| CTRI Number |
CTRI/2025/12/099101 [Registered on: 15/12/2025] Trial Registered Prospectively |
| Last Modified On: |
06/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Study on the benefits of understanding pain for pain relief and neck mobility in neck pain |
|
Scientific Title of Study
|
Assessing the effectiveness of pain neuroscience education on pain, range of motion, muscle strength and functional ability in cervical spondylosis: An experimental study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Malavika A |
| Designation |
Student |
| Affiliation |
Dayananda Sagar University |
| Address |
Musculoskeletal and sports lab, room number HS208, 2nd floor, Health Sciences Building, College of physiotherapy, Dayananda Sagar University, Devarakaggahalli, Harohalli, kanakapura Road, south bangalore, karnataka - 562112
Bangalore
KARNATAKA
562112
India |
| Phone |
9844018488 |
| Fax |
|
| Email |
malvika.anand2001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vinod Kumar K C |
| Designation |
Associate Professor |
| Affiliation |
Dayananda Sagar University |
| Address |
College of Physiotherapy, Dayananda Sagar University, Devarakaggahalli, Harohalli, kanakapura Road Ramanagra Dt
Bangalore
KARNATAKA
562112
India |
| Phone |
9036200878 |
| Fax |
|
| Email |
vinnyphysio07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vimarsha Nayak |
| Designation |
Assistant Professor |
| Affiliation |
Dayananda Sagar University |
| Address |
College of Physiotherapy, Dayananda Sagar University, Devarakaggahalli, Harohalli, kanakapura Road Ramanagra Dt
Bangalore
KARNATAKA
562112
India |
| Phone |
7022248388 |
| Fax |
|
| Email |
vimarsha-physio@dsu.edu.in |
|
|
Source of Monetary or Material Support
|
| Dayananda Sagar University,Devarakaggalahalli, Harohalli, Kanakapura road,south bangalore - karnataka - 562112, India |
|
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Primary Sponsor
|
| Name |
Dayananda Sagar University College of Physiotherapy |
| Address |
College of Physiotherapy, Dayananda Sagar University, devarakaggalahalli, Harohalli, Kanakapura, South bangalore , karnataka 562112, India |
| Type of Sponsor |
Other [Private University] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vinod K C |
Dayananda Sagar University |
Musculocutaneous and sports lab, Room number- HS208, 2nd floor, Health science builiding,College of Physiotherapy,Dayananda Sagar University, Devarakaggahalli, Harohalli, kanakapura Road, south bangalore, karnataka 562112
Bangalore
KARNATAKA |
9036200878
vinnyphysio07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| College of Physiotherapy, Dayananda Sagar University |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M478||Other spondylosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Muscle Energy Techniques, Electrotherapy |
Muscle energy techniques is a manual treatment in which a patient produces a contraction in a precisely controlled position and direction against a counterforce applied by manual therapist Set of 3 repetitions is given bilaterally to the upper trapezius, sternocleidomastoid, scalene, and levator scapulae muscles for 3 sessions per week for 6 weeks Electrotherapy is the use of electric currents that delivers electrical impulses to a patients body to promote and facilitate muscle healing and tissue regeneration ,treatment duration is 20 mins per session, 3 sessions per week for 6 weeks |
| Intervention |
Pain Neuroscience Education, Muscle Energy Techniques, Electrotherapy |
Pain neuroscience education (PNE) is an educational approach that explains pain as a neural output emerging from complex biological, psychological, and social interactions. This intervention aims to facilitate change patients conceptualization of pain, educating them about the neurobiology and neurophysiology of pain and the treatment duration is 1 hour per session,3sessions per week for 6 weeks.
Muscle energy techniques is a manual treatment in which a patient produces a contraction in a precisely controlled position and direction against a counterforce applied by manual therapist Set of 3 repetitions is given bilaterally to the upper trapezius, sternocleidomastoid, scalene, and levator scapulae muscles for 3 sessions per week for 6 weeks
Electrotherapy is the use of electric currents that delivers electrical impulses to a patients body to promote and facilitate muscle healing and tissue regeneration ,treatment duration is 20 mins per session, 3 sessions per week for 6 weeks
|
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Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with cervical-spondylosis grade 2 having neck pain more than 6 months
Pain intensity: 3-7 (NPRS)
Cognitive ability: Able to understand and provide informed consent
Language: Fluent in the language used for data collection and intervention ( kannada and English )
|
|
| ExclusionCriteria |
| Details |
History of previous cervical spine surgery
Cognitive impairment
Contraindications to Muscle Energy Techniques or Electrotherapy like pacemakers, implants
Other condition involving cervical spine(carcinoma of cervical spine, rheumatoid arthritis, acute trauma)
Patients undergoing pharmacological treatment for cervical spondylosis
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| PAIN – Pain Catastrophizing Scale , Revised neurophysiology of pain questionnaire |
Day 0, 6 weeks, 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
RANGE OF MOTION – Inclinometer
|
Day 0, 6 weeks, 8 weeks |
MUSCLE STRENGTH – Dynamometer
|
Day 0, 6 weeks,8 weeks |
FUNCTIONAL ABILITY – Neck disability index
|
Day 1, 6 weeks, 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
25/12/2025 |
| 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" |
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Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
TITLE: Assessing the effectiveness of Pain Neuroscience Education ( PNE ) on pain, range of motion, muscle strength and functional ability in cervical spondylosis - An Experimental Study This study investigated the comparative effectiveness of Pain neuroscience education along with Muscle energy techniques and electrotherapy versus only Muscle energy techniques ( MET) and electrotherapy ( ET ) among cervical spondylosis subjects. The study involved 36 cervical spondylosis subjects aged 40-60 years both male and female. The participants were divided into two groups: one received Pain neuroscience education along with muscle energy techniques and electrotherapy, the other group received only Muscle energy techniques and electrotherapy. Electrotherapy included transcutaneous electrical stimulation. Outcome measured were Pain ( Pain Catastrophizing Scale , Revised neurophysiology of pain questionnaire ), Range of motion ( Inclinometer ), Muscle strength ( Dynamometer ), Functional ability ( Neck disability Index ). The intervention lasted 6 weeks, with assessments at baseline, post treatment 6 weeks and 8 weeks. The study rationale highlighted PNE along with MET and ET benefit in providing pain relief and increasing range of motion, muscle strength and functional ability beyond what muscle energy techniques and electrotherapy alone offer.
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