Clinical trial · Interventional
Scrambler Therapy for the Reduction of Chemotherapy-Induced Neuropathic Pain
Effect of Scramble Therapy on Chemotherapy Induced Peripheral Neuropathic Pain: A Prospective, Pilot Study
NCT04239976CI-TRIAL-00057308completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This trial studies how well scrambler therapy works in reducing chemotherapy-induced neuropathic pain in patients with cancer. Scrambler therapy is a type of treatment that uses electrodes placed on the skin. Electricity is carried from the electrodes through the skin and blocks the pain.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy-Induced Peripheral Neuropathy | — | UNRESOLVED | — |
| Malignant Neoplasm | Malignant Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FitBit | Device | — | UNRESOLVED |
| Gait Assessment Test | Other | — | UNRESOLVED |
| MC5-A Scrambler Therapy | Other | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Quantitative Sensory Testing | Procedure | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive Care (scrambler therapy, sensory test, gait test)
- description
- Patients undergo scrambler therapy over 30-45 minutes QD Monday-Friday for 2 weeks. Patients also undergo a quantitative sensory test and a gait assessment test using a FitBit before receiving scrambler therapy, at the end of the first and second weeks of scrambler therapy, and 1 month after the last day of scrambler therapy.
- interventionNames
- Device: FitBit
- Other: Gait Assessment Test
- Other: MC5-A Scrambler Therapy
- Other: Quality-of-Life Assessment
- Procedure: Quantitative Sensory Testing
- Other: Questionnaire Administration
Primary outcomes (1)
- measure
- Chemotherapy induced peripheral neuropathic pain (CIPN) score difference
- timeFrame
- Baseline to the last day of 2-week treatment
- description
- Will be assessed using descriptive statistics such as mean, standard deviation, median, range and confidence intervals. The t-test or Wilcoxon rank sum test and Fisher's exact test may be used to compare variables between patient groups. Correlation between two continuous measures may be assessed using Pearson or Spearman correlation. Other statistical methods may be utilized when appropriate. The Pain inventory is an assessment of pain level on a 11-point numeric rating scales (0=none to 10=worst).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Have a diagnosis of cancer and suffer from CIPN for at least 3 months after the end of their last cancer chemotherapy * Have average pain intensity of at least 4/10 * Be in stable clinical situation (no surgery, radiotherapy, hormone therapy, chemotherapy or other treatment scheduled) in the month following the enrollment) * Can give a written informed consent Exclusion Criteria: * Pre-existence or history of seizure * Pre-existence or history of peripheral neuropathy due to a cause different from neurotoxic chemotherapy (i.e. idiopathic peripheral neuropathy, diabetic neuropathy * Pregnancy * Present with pacemaker or implantable defibrillators * Present or past psychotropic substances and alcohol dependence * Inability to understand patients' information and informed consent * Skin lesion at the electrode placement site
References
Publications (0)
Data not yet available
No reference posted for this study.