| CTRI Number |
CTRI/2025/11/097798 [Registered on: 20/11/2025] Trial Registered Prospectively |
| Last Modified On: |
17/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing the effect of two different techniques for the treatment of neck radiating pain. |
|
Scientific Title of Study
|
Combined effect of SMWAM as an adjunct to Fascial Distortion Model and Kinetic Chain Activation Technique in cervical radiculopathy on proprioception: A RCT |
| 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 Santosh Metgud |
| Designation |
Professor and Vice Principal |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced Physiotherapy center room no 39 department of Orthopedic Manual Therapy room no 13 Sagar floor Belagavi Karnataka 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9880088400 |
| Fax |
|
| Email |
santoshmetgud@klekipt.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santosh Metgud |
| Designation |
Professor and Vice Principal |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced Physiotherapy center room no 39 department of Orthopedic Manual Therapy room no 13 Sagar floor Belagavi Karnataka 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9880088400 |
| Fax |
|
| Email |
santoshmetgud@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Kanad Anil Dandgavhal |
| Designation |
Post Graduate Student |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced Physiotherapy center room no 39 department of Orthopedic Manual Therapy room no 13 Sagar floor Belagavi Karnataka 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9423194694 |
| Fax |
|
| Email |
dandgavhal.kanad02@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
KLE Academy Of Higher Education And Research |
| Address |
Nehru Nagar, Belagavi, Karnataka, 590010 |
| Type of Sponsor |
Private medical college |
|
|
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 Santosh Metgud |
KLEs Dr Prabhakar Kore Hospital and Medical Research |
KLE Academy of Higher Education and Research, Belagavi, Karnataka, India 590010
Belgaum
KARNATAKA
Belgaum
KARNATAKA |
09880088400
santoshmetgud@klekipt.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethical Committee KAHER Institute of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G55||Nerve root and plexus compressionsin diseases classified elsewhere, (2) ICD-10 Condition: M472||Other spondylosis with radiculopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group A: SMWAM and Conventional treatment (Control group) |
Hot Moist Pack for 10 mins
Trapezius stretching for 30 sec (3 sets)
Transcutaneous Electrical Nerve Stimulator (TENS) for 15 mins
Neck Isometrics with 10 sec hold (3 sets)
Chin tucks with 10 sec hold (3 sets)
Scapular Retraction with 10 sec hold (3 sets)
Spinal Mobilization with Arm Movement |
| Intervention |
Group B Fascial Distortion Model (FDM) along with SMWAM and Conventional treatment |
The two distortions that will be incorporated in Fascial Distortion Model
1. Trigger band (TB)
2. Herniated Trigger Point (HTP)
|
| Intervention |
Group C Kinetic Chain Activation Technique (KCAT) along with SMWAM and Conventional treatment |
The participant will be in supine position. The therapist will be at the head end of the participant.
The therapist will apply vaseline or gel on his knuckles and instruct the patient to laterally flex his/her neck while the therapist slides his knuckles along the orientation of the upper fibers of the trapezius.
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Participants of all genders aged 30-55 years willing to participate
Unilateral and bilateral cervical radiculopathy
Acute/ Subacute onset less than 3 months
Presence of more than or equal to 3 criteria of Wainner et al.(Spurling test, Distraction test, Upper Limb Tension Test (ULTT), and cervical rotation towards painful side less than 60 degree |
|
| ExclusionCriteria |
| Details |
History of recent trauma, fall or injury to the cervical region
History of surgery to cervicothoracic spine less than 6 months
Participants with severe osteoporosis and malignancy
Current use of steroidal anti-inflammatory drugs
Acute infection, fever, or systemic illness
Hypermobile cervical spine or ligamentous instability
Active inflammatory arthritis (e.g., rheumatoid arthritis, ankylosing spondylitis)
Diagnosed cases of Vestibular Insufficiency
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Joint Position Error (JPE) Test
|
Pre and Post 2 weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Visual Analog Scale (VAS)
Range of Motion (ROM)
Cervical Radiculopathy Impact Scale (CRIS) |
Pre and Post 2 weeks of intervention |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/11/2025 |
| Date of Study Completion (India) |
07/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
07/03/2026 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
|
Title:
Combined Effect of Spinal Mobilization with Arm Movement as an Adjunct to Fascial Distortion Model and Kinetic Chain Activation Technique in Cervical Radiculopathy on Proprioception Aim and Objective:
To determine the combined effect of SMWAM with Fascial Distortion Model and Kinetic Chain Activation Technique on proprioception, pain, range of motion, and function in individuals with cervical radiculopathy. Inclusion Criteria:
Participants aged 30 to 55 years of both genders diagnosed with unilateral or bilateral cervical radiculopathy, with acute or subacute onset less than 3 months, and at least three positive findings from Wainner criteria including Spurling test, Distraction test, Upper Limb Tension Test, and reduced cervical rotation less than 60 degrees. Exclusion Criteria:
History of trauma or surgery to the cervical region, severe osteoporosis, malignancy, systemic illness, hypermobility, inflammatory arthritis, or vestibular insufficiency. Outcome Measures: Joint Position Error Test for cervical proprioception Visual Analogue Scale for pain intensity Universal Goniometer for cervical range of motion Cervical Radiculopathy Impact Scale for functional status Procedure:
Participants will be screened as per inclusion and exclusion criteria. After obtaining ethical clearance and informed consent, participants will be randomly divided into three groups. Pre and post intervention assessments will be done for proprioception, pain, cervical range of motion, and function using standard outcome measures. Duration of treatment 2 weeks (3 sessions per week) Intervention (Three Groups): Group A: SMWAM with conventional therapy including hot moist pack, trapezius stretching, TENS, neck isometrics, chin tucks, and scapular retraction exercises. Group B: Fascial Distortion Model techniques including Trigger Band and Herniated Trigger Point, combined with SMWAM and conventional therapy. Group C: Kinetic Chain Activation Technique applied along trapezius fibers, combined with SMWAM and conventional therapy. |