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Clinical Trials/CTRI/2024/07/071675
CTRI/2024/07/071675
Completed
Not Applicable

Effect of Whole Body Vibration versus Proprioceptive Neuromuscular Facilitation on Chemotherapy- Induced Peripheral Neuropathy: A Randomized Clinical Trial

Srushti Jegarkal1 site in 1 country38 target enrollmentStarted: August 26, 2024Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Srushti Jegarkal
Enrollment
38
Locations
1
Primary Endpoint
Self-report Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS)

Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Other
Masking
Participant Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 70.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Willing to participate.
  • Age 18-70 years all genders.
  • Diagnosed case of CIPN.
  • Minimum 3 doses of chemotherapy or have completed chemotherapy treatment.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Self-report Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS)

Time Frame: Baseline and after 3 weeks

Semmes Weinstein Monofilament

Time Frame: Baseline and after 3 weeks

MiniBESTest

Time Frame: Baseline and after 3 weeks

Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group Neurotoxicity (FACT-GOG Ntx)(v4)

Time Frame: Baseline and after 3 weeks

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Srushti Jegarkal
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Srushti Jegarkal

KAHER Institute of Physiotherapy

Study Sites (1)

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