Effects of Muscle Energy Technique Versus Aerobic Exercises on Pain and Disability in Patients With Chronic Pelvic Pain

Chronic Pain Clinical Trial

Official title:

Effects of Muscle Energy Technique Versus Aerobic Exercises on Pain and Disability in Patients With Chronic Pelvic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05429957
• Other study ID #: REC/RCR & AHS/22/0516
• Status: Completed
• Phase: N/A
• Start date: January 20, 2022
• Est. completion date: July 15, 2022

Study information

• Verified date: December 2022
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 15, 2022
• Est. primary completion date: July 15, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Pelvic Pain

Intervention

Other:
• Muscle Energy Technique
Muscle energy technique (Post Isometric relaxation) three times per week for 8 weeks. MET of the Iliopsoas MET of Piriformis muscle MET of Quadratus Lumborum muscle MET of Erector Spinae muscle
• Aerobic Exercises
Aerobic exercise (treadmill walking) three times per week for 8 weeks Warm-up phase: in which each patient alternately steps their legs forward, backward, and sideways in each direction for 5 min Active phase: Treadmill speed was 3km/hour for 5 weeks and progress to 4km/hour after 5 weeks for 20 min. Cool down phase: During a cool down period take a deep breath with both arms overhead and exhale while bringing the arms down, shaking out the legs and arms for 5 min.

Locations

Country	Name	City	State
Pakistan	Jinnah Hospital	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pelvic pain impact questionnaire	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
Primary	Numerical Pain Rating Scale	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	Pain disability index	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