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

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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