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CTRI Number  CTRI/2024/10/075113 [Registered on: 11/10/2024] Trial Registered Prospectively
Last Modified On: 01/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Spencers Muscle Energy Technique versus Proprioceptive Neuromuscular Facilitation on Pain, Range of Motion and Functional Disability in participants with Adhesive Capsulitis-Intervention Study 
Scientific Title of Study   Comparison of Spencers Muscle Energy Technique and Proprioceptive Neuromuscular Facilitation on Pain, Range of Motion and Functional Disability in individuals with Adhesive Capsulitis  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mistry Drashti Rajeshbhai 
Designation  Pursuing Masters of Physiotherapy in Orthopaedics  
Affiliation  Ahmedabad Institute of Medical Sciences 
Address  Room no 1 Division Exercise Therapy Department Physiotherapy, Ahmedabad Institute of Medical Sciences, Near Lions Karnavati Eye Hospital, Lapkaman, Gota-Vadsar, Ahmedabad, Gujarat, India

Ahmadabad
GUJARAT
380060
India 
Phone  9265971058  
Fax    
Email  drashtirmistry@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Alpa Purohit 
Designation  Vice Principal, PhD, PG guide 
Affiliation  Ahmedabad Institute of Medical Sciences 
Address  Room no 1 Division Exercise Therapy Department Physiotherapy, Ahmedabad Institute of Medical Sciences, Near Lions Karnavati Eye Hospital, Lapkaman, Gota-Vadsar, Ahmedabad, Gujarat, India

Ahmadabad
GUJARAT
380060
India 
Phone  9408131305  
Fax    
Email  dralpaphysio@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Alpa Purohit 
Designation  Vice Principal, PhD, PG guide 
Affiliation  Ahmedabad Institute of Medical Sciences 
Address  Room no 1 Division Exercise Therapy Department Physiotherapy, Ahmedabad Institute of Medical Sciences, Near Lions Karnavati Eye Hospital, Lapkaman, Gota-Vadsar, Ahmedabad, Gujarat, India

Ahmadabad
GUJARAT
380060
India 
Phone  9408131305  
Fax    
Email  dralpaphysio@yahoo.co.in  
 
Source of Monetary or Material Support  
Ahmedabad Institute of Medical Sciences Near Lions Karnavati Eye Hospital, Lapkaman, Gota-Vadsar, Ahmedabad, Gujarat-380060 
 
Primary Sponsor  
Name  Ahmedabad Institute of Medical Sciences 
Address  Room no 1 Division Exercise Therapy Department Physiotherapy, Ahmedabad Institute of Medical Sciences, Near Lions Karnavati Eye Hospital, Lapkaman, Gota-Vadsar, Ahmedabad, Gujarat, India  
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 Alpa Purohit  Ahmedabad Institute of Medical Sciences  Room no. 1 Division Exercise therapy Department Physiotherapy Ahmedabad Institute of Medical Sciences Near Lions Karnavati Eye Hospital, Lapkaman, Gota-Vadsar, Ahmedabad, Gujarat-380060
Ahmadabad
GUJARAT 
9408131305

dralpaphysio@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Research And Ethics Committee  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  Proprioceptive Neuromuscular Facilitation + Conventional treatment  Hold – Relax PNF Technique for Upper Extremity “flexion – abduction – external rotation” pattern. Repetition: 8 repetitions per set, 2 sets per session, 1 session per day, each repetition maintained for duration of 5-10 sec Duration will be 4 days/week for 4 weeks. 
Intervention  Spencer’s Muscle Energy Technique + Conventional treatment   5 repetitions per set, 5 sets per session, 1 session per day, each repetition maintained for the duration of 7-10 sec Duration will be 4 days/week for 4 weeks. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Adhesive capsulitis stage 2 and 3.
Unilateral Adhesive Capsulitis.
Complains ongoing for at least 3 months.
Subjects willing to participate.
 
 
ExclusionCriteria 
Details  Post traumatic pain and stiffness.
Recent history of surgery around the shoulder joint.
Any cardiac pacemakers.
Severe musculoskeletal disorder or deformity.
Severe neurological disorders.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Visual Analogue Scale  at baseline and at 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Range of Motion  at baseline & at 4 weeks 
Shoulder Pain And Disability Index  at baseline & at 4 weeks 
 
Target Sample Size   Total Sample Size="38"
Sample Size from India="38" 
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   N/A 
Date of First Enrollment (India)   15/10/2024 
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="0"
Months="6"
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   NEED OF THE STUDY: â€¢ Muscle Energy Technique is a manual therapy that uses the gentle muscle contractions to relax and lengthen muscles and normalize joint motion.

•  Spencer’s technique is an articulatory technique with seven different procedures used to treat shoulder restriction caused by Adhesive Capsulitis.

•  PNF stretch is a technique commonly used in clinical environments to enhance both active and passive ROM.

•  Hold-relax technique is aimed at relaxing tense muscles and restricted joints to make quick gains in ROM.

• Studies have shown that both the Spencer’s technique and PNF are used effectively in the treatment of Adhesive capsulitis.

However, there are no studies found in literature which compare the effects of these two methods of manual therapy.


AIM OF THE STUDY: â€¢  To compare the effect of Spencer’s Muscle Energy Technique and Proprioceptive Neuromuscular Facilitation in individuals with Adhesive Capsulitis.


OBJECTIVES OF THE STUDY: â€¢ To see the effect of Spencer’s Muscle Energy Technique on Pain, Range of Motion and Functional Disability.

• To see the effect of Proprioceptive Neuromuscular Facilitation on Pain, Range of Motion and Functional Disability.

• To see the comparative effect of Spencer’s Muscle Energy Technique and Proprioceptive Neuromuscular Facilitation on Pain, Range of Motion and Functional Disability.

 

PROCEDURE: 

After being approved by the ethical committee, according to inclusion and exclusion criteria 38 subjects will be divided into 2 groups. Informed consent will be taken. In both groups, pre and post data will be measured.

Group A: Spencer’s Muscle Energy Technique + Conventional treatment

•        Conventional therapy and Spencer’s Muscle Energy Technique both will be demonstrated to the subjects.

•        Spencer’s Muscle Energy Technique consist of:

1.     Extension with elbow flexed

2.     Flexion with elbow extended

3.     Circumduction with compression

4.     Circumduction with traction

5.     Adduction with External Rotation

6.     Internal rotation

7.     Distraction in abduction

•        Repetition: 5 repetitions per set, 5 sets per session, 1 session per day, each repetition maintained for the duration of 7-10 sec.

•        Conventional therapy

Group B: Proprioceptive Neuromuscular Facilitation + Conventional treatment

•        Conventional therapy and Proprioceptive Neuromuscular Facilitation both will be demonstrated to the subjects.

•        Proprioceptive Neuromuscular Facilitation

1.     Hold – Relax PNF Technique for Upper Extremity “flexion – abduction – external rotation” pattern.

•        Repetition: 8 repetitions per set, 2 sets per session, 1 session per day, each repetition maintained for duration of 5-10 sec.

•        Conventional therapy

Conventional therapy for both the groups includes,

 1. Modality: hot pack (10 minutes)

 2. Exercises:

•        Capsular stretching of shoulder joint.

•        Isometric strengthening exercise of flexor, extensor, abductors, adductors, external rotators, internal rotators.

•        Scapula stabilization exercise: open chain exercises of scapula stabilizers without weight and progression with light weight dumbbells in prone position.

•        Active free exercises using cane/wand.

•        All the Exercises were performed for all movements namely flexion/extension and abduction-adduction, external and internal rotation.

•        One sets of each 10-15 repetitions within pain-free range. (Total conventional treatment time is 30 minutes

d  Duration of treatment: 4 days/week for 4 weeks


 
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