Effects of Connective Tissue Manipulation Versus Stretching Exercises in Primary Dysmenorrhea
Primary Purpose
Primary Dysmenorrhea
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Connective tissue manipulation
stretching exercises
Sponsored by
About this trial
This is an interventional treatment trial for Primary Dysmenorrhea focused on measuring Primary dysmenorrhea, Connective tissue manipulation, Stretching
Eligibility Criteria
Inclusion Criteria:
- Nulliparous women • Age range of 18 to 25 years
Exclusion Criteria:
- Women with irregular menses (<21 days and >35 days)
- Systemic and gynecological diseases
- Pregnant women
- Women taking contraceptive pills
- Traumatic injuries
- Previous pelvic surgery
Sites / Locations
- Jinah Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Connective tissue manipulation
stretching exercise
Arm Description
technique to remove muscle spasticity
exercises to remove muscle spasticity
Outcomes
Primary Outcome Measures
WaLIDD
WaLIDD (Working ability, location, intensity, days of pain, dysmenorrhea) score and dysmenorrhea severity score.
It was designed, which integrated features of dysmenorrhea such as:
number of anatomical pain locations (no part of the body, lower abdomen, lumbar region, lower limbs, inguinal region),
Wong-Baker pain range (does not hurt, hurts a little, hurts a little more, hurts even more, hurts a lot, hurts a lot more),
number of days of pain during menstruation (0, 1-2, 3-4, ≥5), and
frequency of disabling pain to perform their activities (never, almost never, almost always, always).
Each tool's variable provided a specific score between 0 and 3, and the final score ranged from 0 to 12 points
Score: 0 without dysmenorrhea, 1-4 mild dysmenorrhea, 5-7 moderate dysmenorrhea, 8-12 severe dysmenorrhea. Wong-Baker scale was reclassified to adjust a four-level scale.
Secondary Outcome Measures
Full Information
NCT ID
NCT05357001
First Posted
April 15, 2022
Last Updated
December 7, 2022
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05357001
Brief Title
Effects of Connective Tissue Manipulation Versus Stretching Exercises in Primary Dysmenorrhea
Official Title
Effects of Connective Tissue Manipulation Versus Stretching Exercises on Pain and Symptoms Severity in Females With Primary Dysmenorrhea
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
June 15, 2022 (Actual)
Primary Completion Date
November 15, 2022 (Actual)
Study Completion Date
November 15, 2022 (Actual)
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
The study will be a randomized clinical trial in which the effect of connective tissue manipulation will be compared with the effect of stretching exercises on pain and severity of symptoms in primary dysmenorrhea. Inclusion criteria will include nulliparous females in the age range of 18-25 years old. Exclusion criteria will be women with irregular menses (<21 and >35 days), systemic and gynecological diseases (gastrointestinal, autoimmune, psychiatric diseases, endometriosis, pelvic inflammatory diseases), pregnant women, previous pelvic surgery, traumatic injury. The participants will be allocated to two groups, group A and B. Group A will receive connective tissue manipulation on sacral, lumbar, lower thoracic and anterior pelvic regions with the patient in sitting and supine positions. Group B will receive active stretching exercise regime including forward, backward ad side trunk bending, heel raise, half squatting, knee to chest, hamstring stretching, calf stretching and abdominal contractions.
Detailed Description
The study will be a randomized clinical trial in which the effect of connective tissue manipulation will be compared with the effect of stretching exercises on pain and severity of symptoms in primary dysmenorrhea. Inclusion criteria will include nulliparous females in the age range of 18-25 years old. Exclusion criteria will be women with irregular menses (<21 and >35 days), systemic and gynecological diseases (gastrointestinal, autoimmune, psychiatric diseases, endometriosis, pelvic inflammatory diseases), pregnant women, previous pelvic surgery, traumatic injury. The participants will be allocated to two groups, group A and B. Group A will receive connective tissue manipulation on sacral, lumbar, lower thoracic and anterior pelvic regions with the patient in sitting and supine positions. Group B will receive active stretching exercise regime including forward, backward ad side trunk bending, heel raise, half squatting, knee to chest, hamstring stretching, calf stretching and abdominal contractions.
All the participants will be informed about the manner of research and will be asked to sign the consent form after they are willing to participate in the study. WaLIDD score and dysmenorrhea severity scoring will be used to determine and assess the dysmenorrhea pain and severity. Treatment sessions will be conducted for 8 weeks, 3 times in a week and each session will be carried out for 20 minutes. At the end of two months, subjects will be assessed for their two menstrual cycles. SPSS 21 will be used for data analysis. After checking normality of data appropriate tests will be applied.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Dysmenorrhea
Keywords
Primary dysmenorrhea, Connective tissue manipulation, Stretching
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Connective tissue manipulation
Arm Type
Experimental
Arm Description
technique to remove muscle spasticity
Arm Title
stretching exercise
Arm Type
Experimental
Arm Description
exercises to remove muscle spasticity
Intervention Type
Other
Intervention Name(s)
Connective tissue manipulation
Intervention Description
to remove muscle spasticity
Intervention Type
Other
Intervention Name(s)
stretching exercises
Intervention Description
to remove muscle spasticity
Primary Outcome Measure Information:
Title
WaLIDD
Description
WaLIDD (Working ability, location, intensity, days of pain, dysmenorrhea) score and dysmenorrhea severity score.
It was designed, which integrated features of dysmenorrhea such as:
number of anatomical pain locations (no part of the body, lower abdomen, lumbar region, lower limbs, inguinal region),
Wong-Baker pain range (does not hurt, hurts a little, hurts a little more, hurts even more, hurts a lot, hurts a lot more),
number of days of pain during menstruation (0, 1-2, 3-4, ≥5), and
frequency of disabling pain to perform their activities (never, almost never, almost always, always).
Each tool's variable provided a specific score between 0 and 3, and the final score ranged from 0 to 12 points
Score: 0 without dysmenorrhea, 1-4 mild dysmenorrhea, 5-7 moderate dysmenorrhea, 8-12 severe dysmenorrhea. Wong-Baker scale was reclassified to adjust a four-level scale.
Time Frame
6 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
female only
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Nulliparous women • Age range of 18 to 25 years
Exclusion Criteria:
Women with irregular menses (<21 days and >35 days)
Systemic and gynecological diseases
Pregnant women
Women taking contraceptive pills
Traumatic injuries
Previous pelvic surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Rabiya Noor, PhD
Organizational Affiliation
Riphah International University
Official's Role
Study Chair
Facility Information:
Facility Name
Jinah Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32050307
Citation
Osuga Y, Hayashi K, Kanda S. Long-term use of dienogest for the treatment of primary and secondary dysmenorrhea. J Obstet Gynaecol Res. 2020 Apr;46(4):606-617. doi: 10.1111/jog.14209. Epub 2020 Feb 12.
Results Reference
background
PubMed Identifier
24695505
Citation
Osayande AS, Mehulic S. Diagnosis and initial management of dysmenorrhea. Am Fam Physician. 2014 Mar 1;89(5):341-6.
Results Reference
background
PubMed Identifier
26328887
Citation
Habibi N, Huang MS, Gan WY, Zulida R, Safavi SM. Prevalence of Primary Dysmenorrhea and Factors Associated with Its Intensity Among Undergraduate Students: A Cross-Sectional Study. Pain Manag Nurs. 2015 Dec;16(6):855-61. doi: 10.1016/j.pmn.2015.07.001. Epub 2015 Aug 29.
Results Reference
background
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Effects of Connective Tissue Manipulation Versus Stretching Exercises in Primary Dysmenorrhea
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