| CTRI Number |
CTRI/2024/05/068081 [Registered on: 30/05/2024] Trial Registered Prospectively |
| Last Modified On: |
29/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Graded Sensory and Motor Retraining on pain, fear of movement and posture in young adults population with non-specific chronic low back pain. |
|
Scientific Title of Study
|
Effect of Graded Sensorimotor Retraining on pain, kinesophobia and postural stability among young adults with non-specific chronic low back pain: A Randomised 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 |
Sable Kruti Prakash |
| Designation |
Post graduate |
| Affiliation |
Nitte Institute of Physiotherapy NITTE (Deemed to be university) |
| Address |
Department of Physiotherapy,room no 20,second based division, Nitte Institute of physiotherapy NITTE (Deemed to be university) Derlakatte, Mangaluru, Karnataka, India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8073968611 |
| Fax |
|
| Email |
krutisable04@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nityal Kumar Alagingi |
| Designation |
Assistant Professor |
| Affiliation |
Nitte Institute of Physiotherapy NITTE (Deemed to be university) |
| Address |
Department of Physiotherapy,room no 20,second based division, Nitte Institute of physiotherapy NITTE (Deemed to beuniversity), Derlakatte, Mangaluru, Karnataka, India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7760547669 |
| Fax |
|
| Email |
nityalkumar2020@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Nityal Kumar Alagingi |
| Designation |
Assistant Professor |
| Affiliation |
Nitte Institute of Physiotherapy NITTE (Deemed to be university) |
| Address |
Department of Physiotherapy,room no 20,second based division, Nitte Institute of physiotherapy NITTE (Deemed to beuniversity), Derlakatte, Mangaluru, Karnataka, India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7760547669 |
| Fax |
|
| Email |
nityalkumar2020@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| Nitte Institute of Physiotherapy NITTE(Deemed to be university)
Department of Physiotherapy,room no 20,second based division, Nitte Institute of physiotherapy NITTE (Deemed to be university)Derlakatte,Mangaluru,Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Nitte Instituteof Physiotherapy |
| Address |
Department of Physiotherapy,room no 20,second based division, Nitte Institute of physiotherapy NITTE (Deemed to be university)Derlakatte,Mangaluru,Karnataka, India |
| Type of Sponsor |
Other [Nitte Institute of Physiotherapy NITTE (Deemed to be university)] |
|
|
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 Nityal Kumar Alagingi |
Justice K S Hegde Charitable Hospital |
Department of physiotherapy, Room No 20, Second Base Division, Nitte Institute of Physiotherapy, NITTE (Deemed to be university)
Dakshina Kannada
KARNATAKA
Dakshina Kannada
KARNATAKA |
7760547669
nityalkumar2020@nitte.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe of NITTE Institute of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M545||Low back pain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Physical therapy |
Conventional Physical therapy will be given for 40 mins day for 3 days in week for 8 weeks for both group.Exercises included are 1)Hamstring stretching,2)Quadriceps stretching,3)Abdominal stretching, 4)Cat- Camel exercise,5)Neutral position,6)Curl-Up,7)Dead Bug,8)Side Bridge,9)Superman,10)Pelvic Bridging,11)Quadruped position while lifting one arm and one leg of same side.( each of this exercises will be having 10 repetitions;hold up to 5seconds.
Progresses up to 10 repetitions; hold up to 10 seconds. |
| Intervention |
Sensorimotor Retraining |
Participants included in this group will be given graded sensorimotor retraining which includes treatment divided in 8stages which is categorized in two segments i.e. sensory retraining & motor retraining, Each stage is planned to be executed for 40 mins day for 3 days in a week for 8 weeks duration; all the 3 days treatment will be given by considering both aspects i.e. both sensory retraining and motor retraining. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
28.00 Year(s) |
| Gender |
Both |
| Details |
1)Students who are 18 to 28 years of age
2)Both male & female
3)Chronic low back pain of a non-specific nature
4)Young individuals suffering from at least a single episode of back pain in the past 3 months
5)NPRS ( Numerical Pain Rating Scale) score between 3 out of 10 to 8 outof 10
|
|
| ExclusionCriteria |
| Details |
1)Presence of neurological signs (e.g., perceived weakness in the lower limbs)
2)A diagnosed psychiatric disorder or severe cognitive impairment
3)Having the specific disease (e.g., malignancy, inflammatory joint and bone disease) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Numerical Pain Rating Scale
2) TAMPA scale for kinesophobia
3) Multidirectional functional reach test
|
Once the individual is included in the study, readings will be taken as baseline values and after 8 weeks of treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
Final Enrollment numbers achieved (Total)= "56"
Final Enrollment numbers achieved (India)="56" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| Date of Study Completion (India) |
28/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
In recent scenario,it is estimated that up to 85% of people with low back pain (LBP) who seek primary care are non-specific and major population affected by it is young adults. It has been noted that standard care is effective in treating the condition for a particular period when it comes to recurrent bouts of low back pain. In addition to the goal of reducing pain, postural stability and kinesophobia should be taken into account when treating chronic non-specific low back pain. A multi-modal strategy i.e. graded sensorimotor retraining which includes retraining the brain’s motor and sensory regions helps in not only reduction of pain but also resolve kinesophobia and increases postural stability. The graded approach used in this specific treatment helps to retrain both the aspects. So, this study is proposed to identify the effectiveness of including sensory as well as motor aspect while treating non-specific chronic low back pain.
|