| CTRI Number |
CTRI/2024/07/069811 [Registered on: 02/07/2024] Trial Registered Prospectively |
| Last Modified On: |
15/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The effectiveness of two different protocols in treating Frozen shoulder |
|
Scientific Title of Study
|
Effectiveness of Spencer Technique and Instrument Assisted Soft Tissue Mobilization in Frozen Shoulder |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amita |
| Designation |
Research Scholar |
| Affiliation |
Guru Jambheswar University Of Science and Technology |
| Address |
Room No. 4,
Ground Floor,
Department of Physiotherapy,
Guru Jambheswar University Of Science and Technology
Hisar
HARYANA
125001
India |
| Phone |
8950041416 |
| Fax |
|
| Email |
amitapuniaphysio@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Amita |
| Designation |
Research Scholar |
| Affiliation |
Guru Jambheswar University Of Science and Technology |
| Address |
Room No. 4,
Ground Floor,
Department of Physiotherapy,
Guru Jambheswar University of Science and Technology
Hisar
HARYANA
125001
India |
| Phone |
8950041416 |
| Fax |
|
| Email |
amitapuniaphysio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof. Shabnam Joshi |
| Designation |
Professor |
| Affiliation |
Guru Jambheswar University Of Science and Technology |
| Address |
Room No. 6,
Ground Floor,
Department of Physiotherapy,
Guru Jambheswar University of Science and Technology
Hisar
HARYANA
125001
India |
| Phone |
9729922466 |
| Fax |
|
| Email |
shabnamphysio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Guru Jambheswar University of Science and Technology, Hisar, Haryana-125001
UNIVERSITY OF SCIENCE AND TECHNOLOGY, HISAR, HARYANA-125001 |
|
|
Primary Sponsor
|
| Name |
DEPARTMENT OF PHYSIOTHERAPY |
| Address |
Department of Physiotherapy, Guru Jambheswar University of Science and Technology, Hisar, Haryana- 125001 |
| Type of Sponsor |
Other [University] |
|
|
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 |
| AMITA |
GURU JAMBHESWAR UNIVERSITY OF SCIENCE AND TECHNOLOGY HISAR |
ROOM NO. 4,
GROUND FLOOR,
DEPARTMENT OF
PHYSIOTHERAPY,
GURU JAMBHESWAR
UNIVERSITY OF
SCIENCE AND
TECHNOLOGY, HISAR
Hisar
HARYANA
Hisar
HARYANA |
8950041416
amitapuniaphysio@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Department of Physiotherapy, Institutional Ethical Committee, Guru Jambheshwar University of Science and Technology |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M750||Adhesive capsulitis of shoulder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A: Spencer Technique |
Spencer technique along with conventional treatment.Patient will be positioned in side lying with the shoulder to be treated uppermost, the therapist stood in front of the patient stabilizing the superior aspect of the shoulder girdle, the fixed shoulder girdle provided a resistant structure against which to stretch the soft tissues around the glenohumeral articulation as the arm will be used as a long lever. The therapist then supports the wrist and forearm of the patient and does passive, smooth, rhythmic back and forth motion of arm and is carried to the extreme limit permitted by the contracted muscles, ligaments and the capsule of the shoulder.
Total duration: 4 weeks for thrice a week. |
| Comparator Agent |
Group B: Instrument Assisted Soft Tissue Mobilization (IASTM) |
IASTM is given along with conventional treatment
Total duration: 4 weeks for thrice a week. |
| Comparator Agent |
Group C: Conventional |
conventional treatment which includes hot packs, capsular stretching exercises and Codman’s pendular exercises.
Total duration: 4 weeks for thrice a week. |
| Comparator Agent |
Group D: Combination of Interventions |
combination of IASTM and Spencer technique with conventional treatment.
Total duration: 4 weeks for thrice a week. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants with frozen shoulder diagnosed by Orthopaedician
2. Subjects with age of 40 to 60 years
3. Both male and female subjects
4. Subjects with unilateral Frozen shoulder
5. Clinical presentation of patient with pain and restricted or painful ROM.
|
|
| ExclusionCriteria |
| Details |
1. History of Rheumatoid arthritis
2. Individuals having a recent history of shoulder complex fractures
3. Nervous system abnormalities impacting shoulder performance
4. Individuals with history of tendon injury and rotator cuff lesions
5. Pain or conditions affecting the hand, wrist, elbow, or cervical spine on the affected side
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Pain
• Range of Motion
• Pressure Pain Threshold
|
Baseline, After 6 weeks, After follow up of 2 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Handgrip Strength
• Disability
• Muscle Strength
|
Baseline, After 6 weeks, After follow up of 2 weeks
|
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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
Modification(s)
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/07/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - If asked during any requirement.
- For how long will this data be available start date provided 10-04-2027 and end date provided 10-04-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
To compare the effectiveness of Spencer technique and Instrument Assisted Soft Tissue Mobilization in frozen shoulder. Subjects will be included from the different hospitals of Hisar and from the Departmental OPD, GJUST, Hisar after taking the written informed consent. All the participants will be screened according to the inclusion and exclusion criteria of the study. The explanation of the procedure will be given to all the participants included in the study. After inclusion all subjects will be randomly divided into four different groups. The treatment will be given thrice a week for a total duration of six weeks in all three groups. The assessment will be performed at baseline and after completion of the treatment duration and after the follow up of two weeks. |