Sacroiliac Joint DysfunctionNCT06099860
Therapeutic Impact of KT Along With BT in Patients With Chronic Low Back Pain of Sacroiliac Joint Dysfunction
A study testing Kinesio Taping, Balance Training (BT) and Hot Pack and Stretching Exercises in people with Sacroiliac Joint Dysfunction, run by Najran University at 1 site in India.
Trial summary
This research aimed to determine the impacts of KT and balance exercises in patients with CLBP of SIJ dysfunction. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Sacroiliac Joint Dysfunction
- What is being tested?
- Kinesio Taping, Balance Training (BT) and Hot Pack and Stretching Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- 14 Nov 2022to 12 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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) .
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
This research aimed to determine the impacts of KT and balance exercises in patients with CLBP of SIJ dysfunction.
Read the 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
- Conditions
- Sacroiliac Joint Dysfunction
- Being tested
- Kinesio Taping, Balance Training (BT), Hot Pack and Stretching Exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio TapingOther
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
Balance Training (BT)Other
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.
Hot Pack and Stretching ExercisesOther
A hot pack was applied for 20 minutes, stretching exercises were performed.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | KBT Group Receives: Other: Kinesio Taping; Other: Balance Training (BT); Other: Hot Pack and Stretching Exercises |
| Group B | Experimental | BT Group Receives: Other: Balance Training (BT); Other: Hot Pack and Stretching Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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'
Measured: 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
Measured: 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.
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start14 Nov 2022
- Primary completion15 Sep 2023
- Study completion12 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sacroiliac Joint DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Najran University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hashim Ahmed, Najran University
- Investigators
- Hashim Ahmed, PhD, Principal investigator, Najran University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06099860
- Sponsor's protocol ID
- IE/IIMS&R/2022/78
- Status last verified
- Oct 2023
- First submitted
- 19 Oct 2023
- Last updated
- 25 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06099860
- Acronym / sponsor ID
- IE/IIMS&R/2022/78
- Conditions
- Sacroiliac Joint Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Najran UniversityUniversity, hospital or other
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 12 Oct 2023 (actual)
- First posted
- 25 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Kinesio Taping, Other: Balance Training (BT), Other: Hot Pack and Stretching ExercisesKBT Group |
| Group B | Experimental | Other: Balance Training (BT), Other: Hot Pack and Stretching ExercisesBT Group |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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) .
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kinesio TapingKinesio 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 | Other | Group A |
| Balance Training (BT)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. | Other | Group A, Group B |
| Hot Pack and Stretching ExercisesA hot pack was applied for 20 minutes, stretching exercises were performed. | Other | Group A, Group B |
Primary outcome
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'
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hashim Ahmed, PhD principal investigator
Najran University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesio Taping, Balance Training (BT) and Hot Pack and Stretching Exercises in people with Sacroiliac Joint Dysfunction, run by Najran University at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: 6 Weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2023.