Effects of Myofascial Release and Electrical Stimulation in Chronic Pelvic Pain

Not Applicable

Recruiting

• Conditions: Myofascial Trigger Point Pain; Chronic Pelvic Pain
• Interventions: Device: TENS; Other: Myofascial trigger point release

• Registration Number: NCT05851742
• Lead Sponsor: Riphah International University

Brief Summary

Myofascial pelvic pain (MFPP) caused by myofascial trigger points (MTrPs) is a major contributor to chronic pelvic pain in women.In females,pelvic pain is the single most common indication for referral to women's health services.Pelvic floor physical therapy with myofascial release improve mobility and reduce pain by releasing the painful trigger points.Tools that will be used,for pain numerical pain scale (NPS),functional pelvic pain scale(FPPS) and pelvic floor impact questionnaire-7 will be used to asses pain and functionality.

Detailed Description

Myofascial pelvic pain (MFPP) caused by myofascial trigger points (MTrPs) is a major contributor to chronic pelvic pain in women. In females, pelvic pain ''is the single most common indication for referral to women's health services. Pelvic floor physical therapy with myofascial release improve mobility, and reduce pain by releasing the painful trigger points following restrictions in connective tissues that are related to pelvic floor.In this project we will observe effects of myofascial release with and without electrical stimulation on pain and functionality in women with chronic pelvic pain.It has been hypothesized that myofascial release along with electrical stimulation help in reducing pain and improve functionality in women.Patients will be having sessions for consecutive 4 weeks and will be exposed to both types of techniques to find out the effective results.

The study will be randomized control trial.For pain numerical pain scale (NPS),functional pelvic pain scale(FPPS) and pelvic floor impact questionnaire-7 will be used to asses pain and functionality respectively. A randomized control trial will be conducted on two groups. Group 1 will receive myofascial release with electrical stimulation in women with chronic pelvic pain for 4 weeks with 50-280 Hz frequency and a pulse duration of 50 µs for 10 minutes along with 10 minutes myofascial release..On the other hand Group 2 will receive myofascial release without electrical stimulation on pain and functionality in women with chronic pelvic pain. In previous studies there is ample amount of research conducted on chronic pelvic pain but there were very few recent studies available on myofascial release,so this relation of use of myofascial release with and without electrical stimulation on pain and functionality in chronic pelvic pain should also be carried out.

Study Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2023-03-31
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-09
• Last Update Submitted: 2023-05-09
• Study First Posted: 2023-05-10
• Last Update Posted: 2023-05-10
• Primary Completion: 2023-07-01
• Study Completion: 2023-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 24

Inclusion Criteria

• Age 25-40 years,
• Presence of persistent chronic pelvic pain
• >4 points on a 10 point numeric rating scale for atleast more than 3 months,
• Atleast 1 active MTrp in one of the muscle groups including the obturator internus,
• levator ani,piriformis and coccygeus on pelvic examination.

Exclusion Criteria

• Prolapse of the pelvic organ,
• Pregnency,
• Fibromyalgia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mfofascial release with electrical stimulation	TENS	TENS 50-280 HZ frequency and a pulse duration of 50 us for 10 minutes along with 10 minutes myofascial release.
Myofascial release without electrical stimulation	Myofascial trigger point release	Release of trigger points

Primary Outcome Measures

Name	Time	Method
NPRS (Numeric Pain Rating Scale)	4 weeks	Higher the numeric value is 10 and lower is 0.The patient is asked to make three pain ratings corresponding to current,best and worst pain experienced over the past 24 hours on a scale of 0(no pain)to 10(worst pain imaginable).The average of the 3 ratings was used to represent the patient's level of pain over the previous 24 hours.
FPPS (Functional Pelvic Pain Scale)	4 weeks	Patients score pelvic function on the FPPS form for 8 categories:Bladder,Bowel,Intercourse,Walking,Running,Lifting,Working,Sleeping.The patients rated each category from 0 to 4,with 0 for normal function and 4 for cannot function because of pain.Thus each patient was given a total pelvic function score between 0 and 32.
PFIQ-7 (Pelvic Floor Impact Questionaire)	4 weeks	The PFIQ-7 consists of 7-questions that need to be answered 3 times each considering symptoms related to the Bladder or urine,Bowel or rectum,Vagina or pelvis and their effects on function,social health and mental health in the past 3 months.The responses for each question range from "Not at all-Somewhat-Moderately-Quit a bit". To get scale scores,the mean of each of the 3 scales is individually calculated,which ranges from 0 to 3,this number is then multiplied by 100 and then divided by 3.The scale scores are then added together to get the total PFIQ-7 score,which ranges from 0 to 300.A lower score means there is a lesser effect on quality of life.

Trial Locations

Locations (1)

Jinnah Hospital Lahore; 🇵🇰 Lahore, Punjab, Pakistan