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Therapeutic Impact of KT Along With BT in Patients With Chronic Low Back Pain of Sacroiliac Joint Dysfunction

Primary Purpose

Sacroiliac Joint Dysfunction

Status

Completed

Phase

Not Applicable

Locations

India

Study Type

Interventional

Intervention

Kinesio Taping

Balance Training (BT)

Hot Pack and Stretching Exercises

About this trial

This is an interventional treatment trial for Sacroiliac Joint Dysfunction

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Integral University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Group A

Group B

Arm Description

KBT Group

BT Group

Outcomes

Primary Outcome Measures

Pain Intensity

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'

Functional disability

Functional disability was measured by using the Oswestry Disability Index (ODI), a validated 10-item questionnaire evaluating various dimensions of daily living

Balance

The balance was measured by using the Biodex Balance System (BBS).overall (OA), the anteroposterior (AP), and the mediolateral (ML) stability scores were measured.

Secondary Outcome Measures

Full Information

NCT ID

NCT06099860

First Posted

October 19, 2023

Last Updated

October 19, 2023

Sponsor

Najran University

1. Study Identification

Unique Protocol Identification Number

NCT06099860

Brief Title

Therapeutic Impact of KT Along With BT in Patients With Chronic Low Back Pain of Sacroiliac Joint Dysfunction

Official Title

Therapeutic Impact of Kinesio Taping Along With Balance Training in Patients With Chronic Low Back Pain of Sacroiliac Joint Dysfunction:A Randomized Control Study

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

November 14, 2022 (Actual)

Primary Completion Date

September 15, 2023 (Actual)

Study Completion Date

October 12, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Najran University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

This research aimed to determine the impacts of KT and balance exercises in patients with CLBP of SIJ dysfunction.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sacroiliac Joint Dysfunction

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Description

KBT Group

Arm Title

Group B

Arm Type

Experimental

Arm Description

BT Group

Intervention Type

Other

Intervention Name(s)

Kinesio Taping

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Balance Training (BT)

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Hot Pack and Stretching Exercises

Intervention Description

A hot pack was applied for 20 minutes, stretching exercises were performed.

Primary Outcome Measure Information:

Title

Pain Intensity

Description

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'

Time Frame

6 Weeks

Title

Functional disability

Description

Functional disability was measured by using the Oswestry Disability Index (ODI), a validated 10-item questionnaire evaluating various dimensions of daily living

Time Frame

6 Weeks

Title

Balance

Description

The balance was measured by using the Biodex Balance System (BBS).overall (OA), the anteroposterior (AP), and the mediolateral (ML) stability scores were measured.

Time Frame

6 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hashim Ahmed, PhD

Organizational Affiliation

Najran University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Integral University Hospital

City

Lucknow

State/Province

Uttar Pradesh

ZIP/Postal Code

246749

Country

India

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Therapeutic Impact of KT Along With BT in Patients With Chronic Low Back Pain of Sacroiliac Joint Dysfunction

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