NCT05429957

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 23, 2022

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2022

Completed
Last Updated

December 9, 2022

Status Verified

December 1, 2022

Enrollment Period

6 months

First QC Date

June 20, 2022

Last Update Submit

December 7, 2022

Conditions

Keywords

Pelvic PainFemaleExercise

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Pain disability index

    8th week

Study Arms (2)

Muscle Energy Technique

EXPERIMENTAL

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

Other: Muscle Energy Technique

Aerobic Exercises

EXPERIMENTAL

aerobic exercises (walking on the treadmill)

Other: Aerobic Exercises

Interventions

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

Muscle Energy Technique

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.

Aerobic Exercises

Eligibility Criteria

Age25 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPelvic pain is more common in female
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • History of cancer
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinnah Hospital

Lahore, Punjab Province, 54550, Pakistan

Location

Related Publications (6)

  • 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.

    PMID: 29757068BACKGROUND
  • 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.

    PMID: 30349698BACKGROUND
  • 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.

    PMID: 32979978BACKGROUND
  • 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.

    PMID: 32654406BACKGROUND
  • 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.

    PMID: 34128995BACKGROUND
  • 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.

    PMID: 30703061BACKGROUND

MeSH Terms

Conditions

Pelvic PainChronic PainMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Hafiza Neelam, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2022

First Posted

June 23, 2022

Study Start

January 20, 2022

Primary Completion

July 15, 2022

Study Completion

July 15, 2022

Last Updated

December 9, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations