NCT06099860

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 14, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2023

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2023

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 25, 2023

Completed
Last Updated

October 25, 2023

Status Verified

October 1, 2023

Enrollment Period

10 months

First QC Date

October 19, 2023

Last Update Submit

October 19, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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'

    6 Weeks

  • Functional disability

    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

    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

Study Arms (2)

Group A

EXPERIMENTAL

KBT Group

Other: Kinesio TapingOther: Balance Training (BT)Other: Hot Pack and Stretching Exercises

Group B

EXPERIMENTAL

BT Group

Other: Balance Training (BT)Other: Hot Pack and Stretching Exercises

Interventions

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

Group A

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.

Group AGroup B

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

Group AGroup B

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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) .

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Integral University Hospital

Lucknow, Uttar Pradesh, 246749, India

Location

Study Officials

  • Hashim Ahmed, PhD

    Najran University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 19, 2023

First Posted

October 25, 2023

Study Start

November 14, 2022

Primary Completion

September 15, 2023

Study Completion

October 12, 2023

Last Updated

October 25, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations