- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06303401
Comparison of Thrust Manipulation of Sacroiliac Joint and Pelvic Stabilization Exercises in Post Partum Low Back Pain
March 4, 2024 updated by: Riphah International University
Comparison of Thrust Manipulation of Sacroiliac Joint and Pelvic Stabilization Exercises on Pain and Disability Among Patients With Post-Partum Low Back Pain.
compare the effectiveness of SI joint thrust manipulation and pelvic stabilization exercises on Modified OSWESTRY Low Back pain Index (ODI) and Numeric Pain Rating Scale (NPRS) in patients with post-partum lower back pain.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Patients fulfilling the inclusion criteria will be divided into 2 groups i.e.
Group A and Group B. Patients in Group A will receive thrust manipulation technique and Group B will receive pelvic stabilization exercises, heating pad will be given to both groups.
Patients will be treated 3 times per week for 4 consecutive weeks.
Patient will be evaluated at baseline, midline and at end of 4th week.
Pain, functional status and disability will be evaluated after every 3 sessions.
Study Type
Interventional
Enrollment (Estimated)
44
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Imran Amjad, PhD
- Phone Number: 03324390125
- Email: Imran.amjad@riphah.edu.pk
Study Locations
-
-
KPK
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Peshawar, KPK, Pakistan, 25000
- Recruiting
- Lady Reading Hospital and Shahab Orthopedic & General Hospital
-
Contact:
- Asmar Fatima, MS OMPT
- Phone Number: 03336195644
- Email: asmar.fatima@riphah.edu.pk
-
Principal Investigator:
- Gull alay, MS OMPT*
-
Sub-Investigator:
- Asmar Fatima, MS OMPT
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- age 20-40 years
- Postpartum women (after 6 weeks)(3, 12)
- Postpartum LBP patient
- Patient pain increased by provocation test i.e. Faber test, High thrust test and Gaenslen test
Exclusion Criteria:
- C-section
- inflammatory or malignant type of pain
- Neurological deficit
- Severe trauma
- Pelvic fracture
- Osteoporosis, spinal stenosis, spondylolysis, spondoloesthesisi
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SI joint thrust Manipulation
The patient was supine and the therapist stood contralateral to the side which was to be manipulated.
The patient was passively moved into side bending toward the side to be manipulated.
The therapist passively rotated the patient, and then delivered a quick thrust to the Anterior Superior Iliac Spine (ASIS) in a posterior and inferior direction
|
experimental group given the thrust manipulation along with heating pad. 3 sessions per week will be given for 4 weeks. The pain measure by using NPRS, functional status and disability through ODI will be evaluated. after every 3 sessions. |
|
Active Comparator: Pelvic Stabilization Exercises
Heating pad for 10- 15 mints Pelvic stabilization exercises.
Bridging (3 sets x 10 reps with 10 secs hold), Pelvic Tilt exercise (3 sets x 10 reps with 10 secs hold), Bird-Dog Exercise (3 sets x 10 reps with 10 secs hold), clamshell Exercise (3 sets x 10 reps with 10 secs hold).
|
Heating pad for 10- 15 mints Pelvic stabilization exercises include Bridging (3 sets x 10 reps with 10 secs hold) Pelvic Tilt exercise(3 sets x 10 reps with 10 secs hold) Bird-Dog Exercise (3 sets x 10 reps with 10 secs hold) clamshell Exercise (3 sets x 10 reps with 10 secs hold) .3
sessions per week will be given for 4 weeks.
The pain using NPRS , functional status and disability will be evaluated by using ODI after every 3 sessions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric pain rating scale (NPRS)
Time Frame: 4th week
|
The Numeric Pain Rating Scale (NPRS) measures the subjective intensity of pain.
The NPRS is an eleven-point scale: the patient rates pain from 0 (no pain) to 10 (worst imaginable pain).
|
4th week
|
|
Modified Oswestry Disability Index (ODI)
Time Frame: 4th week
|
The ODI is a disease specific disability measure is used to establish a level of disability stage on a patient activity status and monitor change over the time.
The ODI is made up of 10 questions.
Each question is scored from (o-5) minimum to maximum.
|
4th week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Asmar Fatima, MS OMPT, Riphah International University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 27, 2023
Primary Completion (Estimated)
July 31, 2024
Study Completion (Estimated)
August 30, 2024
Study Registration Dates
First Submitted
March 4, 2024
First Submitted That Met QC Criteria
March 4, 2024
First Posted (Actual)
March 12, 2024
Study Record Updates
Last Update Posted (Actual)
March 12, 2024
Last Update Submitted That Met QC Criteria
March 4, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/MS-PT/01787 Gullalay
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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