| CTRI Number |
CTRI/2022/05/042585 [Registered on: 17/05/2022] Trial Registered Prospectively |
| Last Modified On: |
11/05/2022 |
| 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
|
Education about pain and its effects on physical health. |
|
Scientific Title of Study
|
Impact of Pain Neuroscience Education added as an adjunct to conventional exercises on pain and pain coping/pain behavior in patients with Non specific Neck Pain- A Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Benish Bubere |
| Designation |
Intern |
| Affiliation |
MGM School of Physiotherapy |
| Address |
MGM School of Physiotherapy,
N6 Cidco,
Aurangabad- 431003.
Department of physiotherapy.
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9987388308 |
| Fax |
|
| Email |
benishbubere22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vaibhavi Walimbe |
| Designation |
Assistant Professor |
| Affiliation |
MGM School of Physiotherapy |
| Address |
MGM School of Physiotherapy,
N6 Cidco,
Aurangabad- 431003
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
7058271894 |
| Fax |
|
| Email |
vaibhavi.walimbe@mgmsop.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Vaibhavi Walimbe |
| Designation |
Assistant Professor |
| Affiliation |
MGM School of Physiotherapy |
| Address |
MGM School of Physiotherapy,
N6 Cidco,
Aurangabad- 431003
Department of physiotherapy
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
7058271894 |
| Fax |
|
| Email |
vaibhavi.walimbe@mgmsop.edu.in |
|
|
Source of Monetary or Material Support
|
| MGM School of Physiotherapy |
|
|
Primary Sponsor
|
| Name |
Benish Bubere |
| Address |
MGM School of Physiotherapy
N6 Cidco
Aurangabad |
| 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 |
| BENISH BUBERE |
MGM School of Physiotherapy |
Musculoskeletal OPD C Building MGM Campus
Aurangabad
MAHARASHTRA |
9987388308
benishbubere22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MGM ECRHS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M999||Biomechanical lesion, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Physiotherapy |
Upper Trapezius Stretching
Lower Trapezius Strengthening
2 weeks 12 sessions |
| Intervention |
Pain Neuroscience Education |
2 weeks thrice a week 6 sessions |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Age group between 18-40 years.
2. Neck pain continued for at least more than 5 weeks.
3. Patients whose visual analogue scale is 5 or higher.
4. Medically diagnosed cases of Mechanical neck pain.
|
|
| ExclusionCriteria |
| Details |
1. Cervical radiculopathy.
2. Neck pain associated with vertigo.
3. Diagnosed psychological disorders.
4. Vertebral fractures.
5. Tumors.
6. Traumatic neck pain.
7. Cervical spondylosis.
8. Pregnant ladies.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual Analogue Scale (VAS) |
At first session
After 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Fear Avoidance Belief Questionnaire (FABQ) |
After 2 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
23/05/2022 |
| 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="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Non-specific neck
pain (NSNP) is the most common musculoskeletal disorder occurring in the
middle-aged people. PNE aims to explain to patients the biological and
physiological processes involved in pain and, more importantly, to take the
focus away from associated to anatomical structures such as muscles, cartilage,
discs, and so on. PNE provides constraining evidence in pain
reduction, improving function, pain catastrophizing, and limitation of
physical movement. PNE initially changes a patient’s perception of pain. This study was
conducted to investigate the impact of pain neuroscience education as an
adjunct to conventional exercises on pain coping behavior in NSNP.
|