| CTRI Number |
CTRI/2025/05/086556 [Registered on: 08/05/2025] Trial Registered Prospectively |
| Last Modified On: |
07/05/2025 |
| 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
|
Can shockwave therapy reduce pain and improve movement, daily activities and quality of life in patient with stiff shoulder? A randomized controlled trial |
|
Scientific Title of Study
|
Effect Of Extracorporeal Shockwave Therapy On Pain, Range Of Motion, Function And Quality Of Life In Patients With Adhesive Capsulitis. A 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 |
Snehal Ghule |
| Designation |
Post graduate |
| Affiliation |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy. |
| Address |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy, Department of Musculoskeletal and Sports Physiotherapy,11/12, Thube Park, Shivaji Nagar, Pune.
Pune
MAHARASHTRA
411005
India |
| Phone |
9307503004 |
| Fax |
|
| Email |
snehalghule89@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Venu Mohan |
| Designation |
Associate professor |
| Affiliation |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy. |
| Address |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy, Department of Musculoskeletal and Sports Physiotherapy,11/12, Thube Park, Shivaji Nagar, Pune.
Pune
MAHARASHTRA
411005
India |
| Phone |
9440690707 |
| Fax |
|
| Email |
venumohan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Venu Mohan |
| Designation |
Associate professor |
| Affiliation |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy. |
| Address |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy, Department of Musculoskeletal and Sports Physiotherapy,11/12, Thube Park, Shivaji Nagar, Pune.
Pune
MAHARASHTRA
411005
India |
| Phone |
9440690707 |
| Fax |
|
| Email |
venumohan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sancheti Institute for Orthopaedics and Rehabilitation College of
Physiotherapy , 11/12 Thube Park, Narveer Tanaji Wadi, Shivajinagar, Pune -411005 |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [] |
|
|
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 Snehal Ghule |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy |
Sancheti Institute for Orthopaedics and Rehabilitation College of
Physiotherapy, 1st Floor, Room Number 6, 11/12, Thube Park, Shivaji Nagar, Pune 411005
MAHARASHTRA
Pune
MAHARASHTRA |
9307503004
snehalghule89@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sancheti Institute for Orthopaedics and Rehabilitation Institutional Ethics Committee |
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 |
Extracorporeal Shockwave therapy and Spencer technique |
Extracorporeal shockwave therapy-
The patient sit on chair on which he / she asked to rest their arms. Shockwave
gel will be applied as a thin film over the shoulder joint. Shockwave probe will
be placed at right angle of 90 degree on shoulder joint on anterior and
posterior side. 2 session every week for 4 weeks will be given.
Parameters of ESWT are as follow:
Number of impulses/ beats- 2000 shock
Frequency- 4Hz
Energy- Between 0.1 and 0.3 mJ/mm.
Spencer technique-
The exercise will be repeated 3-5 times with rest intervals, over 3
sessions per week on alternate days for 4 weeks
1) Step 1: Shoulder extension with elbow flexion: The patients elbow was
maintained in a flexed position, and the arm was extended until the
restricted barrier.
2) Step 2: Shoulder flexion with elbow extension: The patients flexed
elbow was extended and moved anteriorly into shoulder flexion until
21
the restricted barrier.
3) Step 3: Circumduction with compression: Grasped the patients elbow
with the shoulder in a 90° abduction, and moved the elbow in small
clockwise and counterclockwise circles with a compressive force.
4) Step 4: Circumduction with distraction: The therapist maintained the
traction of the patients shoulder joint in 90° of abduction and held
either elbow or wrist-induced small clockwise and counterclockwise
circles.
5) Step 5: Shoulder abduction and internal rotation with elbow flexion:
The patient was asked to place his hand on the therapists forearm for
support, and then the therapist performed abduction and internal
rotation of the patients arm. Internal rotation (90°) - The therapist
placed the dorsum of the patients hand behind his or her hip and
moved the patients elbow anteriorly.
6) Step 6: Shoulder adduction and external rotation with elbow flexion:
The patient was asked to place his hand on the therapists forearm for
support, and then the therapist took the patients arm into adduction and
external rotation.
7) Step 7: Stretching tissue and pumping fluids with the arm extended:
The therapist interlocked his fingertips over the deltoid muscle, the
patient‘s hand was placed over the therapists shoulder, and the
therapist slowly moved the arm away from the shoulder and released,
repeated this 5-10 times. |
| Comparator Agent |
Spencer technique |
The exercise will be repeated 3-5 times with rest intervals, over 3
sessions per week on alternate days for 4 weeks
1) Step 1: Shoulder extension with elbow flexion: The patients elbow was
maintained in a flexed position, and the arm was extended until the
restricted barrier.
2) Step 2: Shoulder flexion with elbow extension: The patients flexed
elbow was extended and moved anteriorly into shoulder flexion until
21
the restricted barrier.
3) Step 3: Circumduction with compression: Grasped the patients elbow
with the shoulder in a 90° abduction, and moved the elbow in small
clockwise and counterclockwise circles with a compressive force.
4) Step 4: Circumduction with distraction: The therapist maintained the
traction of the patients shoulder joint in 90° of abduction and held
either elbow or wrist-induced small clockwise and counterclockwise
circles.
5) Step 5: Shoulder abduction and internal rotation with elbow flexion:
The patient was asked to place his hand on the therapists forearm for
support, and then the therapist performed abduction and internal
rotation of the patients arm. Internal rotation (90°) - The therapist
placed the dorsum of the patients hand behind his or her hip and
moved the patients elbow anteriorly.
6) Step 6: Shoulder adduction and external rotation with elbow flexion:
The patient was asked to place his hand on the therapists forearm for
support, and then the therapist took the patients arm into adduction and
external rotation.
7) Step 7: Stretching tissue and pumping fluids with the arm extended:
The therapist interlocked his fingertips over the deltoid muscle, the
patient‘s hand was placed over the therapists shoulder, and the
therapist slowly moved the arm away from the shoulder and released,
repeated this 5-10 times. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients with adhesive capsulitis of Age 40-60 years of either gender.
2)Patients following formal diagnostic criteria.
3)Freezing/ painful stage (8 weeks to 9 months) |
|
| ExclusionCriteria |
| Details |
1)Contraindications to ESWT.
(pacemaker, anticoagulant therapy, defibrillators, respiratory insufficiency,
arterial diseases, coagulation disorders, haemophilia, pregnancy, neoplasia)
2) History of shoulder dislocation, subluxation, fracture at shoulder complex
3) Rotator cuff pathology
4) Recent shoulder surgeries
5) Rheumatic disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Goniometry |
At baseline(0 weeks) and after intervention (4 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
2) Numerical pain rating scale
3) Shoulder pain and disability index
4) SF12 Questionnaire |
At baseline(0 weeks) and after intervention (4 weeks) |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
21/05/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Adhesive capsulitis (frozen shoulder) is a highly disabling condition characterized by progressive fibrosis and contracture of the glenohumeral joint capsule, leading to pain, restricted range of motion, functional limitations, and decreased quality of life. Its prevalence is estimated at 2–5% in the general population and 10–20% among individuals with diabetes, predominantly affecting those aged 40–60 years. Conventional physiotherapy treatments, including electrotherapy modalities, passive and active range of motion exercises, stretching, strengthening, and manual therapy techniques such as the Spencer technique, have demonstrated effectiveness in improving mobility and reducing pain. Extracorporeal Shockwave Therapy (ESWT) has recently emerged as an innovative modality that promotes tissue healing, reduces pain, and improves shoulder function. Therefore, there is a need to compare the effects of the Spencer technique combined with ESWT versus the Spencer technique alone on pain, range of motion, function, and quality of life in patients with adhesive capsulitis. Null hypothesis (Ho): There will be comparable effect on pain, range of motion, function and quality of life between Spencer Technique with Extracorporeal shockwave therapy and Spencer technique alone in patients with adhesive capsulitis. Alternate Hypothesis : (H1) - Spencer technique with Extracorporeal shockwave therapy will be more effective than Spencer technique alone on pain, range of motion, function and quality of life in patients with adhesive capsulitis. (H2) Spencer technique alone will be more effective than Spencer technique with Extracorporeal shockwave therapy on pain, range of motion, function and quality of life in patients with adhesive capsulitis. |