Effects of Myofascial Release With and Without Thiele Massage

Not Applicable

Completed

• Conditions: Quality of Life; Dyspareunia; Pain
• Interventions: Other: Myofascial release techniques; Other: Thiele massage

• Registration Number: NCT05834088
• Lead Sponsor: Riphah International University

Brief Summary

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.

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 Timeline

• Study Start: 2022-11-20
• Study First Submitted: 2023-04-18
• Study First Submitted QC: 2023-04-18
• Study First Posted: 2023-04-28
• Primary Completion: 2023-07-30
• Study Completion: 2023-08-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-11
• Last Update Posted: 2024-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 38

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Myofascial techniques without Thiele massage	Myofascial release techniques	Group B will receive myofascial techniques without Thiele massage. 12 treatment sessions will be given in 12 weeks
Myofascial techniques with Thiele massage	Thiele massage	Group A will receive myofascial techniques with Thiele massage. 12 treatment sessions will be given in 12 weeks
Myofascial techniques with Thiele massage	Myofascial release techniques	Group A will receive myofascial techniques with Thiele massage. 12 treatment sessions will be given in 12 weeks

Primary Outcome Measures

Name	Time	Method
Female sexual function index	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.
Numeric pain rating scale	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".
Functional pelvic pain scale	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).

Trial Locations

Locations (1)

Jinnah hospital; 🇵🇰 Lahore, Punjab, Pakistan