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CTRI Number  CTRI/2024/03/064420 [Registered on: 19/03/2024] Trial Registered Prospectively
Last Modified On: 02/07/2025
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   Gongs mobilization versus Proprioceptive Neuromuscular Facilitation (PNF) in Adhesive Capsulitis 
Scientific Title of Study   Effect of Gong’s Mobilization versus Proprioceptive Neuromuscular Facilitation (PNF) on Pain, Range of Motion and Functional Ability of Shoulder in Adhesive Capsulitis – Randomized Control Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pratiksha Akhade 
Designation  PG Student 
Affiliation  Pravara Institute of Medical Sciences,Loni 
Address  OPD number 403 Department of Orthopedic Physiotherapy Fourth Floor Dr APJ Abdul Kalam College of Physiotherapy, Loni

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  9405869259  
Fax    
Email  pratikshaakhade@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Neeraj Kumar 
Designation  Vice principal,HOD of orthopaedics physiotherapy, Pravara institute of medical sciences 
Affiliation  Pravara Institute of Medical Sciences 
Address  OPD number 403 Department of Orthopedic Physiotherapy Fourth Floor Dr APJ Abdul Kalam College of Physiotherapy, Loni

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  9005411557  
Fax    
Email  drneerajpt@gmail.com  
 
Details of Contact Person
Public Query  
Name  Pratiksha Akhade 
Designation  PG student 
Affiliation  Pravara institute of medical sciences 
Address  OPD number 403 Department of Orthopedic Physiotherapy Fourth Floor Dr APJ Abdul Kalam College of Physiotherapy, Loni

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  9405869259  
Fax    
Email  pratikshaakhade@gmail.com  
 
Source of Monetary or Material Support  
Pravara institute of medical sciences Loni Ahmednagar Maharashtra 
 
Primary Sponsor  
Name  Dr APJ Abdul Kalam College of Physiotherapy 
Address  Dr APJ Abdul Kalam College of Physiotherapy Tal Rahata Dist Ahmednagar 413736 
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 Pratiksha Akhade  Pravara Institute of Medical Sciences   OPD number 403 Department of Orthopedic Physiotherapy Fourth Floor Dr APJ Abdul Kalam College of Physiotherapy, Loni
Ahmadnagar
MAHARASHTRA 		 9405869259

pratikshaakhade@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee of Pravara institute of medical sciences (Deemed to be university) Dr. APJ Abdul Kalam college of physiotherapy Loni   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 treatment  -Ultrasound parameters: continuous waveform for 8 min at setting of (1.5w/cm2) -Maitland mobilization: The glides given included glenohumeral caudal glide, glenohumeral caudal glide progression; glenohumeral postero-anterior glide. Passive oscillatory movements will be performed at the rate of 2-3 glides per second for 30 seconds for each glide given for 5 sets with 1 minute rest between sets. -Codman’s Pendulum exercise -Active-assisted ROM exercises -Capsular stretch (posterior, anterior) -Finger ladder All exercises were performed 3 sets with 15 repetitions per set. The program will be of a Total 2 weeks, 5 sessions per weeks.  
Intervention  Gongs mobilization  The subject will be placed in a side-lying position with the affected shoulder joint facing upward. The patient’s shoulder will be abducted at 90° to maintain the humerus vertical position and the flexed elbow joint in a 90° position. The therapist will use one hand to keep the subject’s elbow joint at 90°, with own elbow below the patient’s elbow joint, and the other hand to press the humerus head from anterior to posterior. The therapist next will elevate their own body, while slightly pulling on the articular capsule of the shoulder joint, keeping the vertical axis of the humerus constant by maintaining shoulder abduction and elbow at 90°. This gentle pushing of the articular capsule will be sustained for 10–15 seconds before relaxing for 5 seconds; the whole manoeuvre lasts roughly 2–3 minutes. The therapist will use one hand to press the shoulder joint from anterior to posterior after slightly extending the articular capsule. This will prevent vertical pulling of the slightly extended articular capsule and the humerus. The therapist with the use of other hand will hold the elbow while performing shoulder medial rotation. Then, to enhance range of motion, oscillation at Maitland’s grades 3 and 4 was performed, followed by 7 seconds of prolonged stretching at the grade 4 technique. (4) Conventional Physiotherapy: Ultrasound parameters: continuous waveform for 8 min at setting of (1.5w/cm2) Maitland mobilization: The glides given included glenohumeral caudal glide, glenohumeral caudal glide progression; glenohumeral postero-anterior glide. Passive oscillatory movements will be performed at the rate of 2-3 glides per second for 30 seconds for each glide given for 5 sets with 1 minute rest between sets. Codman’s Pendulum exercise Active-assisted ROM exercises Capsular stretch (posterior, anterior) Finger ladder All exercises were performed 3 sets with 15 repetitions per set. The program will be of a Total 2 weeks, 5 sessions per weeks.  
Intervention  Proprioceptive Neuromuscular Facilitation   PNF for upper extremity Patient position: Patent will in supine lying position with the arms beside their body. They will be asked to relax shoulders. Therapist position: Therapist will stand beside the affected side of the patient. Technique: Flexion-abduction-external rotation (D2F pattern) with elbow straight pattern of PNF with hold relax technique. It is a relaxing tool based on isometric contractions against to maximum resistance using for improving passive ROM and decreasing pain. Isometric contractions for 5-8 seconds will be performed against to maximum resistance for not balking antagonist muscles to contract including rotation at limitation point. Technique is repeated a few times at edge limitation point and then, proceeded. While applying D2F pattern with elbow straight pattern of PNF, the therapist will use his hand to hold the patient’s upper limb on the opposite side of hip in a posture of shoulder extension/ adduction/internal rotation, elbow extension and forearm pronation. The physiotherapist then asks the patient to raise his hand over head. The patient will attempt to perform this movement, by doing shoulder flexion/abduction/external rotation. During these movements, the therapist will support the patient’s arm with his other hand Repetitions: 10 repetitions Sets:3 Hold time: 5-8 seconds Rest time: 5 seconds PNF scapula Anterior Elevation & Posterior Depression Patient position: Patient lie on the unaffected side Therapist Position: Standing behind the patient, placing one hand superior border of scapula and other on inferior angle of scapula Procedure: The patient is instructed to Push up and push down the scapula against the manual resistance given by therapist. Posterior Elevation & Anterior Depression Patient position: Patient lie on the unaffected side. Therapist Position: Standing behind the patient, placing one hand superior border of scapula and other on inferior angle of scapula Procedure: The patient is instructed to Push back and Push front the scapula against the manual resistance given by therapist. Repetitions: 20 repetitions Set:3 Hold time: 7-10 seconds Rest time: 15-20 seconds Conventional Physiotherapy: Ultrasound parameters: continuous waveform for 8 min at setting of (1.5w/cm2) Maitland mobilization: The glides given included glenohumeral caudal glide, glenohumeral caudal glide progression; glenohumeral postero-anterior glide. Passive oscillatory movements will be performed at the rate of 2-3 glides per second for 30 seconds for each glide given for 5 sets with 1 minute rest between sets. Codman’s Pendulum exercise Active-assisted ROM exercises Capsular stretch (posterior, anterior) Finger ladder All exercises were performed 3 sets with 15 repetitions per set. The program will be of a Total 2 weeks, 5 sessions per weeks.  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Subjects with diagnosed cases of adhesive capsulitis
40-60 years
Unilateral adhesive capsulitis of shoulder joint.
Both males and females.
Pain more than 1 month
Phase II and III of adhesive capsulitis of shoulder joint.
Subjects with restricted ROM (ROM losses of 25% or greater compared with the noninvolved shoulder).
Subjects willing to sign the consent form
 
 
ExclusionCriteria 
Details  Subjects with rotator cuff tears.
Overuse injury.
History of Rheumatoid arthritis, osteoarthritis, and other malignancies in the shoulder region.
Frozen shoulder secondary to neurological disorders.
Unstable shoulders and recurrent dislocations.
Post-surgical cases.
Any respiratory or chronic complication which interrupt the participation in the study
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Visual Analog Scale (VAS)
Range of Motion (ROM)
Shoulder Pain and Disability Index (SPADI)
 		 Baseline week 0 and post-intervention week 2
 
 
Secondary Outcome  
Outcome  TimePoints 
Shoulder Pain & Disability Index (SPADI)  Baseline week 0 & post-intervention week 2 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/04/2024 
Date of Study Completion (India) 25/03/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 25/03/2025 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
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  



INTRODUCTION:

“Adhesive Capsulitis” or “frozen shoulder,” is a soft tissue disorder that results in pain, stiffness, and progressive loss of active and passive range of motion (AROM and PROM) in the glenohumeral joint. The shoulder joint capsule is inflamed and thick, and stiff connective tissue surrounds the shoulder joint.

This condition most often affects the people between 40-60 years old. Approximately 70% of the patients presenting with adhesive capsulitis are women, and 20-30% of those affected develop adhesive capsulitis in opposite shoulder. Adhesive capsulitis is commonly occurring of 10-20% people with diabetes. It is significant on with the incidence of 2% in general population in India.

There are generally three stages of pathology in adhesive capsulitis. In the first Pre-freezing stage, onset is usually one to several months, the second stage “Freezing” usually takes about 3 to 9 months, the third stage “Frozen” is also known as ‘maturation stage’, lasts for 9-14 months. In fourth or chronic stage called as ‘Thawing’, occurs by 12 to 15 months since the onset of adhesive capsulitis.

Evaluation of the position of the scapula is very important in the pathologies of the shoulder because these pathologies are responsible for the second and third most common causes of musculoskeletal pain. Abnormal changes in the position of the scapula at different angles of the shoulder indicate a disturbance of the scapulohumeral rhythm, and these changes adversely affect the functions of the upper extremity. In the pathologies limiting the movements of the glenohumeral joint, the scapulohumeral rhythm can be reversed. Shoulder pathologies, such as AC and subacromial impingement, can lead to changes in the position of the scapula.

Gong’s mobilization technique helps to decrease pain as well as distract the mind of the subject from stress caused due to pain. Gong’s mobilization is an effective technique to improve shoulder abduction, internal and external rotation using anterior-posterior glide. This mobilization technique is applied in end range of available shoulder movement with a corrective glide from anterior to a posterior direction in a dynamic position. The technique is followed by a distraction force applied around the shoulder and performing the restricted movement.

Proprioceptive neuromuscular facilitation (PNF) is an important technology used in rehabilitation manual therapy. It is a stretching technique that can improve muscle elasticity and has been shown to positively affect the active and passive range of motion in patients with frozen shoulder. Proprioceptive neuromuscular facilitation has been reported to be effective in relieving pain and improving functional abilities. Proprioceptive neuromuscular facilitation methods, particularly those involving reciprocal activation of the agonist and antagonist to the desired motion, provide the greatest potential for muscle functioning.

Studies have shown that Gong’s mobilization and PNF effectively increased range of motion, reduce pain and thus improving function. So far none of the studies have shown the comparison between both these techniques. Hence this study is warranted to apply for clinical practice for faster recovery of range of motion and functional recovery in frozen shoulder.





NEED FOR THE STUDY-

Adhesive capsulitis is a common condition affecting 2-5% of the general population. It is a condition of uncertain etiology characterized by progressive loss of shoulder joint mobility as well as functional ability having long term effects. (10)  Several treatment approaches for adhesive capsulitis like medications, intra-articular injections, exercise programs, physiotherapy modalities, manual therapy techniques are been practiced but there is lack of study has reporting supremacy of one technique over another. (3-14) This study is an attempt to know the efficacy of Gong’s mobilization, Proprioceptive neuromuscular facilitation along with conventional physiotherapy to see its beneficial effect on the variables like pain, range of motion and functional ability affected in the population with adhesive capsulitis and determine the better of these to get best result.


 

RESEARCH QUESTION:

Is there any difference between effect of Gongs mobilization and PNF in improving pain, ROM & functional ability in adhesive capsulitis?

 

Aim and Objectives of the study:

 

AIM:

To compare the effectiveness of Gong’s mobilization and Proprioceptive neuromuscular facilitation technique in subjects with adhesive capsulitis.


















OBJECTIVE OF THE STUDY: -

(i)to examine the effectiveness of Gong’s mobilization in reducing pain and functional disability and improving range of motion in patients with adhesive capsulitis.

 (ii) to examine the effectiveness of PNF combined in reducing pain and improving range of motion in patients with adhesive capsulitis.; and

 (iii) to examine the effect of conventional physiotherapy treatment in reducing pain and improving range of motion in patients with adhesive capsulitis.

 HYPOTHESES 

Null Hypothesis (H0):

 There will not be any significant difference between Gong’s mobilization and PNF for reducing pain, improving shoulder range of motion and functional recovery in subjects with  adhesive capsulitis.

 

 Alternative Hypothesis (H1):There will be significant difference between Gong’s mobilization and PNF for reducing pain, improving shoulder range of motion and functional recovery in subjects with adhesive capsulitis.

METHODOLOGY

1.     Source of Data- Dr. APJ Abdul Kalam college of Physiotherapy, PIMS, Loni.

2.     Study setting- Study will be conducted in Out-Patient (OPD) of Orthopedic physiotherapy department, Dr. APJ Abdul Kalam college of Physiotherapy, PIMS, Loni

3.     Duration of study- 2 years

4.     Method of collection of data- Data will be primary collected by principal investigator by assessment.

5.     Study design – Randomized control trial

6.     Study type- Experimental study 

7.     Sampling method- Simple Random Sampling

8.     Sample size- 60 (according to openepi)

9.     Study population- 40–60-year-old diagnosed subjects of adhesive capsulitis.

10.  Materials to be used- consent form, assessment sheet, VAS scale, SPADI scale

Equipment-Goniometer


SELECTION CRITERIA:

 Inclusion criteria-

Ø  Subjects with diagnosed case of adhesive capsulitis

Ø  AGE; 40-60 years.

Ø  Unilateral adhesive capsulitis of shoulder joint.

Ø  Both males and females.

Ø  Pain more than 1 month

Ø  Phase II and III of adhesive capsulitis of shoulder joint.

Ø  Subjects with restricted ROM (ROM losses of 25% or greater compared with the noninvolved shoulder).

Ø  Subjects willing to sign the consent form

 

 

  Exclusion criteria-

Ø  Subjects with rotator cuff tears.

Ø  Overuse injury.

Ø  History of Rheumatoid arthritis, osteoarthritis, and other malignancies in the shoulder region.

Ø  Frozen shoulder secondary to neurological disorders.

Ø  Unstable shoulders and recurrent dislocations.

Ø  Post-surgical cases.

Ø  Any respiratory or chronic complication which interrupt the participation in the study

 

 

Outcome Measures:

1.     Visual Analog Scale (VAS) (0.95)

2.     Range of Motion (ROM)

3. Shoulder Pain and Disability Index (SPADI) (validity -0.99, reliability- 0.98pain, 0.99 disability)

PROCEDURE

Protocol is prepared and ethical clearance is obtained from the IEC.

The Participants will be selected based on the inclusion and exclusion criteria for eligibility.

Informed consent will be obtained from the participants and demographic data will be recorded.

60 Participants will be randomly allocated to 3 groups that is experimental group A (n=20), experimental group B (n=20) and the conventional group (n=20). Prior assessment of the participants will be done.

Group A that is the experimental group will be receiving Gong’s mobilization and conventional physiotherapy treatment, Group B will be receiving Proprioceptive neuromuscular facilitation and conventional physiotherapy treatment and Group C will be given conventional physiotherapy treatment for adhesive capsulitis.

The assessment of each group will be taken individually before and after the intervention. VAS, Shoulder ROM (IR, Abd, ER), and SPADI will be assessed.

 

The program will be of a Total 2 weeks, 5 sessions per weeks.

 

 

 

Experimental Interventions

 

Group A- Gongs mobilization technique

 

The subject will be placed in a side-lying position with the affected shoulder joint facing upward. The patient’s shoulder will be abducted at 90° to maintain the humerus vertical position and the flexed elbow joint in a 90° position. The therapist will use one hand to keep the subject’s elbow joint at 90°, with own elbow below the patient’s elbow joint, and the other hand to press the humerus head from anterior to posterior. The therapist next will elevate their own body, while slightly pulling on the articular capsule of the shoulder joint, keeping the vertical axis of the humerus constant by maintaining shoulder abduction and elbow at 90°. This gentle pushing of the articular capsule will be sustained for 10–15 seconds before relaxing for 5 seconds; the whole manoeuvre lasts roughly 2–3 minutes. The therapist will use one hand to press the shoulder joint from anterior to posterior after slightly extending the articular capsule. This will prevent vertical pulling of the slightly extended articular capsule and the humerus. The therapist with the use of other hand will hold the elbow while performing shoulder medial rotation. Then, to enhance range of motion, oscillation at Maitland’s grades 3 and 4 was performed, followed by 7 seconds of prolonged stretching at the grade 4 technique. (4)

 

Conventional Physiotherapy: Ultrasound parameters: continuous waveform for 8 min at setting of (1.5w/cm2)

Maitland mobilization: The glides given included glenohumeral caudal glide, glenohumeral caudal glide progression; glenohumeral postero-anterior glide. Passive oscillatory movements will be performed at the rate of 2-3 glides per second for 30 seconds for each glide given for 5 sets with 1 minute rest between sets.

Codman’s Pendulum exercise

Active-assisted ROM exercises

Capsular stretch (posterior, anterior)

Finger ladder

All exercises were performed 3 sets with 15 repetitions per set.

 

 

Group B

PNF for upper extremity

 

Patient position: Patent will in supine lying position with the arms beside their body. They will be asked to relax shoulders.

Therapist position: Therapist will stand beside the affected side of the patient.

Technique: “Flexion-abduction-external rotation” (D2F pattern) with elbow straight pattern of PNF with “hold relax” technique. It is a relaxing tool based on isometric contractions against to maximum resistance using for improving passive ROM and decreasing pain. Isometric contractions for 5-8 seconds will be performed against to maximum resistance for not balking antagonist muscles to contract including rotation at limitation point. Technique is repeated a few times at edge limitation point and then, proceeded. While applying D2F pattern with elbow straight pattern of PNF, the therapist will use his hand to hold the patient’s upper limb on the opposite side of hip in a posture of shoulder extension/ adduction/internal rotation, elbow extension and forearm pronation. The physiotherapist then asks the patient to raise his hand over head. The patient will attempt to perform this movement, by doing shoulder flexion/abduction/external rotation. During these movements, the therapist will support the patient’s arm with his other hand

 

Repetitions: 10 repetitions         Sets:3 

Hold time: 5-8 seconds         Rest time: 5 seconds

 

Proprioceptive Neuromuscular Facilitation Technique for Scapula:

 

Anterior Elevation & Posterior Depression

 

Patient position: Patient lie on the unaffected side

Therapist Position: Standing behind the patient, placing one hand superior border of scapula and other on inferior angle of scapula

Procedure: The patient is instructed to Push up and push down the scapula against the manual resistance given by therapist.

 

Repetitions: 20 repetitions              Set:3

Hold time: 7-10 seconds                 Rest time: 15-20 seconds

Treatment session: total 2 weeks, 5 sessions per week

 

 

Posterior Elevation & Anterior Depression

 

Patient position: Patient lie on the unaffected side.

Therapist Position: Standing behind the patient, placing one hand superior border of scapula and other on inferior angle of scapula

Procedure: The patient is instructed to Push back and Push front the scapula against the manual resistance given by therapist.

 

Repetitions: 20 repetitions              Set:3

Hold time: 7-10 seconds                 Rest time: 15-20 seconds

 

 

Conventional Physiotherapy: Ultrasound parameters: continuous waveform for 8 min at setting of (1.5w/cm2)

Maitland mobilization: The glides given included glenohumeral caudal glide, glenohumeral caudal glide progression; glenohumeral postero-anterior glide. Passive oscillatory movements will be performed at the rate of 2-3 glides per second for 30 seconds for each glide given for 5 sets with 1 minute rest between sets.

Codman’s Pendulum exercise

Active-assisted ROM exercises

Capsular stretch (posterior, anterior)

Finger ladder

All exercises were performed 3 sets with 15 repetitions per set.

 

 

Group C

Control Group

Ø  Ultrasound parameters: continuous waveform for 8 min at setting of (1.5w/cm2)

Ø  Maitland mobilization: The glides given included glenohumeral caudal glide, glenohumeral caudal glide progression; glenohumeral postero-anterior glide. Passive oscillatory movements will be performed at the rate of 2-3 glides per second for 30 seconds for each glide given for 5 sets with 1 minute rest between sets.

Ø  Codman’s Pendulum exercise

Ø  Active-assisted ROM exercises

Ø  Capsular stretch (posterior, anterior)

Ø  Finger ladder

All exercises were performed 3 sets with 15 repetitions per set.






 
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