- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07275294
Effects of Pelvic Floor Exercises and Muscle Energy Techniques on Pain and Disability in Sacroiliac Joint Dysfunction
Combined Effects of Pelvic Floor Exercises and Muscle Energy Techniques on Pain and Functional Disability in Patients With Sacroiliac Joint Dysfunction: A Randomized Controlled Trial
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Aneela Bajwa, DPT
- Phone Number: +923304295020
- Email: ubs24lmspt021@ubas.edu.pk
Study Contact Backup
- Name: MUHAMMAD TARIQ RAFIQ, PhD
- Email: rafiqmuhammadtariq149@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria
- Unilateral sacroiliac joint dysfunction pre diagnosed patients
- Both male and female
- Age 30 to 50 years
- Positive on at-least 3/5 provocation tests (Compression, Distraction, Gaenslen, Thigh Thrust, Sacral Thrust and FABER (Flexion, Abduction, External Rotation) test)
- Pain at Fortin area
- Symptoms >3 weeks
Exclusion Criteria:
- Pregnant females
- Any other neurological, orthopedic, or musculoskeletal disorder
- Recent history of pelvic surgery or any history of malignancy
- Lumbar pathologies (scoliosis, spondylosis, spondylolisthesis)
- Sacroiliitis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control group
Muscle Energy Techniques with Hot pack and Transcutaneous Electrical Nerve Stimulation
|
There will be an application of a hot pack for 10minutes and TENS for 10minutes.
After that Muscle Energy Techniques (METs) will be performed as isometric relaxation technique targeting iliopsoas, piriformis, hamstring and gluteus medius muscles.
The protocol will involve isometric contraction in which patients will perform a contraction at ~30% effort against the therapist's resistance for 7-10 seconds.
A 5-second relaxation phase followed by a stretch to the new range barrier, held for 10-60 seconds.
Each stretch will be repeated 3-5 in each session.
This will be performed 3 times per session 3 times per week for 6 weeks.
|
|
Experimental: Experimental Group
Muscle Energy Techniques with Hot pack, Transcutaneous Electrical Nerve Stimulation and Pelvic Floor Exercises
|
There will be an application of a hot pack for 10minutes and TENS for 10minutes. After that Muscle Energy Techniques (METs) will be performed as isometric relaxation technique targeting iliopsoas, piriformis, hamstring and gluteus medius muscles. The protocol will involve isometric contraction in which patients will perform a contraction at ~30% effort against the therapist's resistance for 7-10 seconds. A 5-second relaxation phase followed by a stretch to the new range barrier, held for 10-60 seconds. Each stretch will be repeated 3-5 in each session. This will be performed 3 times per session 3 times per week for 6 weeks. Participants in the experimental group will be instructed to perform the Pelvic Floor Exercises (Kegel exercises, Pelvic Tilts and Bridge with pelvic floor engagement) according to the defined protocol. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain for SIJD provocation tests
Time Frame: From enrollment to the end of treatment at 6 weeks
|
The NRS is a widely used, unidimensional tool for assessing pain intensity.
It asks the individual to rate their pain on a scale of 0 (no pain) to 10 (worst pain imaginable).
It is easy to understand and quick to administer and score.
It is used for various types of pain (acute and chronic) and in different settings.
The NPRS has demonstrated good to excellent reliability and validity with low back pain.
Pain scores categorized as mild pain (1-3), moderate pain (1-3) and severe pain (7-10).
|
From enrollment to the end of treatment at 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional Disability
Time Frame: From enrollment to the end of treatment at 6 weeks
|
Functional disability is measured using the Modified Oswestry Disability Index.
It asks questions about everyday activities such as sitting, standing, walking, lifting, and personal care.
The Modified Oswestry Disability Index is a patient-completed questionnaire that measures functional disability using 10 questions with 6-point Likert scales.
Each question is scored from 0 (no disability) to 5 (maximum disability).
The total Modified Oswestry Disability Index score is a percentage reflecting how much low back pain affects daily life.
It is calculated by dividing the individual's score by the maximum possible score and converting it into a percentage.
The resulting percentage falls into a category that indicates the level of disability.
The participants experience mild pain and can perform most activities with a score of 0-20% (Minimal disability).The participants experience severe functional limitation with a score of 81-100% (bed-bound or exaggerating symptoms).
|
From enrollment to the end of treatment at 6 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Muhammad Tariq Rafiq, PhD, Lahore University of Biological & Applied Sciences
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UBAS/ERB/FoRS/25/027
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sacroiliac Joint Dysfunction
-
PainTEQ, LLCNot yet recruitingSacroiliac Joint Pain | Sacroiliac Joint Dysfunction
-
CornerLocRecruitingSacroiliac Joint Dysfunction | Sacroiliac; FusionUnited States
-
SI-BONE, Inc.Active, not recruitingSacroiliac Joint Pain | Sacroiliac Joint Dysfunction | Sacroiliac Disorder | Sacroiliac; FusionUnited States
-
Kirsehir Ahi Evran UniversitesiRecruitingSacroiliac Joint DysfunctionTurkey (Türkiye)
-
Elite College of Management Sciences, Gujranwala...CompletedSacro Iliac Joint Pain | Sacroiliac Joint Dysfunction | Sacroiliac DisorderPakistan
-
SI-BONE, Inc.Not yet recruitingSacroiliac Joint Disruption | Degenerative Sacroiliitis | Sacro Iliac Joint Pain | Sacroiliac Joint Dysfunction | Sacroiliac Disorder | Sacro-iliac Joints
-
University of Social Welfare and Rehabilitation...Not yet recruitingSacroiliac Joint DysfunctionPakistan
-
Riphah International UniversityRecruitingSacroiliac Joint DysfunctionPakistan
-
Lahore University of Biological and Applied SciencesNot yet recruitingSacroiliac Joint DysfunctionPakistan
-
Foundation University IslamabadNot yet recruitingSacroiliac Joint DysfunctionPakistan
Clinical Trials on Muscle Energy Techniques with Hot pack and Transcutaneous Electrical Nerve Stimulation
-
Riphah International UniversityCompletedLow Back Pain | Sacroiliac Joint DysfunctionPakistan
-
Ankara UniversityCompletedMyofascial Pain SyndromesTurkey
-
Istanbul University - CerrahpasaCompletedChronic Neck Pain | Chronic Low-back Pain (cLBP)Turkey
-
Uşak UniversityAbant Izzet Baysal UniversityCompletedBlood Pressure | Heart Rate | BalneologyTurkey
-
Superior UniversityActive, not recruitingAdhesive CapsulitisPakistan
-
Turkish League Against RheumatismUnknownOsteoarthritis, KneeTurkey
-
Baskent UniversityCompleted
-
Uşak UniversityCompleted
-
Pusan National University Yangsan HospitalCompletedAbdominal ObesityKorea, Republic of
-
Superior UniversityActive, not recruitingHypertensionPakistan