- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04829513
Exercise and Two Different Kinesiotape Applications in Patients With Sacroiliac Joint Dysfunction
August 19, 2024 updated by: Saime Ay, Ufuk University
Exercise and Two Different Kinesiotape Applications in Addition to Exercise in Patients With Sacroiliac Joint Dysfunction: A Randomized Controlled Study
This study is a randomized controlled study.
99 patients between the ages of 18-65 who were diagnosed with sacroiliac joint dysfunction will be included in the study.
Study Overview
Status
Completed
Conditions
Detailed Description
33 patients will be given a home exercise program that strengthens the waist and hip girdle (to be shown once in the hospital by a physiotherapist and the form of the exercises will be given), 33 patients will be given kinesiotaping (KT) with ligament correction technique with the exercise program, and 33 patients will be given kinesiotaping with lymphatic correction technique with the exercise program.
Patients will do the exercises once a day for 1 month.
KT will be repeated once a week for 3 weeks.
When taping is performed, it will be kept for 5 days.The patients' pain at rest and during movement will be measured using the Visuel Analog Scale (VAS).
Patient Global Assessment and Oswestry Disability Index (ODI) will be questioned.
Evaluations will be performed before, 4th week and 1 month after treatment (8th week).
Study Type
Interventional
Enrollment (Actual)
99
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
-
-
-
Ankara, Turkey
- Ufuk University
-
-
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
20 years to 50 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Study Population
75 patients aged 20-50 years with a diagnosis of sacroiliac joint dysfunction.
Description
Inclusion Criteria:
- Patients with sacroiliac joint dysfunction between the ages of 18-65
Exclusion Criteria:
- Patients with rheumatological inflammatory disease
- Inflamatory sacroiliitis
- Patients with polyarthrosis, herniated disc, severe symptomatic disc degeneration, spinal stenosis and spondyloarthrosis.
- Patients with a history of pelvic trauma
- Patients with metabolic bone disease, infection, malignancy, pregnancy
- Patients with open wounds in the lumbar and sacral area
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 |
|---|---|
|
Active Comparator: Home Exercise
The group will be given a home exercise programme involving flexibility and strengthening of the lower back, hip girdle and sacroiliac region.
|
This is a home exercise programme that involves flexibility and strengthening of the waist, hip girdle and sacroiliac region.
These exercises are first shown by the physiotherapist in hospital, and then they are asked to do the exercises at home using illustrated forms.
Patients continue the exercises as a home programme once a day for 1 month.
|
|
Active Comparator: Home Exercise and Ligament Correction Kinesiotaping
In addition to the home exercise program, ligament correction kinesiotaping will be applied to the patients' sacroiliac region.
|
This is a home exercise programme that involves flexibility and strengthening of the waist, hip girdle and sacroiliac region.
These exercises are first shown by the physiotherapist in hospital, and then they are asked to do the exercises at home using illustrated forms.
Patients continue the exercises as a home programme once a day for 1 month.
Ligament correction kinesiotaping will be applied to the patients' sacroiliac region.
Taping will be done once a week.
It will be kept for 5 days.
This application will be repeated 3 times.
|
|
Active Comparator: Home Exercise and Lymphatic Correction Kinesiotaping
In addition to the home exercise program, lymphatic correction kinesiotaping will be applied to the patients' sacroiliac region.
|
This is a home exercise programme that involves flexibility and strengthening of the waist, hip girdle and sacroiliac region.
These exercises are first shown by the physiotherapist in hospital, and then they are asked to do the exercises at home using illustrated forms.
Patients continue the exercises as a home programme once a day for 1 month.
Lymphatic correction kinesiotaping will be applied to the patients' sacroiliac region.
Taping will be done once a week.
It will be kept for 5 days.
This application will be repeated 3 times.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain at rest
Time Frame: Before treatment (T1), After treatment at 4th week (T2), Follow-up at 8th week (T3)
|
Pain at rest will be measured using the Visuel Analog Scale (0-10 cm).Patients are asked to rate their pain at rest over the past week and to mark a point on a 10 cm line with endpoints '0 = no pain' and '10 = worst pain imaginable'.
The distance (cm) measured from the 'no pain' endpoint to the point marked by the patient is reported as the VAS score.
|
Before treatment (T1), After treatment at 4th week (T2), Follow-up at 8th week (T3)
|
|
Pain at movement
Time Frame: Before treatment (T1), After treatment at 4th week (T2), Follow-up at 8th week (T3)
|
Pain at movement will be measured using the Visuel Analog Scale (0-10 cm).Patients are asked to rate their pain at rest over the past week and to mark a point on a 10 cm line with endpoints '0 = no pain' and '10 = worst pain imaginable'.
The distance (cm) measured from the 'no pain' endpoint to the point marked by the patient is reported as the VAS score.
|
Before treatment (T1), After treatment at 4th week (T2), Follow-up at 8th week (T3)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oswestry Disability Index
Time Frame: Before treatment (T1), After treatment at 4th week (T2), Followup at 8th week (T3)
|
Oswestry Disability Index will be questioned to determine the level of disability.The degree of disability is quantified on a scale of 0 to 100%.
As the total score increases, the level of disability also increases.
|
Before treatment (T1), After treatment at 4th week (T2), Followup at 8th week (T3)
|
|
Patient Global Assessment
Time Frame: Before treatment (T1), After treatment at 4th week (T2), Followup at 8th week (T3)
|
Patient Global Assessment in the last week will be questioned by Visuel Analog Scale.
Patients will be asked to mark their global assessment on a 0-10 cm visual analog scale (0:very good -10: very poor).
Lower values indicate better status.
|
Before treatment (T1), After treatment at 4th week (T2), Followup at 8th week (T3)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: saime ay, Ufuk 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)
December 1, 2016
Primary Completion (Actual)
July 20, 2024
Study Completion (Actual)
July 20, 2024
Study Registration Dates
First Submitted
March 29, 2021
First Submitted That Met QC Criteria
April 1, 2021
First Posted (Actual)
April 2, 2021
Study Record Updates
Last Update Posted (Actual)
August 21, 2024
Last Update Submitted That Met QC Criteria
August 19, 2024
Last Verified
August 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15112016-5
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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