- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05429957
Effects of Muscle Energy Technique Versus Aerobic Exercises on Pain and Disability in Patients With Chronic Pelvic Pain
December 7, 2022 updated by: Riphah International University
The aim of study is to find out the effects of muscle energy technique versus aerobic exercises on pain and disability in patients with chronic pelvic pain.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
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 Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54550
- Jinnah hospital
-
-
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
25 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- women with chronic pelvic pain of >6 months' duration and the cause of their pain is unknown
- CPP was located within the true pelvis (between and below the anterior iliac crests)
- Average score of at least 4 out of 10 (0-10) on a numeric rating scale
- moderate to severe pain on pelvic pain impact questionnaire
Exclusion Criteria:
- History of cancer
- Pregnancy at the time of inclusion
- Known pelvic pathology (eg, endometriosis, ovarian cyst, fibroid >3cm)
- Intraabdominal and pelvic surgery within the last six months
- chronic or recurrent gastro-intestinal disease including irritable bowel syndrome
- Received any physiotherapy treatment within the previous month
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: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Muscle Energy Technique
Muscle Energy Technique of Iliopsoas, Piriformis, Quadratus Lumborum and Erector Spinae muscle
|
Muscle energy technique (Post Isometric relaxation) three times per week for 8 weeks.
|
Experimental: Aerobic Exercises
aerobic exercises (walking on the treadmill)
|
Aerobic exercise (treadmill walking) three times per week for 8 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pelvic pain impact questionnaire
Time Frame: 8th week
|
The Pelvic Pain Impact Questionnaire evaluates the pelvic pain impact on life.
It has patient generated language, is easily managed and scored, has psychometric properties and it is appropriate for clinical settings and research across primary, secondary and tertiary care.
The ten-item questionnaire consist of 8 Likert questions and 2 additional, non-scored questions
|
8th week
|
Numerical Pain Rating Scale
Time Frame: 8th week
|
The Numerical Pain Rating Scale (NPRS) is a particular measure in which people rate their pain on an 11-point numerical scale.
The scale is comprised of 0 (no pain at all) to 10, 0 show no pain at all and 10 indicate worst imaginable pain
|
8th week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain disability index
Time Frame: 8th week
|
The Pain Disability Index is a seven-item survey to investigate functional disability.
Every question utilizes an ordinal scale going from 0 to 10, 0 indicates no disability and 10 means worst disability.
Scores can be added to represent a combined score of worldwide disability ranging from 0 to 70 ,where higher scores indicate greater disability
|
8th week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hafiza Neelam, MS, Riphah International University
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
- Fuentes-Marquez P, Cabrera-Martos I, Valenza MC. Physiotherapy interventions for patients with chronic pelvic pain: A systematic review of the literature. Physiother Theory Pract. 2019 Dec;35(12):1131-1138. doi: 10.1080/09593985.2018.1472687. Epub 2018 May 14.
- Chong OT, Critchley HO, Williams LJ, Haraldsdottir E, Horne AW, Fallon M. The impact of meridian balance method electro-acupuncture treatment on chronic pelvic pain in women: a three-armed randomised controlled feasibility study using a mixed-methods approach. Br J Pain. 2018 Nov;12(4):238-249. doi: 10.1177/2049463718776044. Epub 2018 May 14.
- Horne AW, Vincent K, Hewitt CA, Middleton LJ, Koscielniak M, Szubert W, Doust AM, Daniels JP; GaPP2 collaborative. Gabapentin for chronic pelvic pain in women (GaPP2): a multicentre, randomised, double-blind, placebo-controlled trial. Lancet. 2020 Sep 26;396(10255):909-917. doi: 10.1016/S0140-6736(20)31693-7. Erratum In: Lancet. 2020 Oct 24;396(10259):1334.
- Ghai V, Subramanian V, Jan H, Pergialiotis V, Thakar R, Doumouchtsis SK; CHORUS: An International Collaboration for Harmonising Outcomes, Research, Standards in Urogynaecology, Women's Health. A systematic review on reported outcomes and outcome measures in female idiopathic chronic pelvic pain for the development of a core outcome set. BJOG. 2021 Mar;128(4):628-634. doi: 10.1111/1471-0528.16412. Epub 2020 Sep 1.
- Lamvu G, Carrillo J, Ouyang C, Rapkin A. Chronic Pelvic Pain in Women: A Review. JAMA. 2021 Jun 15;325(23):2381-2391. doi: 10.1001/jama.2021.2631.
- Nygaard AS, Stedenfeldt M, Oian P, Haugstad GK. Characteristics of women with chronic pelvic pain referred to physiotherapy treatment after multidisciplinary assessment: a cross-sectional study. Scand J Pain. 2019 Apr 24;19(2):355-364. doi: 10.1515/sjpain-2018-0308.
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)
January 20, 2022
Primary Completion (Actual)
July 15, 2022
Study Completion (Actual)
July 15, 2022
Study Registration Dates
First Submitted
June 20, 2022
First Submitted That Met QC Criteria
June 20, 2022
First Posted (Actual)
June 23, 2022
Study Record Updates
Last Update Posted (Estimate)
December 9, 2022
Last Update Submitted That Met QC Criteria
December 7, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/22/0516
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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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