Scrambler Therapy in Treating Pain and Peripheral Neuropathy in Patients Previously Treated With Chemotherapy
Status: | Completed |
---|---|
Conditions: | Chronic Pain, Neurology |
Therapuetic Areas: | Musculoskeletal, Neurology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | March 2011 |
End Date: | December 2015 |
Scrambler Therapy for the Treatment of Chemotherapy Induced Peripheral Neuropathy: An Open Access Trial
This pilot clinical trial studies scrambler therapy in treating pain and peripheral
neuropathy in patients previously treated with chemotherapy. Scrambler therapy may help
relieve pain from peripheral neuropathy caused by chemotherapy
neuropathy in patients previously treated with chemotherapy. Scrambler therapy may help
relieve pain from peripheral neuropathy caused by chemotherapy
OBJECTIVES:
I. To record the types of patients that we treat, along with the reported efficacy and
potential toxicity associated with scrambler therapy.
II. To get experience with patient reported outcome measurement tools that we use in this
trial, including a report of analgesic use.
OUTLINE: Patients undergo scrambler therapy for 30 minutes daily for up to 10 consecutive
days. Treatment continues in the absence of unacceptable toxicity. After completion of study
treatment, patients are followed up for 10 weeks.
III. To explore neurologic testing changes in patients receiving scrambler therapy.
I. To record the types of patients that we treat, along with the reported efficacy and
potential toxicity associated with scrambler therapy.
II. To get experience with patient reported outcome measurement tools that we use in this
trial, including a report of analgesic use.
OUTLINE: Patients undergo scrambler therapy for 30 minutes daily for up to 10 consecutive
days. Treatment continues in the absence of unacceptable toxicity. After completion of study
treatment, patients are followed up for 10 weeks.
III. To explore neurologic testing changes in patients receiving scrambler therapy.
Inclusion Criteria:
- Pain or symptoms of neuropathy or pain of >= 1 month (30 days) duration for which the
patient wants intervention
- Participants have to relate that tingling or pain was at least a four out of ten
problem during the prior week, on a 0-10 scale where zero was no problem and ten was
the worst possible problem and expected to have tingling or pain of at least 4/10 at
the time of the first treatment
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) = 0, 1, or 2
- Life expectancy >= 3 months (90 days)
- Case review by the study chair, or designate, as a case where treatment should be
tried.
- Ability to complete questionnaire(s) by themselves or with assistance - Ability to
provide informed written consent
Exclusion Criteria:
- Pregnant women
- Patients with implantable drug delivery systems, e.g. Medtronic Synchromed
- Patients with heart stents or metal implants such as pacemakers, automatic
defibrillators, aneurysm clips, vena cava clips and skull plates; (metal implants for
orthopedic repair, e.g. pins, clips, plates, cages, joint replacements are allowed as
are central venous access devices)
- Patients with a history of myocardial infarction or ischemic heart disease within the
past six months
- Patients with history of epilepsy, brain damage, use of anti-convulsants for seizure
prevention, concurrently using ketamine, symptomatic brain metastases; Note:
anti-convulsant use is allowed for neuropathy and heart failure (HF) if on a stable
dose
- Skin conditions such as open sores that would prevent proper application of the
electrodes
- Other medical or other condition(s) that in the opinion of the investigators might
compromise the objectives of the study
- Currently on gabapentin or pregabalin Note: (because of data that support that
patients don't do as well when on gabapentin or pregabalin, all patients on these
medications will be weaned off of them prior to study initiation. The study team will
provide instructions on how to do this).
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