| CTRI Number |
CTRI/2025/11/096894 [Registered on: 04/11/2025] Trial Registered Prospectively |
| Last Modified On: |
04/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
How a specific treatment plan affects pain, muscle strength, functional disability and quality of life in lower back |
|
Scientific Title of Study
|
Effect of selective treatment protocol on pain, muscle strength, functional disability and quality of life in sacroiliac joint dysfunction- A Randomized Controlled Trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANUSHKA A HASHIA |
| Designation |
MUSCULOSKELETAL PHYSIOTHERAPY RESIDENT |
| Affiliation |
|
| Address |
Dr. APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY, ORTHOPAEDIC PHYSIOTHERAPY DEPARTMENT, PRAVARA INSTITUTE OF MEDICAL SCIENCES TAL: RAHATA, DISTRICT: AHMEDNAGAR, LONI MAHARASHTRA PIN: 413736
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
7400367787 |
| Fax |
|
| Email |
anushkahashia36@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. NEERAJ KUMAR |
| Designation |
PROFESSOR & HOD, ORTHOPAEDIC PHYSIOTHERAPY DEPARTMENT |
| Affiliation |
|
| Address |
Dr. APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY, ORTHOPAEDIC PHYSIOTHERAPY DEPARTMENT, PRAVARA INSTITUTE OF MEDICAL SCIENCES TAL-RAHATA, LONI
AHMADNAGAR, MAHARASHTRA, 413736 India
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
9005411557 |
| Fax |
|
| Email |
drneerajpt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ANUSHKA A HASHIA |
| Designation |
MUSCULOSKELETAL PHYSIOTHERAPY RESIDENT |
| Affiliation |
|
| Address |
Dr. APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY, ORTHOPAEDIC PHYSIOTHERAPY DEPARTMENT, PRAVARA INSTITUTE OF MEDICAL SCIENCES TAL-RAHATA, LONI
Ahmadnagar, MAHARASHTRA, 413736 India
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
7400367787 |
| Fax |
|
| Email |
anushkahashia36@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY |
| Address |
Dr. APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY, ORTHOPAEDIC PHYSIOTHERAPY DEPARTMENT, PRAVARA INSTITUTE OF MEDICAL SCIENCES TAL RAHATA, DISTRICT AHMEDNAGAR, LONI MAHARASHTRA PIN 413736 |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| ANUSHKA A HASHIA |
Dr. APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY |
HALL NO 403 DEPARTMENT OF ORTHOPAEDIC PHYSIOTHERAPY TALAUKA RAHATA AHMADAGAR MAHARASHTRA
Ahmadnagar
MAHARASHTRA |
7400367787
2422271426
anushkahashia36@gmail.com |
|
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Details of Ethics Committee
|
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M248||Other specific joint derangements,not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional treatment protocol |
WEEK 1- WEEK 6 -Hot water fomentation (10 mins)
-Ultrasound (5 mins)
(Intensity of 1.3 W/cm2 and frequency of 1 MHZ in a continuous mode)
-Hamstring stretch
-Gluteus medius stretch
-Quadriceps stretch
-Piriformis stretch
-Conventional back bridge
-Gluteus medius wall press
-Pelvic drop exercise
-Sit ups
-Hip adduction for anterior gluteus medius
-Posture awareness 3 reps × 1 set with 30 secs hold
|
| Intervention |
Selective Treatment Protocol |
WEEK 1 -Hot water fomentation (10 mins)
-Ultrasound (5 mins) (Intensity of 1.3 W/cm2 and frequency of 1 MHZ in a continuous mode)
-Hamstring stretch (Affected side)
-Gluteus stretch (Affected side)
-Quadriceps stretch (Affected side)
-Piriformis stretch (Affected side)
-Quadratus lumborum stretch (Affected side)
-Pelvic bridging
-Single knee to chest (Affected side) 4 reps × 1 set with 30 secs hold
WEEK 2 -Hot water fomentation (10 mins)
-Ultrasound (5 mins) (Intensity of 1.3 W/cm2 and frequency of 1 MHZ in a continuous mode)
-Cobra pose
-Abdominal indrawing ex
-Double knee to chest
-Quadruped opposite arm leg lift (Bird dog ex)
-Hip adductor ball squeeze 4 reps × 1 set with 30 secs hold
WEEK 3 -Straight leg raise in 3 planes
-Static back
-Static glutes
-Prone bridge on elbow
-Child pose
-MET for quadratus lumborum (Affected side)
-Hip muscle isometric strengthening ex (with resistance bands or pillow & hand) 4 reps × 1 set with 30 secs hold
WEEK 4 Posterior pelvic tilt
-Spinal twist in supine
-Clampshell
- Quadruped opposite arm leg lift (Bird dog ex) with weight
-strengthening of hamstring and gluteus muscles with weight cuffs or resistance bands 4 reps × 1 set with 30 secs hold
WEEK 5 -Side bridge on elbow
-Side stepping with resistance bands
-Hip circles in standing
-Lateral step ups
-Sit ups 4 reps × 1 set with 30 secs hold
WEEK 6 -Side twisting while seated on swiss ball
-Hip extension on swiss ball
-Back extension on swiss ball
-Butt lifts on swiss ball 4 reps × 1 set with 30 secs hold
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Unilateral sacroiliac joint dysfunction.
2)A pain score of equal to and more than 3/10 on visual analog scale (VAS) for sacroiliac pain in last 1.5 months.
3)Quadratus lumborum MMT 3
4)Pre diagnosed case
5)Using no other nonsteroidal anti-inflammatory drugs during the therapy.
6)Patients volunteered to participate in the study and signed informed consent
|
|
| ExclusionCriteria |
| Details |
1)Radiating pain.
2)Dislocation in lower back and lower extremity, fractures.
3)History of trauma.
4)Any systemic and metabolic disease.
5)Any rheumatologic disease.
6)Existence of known central nervous system or peripheral nervous system disease.
7)Pregnancy.
8)Involved in other treatments for pain relief. |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Visual Analogue Scale (VAS)
2)Modified Oswestry Disability Questionnaire
3)Short form 12 questionnaire (SF-12)
4)Manual Muscle Testing (MMT) of Quadratus Lumborum |
All outcomes measured at baseline and after 6 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Visual Analogue Scale (VAS)
2)Modified Oswestry Disability Questionnaire
3)Short form 12 questionnaire (SF-12)
4)Manual Muscle Testing (MMT) of Quadratus Lumborum |
All outcomes measured at baseline and after 6 weeks. |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
PROJECT TITLE: EFFECT OF SELECTIVE TREATMENT PROTOCOL ON PAIN, MUSCLE STRENGTH, FUNCTIONAL DISABILITY AND QUALITY OF LIFE IN SACROILIAC JOINT DYSFUNCTION- A RANDOMIZED CONTROLLED TRIAL.
Dr. Anushka A Hashia1 Musculoskeletal Physiotherapy Resident, Dr. APJ Abdul Kalam College of Physiotherapy, Loni, Maharashtra, India, Email- anushkahashia36@gmail.com
Dr. Neeraj Kumar2 Head of Department, Department of Orthopaedic Physiotherapy, Dr. APJ Abdul Kalam College of Physiotherapy, Loni, Maharashtra, India, Email- drneerajpt@gmail.com
AIMS AND OBJECTIVES AIM:
The aim of this study is to determine the effect of selective treatment protocol on pain, muscle strength, functional disability & quality of life in sacroiliac joint dysfunction.
OBJECTIVES:
1) To find out the effect of conventional treatment protocol on pain, muscle strength, functional disability and quality of life in sacroiliac joint dysfunction.
2) To find out the effect of selective treatment protocol on pain, muscle strength, functional disability and quality of life in sacroiliac joint dysfunction.
3) To compare effects of conventional treatment protocol and selective treatment protocol on pain, muscle strength, functional disability and quality of life in sacroiliac joint dysfunction.
SELECTION CRITERIA: Inclusion criteria:
1)Age group 30 to 60 years. 2)Both male and female. 3)Unilateral sacroiliac joint dysfunction. 4)A pain score of equal to and more than 3/10 on visual analog scale (VAS) for sacroiliac pain in last 1.5 months. 5)Quadratus lumborum MMT 3 6)Pre diagnosed case 7)Using no other nonsteroidal anti-inflammatory drugs during the therapy. 8)Patients volunteered to participate in the study and signed informed consent
Exclusion criteria: 1) Radiating pain. 2)Dislocation in lower back and lower extremity, fractures. 3)History of trauma. 4)Any systemic and metabolic disease. 5)Any rheumatologic disease. 6)Existence of known central nervous system or peripheral nervous system disease. 7)Pregnancy. 8)Involved in other treatments for pain relief.
METHODOLOGY: Source of Data: Dr. Vitthalrao Vikhe Patil Pravara Rural Hospital, Loni. Study Setting: Department of Orthopedic Physiotherapy at Dr. APJAK College of Physiotherapy, PIMS, LONI. Method of collection of data: Primary Study Design: Single blinded, Randomized Controlled Trial Sample size: 74, Calculated by OpenEpi based on probability based random sampling method. After including 10% attrition rate the total sample size becomes 74+8= 82 Participants: Patients diagnosed with Sacroiliac Joint Dysfunction Sampling Method: Simple Random Sampling Study Duration: 2 years. Material to be used: 1) Data Record Sheet 2)Consent Form Equipment: 1)Hot water fomentation (HWF) 2)Ultrasound 3)Therabands / weight cuff 4)Swiss ball
OUTCOME MEASURES 1)Visual Analogue Scale (VAS) 2)Modified Oswestry Disability Questionnaire 3)Short form 12 questionnaire (SF-12) 4)Manual Muscle Testing (MMT) of Quadratus Lumborum
PROCEDURE After receiving ethical clearance by the Institutional Ethical Committee of Dr. A.P.J Abdul Kalam College of Physiotherapy, PIMS-DU. The Participants will be selected based on the inclusion and exclusion criteria for eligibility. Informed consent will be obtained from the participants, and demographic data is recorded. Participants will be randomly allocated to 2 groups that is experimental group (n=41) and the conventional group(n=41). Prior assessment of the participants will be done. Group A that is the experimental group will be receiving the selective treatment protocol and conventional treatment protocol and Group B will be receiving conventional treatment protocol alone for Sacroiliac Joint Dysfunction. An intervention study was designed to investigate the effect of selective treatment protocol on pain, muscle strength, functional disability and quality of life in Sacroiliac Joint Dysfunction.
Experimental Group- This treatment protocol is designed to treat patients with Sacroiliac Joint Dysfunction. It will be conducted 3 days a week on every alternate days for 6 weeks. Total duration of each treatment session will last for approximately 30 mins. All these sessions will be strictly performed and supervised by the researcher.
Conventional Group- These are conventional treatment to treat Sacroiliac Joint Dysfunction. It will be conducted 3 days a week on every alternate days for 6 weeks. Total duration of each treatment session will last for approximately 30 mins. All these sessions will be strictly performed and supervised by the researcher.
STUDY VARIABLES
| Name of the variable | Measurement method | Statistical analysis | | Age | Interview | Nominal | | Gender | Observation | Nominal | | Pain | Visual Analogue Scale | Ordinal | | Strength | Manual Muscle Testing | Ratio | | Modified Oswestry Disability Questionnaire | Questionnaire | Ordinal | | Short form 12 Questionnaire | Questionnaire | Ordinal |
STATISICAL ANALYSIS Statistical Analysis will be done using appropriate test. |