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Comparison of Regional Manual Therapy and Standard Physical Therapy Intervention in Females With Sacroiliac Joint Pain

Primary Purpose

Sacroiliac; Sprain (Strain)

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Regional treatment
Standard physiotherapy treatment
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sacroiliac; Sprain (Strain)

Eligibility Criteria

20 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Bajwa hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Regional treatment

Standard physiotherapy treatment

Arm Description

Group A was given regional treatment with baseline treatment protocol

Group B was given standard physiotherapy treatment with baseline protocol

Outcomes

Primary Outcome Measures

NPRS
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.
Oswestry low back disability questionnaire
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

Secondary Outcome Measures

Full Information

First Posted
September 29, 2021
Last Updated
September 29, 2021
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05076136
Brief Title
Comparison of Regional Manual Therapy and Standard Physical Therapy Intervention in Females With Sacroiliac Joint Pain
Official Title
Comparison of Regional Manual Therapy and Standard Physical Therapy Intervention in Females With Sacroiliac Joint Pain.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
November 24, 2019 (Actual)
Primary Completion Date
October 10, 2020 (Actual)
Study Completion Date
November 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sacroiliac; Sprain (Strain)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Regional treatment
Arm Type
Experimental
Arm Description
Group A was given regional treatment with baseline treatment protocol
Arm Title
Standard physiotherapy treatment
Arm Type
Active Comparator
Arm Description
Group B was given standard physiotherapy treatment with baseline protocol
Intervention Type
Other
Intervention Name(s)
Regional treatment
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard physiotherapy treatment
Intervention Description
In this treatment patients were given just hip joint mobilizations and quadriceps and hamstrings stretching.
Primary Outcome Measure Information:
Title
NPRS
Description
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.
Time Frame
Eight week
Title
Oswestry low back disability questionnaire
Description
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
Time Frame
Eight week

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tasneem Shahzadi, Mphil
Organizational Affiliation
Riphah international university Lahore
Official's Role
Study Chair
Facility Information:
Facility Name
Bajwa hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
57000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16700283
Citation
Forst SL, Wheeler MT, Fortin JD, Vilensky JA. The sacroiliac joint: anatomy, physiology and clinical significance. Pain Physician. 2006 Jan;9(1):61-7.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
7939978
Citation
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.
Results Reference
background

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Comparison of Regional Manual Therapy and Standard Physical Therapy Intervention in Females With Sacroiliac Joint Pain

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