| CTRI Number |
CTRI/2024/08/072219 [Registered on: 09/08/2024] Trial Registered Prospectively |
| Last Modified On: |
08/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Home exercise adherence program for low back pain patients with support |
|
Scientific Title of Study
|
Effects of Individually Tailored Home Based Exercise Program with Support Adherence for People with Chronic Low Back Pain: 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 |
Seeram Harika |
| Designation |
post graduate student |
| Affiliation |
SRM college of physiotherapy SRM institute of science and technology |
| Address |
Roomno PT05 5th floor SRM college of physiotherapy SRM medical college hospital and research center SRMnagar potheri kattankulthurpost Chengalpattu Kanchipuram Tamilnadu 603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7093132327 |
| Fax |
|
| Email |
harikaseeram6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Balamurugan jankiraman |
| Designation |
research associate |
| Affiliation |
SRM college of physiotherapy SRM institute of science and technology |
| Address |
Roomno PT29 4th floor SRM college of physiotherapy SRM medical college hospital and research center SRMnagar potheri kattankulthurpost Chengalpattu Kanchipuram Tamilnadu 603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9941215503 |
| Fax |
|
| Email |
bala77physio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Balamurugan jankiraman |
| Designation |
research associate |
| Affiliation |
SRM college of physiotherapy SRM institute of science and technology |
| Address |
Roomno PT29 4th floor SRM college of physiotherapy SRM medical college hospital and research center SRMnagar potheri kattankulthurpost Chengalpattu Kanchipuram Tamilnadu 603203
TAMIL NADU
603203
India |
| Phone |
9941215503 |
| Fax |
|
| Email |
bala77physio@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM college of physiotherapy
SRM institute of science and technology
SRM nagar potheri kattankulathur Tamilnadu 603203
India |
|
|
Primary Sponsor
|
| Name |
SRM college of physiotherapy SRM institute of science and te3chnology |
| Address |
Roomno PT05 5th floor SRM college of physiotherapy SRM medical college hospital and research center SRMnagar potheri kattankulthurpost Chengalpattu Kanchipuram Tamilnadu 603203 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Seeram Harika |
SRM medical college and hospital |
room no 5 physiotherapy OPD first floor SRM medical college hospital and research center SRMnagar potheri kattankulthurpost Chengalpattu Kanchipuram Tamilnadu 603203
Kancheepuram
TAMIL NADU |
7093132328
harikaseeram6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM medical college hospital and research centre institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M479||Spondylosis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
home exercise support program for low back pain patient |
a manual detailing home exercise program with appropriate pictures and instructions will be provided with support files
treatment is given five days in a week with duration of 30 minutes in a day the total duration of intervention program will be for 6 weeks and follow up at 12 th week |
| Comparator Agent |
standard home exercise program without patient support file |
patient will be verbally instructed about home exercise program
treatment is given 5 days in a week with duration of 30 minutes in a day the total duration of intervention program will be for 6 weeks and follow up at 12 th week |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Participants aged 18 and above are included
2 patients who had diagnosed with low back pain more than 3months.
3 Patients who are willing to do home exercises with adherence support are mainly included.
|
|
| ExclusionCriteria |
| Details |
1 Patients without personnel smart phone
2 Impaired hearing & speech
3 Cognitive impairment
4 Women planning for pregnancy
5 Patient who are not willing to sign the informed consent
6 Patient with psychological illness
7 Infectious conditions related to spine, groin, and abdomen
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
(1) Exercise Adherence Rating Scale (EARS)
(2) Self efficacy for Exercise (SEE) scale
|
baseline
at 6 weeks
at 12 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Roland Morris Disability Questionnaire
Numeric Pain Rating Scale
|
baseline
at 6 weeks
at 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
09/09/2024 |
| 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="0"
Months="10"
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: Low back pain affects near about 8% of the world adult population, and the life time prevalence of LBP in India was 66%. The standard practice guidelines to manage LBP and improve function recommends the use of exercise to be effective. Non-adherence to exercises is a challenge for healthcare providers particularly in the physical rehabilitation domains. However, most of the time the effect of the home-based exercise programs is often small, not sustained, and poorly adhered. The extent to which the LBP patients engage and adhere to the home-exercise program has been identified as an important predictor of the efficacy of the management and the prognostic outcome. The objective of this study is to determine the efficacy of individually tailored exercise program integrated with exercise adherence strategies in improving the LBP patients home exercise engagements (adherence), exercise self-efficacy, and physical function. Hypothesis;(Ha) Our hypothesis (Ha) is that the individually tailored home-based LBP exercise program with adherence support interventions will be improving the exercise adherence, exercise self-efficacy, and physical function in comparison with the individually tailored home exercise program without adherence support for LBP patients. Methods: A single-center, 2-arm parallel group (1:1 allocation) randomized controlled trial using blinded assessment at baseline, 6 weeks, and 12 weeks, will be conducted. All the eligible adult participants with chronic LBP visiting the SRMIST physiotherapy OPD for LBP management will be checked for eligibility to participate in this study. At the time of home exercise prescription, the participants will be either allocated to the tailored home exercise program with the additional exercise adherence support intervention program spread over the 6 weeks or the standard physiotherapy home-exercise program with the follow up at 12 weeks. Discussion; This research will help in the testing the efficacy of the support adherence program for home exercise engagement for the LBP participants, and the effects of good exercise engagement to home-exercise program in improving the physical function and pain among the LBP patients. |