Clinical trial NCT05429957: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Pain
Chronic Pain
Keywords: Pelvic Pain
Female
Exercise
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-06-23
Enrollment: 40
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Pelvic pain impact questionnaire
timeFrame: 8th week
measure: Numerical Pain Rating Scale
timeFrame: 8th week
Secondary outcomes:
measure: Pain disability index
timeFrame: 8th week
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Jinnah Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Hafiza Neelam, MS
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.