| CTRI Number |
CTRI/2022/11/047395 [Registered on: 17/11/2022] Trial Registered Prospectively |
| Last Modified On: |
22/08/2023 |
| 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
|
Effectiveness of hanging exercise in patients with rotator cuff disease – A Pilot Randomized Controlled Trial |
|
Scientific Title of Study
|
Effectiveness of hanging exercise on pain free ROM and acromiohumeral distance in patients with rotator cuff disease – A Pilot Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rakhi Ramraj Jaju |
| Designation |
Junior Resident |
| Affiliation |
MGM Institute of Physiotherapy, Aurangabad |
| Address |
Department Of Musculoskeletal Sciences, MGM Institute of
Physiotherapy Aurangabad
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
8888925801 |
| Fax |
|
| Email |
rakhijaju12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanket Mungikar |
| Designation |
Associate Professor |
| Affiliation |
MGM Institute of Physiotherapy, Aurangabad |
| Address |
Department Of Musculoskeletal Sciences, MGM Institute of
Physiotherapy Aurangabad
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9730770107 |
| Fax |
|
| Email |
Mungikarphysio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rakhi Ramraj Jaju |
| Designation |
Junior Resident |
| Affiliation |
MGM Institute of Physiotherapy, Aurangabad |
| Address |
Department Of Musculoskeletal Sciences, MGM Institute of
Physiotherapy Aurangabad
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
8888925801 |
| Fax |
|
| Email |
rakhijaju12@gmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
| MGM Institute of Physiotherapy, Aurangabad; Maharashtra |
|
|
Primary Sponsor
|
| Name |
MGM Institute of Physiotherapy |
| Address |
N6, CIDCO, Aurangabad, Maharashtra - 431003 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Rakhi Ramraj Jaju |
MGM Rehabilitation and Fitness Centre |
Department of Musculoskeletal Physiotherapy OPD No 1 MGM Institute of Physiotherapy N 6 CIDCO
Aurangabad 431003
Aurangabad
MAHARASHTRA |
8888925801
rakhijaju12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MGM Institute of Physiotherapy, Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M754||Impingement syndrome of shoulder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional physiotherapy |
Conventional physiotherapy will be 40 min session given for 3 days a week on alternative days for 4 weeks under the supervision of therapist. It includes 1. Therapeautic Ultrasound for 5 min 2. Cryotherapy for 10 min and 3. Conventional exercises for shoulder joint |
| Intervention |
Hanging exercise with conventional physiotherapy |
This will be 50 min session given for 3 days a week on alternative days for 4 week under the supervision of therapist. It includes 1. Conventional physiotherapy 2. Hanging exercise: Partial or full body weight hanging 10-30 sec, 5-8 repetitions. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with symptoms of shoulder pain for less than 3 months
2.Medically or clinically diagnosed with Rotator Cuff Disease (Subacromial impingement syndrome, Rotator cuff tendinitis, Calcific tendinitis )
3.Participants between age group 18- 65 years.
4.Numerical Pain Rating Scale score >3.
5.Two out of three positive impingement tests:
a)Empty Can Test.
b)Hawkins Kennedy Test.
c)Neers Test.
6.No restriction of shoulder PROM.
|
|
| ExclusionCriteria |
| Details |
1.Shoulder instability or dislocation
2.History of shoulder surgery or shoulder fracture
3.Adhesive capsulitis
4.Partial or full ruptures of rotator cuff
5.Cervical pain or radiculopathy that affect upper extremity
6. History of post traumatic stiffness and osteoarthritis of shoulder joint.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Active Pain free ROM by goniometer
2. Acromiohumeral distances by USG of shoulder joint
|
Baseline and at 4 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Pain by Numerical Pain Rating Scale
2. Disability by Shoulder Pain And Disability Index |
Baseline and at 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/11/2022 |
| Date of Study Completion (India) |
29/06/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Disorders of rotator cuff are the most common cause of shoulder pain as it is seen in about 30% of the overall population. A wide range of treatments are available for rotator cuff disease but the overall prognosis is highly variable with 40-50% of patients reporting persistent pain and disability. This highlights the need to deliver effective interventions in the acute stage of rotator cuff tendinopathy. Currently there is a lack of evidence regarding the most appropriate treatment for acute rotator cuff tendinopathy. This condition is caused by tightness or contracture of the arch of the ligament and bone that is the CA arch which covers the structures below are rotator cuff tendons and subacromial bursae. Without overhead arm activity, the space between the acromion bone and the humerus undergoes slow contracture resulting in degenerative changes. The hanging exercise using the force of gravity will provide the force & stretching that will reverse the process that led to deformity and inertia of CA arch. To our knowledge, the effect of hanging exercise on shoulder have never been studied.
Aim: To evaluate the effectiveness of hanging exercise on painfree ROM and acromiohumeral distance in patients with rotator cuff disease.
Methodology: Participants will be randomly allocated to intervention group and control group. Intervention group will receive hanging exercise in addition to conventional physiotherapy for 3 days a week on alternative days for 4 weeks. |