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CTRI Number  CTRI/2022/01/039276 [Registered on: 10/01/2022] Trial Registered Prospectively
Last Modified On: 22/03/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Effect of Motor Imagery, Pain education and exercises on quality of life, pain, fear of movement and anxiety in painful diabetic nerve conditions 
Scientific Title of Study   Effect of Graded Motor Imagery on Quality of Life, Pain, Kinesiophobia, Pain Catastrophization and Anxiety in Painful Diabetic Neuropathy: A 3- Arm Randomized Controlled Trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jorida Fernandes 
Designation  Lecturer in Physiotherapy 
Affiliation  Goa Medical College 
Address  Department of Orthopedics, Goa Medical College
Bambolim Goa
North Goa
GOA
403201
India 
Phone  9060778888  
Fax    
Email  joridaphd2021@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prashant Mukkannavar 
Designation  Professor 
Affiliation  SDM College of Physiotherapy 
Address  Department of Orthopedic Physiotherapy, SDM College of Physiotherapy, Sattur

Dharwad
KARNATAKA
580009
India 
Phone  9036981180  
Fax    
Email  drprashantmb@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prashant Mukkannavar 
Designation  Professor 
Affiliation  SDM College of Physiotherapy 
Address  Department of Orthopedics Physiotherapy, SDM College of Physiotherapy
Dharwad
Dharwad
KARNATAKA
580009
India 
Phone  9036981180  
Fax    
Email  drprashantmb@gmail.com  
 
Source of Monetary or Material Support  
Goa Medical College  
 
Primary Sponsor  
Name  Jorida Fernandes 
Address  Department of Orthopedics, Goa Medical College  
Type of Sponsor  Other [Self Funded] 
 
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 
Jorida Fernandes  Medicine wards, Physiotherapy OPD  Goa Medical College, Bambolim Goa
South Goa
GOA 		 9060778888

joridaphd2021@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Goa Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G63||Polyneuropathy in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Therapy  The session will begin with a 5 min pre-exercise warm-up of gentle stretches and end with a 5 min cool-down of slow walking. As per the participants tolerance the number of repetitions and sets will be progressed from 1 to 3 sets. Following exercises will be given: Range of motion exercises: the participant will perform active movements of the knee (flexion–extension), ankle (dorsi–plantar flexion), forefoot (inversion–eversion) and toe (flexion–extension, adduction–abduction) joints. Muscle strengthening exercises Exercises for improving static balance: tandem leg stance, single leg stance. Exercises for improving dynamic balance: tandem walk, sideways walk, backward walk. Endurance exercises: brisk walking. Participants will have to perform the exercises at least three times a week, once per day. The frequency of self-exercise sessions will be recorded by the principal investigator through telephonic calls and a diary maintained by the participant.  
Comparator Agent  Graded Exposure  Graded exposure includes 2 components which are participant education and activities related to fear. Next the participants will be asked questions related fear provoking movement which will include listing out the fear provoking movement in a hierarchical order from 0 (no fear) to 100 (maximal fear). During the 1st session which will be supervised by the physiotherapist, 2 activities with lower fear rate will be introduced to the participant at intensity, duration, and frequency that will not increase the fear. Participant’s activity level will be progressed based on reporting of decreased fear of exercise and activity to the next 2 activities in the hierarchical order. Participants who report no change in fear will be encouraged to continue exposure at the current intensity. For the home programme, participants will be given a video of the activities which will have to be done for 30 minutes, once a day, 3-5 times a week.  
Intervention  Graded Motor Imagery  The first two weeks of the GMI programme will focus on the training of left/right judgements. The Neuro Orthopaedic Institute’s (NOI) RecogniseTM software application will be used. Fifty photographs of lower limb representing the affected limb and the intact limb will be presented in various positions and alignments. For the home exercise programme, participants will be provided with several magazines containing photographs of people. They will be instructed to identify and circle the limbs that matched the side of their own affected limb. The next 2 weeks will be the imagined movements phase. From a collection of photographs on the NOI RecogniseTM app, participants will be shown an image of a limb that matched the side of their own affected limb. They will be instructed to imagine moving their affected limb slowly and smoothly from the position they felt it to be in, to the posture shown in the image, and then to imagine moving it back to its original position Imagined movements will performed repeatedly, using three images for each 30-minute treatment session. For the home exercise programme, participants will be given three printed images or three images on their smart phones. The next 2 weeks will be the mirror movement phase. A purpose-built mirror box (single aperture 300 mm; cardboard with Perspex mirror on one external surface) (NOIgroup.com, Adelaide, Australia) will be used. The participants will be shown a photograph of the unaffected limb in an easy to attain position and instructed to simultaneously move the intact limb and the affected limb into the presented posture while observing the reflection of the intact limb in the mirror. Mirror therapy tasks will be performed repeatedly, using three photographs for each 30-minute treatment session. For the home exercise programme, participants will be advised to replicate the instructions of the treatment session using the same photographs Activities done in the previous week will be repeated in the last 2 weeks.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Participant of all gender in the age group of 18-75 years.
2. Diabetic participants with diagnosis of Peripheral neuropathy (score 1-4),presenting with pain in the feet.
3. Participants visiting Goa Medical College & Hospital, Dharwad between Jan 2022- Jan 2023.
4. Participants willing to sign the informed consent.

 
 
ExclusionCriteria 
Details  1. Participants with severe OA, knee/ankle ligament sprains and fractures of the lower limb
2. Any other neurological disease than PDN
3. Any other disease that may cause pain in the feet and/or damage to the peripheral nervous system (e.g. ulcers, amputation, vascular insufficiency).
4. Presence of severe cardiovascular and respiratory diseases
5. Participants on chemotherapeutic drugs or radiation in the last 10 years.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
RAND SF-36, Visual Analogue Scale,Tampa scale for Kinesiophobia (TSK), Pain Catastrophization Scale (PCS),  1st week, 8th week 
 
Secondary Outcome  
Outcome  TimePoints 
Pain Anxiety Symptom Scale- Short Form 2, Pain Self Efficacy Questinnaire (PSEQ)  1st week, 8th week 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="90" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   10/01/2022 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [joridaphd2021@gmail.com].

  6. For how long will this data be available start date provided 25-01-2025 and end date provided 25-01-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Pain and its associated disability cannot be attributed only to somatic pathology but to psychological factors like catastrophization of pain, depression and anxiety.  As the focus of treatment in pain reduction has now shifted to the top down approach, cognitive interventions are known to activate specific areas of the brain associated with pain, thus helping the individual to cope and reduce the impact of pain.  The effectiveness of Graded Motor Imagery (GMI) has been extensively studied in neuropathic syndromes which have overlapping features like pain, allodynia and hyperalgesia. These overlapping features can lend themselves to common treatment strategies.  Exercises have benefitted patients with Diabetic Peripheral Neuropathy (DPN) in terms of pain reduction, improvement in balance, nerve function and sensory disturbances leading to better functional mobility. Educating the patient about pain and its associated disabilities works best in combination with physiotherapy to improve pain, pain related fears & QoL. There is dearth of evidence on the effects of GMI in PDN. Hence the present study aims to compare the effects of GMI with Graded Exposure and Conventional physiotherapy in patients with PDN.  


 
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