| CTRI Number |
CTRI/2025/05/087547 [Registered on: 26/05/2025] Trial Registered Prospectively |
| Last Modified On: |
23/05/2025 |
| 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
|
A Study to Compare the Effectiveness of Extracorporeal Shock Wave Therapy and Short-Wave Diathermy in reducing pain, improving range of motion and alleviating functional disability in participants with Adhesive Capsulitis: A Randomized Controlled Trial
|
|
Scientific Title of Study
|
Effectiveness of Extracorporeal Shock Wave Therapy and Short-Wave Diathermy in alleviating the symptoms of 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 |
Aishwarya Patel |
| Designation |
Post Graduate Scholar |
| Affiliation |
faculty of paramedical sciences saifai etawah |
| Address |
Department of Physiotherapy,
Faculty of paramedical Sciences,
Uttar Pradesh University of Medical Sciences, Saifai
Etawah
UTTAR PRADESH
206130
India |
| Phone |
9720489790 |
| Fax |
|
| Email |
aishwaryapatel8366@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Neha Dubey |
| Designation |
Assistant Professor |
| Affiliation |
Uttar Pradesh University of Medical Sciences, Saifai, Etawah |
| Address |
Department of Physiotherapy,
Faculty of Paramedical Sciences,
Uttar Pradesh University of Medical Sciences, Saifai, Etawah
Etawah
UTTAR PRADESH
206130
India |
| Phone |
6395822600 |
| Fax |
|
| Email |
physioneha04@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aishwarya Patel |
| Designation |
Post Graduate Scholar |
| Affiliation |
faculty of paramedical sciences saifai etawah |
| Address |
Department of Physiotherapy,
Faculty of paramedical Sciences,
Uttar Pradesh University of Medical Sciences, Saifai
UTTAR PRADESH
206130
India |
| Phone |
9720489790 |
| Fax |
|
| Email |
aishwaryapatel8366@gmail.com |
|
|
Source of Monetary or Material Support
|
| Uttar Pradesh University of Medical Sciences, Saifai, Etawah-206130 |
|
|
Primary Sponsor
|
| Name |
Uttar Pradesh University of Medical Sciences |
| Address |
Uttar Pradesh University of Medical Sciences, Saifai, Etawah (Uttar Pradesh)- 206130 |
| Type of Sponsor |
Other [Government Medical 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 |
| Dr Aishwarya Patel |
Uttar Pradesh University of Medical Sciences |
Department of Orthopaedics and Physiotherapy, Room no: 7 and 10
Etawah
UTTAR PRADESH |
9720489790
aishwaryapatel8366@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Uttar Pradesh University of Medical Sciences |
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 Shock wave therapy |
Experimental Group (n=28) participants will be given ESWT using radial ESWT modus unit, of 2000 shots on the anterior aspect of the shoulder joint crossing the midline of the joint with energy flux density ranged from low to moderate according to each participant tolerance of pain (0.06-0.14 mJ/mm2) with a pressure of 4 bar and at 8Hz frequency, in continuous mode using a 25mm of convex applicator, after that therapist will perform SME Technique, and a prescribed Home Exercise Program.
Frequency session: 3 sessions per week for 2 weeks.
|
| Comparator Agent |
Short-Wave Diathermy |
Control Group (n=28) participants will be given SWD in the affected shoulder, energy will be delivered using disc electrode in contra planer method with frequency of 27.12 MHz in continuous mode for 20 minutes, per session intensity will be maintained and adjusted to produce comfortable warmth based on participant feedback, after that therapist will perform SME Technique, and a prescribed Home Exercise Program.
Frequency session: 3 sessions per week for 2 weeks.
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
• Participants diagnosed with Adhesive Capsulitis by an Orthopaedics.
• Age 35 to 60 years.
• Both male and female.
• Willing to participate in the study and attend follow up session.
• Painful restricted movement of shoulder, for more than 2 months.
|
|
| ExclusionCriteria |
| Details |
• Surgical intervention on the affected shoulder.
• Active infection or abscess in the affected shoulder.
• Untreated shoulder subluxation, dislocation and fracture.
• Known Contraindication to ESWT and SWD e.g. Pregnancy, Artificial Pacemaker, Sensitive to heat, Malignancy, Osteoporosis.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain Intensity, Range of Motion, and Functional Disability |
Base line, After completing the two weeks of treatment and Follow up post two weeks of treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
05/06/2025 |
| 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" |
|
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
|
This study is a randomized controlled trial (RCT) comparing the effectiveness of Extracorporeal Shock Wave Therapy (ESWT) and Short-Wave Diathermy (SWD) in treating Adhesive Capsulitis (frozen shoulder). Participants (aged 35–60) will be recruited from UPUMS, Saifai’s Orthopaedics OPD, screened for eligibility, and randomly assigned to Group A (ESWT + SME Technique + Home Exercise) or Group B (SWD + SME Technique + Home Exercise). Each group will have 28 participants (adjusted for a 10% dropout rate). Inclusion criteria: Diagnosis of Adhesive Capsulitis, shoulder pain/restricted movement (>2 months), willingness to attend follow-ups. Exclusion criteria: Prior shoulder surgery, active infections, fractures, or contraindications (e.g., pregnancy, pacemakers). Treatment Protocols: Group A: Receives ESWT (2000 shocks, 0.06–0.14 mJ/mm², 8Hz) + SME Technique (7-step manual therapy) + Home Exercises (pendulum, wall climbing, pulley exercises). Group B: Receives SWD (27.12 MHz, 20 mins/session) + SME Technique + the same Home Exercises.
Both groups undergo 3 sessions/week for 2 weeks, with follow-ups at 2 weeks post-treatment.
Outcome Measures: Pain: Numeric Pain Rating Scale (NPRS) and algometer (pressure pain threshold). Range of Motion (ROM): Digital goniometer. Functional Disability: Shoulder Pain and Disability Index (SPADI).
Assessments occur at baseline (t0), post-treatment (t1), and 2-week follow-up (t2).
Statistical Analysis: Data analyzed using SPSS to test hypotheses: Null (H0): No difference between ESWT and SWD. Alternative (H1): Significant difference in pain reduction, ROM, or function.
Novelty: First direct comparison of ESWT+SME vs. SWD+SME, evaluating combined effects on pain, ROM, and function. Ethical approval and informed consent will be obtained. |