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Effects of Myofascial Release With and Without Thiele Massage

Primary Purpose

Dyspareunia, Pain, Quality of Life

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Myofascial release techniques
Thiele massage
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyspareunia focused on measuring Dyspareunia, Pelvic floor disorder, Pelvic pain, Myofascial release technique, Pelvic floor

Eligibility Criteria

23 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Jinnah hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Myofascial techniques with Thiele massage

Myofascial techniques without Thiele massage

Arm Description

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

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

Outcomes

Primary Outcome Measures

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".
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.
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).

Secondary Outcome Measures

Full Information

First Posted
April 18, 2023
Last Updated
June 6, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05834088
Brief Title
Effects of Myofascial Release With and Without Thiele Massage
Official Title
Effects of Myofascial Release With and Without Thiele Massage on Dyspareunia and Pelvic Floor Function in Nulliparous Females
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 20, 2022 (Actual)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspareunia, Pain, Quality of Life
Keywords
Dyspareunia, Pelvic floor disorder, Pelvic pain, Myofascial release technique, Pelvic floor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Myofascial techniques with Thiele massage
Arm Type
Experimental
Arm Description
Group A will receive myofascial techniques with Thiele massage. 12 treatment sessions will be given in 12 weeks
Arm Title
Myofascial techniques without Thiele massage
Arm Type
Active Comparator
Arm Description
Group B will receive myofascial techniques without Thiele massage. 12 treatment sessions will be given in 12 weeks
Intervention Type
Other
Intervention Name(s)
Myofascial release techniques
Intervention Description
12 treatment sessions will be given in 12 weeks
Intervention Type
Other
Intervention Name(s)
Thiele massage
Intervention Description
12 treatment sessions will be given in 12 weeks
Primary Outcome Measure Information:
Title
Numeric pain rating scale
Description
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".
Time Frame
12 weeks
Title
Female sexual function index
Description
The FSFI is a widely-used measure of Female Sexual Dysfunction (FSD). It assesses 6 domains: desire; arousal; lubrication; orgasm; satisfaction; and pain.
Time Frame
12 weeks
Title
Functional pelvic pain scale
Description
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).
Time Frame
12 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Nulliparous females
Minimum Age & Unit of Time
23 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sabiha Arshad, M.phil
Phone
0324845979
Email
s.arshad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabiha Arshad, M.phil
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jinnah hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabiha Arshad, M.phil
Phone
0324845979
Email
s.arshad@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Seher Faryad, Dpt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28120373
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.
Results Reference
background
PubMed Identifier
32965830
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/
Results Reference
background
PubMed Identifier
36010178
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.
Results Reference
background
PubMed Identifier
35115480
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.
Results Reference
background
PubMed Identifier
30113086
Citation
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.
Results Reference
background
PubMed Identifier
27773810
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.
Results Reference
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Effects of Myofascial Release With and Without Thiele Massage

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