| CTRI Number |
CTRI/2025/02/080674 [Registered on: 17/02/2025] Trial Registered Prospectively |
| Last Modified On: |
24/01/2025 |
| 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
|
Comparison of handgrip exercises and standard physiotherapy versus controlled muscle training and standard physiotherapy for shoulder pain, muscle strength, and function in people with shoulder pain. |
|
Scientific Title of Study
|
Effect of handgrip strengthening exercises and conventional
physiotherapy vs eccentric training for external rotators of
shoulder and conventional physiotherapy on pain, rotator
cuff muscle strength and function of shoulder in patients with
subacromial pain syndrome -a comparative study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sakshi Deshmukh |
| Designation |
MPT |
| Affiliation |
MAEERS Physiotherapy College Talegaon Dabhade |
| Address |
MAEERS Physiotherapy College near railway station 2nd floor Musculoskeletal Physiotherapy Cabin no A 207 Talegaon Dabhade
Pune MAHARASHTRA 401507 India |
| Phone |
9665619940 |
| Fax |
|
| Email |
deshmukh31sakshi@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Snehal Ghodey |
| Designation |
professor |
| Affiliation |
MAEERS Physiotherapy College Talegaon Dabhade |
| Address |
MAEERS Physiotherapy College near railway station 2nd floor Musculoskeletal Physiotherapy Cabin no A 207 Talegaon Dabhade
Pune MAHARASHTRA 410507 India |
| Phone |
9422326959 |
| Fax |
|
| Email |
gsnehavi@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Snehal Ghodey |
| Designation |
professor |
| Affiliation |
MAEERS Physiotherapy College Talegaon Dabhade |
| Address |
MAEERS Physiotherapy College near railway station 2nd floor Musculoskeletal Physiotherapy Cabin no A 207 Talegaon Dabhade
MAHARASHTRA 410507 India |
| Phone |
9422326959 |
| Fax |
|
| Email |
gsnehavi@gmail.com |
|
|
Source of Monetary or Material Support
|
| MAEERS Physiotherapy College near railway station 2nd floor Musculoskeletal Physiotherapy Cabin no A 207
Talegaon Dabhade Pune India, 410507 |
|
|
Primary Sponsor
|
| Name |
MAEERS Physiotherapy College |
| Address |
MAEERS Physiotherapy College near railway station 2nd floor Musculoskeletal Physiotherapy Cabin no A 207
Talegaon Dabhade Pune India, 410507 |
| 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 |
| Dr Snehal Ghodey |
MAEERS Physiotherapy College |
MAEERS Physiotherapy College near railway station 2nd floor Musculoskeletal Physiotherapy Cabin no A-207
Talegaon Dabhade Pune India, 410507 Pune MAHARASHTRA |
9422326959
gsnehavi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAEERS Cpllege of Physiotherapy Talegaon Dabhade |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M638||Disorders of muscle in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Eccentric training of external rotators (ETER) and conventional physiotherapy |
Eccentric training of external rotators (ETER) twice a week
for 6 weeks.
For training external rotators eccentrically resistance band will be used.
To ensure that there is no slack in the band, the participants starting
position is set by standing just far enough away from the anchor point.
Arm is taken in concentric portion to achieve end-range External rotators with the
assistance of the therapist.
2-second Isometric hold will be performed at end range followed by a slow 3-second eccentric return to the starting position
3 sets of 15 repetitions will be given.
To control the elastic recoil of the band the muscle will act eccentrically.
Conventional physiotherapy given will be:
Wand exercises for shoulder in flexion, abduction and extension with 10 repetitions in all directions.
Codman exercises 10 repetitions each in all directions and upper
trapezius stretching (5 repetitions)
Strength training for the scapular stabilizers, rotator cuff,
and deltoid muscles when appropriate using a Resistance band(3 sets of 10 repetitions with 1-minute rest between sets).
When 3 sets were performed easily, resistance was increased by changing
the band colour.
Stretching Exercises: pectoralis minor stretching, posterior capsule
stretching, levator scapula stretching, and latissimus dorsi stretching.(All stretches were performed daily, 3 sets of 5 repetitions with 30 seconds hold.)
Trans Electrical Nerve Stimulation (TENS) at the site of pain- 3 sessions
|
| Intervention |
Handgrip strengthening exercise and conventional physiotherapy |
Handgrip strengthening exercise (HGSE) twice a week for 6
weeks.
Patient will be standing against wall.
Starting with
30° arm in abduction
progressing to 60° arm in abduction progressing to
90° arm in abduction progressing to 90° arm in abduction + 90° External Rotation with elbow in flexion
3 sets of 10 repetitions
The resistance will be reset to the 10-repetition maximum every week.
The arm position is progressed to higher degrees of arm abduction as
patient tolerance is increased.
Conventional physiotherapy given will be:
Wand exercises for shoulder in flexion, abduction and extension with 10 repetitions in all directions.
Codman exercises 10 repetitions each in all directions and upper
trapezius stretching (5 repetitions)
Strength training for the scapular stabilizers, rotator cuff,
and deltoid muscles when appropriate using a Resistance band(3 sets of 10 repetitions with 1-minute rest between sets).
When 3 sets were performed easily, resistance was increased by changing
the band colour.
Stretching Exercises: pectoralis minor stretching, posterior capsule
stretching, levator scapula stretching, and latissimus dorsi stretching.(All stretches were performed daily, 3 sets of 5 repetitions with 30 seconds hold.)
Trans Electrical Nerve Stimulation (TENS) at the site of pain- 3 sessions
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Pain intensity of 3 to 8
Patient must be positive for at least 3 of 5 of the following criteria:
(The Dutch Orthopaedic Association Guidelines for diagnosis and treatment
of subacromial pain syndrome, 2014)
1. the Neer impingement test,
2. the Hawkins-Kennedy impingement test,
3. the empty can test
4. pain with resisted external rotation,
5. painful arc from 60° to 120° during active abduction. |
|
| ExclusionCriteria |
| Details |
1. Patients with Positive drop arm test
2. Full-thickness rotator cuff tear
3. inflammatory joint disease
4. malignancy surgery on the shoulder or neck
5. any other shoulder pathology
6. any trauma or injury to shoulder in past 6 months
cervical radiculopathy |
|
|
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 |
Pain using Visual Analog Scale
Strength using Handheld dynamometer
Function using The Shoulder Pain and Disability Index (SPADI) |
Pre and post intervention 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Function using The Shoulder Pain and Disability Index (SPADI) |
Pre and post intervention 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="46" Sample Size from India="46"
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 2 |
|
Date of First Enrollment (India)
|
01/03/2025 |
| 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="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
|
The term "subacromial pain syndrome" (SAPS) refers to any non-traumatic, mostly unilateral shoulder issues that cause discomfort in the area of the acromion and frequently get worse when lifting one arm. The SAPS includes all disorders about subacromial structures, including tendon cuff degeneration, biceps tendinopathy, rotator cuff tears, subacromial bursitis, calcific tendonitis, and rotator cuff tendinopathy. SAPS is associated with Pain, decreased strength of shoulder; arm and hand muscles, and reduced range of shoulder joint. Common shoulder strengthening rehabilition exercises typically involve movements that result in shortening the muscle length while simultaneously loading the muscles. However, recent studies focus on eccentric training which involves lengthening of muscles during loading and have shown significant improvement in the strength and performance of the rotator cuff in SAPS. Handgrip strength is negatively affected in subacromial pain syndrome and thus, the addition of handgrip-strengthening exercises to conventional physiotherapy has shown to help in the activation of rotator cuff muscles and decrease activation of anterior and middle deltoid. While a variety of exercise protocols demonstrating effectiveness exist, a clearly defined best method of resisted exercise for SAPS has yet to be established. This study will be comparing the effects of handgrip strengthening exercises and eccentric training for external rotators (ETER) of the shoulder in addition to conventional therapy on pain, rotator cuff muscle strength and function of shoulder to increase the efficacy of streamline physiotherapy treatment. Patients will be recruited on the basis of inclusion and exclusion criteria and will be divided into 2 groups. Patients will be assesed pre and post treatment sessions for pain with VAS, for strength of external and internal rotators with dynamometer and function with Shoulder pain and disability index (SPADI).Both groups will receive conventional physiotherapy for 6 weeks which includes TENS for 3 sessions wand exercises and codman exercises, strength training using theraband, Stretching Exercises for pectoralis minor, posterior capsule, levator, and latissimus dorsi. In addition to conventional physiotherapy one group will receive Handgrip strengthening exercise (HGSE) twice a week for 6 weeks and other group will receive -Eccentric training of external rotators (ETER) twice a week for 6 weeks. |