| CTRI Number |
CTRI/2020/03/024058 [Registered on: 19/03/2020] Trial Registered Prospectively |
| Last Modified On: |
11/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Shoulder impingement syndrome: manual therapy with Connective tissue massage to shoulder or periscapular region- Which one is effective? |
|
Scientific Title of Study
|
Combined manual therapy and connective tissue massage to shoulder or periscapular region in shoulder impingement syndrome |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sapna Dhiman |
| Designation |
Assistant Professor,Physiotherapy |
| Affiliation |
Delhi Pharmaceutical Sciences and Research University |
| Address |
Room no-610,6th floor, School of Physiotherapy, Delhi Pharmaceutical Sciences and Research University,Pushp Vihar,sector-III,New Delhi
South
DELHI
110017
India |
| Phone |
8588055147 |
| Fax |
|
| Email |
sapnadhi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pradeep Kumar Sahu |
| Designation |
Physiotherapist |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room no- 17, 6th floor,
Neurosciences Centre, AIIMS
South
DELHI
110029
India |
| Phone |
08384065426 |
| Fax |
|
| Email |
pksahu9938@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Deepanshu Sehrawat |
| Designation |
7th semester Bachelor of Physiotherapy(BPT) student |
| Affiliation |
Delhi Pharmaceutical Sciences and Research University |
| Address |
6th floor, School of Physiotherapy, Delhi Pharmaceutical Sciences and Research University,Pushp Vihar,sector-III,New Delhi
Plot no-1, sector-4, Bahawalpur apartment, Dwarka, New Delhi, 110078
South West
DELHI
110017
India |
| Phone |
83377921587 |
| Fax |
|
| Email |
deepanshu.sehrawat997@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sapna Dhiman |
| Address |
Room no-610,6th floor, School of Physiotherapy, Delhi Pharmaceutical Sciences and Research University,Pushp Vihar,sector-III,New Delhi |
| 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 Sapna Dhiman |
Physiotherapy OPD |
Room no-610,6th floor, School of Physiotherapy, Delhi Pharmaceutical Sciences and Research University,Pushp Vihar,sector-III,New Delhi
South
DELHI |
8588055147
sapnadhi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Delhi Pharmaceutical Sciences and Research University, Delhi |
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 |
Manual therapy with connective tissue massage to periscapular region |
In this group, all participants will be receive manual therapy to glenohumeral joint and upper thoracic spine as described by Maitland etal.,2001. Then connective tissue massage(kneading, Ischemic compression techniques) will be done to periscapular muscles. Total duration of intervention will be 15-20 minutes. Frequency will be done four times a week and a period of three weeks. |
| Intervention |
Manual therapy with connective tissue massage to shoulder |
mobilization of glenohumeral joint and upper thoracic spine will be done as described by Maitland etal.,2001. Then connective tissue massage(DTFM)to supraspinatus and long head of bicep tendon will be done.ency of intervention w Total duration of intervention will be 15-20 minutes. Frequency will be done four times a week and a period of three weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Shoulder pain ≥ 6 weeks
2.Impingement syndrome will be diagnosed if they exhibit at least 2 of the following:
(a) painful arc during flexion or abduction; (b) a positive Neer or Hawkins-Kennedy test; and (c) painful resisted external rotation, abduction, or Jobe test.
|
|
| ExclusionCriteria |
| Details |
1.Patient with soft tissue injury around shoulder
2. Patient with fracture of upper limb
3. Patient with neurological problem
4. Patient with psychological problem
5. Any previous surgery around shoulder or cervical region
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Intensity of Pain in VAS
2. Shoulder pain and disability index
3. Range of motion of shoulder
|
1. Baseline
2. At 3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Grip strength by dynamometer |
1. Baseline
2. At 3 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)
|
19/03/2020 |
| Date of Study Completion (India) |
20/04/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this randomized clinical trial, eligible impingement syndrome of shoulder patients will be randomly allocated in to two groups. One group will receive manual therapy with connective tissue massage to shoulder whereas other group will receive manual therapy with connective tissue massage to periscapular region. Outcome measures such as intensity of pain in VAS, Range of motion, disability and grip strength will be evaluated at baseline and at three weeks. |