- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05076136
Comparison of Regional Manual Therapy and Standard Physical Therapy Intervention in Females With Sacroiliac Joint Pain
September 29, 2021 updated by: Riphah International University
Comparison of Regional Manual Therapy and Standard Physical Therapy Intervention in Females With Sacroiliac Joint Pain.
The SIJ has long been considered an important source of low back pain because of the empirical finding that treatment targeting the SIJ can relieve pain.This study was be a Randomized Clinical Trail conducted at Riphah Rehabilitation Centre Lahore.
The study was be completed within the time duration of Six months.
Purposive sampling technique was be used.
Sample size is calculated by using the G power 3.1.
The sample size of 64 patients was be taken in this study to find the comparison of regional manual therapy and standard physiotherapy intervention in females with sacroiliac joint pain.
Patients was be divided into two groups.. Patients was be divided into two groups.
Group A was be treated with regional manual therapy.
In regional manual therapy patients was be given mobilization to lumber region and SIJ, pelvic floor exercises and core strengthening exercises and Group B was be treated with standard physiotherapy in which patients was be given SIJ mobilization and Straight leg raise.
Both groups was receive transcutaneous electrical nerve stimulator and heating pad as a common treatment protocol.
Numeric pain rating scale (NPRS) and oswestry low back disability questionnaire was be used as Data collecting tools.
Two session of treatment per week for eight weeks was be given.
Data was be analyzed on SPSS 21.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
64
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 Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 57000
- Bajwa hospital
-
-
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
20 years to 50 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Females with sacroiliac joint pain
- Age: 20 to 50 years
Exclusion Criteria:
- Patients withany red flag signs i.etumor, fracture, metabolic diseases, rheumatoid arthritis, prolonged history of steroids use, etc.
- Females with sciatica
- Females with radiating pain
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
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Regional treatment
Group A was given regional treatment with baseline treatment protocol
|
In reginal treatment patients were given physiotherapy exercises and manual therapies on hip joint as well as on surrounding areas of hip joint such as lumber area and sacroiliac joint.
|
|
ACTIVE_COMPARATOR: Standard physiotherapy treatment
Group B was given standard physiotherapy treatment with baseline protocol
|
In this treatment patients were given just hip joint mobilizations and quadriceps and hamstrings stretching.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
NPRS
Time Frame: Eight week
|
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain.
|
Eight week
|
|
Oswestry low back disability questionnaire
Time Frame: Eight week
|
The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability.
The test is considered the 'gold standard' of low back functional outcome tools
|
Eight week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Tasneem Shahzadi, Mphil, Riphah International University Lahore
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Forst SL, Wheeler MT, Fortin JD, Vilensky JA. The sacroiliac joint: anatomy, physiology and clinical significance. Pain Physician. 2006 Jan;9(1):61-7.
- 5. Merskey H, Bogduk N. Classification of Chronic Pain:Descriptions of Chronic Pain Syndromes and Definitions of Pain Terms. 2nd ed. Seattle, WA: IASP Press; 1994.
- Fortin JD, Dwyer AP, West S, Pier J. Sacroiliac joint: pain referral maps upon applying a new injection/arthrography technique. Part I: Asymptomatic volunteers. Spine (Phila Pa 1976). 1994 Jul 1;19(13):1475-82.
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)
November 24, 2019
Primary Completion (ACTUAL)
October 10, 2020
Study Completion (ACTUAL)
November 10, 2020
Study Registration Dates
First Submitted
September 29, 2021
First Submitted That Met QC Criteria
September 29, 2021
First Posted (ACTUAL)
October 13, 2021
Study Record Updates
Last Update Posted (ACTUAL)
October 13, 2021
Last Update Submitted That Met QC Criteria
September 29, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCRS/20/1017
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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