| CTRI Number |
CTRI/2024/08/072699 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
12/08/2024 |
| 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
|
Effect of Spiral Stretch technique on range, pain and disability in patients with shoulder pain |
|
Scientific Title of Study
|
Effect of Spiral Stretch technique on Range of Motion, Pain and Disability in patients with Adhesive Capsulitis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Krishnagopal Mondal |
| Designation |
MPT Student |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabiitation |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation (Physiotherapy General OPD), Maharishi Markandeshwar (Deemed-to-be-University), Mullana-Ambala, Haryana PIN - 133207
Ambala
HARYANA
133207
India |
| Phone |
|
| Fax |
|
| Email |
krisha1998gopal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sunita Sharma |
| Designation |
Associate Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Department of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed-to-be-University), Mullana-Ambala, Haryana PIN - 133207
Ambala
HARYANA
133207
India |
| Phone |
9467633734 |
| Fax |
|
| Email |
drsunita.sharma@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Sunita Sharma |
| Designation |
Associate Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Department of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed-to-be-University), Mullana-Ambala, Haryana PIN - 133207
HARYANA
133207
India |
| Phone |
9467633734 |
| Fax |
|
| Email |
drsunita.sharma@mmumullana.org |
|
|
Source of Monetary or Material Support
|
| Outpatients Department, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation (MMIPR), Maharishi Markandeshwar (Deemed-to-be-University), Mullana, Ambala, Haryana, India, PIN - 133207 |
|
|
Primary Sponsor
|
| Name |
Krishnagopal Mondal |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation (MMIPR), Maharishi Markandeshwar (Deemed-to-be-University), Mullana-Ambala, Haryana |
| Type of Sponsor |
Other [Self] |
|
|
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 Krishnagopal Mondal PT |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation (MMIPR) |
Outpatients Department of Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation (MMIPR), Maharishi Markandeshwar (Deemed-to-be-University), Mullana-Ambala, Haryana PIN - 133207
Ambala
HARYANA |
7003937351
krisha1998gopal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL 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 |
| Comparator Agent |
Conventional |
1. Moist Heat Pack (MHP) for 10min 2. Ultrasound Therapy for 8min 3. Codmans Pendular Exercise 4. Finger Ladder Exercise 6. Wand Exercises. Total Treatment time is 45min. |
| Intervention |
Experimental |
1. Moist Heat Pack (MHP) for 10min 2. Ultrasound Therapy for 8min 3. Spiral Stretch Technique for 5min 4. Codmans Pendular Exercise 5. Finger Ladder Exercise 6. Wand Exercises. Total Treatment time is 45min. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
(1) Age 40-60 years (2) Both males and females (3) Patient in the 1st and 2nd stage of frozen shoulder (4) Diabetic |
|
| ExclusionCriteria |
| Details |
(1) Subjects with recent history of surgery on affected shoulder (2) Rheumatoid arthritis (3) Subjects with history of any trauma/ fracture around shoulder complex (4) Osteoporosis and malignancies in shoulder region (5) Neurological deficits affecting shoulder function (6) Subjects with rotator cuff lesion and, tendon calcification (7) Pain or disorders of cervical spine, elbow, wrist or hand on affected side |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Goniometry for Shoulder Range of Motion |
At baseline and after intervention (after 4 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Numerical Pain Rating Scale (NPRS)
2. Shoulder Pain and Disability Index (SPADI) |
At baseline and after intervention (after 4 weeks) |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
16/09/2024 |
| 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="0"
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, often known as frozen shoulder, is an etiologically unknown disorder marked by a painful, increasing restriction of total joint motion that gradually gets worse months to years until spontaneously regaining partly or completely. "Spiral Stretch" technique is unique in its application which ,increase the range of motion in flexion ,adduction and external rotation of shoulder. so the study will be performed to evaluate the effect of "spiral stretch "technique on adhesive capsulitis. The purpose of study to find the effect of " spiral stretch " technique in patient with adhesive capsulitis . Subject will randomly allocated into two groups based on inclusion and exclusion criteria . Experimental group will receive spiral stretch with conventional treatment ,control group will receive conventional treatment. Each session 3 week, over a duration of 4 weeks . Descriptive and inferential statistics will performed for analysis data. Based on normality test, parametric or non parametric tools will be used for with in group and between analysis. |