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

January 11, 2026 updated by: Manisha Pramod Shenoy, Hamad Medical Corporation

Effects of PEMM in Chronic Low Back Pain Women With Urinary Incontinence A Randomised Controlled Trial

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 values standard normal variate e.g., at 5% level of significance Z?/2 = 1.96, and with 80% power the value of Z?= 0.84; ? is the polled Standard deviation and m1 and m2 are the mean outcome values s in group 1 and group 2 respectively.

Blinding:

Single blinding: patient will be blinded to the group allocation. The assessor is blinded to the treatment

Material and tools :

Theragun - Theragun Elite, 20 V, Myofascial tools - foam roll, foam ball, Questionnaires - SF 3642,43,44, Oswestry Low back pain questionnaire (ODI)45 and The International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI-SF)46 PROCEDURE In the course of the study the total number of patients referred to physiotherapy department with LBP will be interviewed to identify patients with or without UI having LBP. The data obtained from this will be recoded as prevalence in results. The documents of the patients having LBP with UI will be reviewed to check who fulfills the inclusion criteria. All who meets the inclusion criteria will be approached face to face with the aim of the study. Informed consent form will be given to patients who are volunteering to participate in the study. The data of the participants who do not wish to participate in the study will also be recorded.

The participants who have consented to participate in the study will be then assessed. Since the participants has UI she will be directed to a Urologist for an assessment. After urologist assessment, patients will be randomly allocated to experimental and control groups. Random allocation will be administered by the random numbers generated and will be presented in a concealed envelope for the participants to choose. 1st week, the demographic data and Outcome measure of pain, SF36, ODI, ICIQ-UI-SF will be recorded (1st time) on the day of assessment. The outcome measures will be printed on paper and will be given to the patients to fill up with a pen, all questionnaires are self reported outcome measures. Treatment will commence a week after, where experimental group will undergo PEMM therapy with strengthening for 6 weeks duration and the control group will have conventional symptomatic pain treatment with strengthening (2nd to 7th week). Treatment will be given for 6 weeks (1 sessions in a week). The treatment day may vary any day between 4th and 7th day post one session. After 6 sessions of treatment, patient will be advised HEP (Home exercise program) to continue at home. Reassessment will be done on the 8th week where the outcome measures of pain, SF36, ODI, ICIQ-UI-SF will be recorded. Participants will be educated and advised regarding HEP. Exercises will be taught to the patient by explanation, demonstration, teach-back method, and printed sheet of exercise. Compliance to HEP will be recorded before final Outcome measure

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: MANISHA P SHENOY, Masters
  • Phone Number: +97450202795
  • Email: mshenoy@hamad.qa

Study Locations

  • Qatar
    • Baladīyat ad Dawḩah
      • Doha, Baladīyat ad Dawḩah, Qatar, 0000
        • Recruiting
        • Hamad Medical Corporation
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Anashiya Aftab, Masters
        • Sub-Investigator:
          • Seema Lourthu Dinesh Kumar, Masters
        • Sub-Investigator:
          • sadia Kazi, Masters
        • Sub-Investigator:
          • Reshma S Gurav, Masters
        • Sub-Investigator:
          • Aethelfleda A De Roma, Masters
        • Principal Investigator:
          • MANISHA P SHENOY, Masters

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PEMM
PEMM therapy with theragun and strengthening for 6 weeks duration.
Other: PEMM with Theragun
PEMM will be given with theragun at specific assessed points and strengthening exercises will be given
Other Names:
  • Pelvic External Myofascial Mobilisation
Active Comparator: Control
TENS and hot pack for 15 min, symptomatic pain treatment with strengthening for 6 weeks duration.
Other: Active Comparator: Control
Pain modulation will be given with TENS and hot pack, and strengthening exercises will be given
Other Names:
  • TENS and strengthening

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS Pain
Time Frame: Week 1 and week 8
Visual analogue scale
Week 1 and week 8
Oswestry disability index
Time Frame: Week 1 and week 8
Week 1 and week 8
urinary incontinence scale
Time Frame: Week 1 and week 8
ICIQ-UI-SF - International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form
Week 1 and week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mental and physical quality of life
Time Frame: Week 1 and week 8
SF 36
Week 1 and week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamad Medical Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

December 30, 2025

First Submitted That Met QC Criteria

January 11, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 11, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRC-01-24-698

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

I will be happy to share it if the organisation i am working under allows me.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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