| CTRI Number |
CTRI/2025/12/099375 [Registered on: 18/12/2025] Trial Registered Prospectively |
| Last Modified On: |
17/12/2025 |
| 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 pain neuroscience and conventional physiotherapy intervention in participants with adhesive capsulitis with main outcome of pain and range of motion of shoulder joint |
|
Scientific Title of Study
|
Combined effect of Pain Neuroscience
Education and conventional Physiotherapy
in improving pain, range of motion, and
Cytokine response in individuals with
adhesive capsulitis – A pilot 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 |
Kshama Susheel Shetty |
| Designation |
Physiotherapist |
| Affiliation |
Alvas College of Physiotherapy and Research Centre |
| Address |
Alvas College of Physiotherapy and Research Center.
Department of Musculoskeletal Sciences
Alvas Health Center
Moodabidri-574227
Karnataka
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9591593863 |
| Fax |
|
| Email |
poonjakshama@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kshama Susheel Shetty |
| Designation |
Guide(Physiotherapist) |
| Affiliation |
Alvas College of Physiotherapy and Research Centre |
| Address |
Alvas College of Physiotherapy and Research Center.
Department of Musculoskeletal Sciences
Alvas Health Center
Moodabidri-574227
Karnataka
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9591593863 |
| Fax |
|
| Email |
poonjakshama@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kshama Susheel Shetty |
| Designation |
Physiotherapist |
| Affiliation |
Alvas College of Physiotherapy and Research Centre |
| Address |
Alvas College of Physiotherapy and Research Center.
Department of Musculoskeletal Sciences
Alvas Health Center
Moodabidri-574227
Karnataka
KARNATAKA
574227
India |
| Phone |
9591593863 |
| Fax |
|
| Email |
poonjakshama@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas College of Physiotherapy and Research Centre
Musculoskeletal Sciences Department
Alvas Health Sciences
Moodabidri-574227
Karnataka |
|
|
Primary Sponsor
|
| Name |
Alvas College of Physiotherapy and Research Centre |
| Address |
Departmnent of Musculoskeletal Sciences
Alvas |
| Type of Sponsor |
Other [Institution ] |
|
|
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 Kshama Susheel Shetty |
Alvas College of Physiotherapy and Research Centre |
Department of Musculoskeletal Sciences
Alvas Health Sciences
Moodabidri-574227
Karnataka
Dakshina Kannada
KARNATAKA |
9591593863
poonjakshama@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Alvas College of Physiotherapy and Research Centre - Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Physiotherapy |
Includes Maitland or Mulligan’s mobilization with movement techniques
for shoulder, capsular stretches and
scapular stabilization exercises.
|
| Intervention |
Pain Neuroscience Education |
The intervention was provided
for 60 min/session, 1 session/week for 8
weeks. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Both genders aged from 40 to 55 years,
diagnosed with idiopathic adhesive
capsulitis by the orthopaedic physician,
with no history of co-morbid conditions or
recent musculoskeletal injuries or
neurological disorders. |
|
| ExclusionCriteria |
| Details |
Individuals with a history of recent
hospitalizations, complaining of pain in the
upper limb (other than shoulder) or spine,
adhesive capsulitis secondary to systemic
conditions. Congenital deformities, poor
cognition, hearing or visual deficits, and
unwilling to provide consent. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain and shoulder range of motion
|
Baseline and 8 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
31/01/2026 |
| 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="3"
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
|
Objective- The objectives of this study is to analyse the effect of pain neuroscience education and conventional physiotherapy in pain , range of motion and inflammatory cytokine response individuals with adhesive capsulitis Study duration -8 weeks
Procedure- Pain Neuroscience interventioncombined with conventional physiotherapy. Pain Neuroscience education was administered by a physiotherapist trained in pain neuroscience education strategies and having more than 10 years of experience in treating chronic pain conditions. The intervention was provided for 60mim/session, 1 session / week for 8 weeks.
Conventional Physiotherapy- Includes Maitland or Mulligan’s mobilization with movement technique for shoulder , capsular strtchs and scapular stabilization exercises.
Implication- The study results could help to identify integrating pain neuroscience education in conventional adhesive capsulitis rehabilitation can improve pain, shoulder range of motion and inflammatory cytokine levels. New Insight regarding the inflammatory cytokine response to conventional physiotherapy rehabilitation and pain neuroscience education could be revealed.
|