| 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
|
|
|
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
|
|
|
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. |