| CTRI Number |
CTRI/2025/03/082750 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
17/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Role of Therapeutic Alliance in Enhancing Clinical Outcomes for Chronic Low Back Pain Patients |
|
Scientific Title of Study
|
Therapeutic Alliance between Patient and Physiotherapist to Predict the Clinical Outcome Of Chronic Low Back Pain |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shazia Mattu |
| Designation |
PhD Scholar |
| Affiliation |
Teerhanker Mahaveer University |
| Address |
Teerthankar Mahaveer University
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9634616290 |
| Fax |
|
| Email |
shazia.scholar@tmu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Amit Saraf |
| Designation |
Head of orthopedics Department |
| Affiliation |
Teerhanker Mahaveer University |
| Address |
Teerthankar Mahaveer Hospital
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9780029750 |
| Fax |
|
| Email |
AMITSARAF_75@Yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
AMIT SARAF |
| Designation |
HEAD OF ORTHOPEDICS |
| Affiliation |
Teerhanker Mahaveer Hospitaland University |
| Address |
DEPARTMENT OF ORTHOPEDICS 4TH FLOOR TEERTHANKER MAHAVEER HOSPITAL
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9634616290 |
| Fax |
|
| Email |
amitsaraf_75@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Shazia Mattu |
| Address |
5th Floor Nursing Building Department of Physiotherapy Teerthanker Mahaveer University |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| SHAZIA MATTU |
TEERTHANKER MAHAVEER HOSPITAL |
Physiotherapy OPD Ground Floor
Teerthanker Mahaveer Hospital Moradabad
Moradabad
UTTAR PRADESH |
9634616290
shazia.scholar@tmu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TEERTHANKER MAHAVEER UNIVERSITY COLLEGE OF PARAMEDICAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NON SPECFIC CHRONIC LOW BACK PAIN |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Experimental |
Data will be collected from the Outpatient department of Teerthanker Mahaveer University. A total of 112 subjects suffering from Non-specific Low back pain will be included in the study. The subjects will be divided into 2 groups. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patient with Low Back Pain without radicular pain and without radiological features of Lumbar Spine pathology.(Non-Specific Chronic Low Back pain for at least 3 months.)
Aged between 18 to 40 years.
NPRS (Pain Intensity Score between 3 to 8)
Both male and female
|
|
| ExclusionCriteria |
| Details |
Other than Non – specific Chronic Low back pain.
Contraindication to exercise.
Contraindication to Electrotherapeutic Modality.
Patient who is already on Pain Medication.
Patient who is already taking Psychological Counselling.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
NPRS
PROMIS 29+
DISABILITY SCALE(ODS)
Working Alliance Inventory Scale
EMG biofeedback |
Baseline assessment
assessment on the 4th week
Assessment on 8th Week
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
NPRS
PROMIS29+
WORKING ALLIANCE INVENTORY SCALE
EMG BIOFEEDBACK |
Baseline Assessment
Assessment will be on 4th week
Assessment on 8th week |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
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)
|
17/04/2025 |
| 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="1"
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
|
Background: The diverse range of
approaches mentioned, from screening
tools to cognitive-behavioral therapy and mindfulness, highlights the need for
a holistic and personalized approach to address the complexity of chronic LBP.
The rationale is based on existing
research indicating the positive
influence of therapeutic alliance on
clinical outcomes
and treatment adherence in other health
conditions. The widespread
acceptance of the biopsychosocial model of pain characterizes chronic pain as a
complex interplay among physiological, psychological, and social factors. This
multidimensional and dynamic perspective is crucial for understanding and
addressing the complexity of chronic pain conditions.
Purpose: Considering the specific physical
interventions, the broader environment, the patient-clinician
relationship, and overall contextual factors. The idea is that optimizing the
context in which physical
therapy is delivered can contribute to more effective outcomes for
patients. |