Sacroiliac Joint DysfunctionNCT06062459
Synergistic Benefits of MCE and BT in Sacroiliac Joint Dysfunction: A Randomized Controlled Trial
A study testing Balance Training in people with Sacroiliac Joint Dysfunction, run by Najran University at 2 sites in 2 countries.
Trial summary
This research aimed to ascertain the combined and individual efficacies of MCE and BT in alleviating SIJD symptoms. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Sacroiliac Joint Dysfunction
- What is being tested?
- Balance Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Nov 2022to 20 Sep 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age-30-60 Years
- sacroiliac joint pain (>3 months)
- 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; known localized spinal pathology
- known congenital anomalies of hip, pelvis or spine that limits mobility
- known 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
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Synergistic Benefits of Motor Control Exercises and Balance Training in Sacroiliac Joint Dysfunction: A Randomized Controlled Trial
This research aimed to ascertain the combined and individual efficacies of MCE and BT in alleviating SIJD symptoms.
Read the detailed description
The study will be based on a four-arm parallel group randomized control design. one hundred and twenty participants with SIJD 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 four groups A, B, C, and D. Experimental group A will be receiving the hot pack, Stretching exercise, and MCE intervention, group B will receive the hot pack, Stretching exercise, and BT exercise and Group C will be receiving the hot pack, Stretching exercise, and MCE \& BT intervention, control group D will receive the hot pack, Stretching exercise intervention.
- Conditions
- Sacroiliac Joint Dysfunction
- Being tested
- Motor Control Exercise, Balance Training, Control Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor Control ExerciseOther
Motor control exercises focusing on the activation and control of deep spinal muscles
Balance TrainingOther
Balance training exercises on to enhance proprioception and stability
Control GroupOther
Participants received hot pack and stretching exercise
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | MCE Group Receives: Other: Motor Control Exercise; Other: Control Group |
| Group B | Experimental | BT Group Receives: Other: Balance Training; Other: Control Group |
| Group C | Experimental | Combined MCE \& BT Group Receives: Other: Motor Control Exercise; Other: Balance Training; Other: Control Group |
| Group D | Other | Control Group Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
The pain intensity was assessed Using a numeric pain rating scale (NPRS), It's a 11 point scale, where zero indicates no pain and 10 indicates severe pain
Measured: 6 Weeks
Functional disability
Functional limitation was assessed by using Oswestry disability Index questionnaire Each section is scored on a 0-5 scale, 5 representing the greatest disability.
Measured: 6 Weeks
self-reported measure of health
It comprises 36 questions that cover eight domains of health
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 posted2 Oct 2023
- Study start1 Nov 2022
- Primary completion31 Aug 2023
- Study completion20 Sep 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
- 120 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
- NCT06062459
- Sponsor's protocol ID
- IE/IIMS&R/2022/87
- Status last verified
- Sep 2023
- First submitted
- 25 Sep 2023
- Last updated
- 2 Oct 2023
- Results posted
- No
- Data monitoring committee
- 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 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synergistic Benefits of Motor Control Exercises and Balance Training in Sacroiliac Joint Dysfunction: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06062459
- Acronym / sponsor ID
- IE/IIMS&R/2022/87
- Conditions
- Sacroiliac Joint Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Najran UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 20 Sep 2023 (actual)
- First posted
- 2 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 ascertain the combined and individual efficacies of MCE and BT in alleviating SIJD symptoms.
Detailed description
The study will be based on a four-arm parallel group randomized control design. one hundred and twenty participants with SIJD 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 four groups A, B, C, and D. Experimental group A will be receiving the hot pack, Stretching exercise, and MCE intervention, group B will receive the hot pack, Stretching exercise, and BT exercise and Group C will be receiving the hot pack, Stretching exercise, and MCE \& BT intervention, control group D will receive the hot pack, Stretching exercise intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Motor Control Exercise, Other: Control GroupMCE Group |
| Group B | Experimental | Other: Balance Training, Other: Control GroupBT Group |
| Group C | Experimental | Other: Motor Control Exercise, Other: Balance Training, Other: Control GroupCombined MCE \& BT Group |
| Group D | Other | Other: Control GroupControl Group |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age-30-60 Years
- sacroiliac joint pain (>3 months)
- 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 (6 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; known localized spinal pathology
- known congenital anomalies of hip, pelvis or spine that limits mobility
- known 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
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 |
|---|---|---|
| Motor Control ExerciseMotor control exercises focusing on the activation and control of deep spinal muscles | Other | Group A, Group C |
| Balance TrainingBalance training exercises on to enhance proprioception and stability | Other | Group B, Group C |
| Control GroupParticipants received hot pack and stretching exercise | Other | Group A, Group B, Group C, Group D |
Primary outcome
Pain Intensity
Time frame: 6 Weeks
The pain intensity was assessed Using a numeric pain rating scale (NPRS), It's a 11 point scale, where zero indicates no pain and 10 indicates severe pain
Functional disability
Time frame: 6 Weeks
Functional limitation was assessed by using Oswestry disability Index questionnaire Each section is scored on a 0-5 scale, 5 representing the greatest disability.
self-reported measure of health
Time frame: 6 Weeks
It comprises 36 questions that cover eight domains of health
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 2 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
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance Training in people with Sacroiliac Joint Dysfunction, run by Najran University at 2 sites in 2 countries.
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 6 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 2 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 2 sites in India, Saudi Arabia. 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 2 Oct 2023.