| CTRI Number |
CTRI/2022/09/045378 [Registered on: 09/09/2022] Trial Registered Prospectively |
| Last Modified On: |
02/09/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To find the effect of combined exercise programme on less physical activity workers with ill defined chronic low back pain. |
|
Scientific Title of Study
|
Effectiveness of combined exercise intervention protocol on sedentary workers with nonspecific 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 |
SAINA SWATHI |
| Designation |
Research scholar |
| Affiliation |
Chettinad academy of research and education(CARE) |
| Address |
Chettinad academy of research and education(CARE),Chettinad health city,Rajiv gandhi salai(OMR),Kelambakkam,Tamil nadu 603103
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
09030927600 |
| Fax |
|
| Email |
swathithamada@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrPSenthil |
| Designation |
Professor |
| Affiliation |
Chettinad academy of research and education |
| Address |
Chettinad academy of research and education(CARE),Chettinad health city,Rajiv gandhi salai(OMR),Kelambakkam,Tamil nadu 603103
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9841667912 |
| Fax |
|
| Email |
senthil.p@care.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
DrPSenthil |
| Designation |
Professor |
| Affiliation |
Chettinad academy of research and education |
| Address |
Chettinad academy of research and education(CARE),Chettinad health city,Rajiv gandhi salai(OMR),Kelambakkam,Tamil nadu 603103
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9841667912 |
| Fax |
|
| Email |
senthil.p@care.edu.in |
|
|
Source of Monetary or Material Support
|
| Chettinad academy of research and education,CARE |
|
|
Primary Sponsor
|
| Name |
Chettinad academy of research and education CARE |
| Address |
Chettinad health city,rajiv gandhi salai OMR,Kelambakkam,
Tamil nadu 603103 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Sswathi |
Chettinad academy of research and education,Chettinad health city,Rajiv gandhi salai(OMR),Kelambakkam,Tamil nadu 603103 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Saina Swathi |
Chettinad hospital and research institute |
chettinad health city,rajiv gandhi salai,OMR,Kelambakkam ,Tamil nadu
Kancheepuram
TAMIL NADU |
09030927600
swathithamada@gmail.com |
| DrSabiha nikhat |
S.A.Poly clinic, |
24/1 ,Perambur barracks road ,pattalam,
Chennai
TAMIL NADU |
9789949907
mascot.nikki77@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional human ethics commitee for student research (CARE IHEC-I,Chettinad academy of research and education. |
Approved |
| S.A.PolyClinic |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M95-M95||Other disorders of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Combined exercise intervention |
It includes stretching, strengthening and aerobic exercises, along with pain neuro science education. Study duration for 12 weeks, 3days/week,60 minutes treatment duration. |
| Comparator Agent |
Stabilization exercises |
stabilization exercises along with pain neuro science education. Study duration for 12 weeks, 3days/week,60 minutes treatment duration. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Nonspecific chronic low back pain (>3 months duration).
2. Sedentary workers with a low level of physical activity.
3. Subjects with CSI Score > 40.
|
|
| ExclusionCriteria |
| Details |
1. Subjects with red flag signs.
2. Subjects with neurological abnormalities (motor
or sensory deficits)
3. Subjects who are pregnant.
4. Subjects with systemic diseases.
5. Subjects with specific conditions such as fracture, spondylosis, spondylolisthesis, spinal stenosis, ankylosing spondylitis, and previous low back surgery.
6. Subjects who are under medication or any co-interventions
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Numerical Pain Rating Scale (NPRS),SF-36 Quality Of Life, Oswestory Disability Index (ODI), |
Base line ,4th week,12th week. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Wells flexibility test : SIT TO REACH TEST
Lumbar muscle functioning: Ultrasonography.
Sub maximal exercise testing:6 minute walk test.
Central Sensitization Inventory Questionnaire. |
BASELINE,6THWEEK,12TH WEEK. |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
15/09/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
•Low back pain is the leading cause of years lived with disability YLD globally. It has been increasing every year and results in activity limitation and absenteeism from work. The lifetime prevalence of low back pain is reported to be as high as 84%, and best estimates suggest that the prevalence of chronic low back pain is about 23%, with 11–12% of the population being disabled by it. Research has highlighted the increased prevalence of LBP among young and middle-aged people. The incidence of low back pain in employees with sedentary behavior was 14. 37% and the prevalence of people experiencing low back pain is 34-62%. •Non-specific low back pain is defined as low back pain not attributable to a known cause and represents 90–95% of the cases of Low back pain. The estimated point prevalence of non-specific low back pain is 18%. In the working population, 24.61 percent of patients with recent onset of LBP developed chronicity. The pain, disability, and impaired quality of life related to chronic LBP contribute to a considerable socio-economic burden for people with chronic low back pain and society. The etiology of low back pain is widely accepted to be of multifactorial origin, including individual, physical, and psychosocial factors.•Sedentary workers usually requires pro- longed sitting posture. Lack of movement during sitting may induce the shortening of soft tissues, which consequently limits the available joint range of movement. Limited joint movement may distort the normal body bio-mechanics and contributes to musculoskeletal disorders. Moreover, the subjects with chronic low back pain had limitations of activity due to central sensitization. Clinical practice guidelines often recommend pain neuroscience education alongside other Physical therapy interventions such as exercise to patients with chronic low back pain as the first line treatment. •However, it remains unclear which exercise program has a greater effect and a longer lasting positive effect on people suffering from LBP and performing sedentary work |