Sacroiliac Joint DysfunctionNCT06442540
Effects of Intra Muscular Electrotherapy Combined With Manipulative Therapy in Patients With Sacral Torsion
A study testing Physical Agents, Manipulation and Core Stability Exercises in people with Sacroiliac Joint Dysfunction, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
This study is a randomised controlled trial and the purpose of this study is to determine the effect of intra muscular electrotherapy combined with manipulative therapy in terms of pain, mobility, range of motion, and disability." Read more about this study
- Who is it for?
- Ages 22 to 44 years
- Conditions the study is for
- Sacroiliac Joint Dysfunction
- What is being tested?
- Physical Agents, Manipulation and Core Stability Exercises
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jul 2023to 20 Jun 2024
- 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 22 to 44 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age group: 22-44 years old
- Both males and females
- Clinically diagnosed sacral torsion
- Patients with pain intensity of at least 5 on NPRS
- Positive backward bent test
- Positive forward bent test
Show all 9Show fewer
- Uneven Sacral sulcus
- Uneven ILA of sacrum
- Piriformis syndrome
Who cannot join
- Any congenital deformities
- Demonstrated neurological deficit.
- Pregnant females
- History of spinal surgery
- Spondylolisthesis
- Severe lumbar spondylosis
Show all 9Show fewer
- Spinal stenosis
- Serious spinal conditions like infection, tumors, osteoporosis, spinal fracture
- osteoporosis
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Foundation University College of Physical Therapy
Rawalpindi, Punjab Province, 46000
Nida Mushtaq, DPT,MSNMPT, 033300418548, nida.mushtaq@fui.edu.pk
About this study
This study is a randomised controlled trial and the purpose of this study is to determine the effect of intra muscular electrotherapy combined with manipulative therapy in terms of pain, mobility, range of motion, and disability."
Read the detailed description
The purpose of this study is to determine the effect of intra muscular electrotherapy combined with manipulative therapy in terms of pain, mobility, range of motion, and disability in patients with sacral torsion." (age : 22-44 years )
- Numeric pain rating scale
- Inclinometer Lumbar Flexion
- Oswestry Disability Questionairre
- Goniometer SLR ROM Data will be collected before and after the intervention protocol for each participant.
Data collection procedure: Participants of interest would be approached and explained about the research. Informed written consent will be taken. Pre and post intervention scores will be recorded.
- Conditions
- Sacroiliac Joint Dysfunction
- Being tested
- Physical Agents, Manipulation, Core Stability Exercises, Intramusular electrotherapy, Soft tissue mobility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical AgentsProcedure or surgery
Hot pack
ManipulationProcedure or surgery
HVLA manipulation of SI joint
Core Stability ExercisesProcedure or surgery
Supine abdominal draw-in Hold 8s 3s off x 2 Abdominal draw-in, with one knee drawn to the chest. Hold 8s 3s off x 2 Abdominal draw-in, with the heels sliding backward one after the other. 10 reps 3s off x 2 Abdominal draw-in, with both knees drawn to the chest. Hold 8s 3s off x 2 Supine twist 15 reps 3s off x 3 Prone bridging on elbows Hold 8s 3s off x 3 Side bridging on elbows Hold 8s 3s off x 3 Quadruped opposite arm-leg lift Hold 8s 3s off x 3 Advance to the stage 2 when the patient can hold 30 reps for an 8-sec hold.
Intramusular electrotherapyProcedure or surgery
Intramuscular electrotherapy/ 3 sessions per week
Soft tissue mobilityProcedure or surgery
Stretching and Myofacial Release of piriformis and erector spinae
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | HVLA thrust for SI Joint once per week:
Core stability exercises Intramuscular electrotherapy / 3 sessions per week 10 mins / frequency 100hz muscles( piriformis, erector spinae ) Receives: Procedure: Manipulation; Procedure: Core Stability Exercises; Procedure: Intramusular electrotherapy |
| Group 2 | Experimental | Hot pack 10 mins soft tissue / myofacial release ( piriformis, erector spinae ) Piriformis stretching core stability exercises Receives: Procedure: Physical Agents; Procedure: Core Stability Exercises; Procedure: Soft tissue mobility |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Numeric Pain Rating Scale (NPRS): ICC (0.93-0.96) It has a scale of 0-10 or 0-100 points and can be given verbally or in writing
Measured: 4 weeks
Lumbar ROM
Lumbar ROM will be measured using Inclinometer
Measured: 4 weeks
SLR ROM
SLR ROM will be measured using Goniometer
Measured: 4 weeks
Level of Disability
Oswestry disability questionairre
Measured: 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start15 Jul 2023
- Primary completion20 May 2024
- Study completion20 Jun 2024 (estimated)
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.
- More trials run by Foundation University IslamabadThe sponsor's other registered studies.
- 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
- Model description
- Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06442540
- Sponsor's protocol ID
- FUI/CTR/2024/11
- Status last verified
- May 2024
- First submitted
- 27 May 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intra Muscular Electrotherapy Combined With Manipulative Therapy in Patients With Sacral Torsion
- ClinicalTrials.gov ID
- NCT06442540
- Acronym / sponsor ID
- FUI/CTR/2024/11
- Conditions
- Sacroiliac Joint Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- 20 May 2024 (actual)
- Study completion
- 20 Jun 2024 (estimated)
- First posted
- 4 Jun 2024 (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 study is a randomised controlled trial and the purpose of this study is to determine the effect of intra muscular electrotherapy combined with manipulative therapy in terms of pain, mobility, range of motion, and disability."
Detailed description
The purpose of this study is to determine the effect of intra muscular electrotherapy combined with manipulative therapy in terms of pain, mobility, range of motion, and disability in patients with sacral torsion." (age : 22-44 years )
- Numeric pain rating scale
- Inclinometer Lumbar Flexion
- Oswestry Disability Questionairre
- Goniometer SLR ROM Data will be collected before and after the intervention protocol for each participant.
Data collection procedure: Participants of interest would be approached and explained about the research. Informed written consent will be taken. Pre and post intervention scores will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Procedure: Manipulation, Procedure: Core Stability Exercises, Procedure: Intramusular electrotherapyHVLA thrust for SI Joint once per week: Core stability exercises Intramuscular electrotherapy / 3 sessions per week 10 mins / frequency 100hz muscles( piriformis, erector spinae ) |
| Group 2 | Experimental | Procedure: Physical Agents, Procedure: Core Stability Exercises, Procedure: Soft tissue mobilityHot pack 10 mins soft tissue / myofacial release ( piriformis, erector spinae ) Piriformis stretching core stability exercises |
Who may qualify
- Ages
- 22 to 44 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age group: 22-44 years old
- Both males and females
- Clinically diagnosed sacral torsion
- Patients with pain intensity of at least 5 on NPRS
- Positive backward bent test
Key exclusion criteria (9 listed)
- Any congenital deformities
- Demonstrated neurological deficit.
- Pregnant females
- History of spinal surgery
- Spondylolisthesis
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 |
|---|---|---|
| Physical AgentsHot pack | Procedure or surgery | Group 2 |
| ManipulationHVLA manipulation of SI joint | Procedure or surgery | Group 1 |
| Core Stability ExercisesSupine abdominal draw-in Hold 8s 3s off x 2 Abdominal draw-in, with one knee drawn to the chest. Hold 8s 3s off x 2 Abdominal draw-in, with the heels sliding backward one after the other. 10 reps 3s off x 2 Abdominal draw-in, with both knees drawn to the chest. Hold 8s 3s off x 2 Supine twist 15 reps 3s off x 3 Prone bridging on elbows Hold 8s 3s off x 3 Side bridging on elbows Hold 8s 3s off x 3 Quadruped opposite arm-leg lift Hold 8s 3s off x 3 Advance to the stage 2 when the patient can hold 30 reps for an 8-sec hold. | Procedure or surgery | Group 1, Group 2 |
| Intramusular electrotherapyIntramuscular electrotherapy/ 3 sessions per week | Procedure or surgery | Group 1 |
| Soft tissue mobilityStretching and Myofacial Release of piriformis and erector spinae | Procedure or surgery | Group 2 |
Primary outcome
Pain Intensity
Time frame: 4 weeks
Numeric Pain Rating Scale (NPRS): ICC (0.93-0.96) It has a scale of 0-10 or 0-100 points and can be given verbally or in writing
Lumbar ROM
Time frame: 4 weeks
Lumbar ROM will be measured using Inclinometer
SLR ROM
Time frame: 4 weeks
SLR ROM will be measured using Goniometer
Level of Disability
Time frame: 4 Weeks
Oswestry disability questionairre
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
Related trials for Sacroiliac Joint Dysfunction
Not yet recruiting
Effect of Retro Walking in Patients With Sacroiliac Joint Dysfunction
Sacroiliac Joint Dysfunction
RecruitingObservational study
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
Fracture; Pelvic, Insufficiency Fractures
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Not yet recruitingObservational study
Correlation Between Trunk Muscles Endurance and Dynamic Balance in Sacroiliac Joint Dysfunction
Trunk Extensor Muscle Endurance
Active, not recruitingObservational study
Post-Market Clinical Study on a Modular SI Joint Fusion System
Sacroiliitis, Sacroiliac Joint Dysfunction
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Agents, Manipulation and Core Stability Exercises in people with Sacroiliac Joint Dysfunction, run by Foundation University Islamabad at 1 site in Pakistan.
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 9 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 4 Jun 2024. 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 Pakistan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Usama Ibrar, MS-MSKPT* (03035954053, usamaibrar35@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: 4 weeks). The study lists 4 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 4 Jun 2024.