| CTRI Number |
CTRI/2025/06/089119 [Registered on: 19/06/2025] Trial Registered Prospectively |
| Last Modified On: |
17/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA)
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing acceptance and commitment therapy with exercise therapy versus only exercise therapy in chronic low back pain patients |
|
Scientific Title of Study
|
Comparing acceptance and commitment therapy with exercise therapy versus only exercise therapy in chronic low back pain patients with central sensitization: A randomized control 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 |
Praveenkumar M |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical sciences |
| Address |
Department of Physical medicine and rehabilitation, All India Institute of Medical sciences, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9786141099 |
| Fax |
|
| Email |
praveenkumarm233@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S L Yadav |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical sciences |
| Address |
Room no three, Department of Physical medicine and rehabilitation, All India Institute of Medical sciences, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9560678577 |
| Fax |
|
| Email |
slyaiims59@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Praveenkumar M |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical sciences |
| Address |
Department of Physical medicine and rehabilitation, All India Institute of Medical sciences, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9786141099 |
| Fax |
|
| Email |
praveenkumarm233@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Praveenkumar M |
| Address |
Physical Medicine and Rehabilitation, AIIMS New Delhi |
| Type of Sponsor |
Other [Self] |
|
|
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 Praveenkumar M |
All India Institute of Medical Sciences New Delhi |
Room no one, Department of Physical Medicine and Rehabilitation
West
DELHI |
9786141099
praveenkumarm233@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee AIl India Institue of Medical Sciences New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, (2) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Acceptance and commitment therapy |
Acceptance and commitment therapy will be given on weekly basis as one session per week for six weeks Participants will also receive home based exercise therapy for six weeks Participants will be evaluated at zero six and twelve weeks
They will be evaluated at zero six and twelve weeks |
| Comparator Agent |
Exercise therapy |
Participants in this group will receive home based exercise therapy as three phases Basic intermediate and advanced levels Each phase will be for two weeks and the patients will be assessed at zero six and twelve weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of Chronic Low Back Pain patients having pain in the area between costal margin and inferior gluteal fold for more than three months in the past six months
Individuals of either sex
Individuals of age between eighteen to sixty years
Individuals with BMI eighteen point nine to twenty nine point nine
Individuals with CSI score more than or equal to thirty
Individuals who can read and understand English or Hindi
|
|
| ExclusionCriteria |
| Details |
Individuals with history of spinal trauma which had led to neurological deficit or deformity and spinal surgery
Individuals with history of deformity kyphosis scoliosis
Individuals with history of spinal infection
Individuals who are immunocompromised history of unintentional weight loss fever night sweats HIV infection
Individuals with inflammatory back pain conditions iritis skin rashes morning stiffness for more than thirty minutes history of rheumatic disease
Individuals with malignancy
Individuals with any illness impairing daily functioning
Pregnant women
Red flags or clinical signs such as progressive motor or sensory loss new onset urinary retention or overflow incontinence history of cancer recent history of invasive spinal procedure significant trauma radiating pain from lower back
Individuals with severe pain VAS score more than or equal to seven
Individuals who refuse to participate
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare the reduction in central sensitization in chronic low back pain patients using central sensitization inventory(CSI). |
0 week 6 weeks 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Chronic low back pain will be measured using Visual Analogue Scale.
2) Pain related disability due to chronic low back pain will be measured using Modified Oswestry Disability Index .
3) Psychological factors like depression, anxiety and stress will be measured using Depression Anxiety and Stress scale (DASS-21.
|
0 week 6 weeks 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
29/06/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
To assess and compare the effectiveness of acceptance and commitment therapy including exercise therapy with only exercise therapy in people with chronic low back pain and central sensitization. It is a randomised control single blinded comparator trial. Exercise therapy will be given for both groups whereas acceptance and commitment therapy will be given only to interventional group. Both the groups will be assessed at 0,6 and 12 weeks. |