| CTRI Number |
CTRI/2023/03/050346 [Registered on: 03/03/2023] Trial Registered Prospectively |
| Last Modified On: |
02/03/2023 |
| 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
|
Effect of treatment program on pain, function and disability in type 2 Diabetic individuals with long term low back pain |
|
Scientific Title of Study
|
Effect of comprehensive rehabilitation program on pain, function and disability in Type 2 Diabetes Mellitus individuals with chronic low back pain |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shetty Shrija Jaya |
| Designation |
Ph.D. Scholar |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka-576104
Udupi
KARNATAKA
576104
India |
| Phone |
8861871688 |
| Fax |
|
| Email |
shettyshrija@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shetty Shrija Jaya |
| Designation |
Ph.D. Scholar |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka-576104
Udupi
KARNATAKA
576104
India |
| Phone |
8861871688 |
| Fax |
|
| Email |
shettyshrija@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr G Arun Maiya |
| Designation |
Professor- Department of Physiotherapy and Dean-Manipal College of Health Professions |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Second floor, Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka-576104
Udupi
KARNATAKA
576104
India |
| Phone |
9845350823 |
| Fax |
08202571915 |
| Email |
arun.maiya@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Centre for diabetic foot care and research; and Kasturba hospital |
|
|
Primary Sponsor
|
| Name |
Spry Therapeutics Private Limited |
| Address |
18 Sangam B Wing, Four Bungalows, Haridwar Marg, Andheri West, Mumbai- 400061, Maharashtra
|
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Shetty Shrija Jaya |
Kasturba Hospital |
Room number- 4, Centre for Diabetic foot care and research, Department of Physiotherapy, First floor, N Block, Kasturba Hospital, Manipal, Udupi, Karnataka-576104
Udupi
KARNATAKA |
08202923054
shettyshrija@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba medical college and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comprehensive exercise based rehabilitation program |
Comprehensive exercise based rehabilitation program will include pain management using photobiomodulation
therapy; pain education and ergonomic advice; and exercise interventions targeting functional
restoration and recovery which will include low back exercises, core exercises, lower limb
exercises, and ambulation which will include postural exercises, functional strength restoration,
flexibility training, lumbar stabilization exercises, neural mobilization, and functional exercises
along with standard care.
Duration of intervention will be of 12 weeks. These exercises will be progressed as per speed, resistance,
repetition, and difficulty at 4th and 8th week. |
| Comparator Agent |
Standard protocol |
It will include standard care provided by Orthopedician, moist heat for pain relief and Conventional exercises provided by physiotherapist which will include low back exercises
and core exercises. Total duration of exercises in control group will be of 12 weeks.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Phase I: Age 18 to 65 years, participants diagnosed with T2DM and on medication from past 1 year, T2DM with or without peripheral neuropathy, HbA1c > 6.4%
Phase II: Age 18 to 65 years, history of low back pain LBP> 3 months, Participants diagnosed with Type 2 Diabetes Mellitus and on medication from past 1 year, HbA1c > 6.4%, Numeric pain rating scale >3, Oswestry disability index Score >20%. |
|
| ExclusionCriteria |
| Details |
Phase I: Infections or tumors of the spine, systemic bone or joint disorders, neuromuscular pathology, presence of a diagnosed severe psychiatric disorder, confirmed pregnancy, acute disc prolapse, prolapsed Intervertebral disc of other causes, low back pain due to traumatic causes
Phase II: Infections or tumors of the spine, systemic bone or joint disorders, unstable
cardiovascular and pulmonary diseases, polyneuropathies and musculoskeletal system diseases, presence of a diagnosed severe psychiatric disorder, confirmed pregnancy, any systemic complications which prevents their participation in study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Pressure pain Threshold using algometer
• Gait analysis using Win-track
• Pain using Numeric pain rating scale |
Before start of the intervention, at 12 weeks and at 24 weeks after that |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Disability using Oswestry disability index
• Soft tissue changes using MRI of low back |
Before start of the intervention, at 12 weeks and at 24 weeks after that |
|
|
Target Sample Size
|
Total Sample Size="124"
Sample Size from India="124"
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)
|
10/03/2023 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomized controlled trial. Aim of this study is to evaluate the effect of Comprehensive exercise based rehabilitation program on Pain, Function, and Disability in Type 2 Diabetes Mellitus Individuals with Chronic Low Back Pain. Objectives of this study are Phase 1: To profile characteristics of low back pain in Individuals with Type 2 Diabetes Mellitus; Phase 2: To evaluate the effect of comprehensive rehabilitation in Type 2 Diabetes Mellitus individuals suffering from chronic low back pain. There will be 2 groups, intervention group and control group. Intervention group will receive comprehensive exercise based rehabilitation program and control group will receive standard protocol. Comprehensive exercise based rehabilitation program will include pain management using photobiomodulation therapy; pain education and ergonomic advice; and exercise interventions targeting functional restoration and recovery which will include low back exercises, core exercises, lower limb exercises, and ambulation which will include postural exercises, functional strength restoration, flexibility training, lumbar stabilization exercises, neural mobilization, and functional exercises along with standard care. Exercises will be done for 12 weeks. These exercises will be progressed as per speed, resistance, repetition, and difficulty at 4th and 8th week. Control group will receive standard care, moist heat for pain relief and conventional exercises which will include core and low back exercises. Primary outcome measures are Pressure pain Threshold using algometer, Gait analysis using Win-track and Pain using Numeric pain rating scale. Secondary outcome measures are Disability using Oswestry disability index and Soft tissue changes using MRI of low back. Outcomes will be measured at baseline, at 12 weeks and at 24 weeks. |