| CTRI Number |
CTRI/2026/04/107267 [Registered on: 01/04/2026] Trial Registered Prospectively |
| Last Modified On: |
27/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Improving Function and Reducing Fear in Chronic Low Back Pain: A Study on Cognitive Functional Therapy and Relaxation Techniques |
|
Scientific Title of Study
|
EFFECT OF COGNITIVE FUNCTIONAL THERAPY AND JACOBSON’S RELAXATION TECHNIQUE ON FUNCTIONAL STATUS, PAIN CATASTROPHISATION AND FEAR AVOIDANCE BELIEF IN MIDDLE AGED ADULTS WITH CHRONIC NON SPECIFIC LOW BACK PAIN 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 |
Ayushi Lanjewar |
| Designation |
Post graduate student |
| Affiliation |
School of Allied Health and Sciences |
| Address |
Department of physiotherapy,School of Allied Health and Sciences,
Malla Reddy University,
Maisamaguda,
Hyderabad
Hyderabad
TELANGANA
500055
India |
| Phone |
8329391642 |
| Fax |
|
| Email |
lanjewaraayushi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mubeena Banu N |
| Designation |
Assistant Professor |
| Affiliation |
School of Allied Health and Sciences |
| Address |
Department of physiotherapy ,School of Allied Health and Sciences,
Malla Reddy University,
Maisamaguda,
Hyderabad
Hyderabad
TELANGANA
500055
India |
| Phone |
7358225669 |
| Fax |
|
| Email |
lanjewaraayushi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ayushi Lanjewar |
| Designation |
Post graduate student |
| Affiliation |
School of Allied Health and Sciences |
| Address |
School of Allied Health and Sciences,
Malla Reddy University,
Maisamaguda,
Hyderabad
TELANGANA
500055
India |
| Phone |
8329391642 |
| Fax |
|
| Email |
lanjewaraayushi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of physiotherapy ,School of Allied Health and Sciences,
Malla Reddy University,
Maisamaguda,
Hyderabad
500055
INDIA |
|
|
Primary Sponsor
|
| Name |
MALLA REDDY UNIVERSITY |
| Address |
School of Allied Health and Sciences,
Malla Reddy University,
Maisamaguda,
Hyderabad
500055
INDIA |
| 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 |
| DrAyushi Lanjewar |
Malla Reddy University |
Department of Physiotherapy,School of Allied Health and Sciences,
Malla Reddy University,
Maisamaguda,
Hyderabad
Hyderabad
TELANGANA |
08329391642
lanjewaraayushi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe for biomedical and health research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
cognitive functional therapy and Jacobsons relaxation technique |
12 direct sessions and 12 On call session
8 week training intervention of 3 non consecutive days a week
Duration is 60 min per session
The intervention consists of the following 3 main stages:A. Making sense of pain that is completely reflective, where physical therapist could use the context of the patient’s own story to provide a new understanding of their condition and question their old beliefs .
B. Exposure with control which is designed to normalize maladaptive or provocative movement and posture related to activities of daily living that is integrated into each patient’s functional impairments, including teaching how to relax trunk muscles, how to have normal body posture while sitting, lying, bending, lifting, moving, and standing, and how to avoid pain behaviors, which aims to break poor postural habits; and
C.Lifestyle change which is investigating the influence of unhealthy lifestyles in the patient’s pain context.
JACOBSON’S RELAXATION TECHNIQUE
20 min per session
For both group A and group B
a. To sit on a chair as comfortably as possible. Keep your body loose light and free.
b. Be calm and comfortable.
c. Keep your eye closed.
d. Avoid stray thoughts.
e. Avoid extra movements of the body.
f. During the part of the exercise cycle tense the muscle tightly and hold for slow count of 5 seconds.
g. During the relation part of exercise cycle relaxes the muscle quickly and completely .let your mind relax and appreciate how relaxed the muscle is feeling for 10 seconds.
h. Try to keep all other muscles relaxed as you exercise specific muscle group.
i. As you exercise from head to toe.Observe changes like tightness and the development of light and soothing sensations.
j. Relax by taking three deep breaths inhaling through nose and exhaling through mouth after each step.
k. Now make your body completely loose,lightand free.
l. Let us being your exercise
|
| Comparator Agent |
Lumbar stabilisation exercise and Jacobsons relaxation technique |
8 week stabilization exercise program on lumbar proprioception in patients with low back pain
3 sessions per week for 8 weeks
Duration is 30 min per session
Lumbar stabilization exercises consisted of 16 exercises, which are aimed to strengthen the deep lumbar stabilizing muscles: the transversus abdominis, lumbar multifidi,and internal obliques.
All 16 stabilization exercises will be performed once, consecutively, and in the same order .
Before each exercise, the verbal explanation and visual instructions, regarding the start and end positions will be told.
The final static position will be held for 10 seconds, and each exercise will be performed for 10 repetitions. There will be a pause of 3 seconds between repetitions and a 60 second rest between each exercise.
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients with non specific chronic low back pain Duration of pain atleast 12 weeks,Moderate pain ( more than or equal to 4 NPRS ),Independently mobile,Patients who can communicate in Hindi or English language,Medical clearance able to participate in an exercise program as confirmed by a physician or orthopaedician
|
|
| ExclusionCriteria |
| Details |
Acute low back pain,history of lumbar spine surgery or fracture,neurological disorder- Condition affecting motor control (eg: parkinsons disease ,
Multiple sclerosis,stroke),Systemic Inflammatory conditions – Diagnosed Autoimmune disorder,metabolic or Hormonal condition
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
TUG test,Fear Avoidance Belief’s Questionnaire ,Pain Catastrophising scale
|
8 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Lumbar Range of Motion,Corset Effect with pressure biofeedback unit(PBFU)
|
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
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)
|
10/04/2026 |
| 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
|
The study is about effect of cognitive functional therapy on chronic non specific low back pain in middle aged adults .The outcome measures to be used are TUG test for functional ability , pain catastrophising scale to know pain catatrophisation , fear avoidance belief questionnaire to know fear develpoed among individuals regarding work and physical activities, range of motion to know improvement in lumbar ranges and corset effect using pressure biofeedback unit to check strength of abdominal muscles. |