- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05811325
Kinesio Taping With &Without Craniosacral Therapy in Pregnant Females With SIJ Dysfunction.
March 31, 2023 updated by: Riphah International University
Effect of Kinesio Taping With and Without Craniosacral Therapy on Pain, Disability, and Quality of Life in Pregnent Female With Sacroiliac Joint Dysfunction
SIJ dysfunction adversely affects quality of life and causes functional impairment and disability.
Although, K taping and craniosacral therapy were previously affective in treating SI joint dysfunction, the combined affects of these intervention have not been compared previously to K taping alone.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study is a randomized controlled trial and have 30 pregnant women suffering from SIJH dysfunction.
There is 2 groups and both have received treatment for 6 weeks.
The data on pain is collected through VAS and the data on disability is collected through Oswestry Disability Index, and data on quality of life will be collected using SF-36.
Measurements will be taken at the beginning of the study and at the end of the 4th week, at the completion of the study.
Data will be analyzed using SPSS.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Lahore, Pakistan
- Mayo Hopital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- age between 18-35
- pregnant females in 3rd trimester
- pregnant females with SIJ dysfunction
Exclusion Criteria:
- high risk pregnancy
- pregnant females with hypermobility syndrome
- previous pelvic history
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: kinesio taping without craniosacral therapy
This group received Kinesio taping for improvement in pain,disability and quality of life.
|
The first treatment group will receive kinesio taping for 6 weeks atleast 4 times per week
|
|
Active Comparator: kinesio taping group with craniosacral therapy
Group received kinesio Taping with craniosacral therapy for improvement in pain,disability and quality of life.
|
The second treatment group will receive kinesio taping with craniosacral therapy for 6 weeks atleast 4 times per week with each session lasting for 60 minutes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
VISUAL ANALOGUE SCALE
Time Frame: 6 WEEKS
|
This scale is used to assess pain.
|
6 WEEKS
|
|
Oswestry Disability Index
Time Frame: 4 weeks
|
it is used to measure disability.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
SF-36
Time Frame: 4 weeks
|
Data on quality of life is measured by this scale.
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: tahreem Masood, Ripah International university
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 11, 2022
Primary Completion (Actual)
December 30, 2022
Study Completion (Actual)
January 30, 2023
Study Registration Dates
First Submitted
March 31, 2023
First Submitted That Met QC Criteria
March 31, 2023
First Posted (Estimate)
April 13, 2023
Study Record Updates
Last Update Posted (Estimate)
April 13, 2023
Last Update Submitted That Met QC Criteria
March 31, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- REC/RCR&AHS/22/0538
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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