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Completed

NCT Number: NCT05834088

Effects of Myofascial Release With and Without Thiele Massage

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.

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Key information

Conditions

Dyspareunia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Male Urogenital Diseases Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pelvic Floor Disorders Pelvic Pain Pregnancy Complications Quality of Life Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Signs and Symptoms Urogenital Diseases

Age range

23 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Jinnah hospital

Lahore, Punjab Province, 54000, Pakistan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age 23-40

  • Dyspareunia symptoms for more than 6 months
  • Females with tenderness of pelvic muscles from last 6 months
  • Nulliparous women

Exclusion criteria

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

Treatment and study plan

Myofascial Release Techniques

Other

12 treatment sessions will be given in 12 weeks

Thiele massage

Other

12 treatment sessions will be given in 12 weeks

Primary outcomes

  1. 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".

  2. 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.

  3. 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).

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 28, 2023
Registry last updated
Jun 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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