Effects of Myofascial Release With and Without Thiele Massage

NCT05834088 | Completed

• 1 other identifier: REC/RCR & AHS/23/0513
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyspareunia; Pain; Quality of Life

Keywords

Dyspareunia; Pelvic floor disorder; Pelvic pain; Myofascial release technique; Pelvic floor

Outcome Measures

Primary Outcomes (3)

• Numeric pain rating scale

  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

  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

  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

Study Arms (2)

Myofascial techniques with Thiele massage

EXPERIMENTAL

Group A will receive myofascial techniques with Thiele massage. 12 treatment sessions will be given in 12 weeks

Other: Myofascial release techniques; Other: Thiele massage

Myofascial techniques without Thiele massage

ACTIVE COMPARATOR

Group B will receive myofascial techniques without Thiele massage. 12 treatment sessions will be given in 12 weeks

Other: Myofascial release techniques

Interventions

Myofascial release techniques OTHER

12 treatment sessions will be given in 12 weeks

Myofascial techniques with Thiele massage; Myofascial techniques without Thiele massage

Thiele massage OTHER

12 treatment sessions will be given in 12 weeks

Myofascial techniques with Thiele massage

Eligibility Criteria

• Age: 23 Years - 40 Years
• Gender Eligibility Details: Nulliparous females
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 23-40
• Dyspareunia symptoms for more than 6 months
• Females with tenderness of pelvic muscles from last 6 months
• Nulliparous women

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Jinnah hospital

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (6)

• Mitchell KR, Geary R, Graham CA, Datta J, Wellings K, Sonnenberg P, Field N, Nunns D, Bancroft J, Jones KG, Johnson AM, Mercer CH. Painful sex (dyspareunia) in women: prevalence and associated factors in a British population probability survey. BJOG. 2017 Oct;124(11):1689-1697. doi: 10.1111/1471-0528.14518. Epub 2017 Jan 25.

  PMID: 28120373 BACKGROUND

• Tayyeb M, Gupta V. Dyspareunia. 2023 Jun 5. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK562159/

  PMID: 32965830 BACKGROUND

• Castellanos-Lopez E, Castillo-Merino C, Abuin-Porras V, Lopez-Lopez D, Romero-Morales C. Ultrasonography Comparison of Pelvic Floor and Abdominal Wall Muscles in Women with and without Dyspareunia: A Cross-Sectional Study. Diagnostics (Basel). 2022 Jul 29;12(8):1827. doi: 10.3390/diagnostics12081827.

  PMID: 36010178 BACKGROUND

• Rosen NO, Dawson SJ, Binik YM, Pierce M, Brooks M, Pukall C, Chorney J, Snelgrove-Clarke E, George R. Trajectories of Dyspareunia From Pregnancy to 24 Months Postpartum. Obstet Gynecol. 2022 Mar 1;139(3):391-399. doi: 10.1097/AOG.0000000000004662.

  PMID: 35115480 BACKGROUND

• Alimi Y, Iwanaga J, Oskouian RJ, Loukas M, Tubbs RS. The clinical anatomy of dyspareunia: A review. Clin Anat. 2018 Oct;31(7):1013-1017. doi: 10.1002/ca.23250. Epub 2018 Oct 26.

  PMID: 30113086 BACKGROUND

• Geller EJ, Babb E, Nackley AG, Zolnoun D. Incidence and Risk Factors for Pelvic Pain After Mesh Implant Surgery for the Treatment of Pelvic Floor Disorders. J Minim Invasive Gynecol. 2017 Jan 1;24(1):67-73. doi: 10.1016/j.jmig.2016.10.001. Epub 2016 Oct 20.

  PMID: 27773810 BACKGROUND

MeSH Terms

Conditions

Dyspareunia; Pain; Pelvic Floor Disorders; Pelvic Pain

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pregnancy Complications

Study Officials

• Sabiha Arshad, M.phil

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: April 28, 2023
• Study Start: November 20, 2022
• Primary Completion: July 30, 2023
• Study Completion: August 1, 2023
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)