 3 months or more Exclusion Criteria: * Chronic Low Back Pain with red flags * Not able to read and write in English /Arabic * Pregnant ladies and post partum 1 year * UTI, Pelvic floor Surgery * Any systemic condition of renal and cardiac * Patient with active carcinoma or any inflammatory disease

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07351851