Effects of Myofascial Release With and Without Thiele Massage

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05834088
• Other study ID #: REC/RCR & AHS/23/0513
• Status: Completed
• Phase: N/A
• Start date: November 20, 2022
• Est. completion date: August 1, 2023

Study information

• Verified date: December 2023
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: August 1, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 23 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyspareunia
• Pain
• Quality of Life

Intervention

Other:
• Myofascial release techniques
12 treatment sessions will be given in 12 weeks
• Thiele massage
12 treatment sessions will be given in 12 weeks

Locations

Country	Name	City	State
Pakistan	Jinnah hospital	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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