Effects of Myofascial Release and Electrical Stimulation in Chronic Pelvic Pain

Sponsor
Riphah International University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05851742
Collaborator
(none)
24
1
2
7
3.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: TENS
  • Other: Myofascial trigger point release
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Effects of Myofascial Release With and Without Electrical Stimulation on Pain and Functionality in Women With Chronic Pelvic Pain
Actual Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Mfofascial release with electrical stimulation

TENS 50-280 HZ frequency and a pulse duration of 50 us for 10 minutes along with 10 minutes myofascial release.

Device: TENS
TENS 50-280 HZ frequency and a pulse duration of 50 us for 10 minutes along with 10 minutes myofascial release.

Experimental: Myofascial release without electrical stimulation

Release of trigger points

Other: Myofascial trigger point release
Release of trigger points

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jinnah Hospital Lahore Lahore Punjab Pakistan

Sponsors and Collaborators

  • Riphah International University

Investigators

  • Principal Investigator: Hafiza Mehjabeen, MSWHPT, Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Riphah International University
ClinicalTrials.gov Identifier:
NCT05851742
Other Study ID Numbers:
  • REC/RCR & AHS/23/0507
First Posted:
May 10, 2023
Last Update Posted:
May 10, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Riphah International University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 10, 2023