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Comparison of Different Massages Tecniques on Chronic Pelvic Pain

Primary Purpose

Chronic Pelvic Pain Syndrome

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Thiele Massage
Transverse Friction Massage
Sponsored by
Atlas University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pelvic Pain Syndrome

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Clinical Diagnosis of Pelvic floor muscle tenderness, Clinical Diagnosis of Chronic Pelvic Pain Syndrome Exclusion Criteria: Neurological pathologies ( such as hemiplegia, epilepsy, multiple sclerosis and parkinson's disease) Urogynecological surgery in the last 6 months, Severe pelvic prolapse, Pelvic malignancy and pelvic radiotherapy.

Sites / Locations

  • Medicine Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Thiele Group

Transverse Friction Group

Arm Description

The group will be given Thiele Massage twice a week for 4 weeks. Thiele massage will be done with a stripping motion in the direction of the pelvic floor muscle fibers. Approximately 15-20 repetitions will be applied to each of the pelvic floor muscle groups for 30 minutes.

The group will be given Transverse Friction Massage twice a week for 4 weeks. Transverse friction massage will be applied to each tense muscle group and trigger points for 3-5 minutes, crossing the direction of the pelvic floor muscle fibers. Massage duration is approximately 30 minutes for each session.

Outcomes

Primary Outcome Measures

Visual Analog Scale (VAS)
The Visual Analog Scale is used to determine the severity of pain. At the beginning of a 10 cm long line, there is the phrase "no pain" and "unbearable pain" at the end. The person to be evaluated is asked to put a mark on the scale according to the severity of the pain. Pain intensity is determined by measuring the distance from the expression "No pain" to the area where the person puts a sign. Researchers will take two measurements, at the beginning and at the end of the intervention, to determine the change in pain parameters.
McGill Melzack Pain Questionnaire (MMPQ)
The scale consists of four parts. In the first part, the painful place is marked on the human body diagram and it is stated that it is deep and/or superficial. In the second part, where the characteristics of pain are questioned, the words that best describe pain are marked, one from each box out of 20 boxes. In this part, the sensory and perceptual dimensions of pain are evaluated. The third section evaluates the time-dependent variation of pain. In the fourth section, the severity of pain is measured comparatively. The scoring ranges from 0 to 112. A higher score indicates worsening of pain and related parameters. Researchers will take two measurements, at the beginning and at the end of the intervention, to determine the change in pain parameters.
Notthingam Health Profile Questionnaire (NHP)
It is a valid and reliable scale that measures general health status in musculoskeletal disorders and chronic diseases. It questions the well-being of individuals in physical, emotional and social areas. The first part consists of 38 questions and six subheadings: pain, emotional reactions, sleep, social isolation, physical activity and energy level. In the second part, it is evaluated to what extent the limitations experienced by individuals in their daily activities due to their health status affect their quality of life. The first part score is calculated between 0-600 points, with a maximum of 100 points for each sub-title, and the second part is calculated between 0-7 points. High scores indicate low quality of life. Researchers will take two measurements, at the beginning and at the end of the intervention, to determine the change in quality of life.
Female Sexual Function Index (FSFI)
It is a 5-point Likert-type scale consisting of 19 items and 6 sub-parameters. It evaluates many parameters such as frequency and level of sexual desire, level of arousal, frequency and difficulty of lubrication, ability to maintain lubrication, frequency and difficulty of orgasm, emotional intimacy in sexual intercourse, satisfaction with sexual life, pain during sexual intercourse. The first two questions are calculated between 1-5 points and the other questions between 0-5 points. When the raw scores are multiplied by the coefficients, the highest possible score is 36.0 and the lowest score is 2.0. A high score means that sexual functions are good. The cut-off value of the scale is 26.55. Researchers will take two measurements, at the beginning and at the end of the intervention, to determine the change in female sexual functions.
Bristol Female Lower Urinary System Symptom Index (BFLUSSI)
It was developed to evaluate female lower urinary tract symptoms, their severity, and the effects of these symptoms on quality of life and sexual functions. It consists of 34 Likert type questions. 19 questions assess mixing functions, 4 questions assess sexual functions and 11 questions assess quality of life. It consists of 5 sub-parameters, these are storage (questions 1-4), urination (questions 5-7), incontinence (questions 8-12), sexual life (questions 13-14) and quality of life (questions 15-19). Scoring is between 0.71. A high score indicates worsening of lower urinary tract symptoms. Researchers will take two measurements, at the beginning and at the end of the intervention, to determine the change in lower urinary system symptoms.

Secondary Outcome Measures

Full Information

First Posted
March 10, 2023
Last Updated
April 4, 2023
Sponsor
Atlas University
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1. Study Identification

Unique Protocol Identification Number
NCT05788653
Brief Title
Comparison of Different Massages Tecniques on Chronic Pelvic Pain
Official Title
Comparison of the Effectiveness of Transverse Friction Massage and Thiele Massage in Female Patients With Chronic Pelvic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 20, 2023 (Actual)
Primary Completion Date
March 27, 2023 (Actual)
Study Completion Date
March 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Atlas 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
The aim of this study is to investigate and compare the effectiveness of transverse friction and Thiele massage on pain, quality of life and sexual functions in female patients with chronic pelvic pain. The study will be performed on 20 female patients with pelvic floor muscle tenderness, who applied to the Urology Clinic in Istanbul and were diagnosed with chronic pelvic pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pelvic Pain Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Thiele Group
Arm Type
Active Comparator
Arm Description
The group will be given Thiele Massage twice a week for 4 weeks. Thiele massage will be done with a stripping motion in the direction of the pelvic floor muscle fibers. Approximately 15-20 repetitions will be applied to each of the pelvic floor muscle groups for 30 minutes.
Arm Title
Transverse Friction Group
Arm Type
Active Comparator
Arm Description
The group will be given Transverse Friction Massage twice a week for 4 weeks. Transverse friction massage will be applied to each tense muscle group and trigger points for 3-5 minutes, crossing the direction of the pelvic floor muscle fibers. Massage duration is approximately 30 minutes for each session.
Intervention Type
Procedure
Intervention Name(s)
Thiele Massage
Intervention Description
Transvaginal Massage
Intervention Type
Procedure
Intervention Name(s)
Transverse Friction Massage
Intervention Description
Transvaginal Massage
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS)
Description
The Visual Analog Scale is used to determine the severity of pain. At the beginning of a 10 cm long line, there is the phrase "no pain" and "unbearable pain" at the end. The person to be evaluated is asked to put a mark on the scale according to the severity of the pain. Pain intensity is determined by measuring the distance from the expression "No pain" to the area where the person puts a sign. Researchers will take two measurements, at the beginning and at the end of the intervention, to determine the change in pain parameters.
Time Frame
4 weeks
Title
McGill Melzack Pain Questionnaire (MMPQ)
Description
The scale consists of four parts. In the first part, the painful place is marked on the human body diagram and it is stated that it is deep and/or superficial. In the second part, where the characteristics of pain are questioned, the words that best describe pain are marked, one from each box out of 20 boxes. In this part, the sensory and perceptual dimensions of pain are evaluated. The third section evaluates the time-dependent variation of pain. In the fourth section, the severity of pain is measured comparatively. The scoring ranges from 0 to 112. A higher score indicates worsening of pain and related parameters. Researchers will take two measurements, at the beginning and at the end of the intervention, to determine the change in pain parameters.
Time Frame
4 weeks
Title
Notthingam Health Profile Questionnaire (NHP)
Description
It is a valid and reliable scale that measures general health status in musculoskeletal disorders and chronic diseases. It questions the well-being of individuals in physical, emotional and social areas. The first part consists of 38 questions and six subheadings: pain, emotional reactions, sleep, social isolation, physical activity and energy level. In the second part, it is evaluated to what extent the limitations experienced by individuals in their daily activities due to their health status affect their quality of life. The first part score is calculated between 0-600 points, with a maximum of 100 points for each sub-title, and the second part is calculated between 0-7 points. High scores indicate low quality of life. Researchers will take two measurements, at the beginning and at the end of the intervention, to determine the change in quality of life.
Time Frame
4 weeks
Title
Female Sexual Function Index (FSFI)
Description
It is a 5-point Likert-type scale consisting of 19 items and 6 sub-parameters. It evaluates many parameters such as frequency and level of sexual desire, level of arousal, frequency and difficulty of lubrication, ability to maintain lubrication, frequency and difficulty of orgasm, emotional intimacy in sexual intercourse, satisfaction with sexual life, pain during sexual intercourse. The first two questions are calculated between 1-5 points and the other questions between 0-5 points. When the raw scores are multiplied by the coefficients, the highest possible score is 36.0 and the lowest score is 2.0. A high score means that sexual functions are good. The cut-off value of the scale is 26.55. Researchers will take two measurements, at the beginning and at the end of the intervention, to determine the change in female sexual functions.
Time Frame
4 weeks
Title
Bristol Female Lower Urinary System Symptom Index (BFLUSSI)
Description
It was developed to evaluate female lower urinary tract symptoms, their severity, and the effects of these symptoms on quality of life and sexual functions. It consists of 34 Likert type questions. 19 questions assess mixing functions, 4 questions assess sexual functions and 11 questions assess quality of life. It consists of 5 sub-parameters, these are storage (questions 1-4), urination (questions 5-7), incontinence (questions 8-12), sexual life (questions 13-14) and quality of life (questions 15-19). Scoring is between 0.71. A high score indicates worsening of lower urinary tract symptoms. Researchers will take two measurements, at the beginning and at the end of the intervention, to determine the change in lower urinary system symptoms.
Time Frame
4 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Both intervention methods are transvaginal massage. It can only be applied to female patients.
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical Diagnosis of Pelvic floor muscle tenderness, Clinical Diagnosis of Chronic Pelvic Pain Syndrome Exclusion Criteria: Neurological pathologies ( such as hemiplegia, epilepsy, multiple sclerosis and parkinson's disease) Urogynecological surgery in the last 6 months, Severe pelvic prolapse, Pelvic malignancy and pelvic radiotherapy.
Facility Information:
Facility Name
Medicine Hospital
City
Istanbul
State/Province
Bağcılar
ZIP/Postal Code
34203
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Comparison of Different Massages Tecniques on Chronic Pelvic Pain

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