| CTRI Number |
CTRI/2024/10/075437 [Registered on: 17/10/2024] Trial Registered Prospectively |
| Last Modified On: |
09/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Education about Pain on pain perception in adult individuals with longstanding low back pain |
|
Scientific Title of Study
|
Effect of Pain Neuroscience Education on pain perception in adult individuals with chronic non-specific 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 |
Dr Chhaya V Verma |
| Designation |
Professor and Head of Department |
| Affiliation |
Topiwala National Medical College and Dr B.Y.L. Charitable Hospital |
| Address |
OPD 24, PT School and Centre, Topiwala National Medical College and Dr B.Y.L.Charitable Hospital, Dr A.L, Dr Anandrao Nair Marg, Mumbai Central
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9082797203 |
| Fax |
|
| Email |
cvverma100@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chhaya V Verma |
| Designation |
Professor and Head of Department |
| Affiliation |
Topiwala National Medical College and Dr B.Y.L. Charitable Hospital |
| Address |
OPD 24, PT School and Centre, Topiwala National Medical College and Dr B.Y.L.Charitable Hospital, Dr A.L, Dr Anandrao Nair Marg, Mumbai Central
MAHARASHTRA
400008
India |
| Phone |
9082797203 |
| Fax |
|
| Email |
cvverma100@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bilwa Sawant |
| Designation |
Post Graduate student |
| Affiliation |
Topiwala National Medical College and Dr B.Y.L. Charitable Hospital |
| Address |
Topiwala National Medical College and Dr B.Y.L.Charitable Hospital, Dr A.L, Dr Anandrao Nair Marg, Mumbai Central
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9702421763 |
| Fax |
|
| Email |
bilwaysawant@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Chhaya V Verma |
Topiwala National Medical College |
Department of Physiotherapy (OPD 24) PT School and Centre, Topiwala National Medical College and Dr B.Y.L.Charitable Hospital, Dr A.L, Dr Anandrao Nair Marg, Mumbai Central
Mumbai
MAHARASHTRA |
9082797203
cvverma100@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Academic Research Projects (ECARP) PG Academic Committee T.N. Medical College and B.Y.L Nair Ch Hospital |
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 |
Only Standard of care Physiotherapy |
The individuals will receive standard of care physiotherapy only. (Patient education regarding importance of exercise and ergonomic advice; range of motion, stretching, and strengthening exercises; adjuvant therapy in the form of electrotherapeutic modalities as indicated). This will be for a period of 2 weeks with 3 sessions (alternate days) per week. |
| Intervention |
Pain Neuroscience Education along with standard of care physiotherapy |
The experimental group will receive ‘Pain Neuroscience education’. Pain Neuroscience Education is an educational strategy within the bio-psycho-social model of care for individuals with pain-related musculoskeletal conditions, which fits into the International Classification of Functioning, Disability & Health criteria.
It is an approach that shifts the focus from damaged anatomical structures to sensitization, and psychosocial factors as plausible causes of chronic pain. It intends to shift the individual’s conceptualization of pain from that of a marker of tissue damage or disease to that of an indicator of the perceived need to protect body tissue. The individuals will receive Pain Neuroscience Education (Educational video) after which any doubts regarding the same will be addressed before commencing the first session. This will be followed by standard of care physiotherapy. Standard of care physiotherapy treatment will be continued in the second and third sessions. To refresh the education and reinforce its impact, the Pain Neuroscience Education video will be presented to individuals at the beginning of the fourth session, marking the start of the second week. Standard of care physiotherapy treatment will be continued in the fifth and sixth sessions, ensuring a comprehensive approach to patient care |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult individuals (18 to 60 years) with chronic non-specific low back pain
2. Minimum score of 30 points on the Central Sensitization 25
3. Ability to understand either English, Hindi or Marathi
4. Willingness to participate in the study |
|
| ExclusionCriteria |
| Details |
1. Individuals in whom a specific LBP cause has been clearly determined (e.g. vertebral fracture, malignancy, infection, inflammatory arthritis, rheumatological conditions, lumbar radiculopathy, prolapsed intervertebral discs etc)
2. Individuals diagnosed with mental or cognitive issues
3. Individuals who have undergone lumbar fusion and/or disc replacement at any time
4. Pregnant women
5. Illiterate individuals (Individuals who cannot read or write) |
|
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Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain perception using Numerical Rating Scale and Pain Pressure Threshold Algometer |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Functional status using Roland Morris Disability Questionnaire |
6 months |
| Fear of Movement using Tampa Scale of Kinesiophobia-11 |
6 months |
| Pain Catastrophizing using Pain Catastrophizing Scale |
6 months |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
20/10/2024 |
| 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="6"
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
|
According to The International Association for the Study of Pain, Chronic non-specific low back pain is pain experienced between the lower ribcage and buttock creases which can extend into the legs, that persists or recurs for longer than 3 months, is associated with emotional distress and/or functional disability and symptoms that cannot be better accounted for by another diagnosis, such as tissue damage or a disease process. The consequences of chronic non-specific low back pain extend beyond physical discomfort, with increased anxiety and depression consequently impacting social, recreational, and work life of individuals. Psycho-social factors such as kinesiophobia, fear avoidance, and pain-catastrophizing behaviours are significant in determining the course of low back pain and its shift from acute towards chronic pain. Limiting beliefs not only make pain worse but also make therapeutic interventions and rehabilitation initiatives less successful. A holistic approach centred on the bio-psycho-social model of care is thus most beneficial for individuals with chronic non-specific low back pain. Pain Neuroscience Education is an educational strategy within the bio-psycho-social model of care for individuals with pain-related musculoskeletal conditions, which fits into the International Classification of Functioning, Disability & Health criteria. Pain Neuroscience Education is intended to help people reconceptualize their pain, desensitize their nervous system and change their pain-related beliefs and behaviours for the better. Studying the effect of Pain Neuroscience Education on pain perception is essential to strengthen the understanding of chronic pain management and potentially enhance the quality of care provided to individuals with chronic non-specific low back pain. Ai Aim: To study the effect of Pain Neuroscience Education on pain perception in adult individuals with chronic nonspecific low back pain Primary Objectives: (Control Group: Adult individuals with chronic non-specific low back pain receiving Standard of Care Physiotherapy. Experimental Group: Adult individuals with chronic non-specific low back pain receiving Pain Neuroscience Education along with Standard of Care Physiotherapy) 1. To assess Pain using Numerical Rating Scale and Pain Pressure Threshold Algometer, Functional Status using Roland Morris Disability Questionnaire, Fear of Movement using Tampa Scale of Kinesiophobia -11 and Pain Catastrophizing using Pain Catastrophizing Scale, pre and post intervention in control group and experimental group 2. To compare pre and post intervention values of pain, functional status, fear of movement, and pain catastrophizing in control group 3. To compare pre and post intervention values of pain, functional status, fear of movement, and pain catastrophizing in experimental group 4. To compare post intervention values of pain, functional status, fear of movement, and pain catastrophizing between control group and experimental group Intervention & Procedure: Intervention duration: 2 Weeks (Follow up thrice a week, alternate days). Both the control group as well as the experimental group will receive a total of 6 sessions in the study. Control group: The individuals will receive standard of care physiotherapy only. (Patient education regarding importance of exercise and ergonomic advice; range of motion, stretching, and strengthening exercises; adjuvant therapy in the form of electrotherapeutic modalities as indicated). Experimental group: The experimental group will receive ‘Pain Neuroscience education’, via a 4 minute, 30 seconds long video. The video is licensed under the terms of the Creative Commons Attribution Non-commercial license, which permits unrestricted non-commercial use, distribution and reproduction in any medium, remixed or adapted, provided the original work is properly cited. The original video in English has been translated into Marathi and Hindi. This will be followed by standard of care physiotherapy. Pre and post assessment of participants will be done by assessor from peer group. |