Comparison of Electrotherapies for Chronic Low Back Pain

NCT01658735 | Completed Results DMC

• 1 other identifier: IRB_00052918
• Study Type: interventional
• Target: 113
• Locations: 0 countries
• Sites: N/A

Brief Summary

The intent of this project is to execute a high-quality double-blinded randomized controlled clinical trial that compares the H-Wave® device with a commonly used TENS device with a sub-therapeutic electrocurrent device. This study will provide a definable level of evidence for treatment efficacy, and provide a basis for evidence-based recommendation for or against utilization for these two modalities. The results for H-Wave® device, if positive, could significantly impact morbidity by providing a non-invasive, non-pharmacologic treatment for symptomatic relief, and reduce overall disability and health care costs associated with chronic low back pain.

Conditions

Non-specific Chronic Low Back Pain

Keywords

Chronic low back pain; Electrotherapy; H-Wave; H wave; TENS; Trial

Outcome Measures

Primary Outcomes (4)

• Change From Baseline in Oswestry Disability Index at 1 Week

  Measure of the change in Oswestry Disability Index (ODI) after one week of treatment compared with baseline measure. The ODI is a commonly used outcome-measure questionnaire for low back pain. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage, with a possible range of 0 to 100. Higher scores represent higher reported disability.

  1 week

• Change From Baseline in Oswestry Disability Index at 4 Weeks

  Measure of the change in Oswestry Disability Index (ODI) after four weeks of treatment compared with baseline measure. The ODI is a commonly used outcome-measure questionnaire for low back pain. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage, with a possible range of 0 to 100. Higher scores represent higher reported disability.

  Week 4

• Change From Baseline in Oswestry Disability Index at 8 Weeks

  Measure of the change in Oswestry Disability Index (ODI) after eight weeks of treatment compared with baseline measure. The ODI is a commonly used outcome-measure questionnaire for low back pain. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage, with a possible range of 0 to 100. Higher scores represent higher reported disability.

  Week 8

• Change From Baseline in Oswestry Disability Index at 12 Weeks

  Measure of the change in Oswestry Disability Index (ODI) after twelve weeks of treatment compared with baseline measure. The ODI is a commonly used outcome-measure questionnaire for low back pain. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage, with a possible range of 0 to 100. Higher scores represent higher reported disability.

  Week 12

Secondary Outcomes (4)

• Change From Baseline in VAS Pain Score at 1 Week

  Week 1

• Change From Baseline in VAS Pain Score at 4 Weeks

  Week 4

• Change From Baseline in VAS Pain Score at 8 Weeks

  Week 8

• Change From Baseline in VAS Pain Score at 12 Weeks

  Week 12

Study Arms (3)

H-Wave Device

ACTIVE COMPARATOR

H-Wave Device with Usual Care

Device: H-Wave

TENS

ACTIVE COMPARATOR

Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care

Device: Transcutaneous Electrical Nerve Stimulation (TENS)

Sham Electrotherapy

SHAM COMPARATOR

Sham Device plus Usual Care.

Device: Sham

Interventions

H-Wave DEVICE

Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect.

Also known as: H-Wave is the proprietary name of the device. There is only one model currently.

H-Wave Device

Transcutaneous Electrical Nerve Stimulation (TENS) DEVICE

Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding.

Also known as: Chattanooga Intellect TENS Device

TENS

Sham DEVICE

The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical.

Sham Electrotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic Low Back Pain of at least 3 months duration
• ages 18-65
• Current VAS Pain Rating of 5 on 10 point scale
• No pain below the knee
• % of pain located in low back or buttock pain rather than lower extremity pain
• Proficient in English
• Able to complete and tolerate treatment for the study period.

You may not qualify if:

• Prior home use of H-Wave Device or TENS.
• Prior history of spinal fusion or failed spinal surgery syndrome.
• Laminectomy, laminotomy or discectomy within 12 months of enrollment.
• Diagnostic or interventional injections or any low back surgeries not mentioned above, including radiofrequency, neuroablation within 6 months of enrollment.
• Current implanted cardiac demand pacemakers, defibrillators, cardiac pumps, or other implanted electronic devices.
• Active psychiatric disorders will be excluded (e.g. use of antipsychotic medication, bipolar disorder, schizophrenia, uncontrolled depression or anxiety disorder).
• Patients currently or who become pregnant will be excluded.

Sponsors & Collaborators

• University of Utah: lead
• Electronic Waveform Lab, Inc.: collaborator

Related Publications (1)

• Thiese MS, Hughes M, Biggs J. Electrical stimulation for chronic non-specific low back pain in a working-age population: a 12-week double blinded randomized controlled trial. BMC Musculoskelet Disord. 2013 Mar 28;14:117. doi: 10.1186/1471-2474-14-117.

  PMID: 23537462 BACKGROUND

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Limitations and Caveats

Participant enrollment was based on chronic pain VAS score of \>= 5.0 (0-10 scale). High baseline VAS scores did not translate to a priori hypothesized high ODI scores, resulting in study being underpowered to detect differences in primary outcomes.

Results Point of Contact

• Title: Matthew A Hughes, MD, MPH
• Organization: University of Utah School of Medicine

matthew.hughes@hsc.utah.edu

8015814800

Study Officials

• Matthew A Hughes

  DFPM-ADMINISTRATION

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor (clinical)

Study Record Dates

• First Submitted: July 30, 2012
• First Posted: August 7, 2012
• Study Start: July 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: March 9, 2015
• Results First Posted: March 9, 2015

Record last verified: 2015-02