BioWave High-frequency Neurostimulation Versus TENS for the Treatment of Chronic Low Back Pain

BioWave Corporation

Status: Completed

Conditions: Lumbar Pain Syndrome; Chronic Pain; Low Back Pain

Treatments: Device: TENS; Device: BioWave

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05511181

BIOWAVEVSTENSLBP1

Details and patient eligibility

About

This will be a multicenter randomized crossover clinical trial comparing the therapeutic efficacy of BioWave therapy versus TENS for the management of chronic low back pain. This study also aims to evaluate the impact of these therapies on physical activity, patient perception of therapeutic efficacy, and activities of daily living.

Full description

This will be a multicenter randomized crossover clinical trial comparing the therapeutic efficacy of BioWave therapy versus TENS for the management of chronic low back pain. This study also aims to evaluate the impact of these therapies on physical activity, patient perception of therapeutic efficacy, and activities of daily living. Patients will start a 30 minute treatment session with either BioWave therapy or TENS device followed by a 30 minute washout and ending with a final 30 minute treatment. Patients will then be instructed to perform two 30 minute treatment sessions daily at home for 2 weeks. Follow-up will be after 2 weeks and the patients will be assessed in clinic for physiologic measures of pain response. A washout period of 2 weeks will follow and the patients will crossover to receive the alternative treatment.

Enrollment: 120 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject must have signed consent before study entry
• Subject must have a body weight of 45 kg or more and a body mass index (BMI) of 40 kg/m2 or less.
• Subject must be aged 18-85 on the date of enrollment and subjects consecutively enrolled
• Subject must have a qualifying baseline pain score of≥5
• Subject must have a stable pain medication regimen for a period of at least 2 weeks prior to study enrollment. Both medication dosages and total number of medications must be stable prior to initiation.
• Subject's pain indication must be defined as chronic low back pain

Exclusion criteria

• Subject has a known history of allergic reaction or clinically significant intolerance to medical adhesives, glues, or textiles.
• Subject is currently receiving chronic opioid therapy defined as >30 morphine equivalents units per day (daily use for >2 weeks)
• Subject has an implanted spinal cord stimulator (SCS).
• Subject has any clinically significant clinical, physical, laboratory, or radiographic finding at Screening that, in the opinion of the investigator, contraindicates study participation.
• Subject is currently pregnant.
• Subject has history of or current medical, surgical, post surgical, or psychiatric condition that would confound interpretation of safety, tolerability, or efficacy, (eg, uncontrolled diabetes mellitus, uncontrolled hypertension, hemodynamic instability, or respiratory insufficiency, cancer or palliative care).
• Subject received an experimental drug or used an experimental medical device within 30 days prior to Screening or has previously participated in this trial.
• Subject is unable to comply with the requirements of the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

BioWave

Experimental group

Description:

BioWaveGO is a FDA 510(k) cleared high frequency neurostimulator. Patients that are first randomized to the BioWave arm will receive a 30 minute treatment in the clinic with a BioWaveGO device followed by a 30 minute washout and ending with a final 30 minute treatment. Data will be collected before, and after the final treatment. Patients will then be instructed to take the BioWaveGO device home and perform two 30 minute treatment sessions daily at home for 2 weeks. Follow-up in the clinic will be after the 2-week treatment period and the patients will be assessed in clinic for physiologic measures of pain response. A washout period of 2 weeks will follow, the patients will return to the clinic at week 4 and the patients will crossover to receive the TENS treatment (as described in the TENS arm).

Treatment:

Device: BioWave

TENS

Active Comparator group

Description:

Patients that are first randomized to the TENS arm will receive a 30 minute treatment in the clinic with an Intensity 5000 TENS device followed by a 30 minute washout and ending with a final 30 minute treatment. Data will be collected before, and after the final treatment. Patients will then be instructed to take the TENS device home and perform two 30 minute treatment sessions daily at home for 2 weeks. Follow-up in the clinic will be after the 2-week treatment period and the patients will be assessed in clinic for physiologic measures of pain response. A washout period of 2 weeks will follow, the patients will return to the clinic at week 4 and the patients will crossover to receive the BioWaveGO treatment (as described in the BioWave arm).

Treatment:

Device: TENS