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

Primary Purpose

Pelvic Pain, Chronic Pain

Status

Completed

Phase

Not Applicable

Locations

Pakistan

Study Type

Interventional

Intervention

Muscle Energy Technique

Aerobic Exercises

About this trial

This is an interventional treatment trial for Pelvic Pain focused on measuring Pelvic Pain, Female, Exercise

Eligibility Criteria

25 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Jinnah Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Muscle Energy Technique

Aerobic Exercises

Arm Description

Muscle Energy Technique of Iliopsoas, Piriformis, Quadratus Lumborum and Erector Spinae muscle

aerobic exercises (walking on the treadmill)

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT05429957

First Posted

June 20, 2022

Last Updated

December 7, 2022

Sponsor

Riphah International University

1. Study Identification

Unique Protocol Identification Number

NCT05429957

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

January 20, 2022 (Actual)

Primary Completion Date

July 15, 2022 (Actual)

Study Completion Date

July 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pelvic Pain, Chronic Pain

Keywords

Pelvic Pain, Female, Exercise

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Muscle Energy Technique

Arm Type

Experimental

Arm Description

Muscle Energy Technique of Iliopsoas, Piriformis, Quadratus Lumborum and Erector Spinae muscle

Arm Title

Aerobic Exercises

Arm Type

Experimental

Arm Description

aerobic exercises (walking on the treadmill)

Intervention Type

Other

Intervention Name(s)

Muscle Energy Technique

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Aerobic Exercises

Intervention Description

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.

Primary Outcome Measure Information:

Title

Pelvic pain impact questionnaire

Description

Time Frame

8th week

Title

Numerical Pain Rating Scale

Description

Time Frame

8th week

Secondary Outcome Measure Information:

Title

Pain disability index

Description

Time Frame

8th week

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Pelvic pain is more common in female

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hafiza Neelam, MS

Organizational Affiliation

Riphah International University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Jinnah Hospital

City

Lahore

State/Province

Punjab

ZIP/Postal Code

54550

Country

Pakistan

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

29757068

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.

Results Reference

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PubMed Identifier

30349698

Citation

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.

Results Reference

background

PubMed Identifier

32979978

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.

Results Reference

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PubMed Identifier

32654406

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.

Results Reference

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PubMed Identifier

34128995

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.

Results Reference

background

PubMed Identifier

30703061

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.

Results Reference

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

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