| CTRI Number |
CTRI/2023/03/050458 [Registered on: 07/03/2023] Trial Registered Prospectively |
| Last Modified On: |
04/03/2023 |
| 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
|
What happens to pain and how the patient feels about neck pain after educating him about his pain |
|
Scientific Title of Study
|
Impact of Pain Neuroscience Education on Pain and Patient-Reported Experience Measure in Individuals with Chronic 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 |
Shweta Sanjeev Acharya |
| Designation |
Intern |
| Affiliation |
MGM School of Physiotherapy |
| Address |
MGM School of Physiotherapy, N-6 CIDCO Aurangabad, 431003
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
7977131240 |
| Fax |
|
| Email |
shwetaacharya001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrVaibhavi Walimbe |
| Designation |
Assistant Professor |
| Affiliation |
MGM School of Physiotherapy |
| Address |
MGM School of Physiotherapy, N-6 CIDCO Aurangabad, 431003
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
7058271894 |
| Fax |
|
| Email |
vaibhavi181994@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shweta Sanjeev Acharya |
| Designation |
Intern |
| Affiliation |
MGM School of Physiotherapy |
| Address |
MGM School of Physiotherapy, N-6 CIDCO Aurangabad, 431003
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
7977131240 |
| Fax |
|
| Email |
shwetaacharya001@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM School of Physiotherapy, Aurangabad |
|
|
Primary Sponsor
|
| Name |
Shweta Acharya |
| Address |
MGM School of Physiotherapy, N-6 CIDCO, Aurangabad |
| Type of Sponsor |
Other [Shweta Acharya (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 |
| Shweta Acharya |
MGM School of Physiotherapy |
Musculoskeletal Department, MGM OPD, N-6 CIDCO, Aurangabad, 431003
Aurangabad
MAHARASHTRA |
7977131240
shwetaacharya001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Missions Ethics Committee for Research on Human Trials |
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 |
| Comparator Agent |
Pain Neuroscience Education |
Time - 30 minutes per session
1 session per week for 4 weeks
Total sessions - 4
Explaining the patient anatomy of cervical region, upper back and thorax, physiology of pain, and explaining the role of exercises |
| Intervention |
TENS and Conventional therapy |
TENS in continuous mode with frequency of 100 to 150 Hz and intensity of 12 to 30 mA for 15 to 20 minutes per day
Conventional therapy including Chin tucks (10 sec hold,10 reps), AROM exercises (10 reps), Pectoral Stretch (30 sec hold,10 reps) and Cervical isometric exercises (15 sec hold, 10 reps) |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Neck pain for more than 3 months (12 weeks)
Radiating and non-radiating pain
NPRS score greater than 3 on rest or activity |
|
| ExclusionCriteria |
| Details |
Patients without consent
Neck pain for less than 3 months
Deformity of the spine
History of neck trauma
Spinal surgeries
Malignancy
Rheumatological conditions
Vision, Hearing or vestibular problems |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Numerical Pain Rating Scale (NPRS) |
At baseline, 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient-Reported Experience Measure (PREM) - CARE measure |
At baseline, 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
17/03/2023 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Introduction: Neck pain is one of the most widespread
musculoskeletal disorders. The patients with chronic neck pain have impaired
cognitive capacity. Thus, psychological factors should be considered and
acknowledged in patients with prolonged disabilities by the healthcare
providers. Pain neuroscience education is promising, consisting of sessions in
which the neurobiology and neurophysiology of the chronic pain and pain
processing is described. The aim of pain neuroscience education during physical
therapy care is to teach the patients more about their pain experience in terms
of biological and physiological aspects. Patient-reported experience measures
(PREMs) are tools that quantify the quality of patient-clinician relationship. The
Consultation-and-Relational-Empathy (CARE) measure, a relational questionnaire,
is a form of PREM tool which identifies the experience of the patients of their
relationship during treatment. Hence, this study intends to evaluate
the impact of pain neuroscience education on pain and patient-reported
experience measure in the patients with chronic neck pain.
Aim: Analyze the impact of pain neuroscience education
on pain and Patient-reported experience measure in chronic neck pain patients.
Methodology: The study will be carried out in a total
of 70 participants. Participants will be selected based on the inclusion and
exclusion criteria. Informed consent will be taken from the patients. The participants
will be divided equally into 2 groups – the control group and the experimental
group. The control group is receiving conventional therapy and TENS while the
experimental group will be receiving Pain Neuroscience Education along with conventional
therapy and TENS. The outcome measures used are Numerical Pain Rating Scale (NPRS)
and CARE measure which is a Patient-Reported Experience Measure (PREM).
Results: Yet to be calculated. |