Chronic Low-back Pain (cLBP)NCT07351851
Effects of PEMM in Chronic Low Back Pain Women With Urinary Incontinence
A study testing PEMM with Theragun in people with Chronic Low-back Pain (cLBP) and Urinary Incontinence (UI), run by Hamad Medical Corporation at 1 site in Qatar.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Chronic Low-back Pain (cLBP), Urinary Incontinence (UI), Pelvic External Myofascial Mobilisation
- What is being tested?
- PEMM with Theragun
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteQatar
- Study dates
- 29 Sep 2025to Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Qatar1 site, 1 recruiting
- Recruiting
Hamad Medical Corporation
Doha, Baladiyat ad Dawhah, 0000
MANISHA P SHENOY, Masters, +97450202795, mshenoy@hamad.qa
mshenoy@hamad.qa
About this study
Official title: 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.
Read more
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
- Conditions
- Chronic Low-back Pain (cLBP), Urinary Incontinence (UI), Pelvic External Myofascial Mobilisation, Myofascial Techniques, Pelvic Pain
- Being tested
- PEMM with Theragun, Active Comparator: Control
- Keywords
- chronic low back pain, urinary incontinence, myofascial mobilisation, PEMM, female pelvic pain
- Medical subject headings
- Urinary Incontinence, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEMM with TheragunOther
Also called Pelvic External Myofascial Mobilisation
PEMM will be given with theragun at specific assessed points and strengthening exercises will be given
Active Comparator: ControlOther
Also called TENS and strengthening
Pain modulation will be given with TENS and hot pack, and strengthening exercises will be given
| Study group | Role | What they receive |
|---|---|---|
| PEMM | Experimental | PEMM therapy with theragun and strengthening for 6 weeks duration. Receives: Other: PEMM with Theragun |
| Control | Active comparator | TENS and hot pack for 15 min, symptomatic pain treatment with strengthening for 6 weeks duration. Receives: Other: Active Comparator: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS Pain
Visual analogue scale
Measured: Week 1 and week 8
Oswestry disability index
Measured: Week 1 and week 8
urinary incontinence scale
ICIQ-UI-SF - International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form
Measured: Week 1 and week 8
Secondary outcomes (1)
mental and physical quality of life
SF 36
Measured: Week 1 and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start29 Sep 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Chronic Low-back Pain (cLBP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will involve recruiting women having UI and CLBP. Patients meeting the inclusion criteria will be randomly allocated in experimental and control group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Manisha Pramod Shenoy, Hamad Medical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07351851
- Sponsor's protocol ID
- MRC-01-24-698
- Status last verified
- Sep 2025
- First submitted
- 30 Dec 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: I will be happy to share it if the organisation i am working under allows me.
Publications
Ajimsha MS, Ismail LA, Al-Mudahka N, Majzoub A. Effectiveness of external myofascial mobilisation in the management of male chronic pelvic pain of muscle spastic type: A retrospective study. Arab J Urol. 2021 Jul 26;19(3):394-400. doi: 10.1080/2090598X.2021.1954414. eCollection 2021.
PubMed 34552791Park SH, Kang CB. Effect of Kegel exercises on the management of female stress urinary incontinence: a systematic review of randomized controlled trials. Advances in Nursing. 2014
.Lin, A., Abbas, H., Sultan, M., & Tzeng, T. (2022). A critical review of interventional treatments for myofascial pelvic pain. Journal of the International Society of Physical and Rehabilitation Medicine,
Tozzi P, Bongiorno D, Vitturini C. Fascial release effects on patients with non-specific cervical or lumbar pain. J Bodyw Mov Ther. 2011 Oct;15(4):405-16. doi: 10.1016/j.jbmt.2010.11.003. Epub 2011 Jan 8.
PubMed 21943614Lin, A., Abbas, H., Sultan, M., & Tzeng, T. (2022). A critical review of interventional treatments for myofascial pelvic pain. Journal of the International Society of Physical and Rehabilitation Medicine
Pool-Goudzwaard A, van Dijke GH, van Gurp M, Mulder P, Snijders C, Stoeckart R. Contribution of pelvic floor muscles to stiffness of the pelvic ring. Clin Biomech (Bristol). 2004 Jul;19(6):564-71. doi: 10.1016/j.clinbiomech.2004.02.008.
PubMed 15234479Hodges PW, Sapsford R, Pengel LH. Postural and respiratory functions of the pelvic floor muscles. Neurourol Urodyn. 2007;26(3):362-71. doi: 10.1002/nau.20232.
PubMed 17304528Sapsford RR, Hodges PW. Contraction of the pelvic floor muscles during abdominal maneuvers. Arch Phys Med Rehabil. 2001 Aug;82(8):1081-8. doi: 10.1053/apmr.2001.24297.
PubMed 11494188Radebold A, Cholewicki J, Panjabi MM, Patel TC. Muscle response pattern to sudden trunk loading in healthy individuals and in patients with chronic low back pain. Spine (Phila Pa 1976). 2000 Apr 15;25(8):947-54. doi: 10.1097/00007632-200004150-00009.
PubMed 10767807Hodges PW, Richardson CA. Inefficient muscular stabilization of the lumbar spine associated with low back pain. A motor control evaluation of transversus abdominis. Spine (Phila Pa 1976). 1996 Nov 15;21(22):2640-50. doi: 10.1097/00007632-199611150-00014.
PubMed 8961451Barr KP, Griggs M, Cadby T. Lumbar stabilization: a review of core concepts and current literature, part 2. Am J Phys Med Rehabil. 2007 Jan;86(1):72-80. doi: 10.1097/01.phm.0000250566.44629.a0.
PubMed 17304690Mogren IM, Pohjanen AI. Low back pain and pelvic pain during pregnancy: prevalence and risk factors. Spine (Phila Pa 1976). 2005 Apr 15;30(8):983-91. doi: 10.1097/01.brs.0000158957.42198.8e.
PubMed 15834344Welk B, Baverstock R. Is there a link between back pain and urinary symptoms? Neurourol Urodyn. 2020 Feb;39(2):523-532. doi: 10.1002/nau.24269. Epub 2020 Jan 3.
PubMed 31899561Cassidy T, Fortin A, Kaczmer S, Shumaker JTL, Szeto J, Madill SJ. Relationship Between Back Pain and Urinary Incontinence in the Canadian Population. Phys Ther. 2017 Apr 1;97(4):449-454. doi: 10.1093/ptj/pzx020.
PubMed 28339852Mutaguchi M, Murayama R, Takeishi Y, Kawajiri M, Yoshida A, Nakamura Y, Yoshizawa T, Yoshida M. Relationship between low back pain and stress urinary incontinence at 3 months postpartum. Drug Discov Ther. 2022;16(1):23-29. doi: 10.5582/ddt.2022.01015.
PubMed 35264471