- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06099860
Therapeutic Impact of KT Along With BT in Patients With Chronic Low Back Pain of Sacroiliac Joint Dysfunction
October 19, 2023 updated by: Hashim Ahmed, Najran University
Therapeutic Impact of Kinesio Taping Along With Balance Training in Patients With Chronic Low Back Pain of Sacroiliac Joint Dysfunction:A Randomized Control Study
This research aimed to determine the impacts of KT and balance exercises in patients with CLBP of SIJ dysfunction.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study will be based on a two-arm parallel group randomized control design.
thirty participants of CLBP of SIJ Dysfunction will be recruited from the Physiotherapy department, at Integral University, India.
Study objectives and procedure will be properly explained and written informed consent will be obtained at the beginning of the study.
All the participants will be randomly divided into two groups A and B. Experimental group A will receive the hot pack, Stretching exercise, and Kinesio taping along with balance training (KBT), and group B will receive the hot pack, Stretching exercise, and Balance training (BT) exercise
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
-
-
Uttar Pradesh
-
Lucknow, Uttar Pradesh, India, 246749
- Integral University Hospital
-
-
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:
- Subjects having chronic (>3 months) non-specific low back pain (NSLBP) of sacroiliac joint (SIJ) origin
- Age 20-50 years.
- Presence of pain exacerbated as a result of bending laterally or backward.
- Positive results on at least 2 of the pain-provocation tests [FABER, Posterior shear, and Gaenslen pain provocation tests) and one of the motion palpation tests (ie, Gillet and forward flexion tests) .
Exclusion Criteria:
- past or current history of surgery or major trauma to spine, pelvis, lower limb, chest or abdomen in the past 12 months.
lower extremity musculoskeletal disorders.
.localized spinal pathology, congenital anomalies of hip, pelvis or spine that limits mobility -systematic arthropathy, neuropathy or metabolic disorder
- Presence of other causes of LBP such as lumbar discopathy and spinal stenosis discovered via clinical examination and MRI scanning
- pregnancy.
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group B
BT Group
|
The balance training was performed on the Biodex balance system, participants wwere instructed to stand on a podium and stabilize themselves to keep the cursor in the middle of co-centered circle on the displayed screen/monitor.
Stability level of platform was set on eight for first two sessions and then reduced to one level on every two sessions so that in the 9th and 10th session the stability level was four.
From session four onwards, the participants performed the limit of stability exercises with Biodex Balance System.
The participants performed this exercise protocol two times in each session.
Total 12 sessions were given in time period of six weeks.
A hot pack was applied for 20 minutes, stretching exercises were performed.
|
|
Experimental: Group A
KBT Group
|
Kinesio tape with a 5 cm width was used.
Participants were positioned on the side lying on the non-involved side with the hip joint of the involved side flexed to 45 degrees and the femur supported in neutral rotation.
First, the tape was placed over the area between the ASIS and PSIS to protect the skin.
Next, two strips of tape were applied over the first tape to correct anterior innominate rotation.
The first piece was applied at the ASIS and pulled firmly to the PSIS in a straight anterior-to-posterior direction.
The second piece was applied in an arching manner pulled firmly from the ASIS to the PSIS. the tape was changed once every 3 days
The balance training was performed on the Biodex balance system, participants wwere instructed to stand on a podium and stabilize themselves to keep the cursor in the middle of co-centered circle on the displayed screen/monitor.
Stability level of platform was set on eight for first two sessions and then reduced to one level on every two sessions so that in the 9th and 10th session the stability level was four.
From session four onwards, the participants performed the limit of stability exercises with Biodex Balance System.
The participants performed this exercise protocol two times in each session.
Total 12 sessions were given in time period of six weeks.
A hot pack was applied for 20 minutes, stretching exercises were performed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity
Time Frame: 6 Weeks
|
Pain intensity was measured by using the Visual Analog Scale (VAS), a linear scale wherein patients indicate their pain intensity on a 10 cm line ranging from 'no pain' to 'worst imaginable pain'
|
6 Weeks
|
|
Functional disability
Time Frame: 6 Weeks
|
Functional disability was measured by using the Oswestry Disability Index (ODI), a validated 10-item questionnaire evaluating various dimensions of daily living
|
6 Weeks
|
|
Balance
Time Frame: 6 Weeks
|
The balance was measured by using the Biodex Balance System (BBS).overall
(OA), the anteroposterior (AP), and the mediolateral (ML) stability scores were measured.
|
6 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hashim Ahmed, PhD, Najran 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)
November 14, 2022
Primary Completion (Actual)
September 15, 2023
Study Completion (Actual)
October 12, 2023
Study Registration Dates
First Submitted
October 19, 2023
First Submitted That Met QC Criteria
October 19, 2023
First Posted (Actual)
October 25, 2023
Study Record Updates
Last Update Posted (Actual)
October 25, 2023
Last Update Submitted That Met QC Criteria
October 19, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IE/IIMS&R/2022/78
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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