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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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