FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/07/071675 [Registered on: 31/07/2024] Trial Registered Prospectively
Last Modified On: 21/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Two different therapies for treating nerve damage from chemotherapy 
Scientific Title of Study   Effect of Whole Body Vibration versus Proprioceptive Neuromuscular Facilitation on Chemotherapy- Induced Peripheral Neuropathy: A Randomized Clinical 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  Srushti Jegarkal 
Designation  Post Graduate Student 
Affiliation  KAHER Institute of Physiotherapy 
Address  Advanced Physiotherapy Centre, Room.no 39, Sagar Floor, KLES Dr. Prabhakar Kore Hospital and MRC. Belgaum, Karnataka- 590010 India

Belgaum
KARNATAKA
590010
India 
Phone  8123329036  
Fax    
Email  srushtijegarkal@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sanjiv Kumar 
Designation  Principal and Professor 
Affiliation  KAHER Institute of Physiotherapy 
Address  Advanced Physiotherapy Centre, Room.no 39, Sagar Floor, KLES Dr. Prabhakar Kore Hospital and MRC. Belgaum, Karnataka- 590010 India

Belgaum
KARNATAKA
590010
India 
Phone  9448745648  
Fax    
Email  sanjiv3303@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Srushti Jegarkal 
Designation  Post Graduate Student 
Affiliation  KAHER Institute of Physiotherapy 
Address  Advanced Physiotherapy Centre, Room.no 39, Sagar Floor, KLES Dr. Prabhakar Kore Hospital and MRC. Belgaum, Karnataka- 590010 India

Belgaum
KARNATAKA
Belagavi
India 
Phone  08123329036  
Fax    
Email  srushtijegarkal@gmail.com  
 
Source of Monetary or Material Support  
KLES Dr. Prabhakar Kore Hospital and MRC, Nehru Nagar Belgaum Karnataka 590010, India 
 
Primary Sponsor  
Name  Srushti Jegarkal 
Address  Advanced Physiotherapy Centre, Room.no 39, Sagar Floor, KLES Dr. Prabhakar Kore Hospital and MRC. Belgaum, Karnataka- 590010 India 
Type of Sponsor  Other [Self] 
 
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 
Srushti Jegarkal  KLES Dr Prabhakar Kore Hospital  Sagar Floor, Advanced Physiotherapy Centre, Room.no 39
Belgaum
KARNATAKA 
8123329036

srushtijegarkal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research and Ethical Committee, KAHER Institute of Physitherapy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Chemotherapy Induced Peripheral Neuropathy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
Intervention  Proprioceptive neuromuscular facilitation and regular physiotherapy treatment  PNF techniques which include: hold – relax, contract- relax, slow reversal and rhythmic stabilization along with diagonal patterns of the lower limb i.e., D1 flexion, D1 extension, D2 flexion and D2 extension.3 sets of exercises. Each set of exercise consists of 5 repetitions PNF patterns. Adequate rest between each set. Regular Physiotherapy Treatment Strengthening Exercises Flexibility Exercises Balance Exercises for 3days/week for 3 weeks  
Intervention  Whole Body Vibration and regular physiotherapy treatment  Each training session consisted of four progressing sets of 30-s to 1-min vibration, with a frequency from 18 to 35 Hz and amplitude of 2–4 mm. 1-min rest will be kept between each set to avoid neuronal fatigue. Regular Physiotherapy Treatment Strengthening Exercises Flexibility Exercises Balance Exercises for 3days/ week for 3 weeks  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Willing to participate.
Age 18-70 years all genders.
Diagnosed case of CIPN.
Minimum 3 doses of chemotherapy or have completed chemotherapy treatment.
 
 
ExclusionCriteria 
Details  Severe neuropathic symptoms requiring immediate medical care.
Pre-existing peripheral neuropathy not related to chemotherapy treatment.
Individuals with a history of severe cardiovascular disease or orthopedic conditions.
Cognitive impairment or psychiatric disorders.
Unstable medical conditions.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Self-report Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS)
Semmes Weinstein Monofilament
MiniBESTest
Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group Neurotoxicity (FACT-GOG Ntx)(v4)
 
Baseline and after 3 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="38"
Sample Size from India="38" 
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" 
Phase of Trial   N/A 
Date of First Enrollment (India)   26/08/2024 
Date of Study Completion (India) 12/04/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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
Modification(s)  

This randomized clinical trial was conducted to assess and compare the therapeutic impacts of WBV and PNF on neuropathic pain, sensory function, balance, and quality of life in individuals suffering from CIPN. A total of 32 participants, each having undergone a minimum of three cycles of chemotherapy, were randomly divided into two groups: one receiving WBV and the other PNF, with both groups also participating in standard physiotherapy exercises. Over a span of three weeks, participants engaged in nine intervention sessions, and outcomes were measured using validated assessment tools such as the S-LANSS, SWMT, MiniBESTest, and the FACT-GOG-Ntx. The results indicated significant improvements across all measured outcomes in both groups, highlighting the effectiveness of both treatment modalities. WBV was particularly effective in enhancing sensory function, while PNF yielded better results in terms of balance and the functional and social aspects of quality of life. Both interventions resulted in a statistically significant decrease in neuropathic pain, although no notable differences were found between the two groups in this area. The study advocates for the use of WBV and PNF as safe, accessible, and effective non-pharmacological rehabilitation methods for managing CIPN, suggesting that personalized physiotherapy strategies could be developed based on individual functional impairments. 

 
Close