Effects of Myofascial Release With and Without Thiele Massage

December 26, 2023 updated by: Riphah International University

Effects of Myofascial Release With and Without Thiele Massage on Dyspareunia and Pelvic Floor Function in Nulliparous Females

Dysperunia is caused by chronic discomfort during sexual intercourse causing pain during vaginal intercourse.Sexual pain causes relationship decreasing quality of life following anxiety and depression.Myofascial techniques with and without Thiele massage will be used via randomised controlled trial following sample size of 38.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Dyspareunia is characterised by recurring or chronic discomfort during sexual intercourse that causes distress. Dyspareunia can be superficial, causing pain when vaginal insertion is tried, or profound. Women who experience sexual pain are more likely to experience sexual dysfunction, relationship distress, decreased quality of life, anxiety, and depression. One in five nulliparous women (a female who has never given birth to a baby) experiences moderate dyspareunia. Myofascial pain is typically treated using manual manipulation (Manual manipulation involves using skilled, hands-on maneuvers to perform soft tissue mobilization, myofascial release and more) or Thiele massage. In this study the aim is to find the individual and combined effect of these techniques. The study will be Randomized Controlled Trial (RCT). Non probabiity convenient sampling technique will be used to assign randomly half of patients in group A for the experimental group and half in group B who will meet the inclusion criteria. Group A will include participants who will receive myofascial releases and Thiele massage. Whereas Group B will include participants who will receive myofascial releasing techniques but not Thiele massage.

Both group will have 1 session per week for 12 weeks. Numeric pain rating scale, Female sexual function index, Functional pelvic pain scale would be used as an outcome measure tools.

The collected data will be analyzed in Statistical Package for the Social Sciences (SPSS) 25

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Jinnah Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Age 23-40

  1. Dyspareunia symptoms for more than 6 months
  2. Females with tenderness of pelvic muscles from last 6 months
  3. Nulliparous women

Exclusion Criteria:

  1. Any pelvic organ prolapse
  2. Any current genital malignancy
  3. Cases of chronic pelvic pain due to any other issue
  4. Any traumatic conditions around the pelvis and lower limbs, any infectious, tumors conditions around the pelvis.
  5. Pregnant females
  6. Any lower limb abnormalities, any recently underwent abdominal and low back surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Myofascial techniques with Thiele massage
Group A will receive myofascial techniques with Thiele massage. 12 treatment sessions will be given in 12 weeks
Other: Myofascial release techniques
12 treatment sessions will be given in 12 weeks
Other: Thiele massage
12 treatment sessions will be given in 12 weeks
Active Comparator: Myofascial techniques without Thiele massage
Group B will receive myofascial techniques without Thiele massage. 12 treatment sessions will be given in 12 weeks
Other: Myofascial release techniques
12 treatment sessions will be given in 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric pain rating scale
Time Frame: 12 weeks
The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable".
12 weeks
Female sexual function index
Time Frame: 12 weeks
The FSFI is a widely-used measure of Female Sexual Dysfunction (FSD). It assesses 6 domains: desire; arousal; lubrication; orgasm; satisfaction; and pain.
12 weeks
Functional pelvic pain scale
Time Frame: 12 weeks
Functional Pelvic Pain Scale (FPPS), designed to measure pelvic pain intensity as it relates to functions of daily living (bladder and bowel function, intercourse, walking, running, lifting, working, and sleeping).
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Sabiha Arshad, M.Phil, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2022

Primary Completion (Actual)

July 30, 2023

Study Completion (Actual)

August 1, 2023

Study Registration Dates

First Submitted

April 18, 2023

First Submitted That Met QC Criteria

April 18, 2023

First Posted (Actual)

April 28, 2023

Study Record Updates

Last Update Posted (Estimated)

December 27, 2023

Last Update Submitted That Met QC Criteria

December 26, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR & AHS/23/0513

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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