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Comparison of Electrotherapies for Chronic Low Back Pain

This study has been completed.
Sponsor:
Collaborator:
Electronic Waveform Lab, Inc.
Information provided by (Responsible Party):
Matt Hughes, MD, MPH, University of Utah
ClinicalTrials.gov Identifier:
NCT01658735
First received: July 30, 2012
Last updated: February 24, 2015
Last verified: February 2015
Results First Received: February 9, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Non-specific Chronic Low Back Pain
Interventions: Device: H-Wave
Device: Transcutaneous Electrical Nerve Stimulation (TENS)
Device: Sham

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
H-Wave Device

H-Wave Device with Usual Care

H-Wave: 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.

TENS

Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care

Transcutaneous Electrical Nerve Stimulation (TENS): 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.

Sham Electrotherapy

Sham Device plus Usual Care.

Sham: 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.


Participant Flow:   Overall Study
    H-Wave Device   TENS   Sham Electrotherapy
STARTED   39   36   38 
COMPLETED   34   29   34 
NOT COMPLETED   5   7   4 
Lack of Efficacy                1                0                1 
Lost to Follow-up                1                1                0 
Protocol Violation                0                1                0 
Withdrawal by Subject                3                5                3 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
H-Wave Device

H-Wave Device with Usual Care

H-Wave: 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.

TENS

Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care

Transcutaneous Electrical Nerve Stimulation (TENS): 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.

Sham Electrotherapy

Sham Device plus Usual Care.

Sham: 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.

Total Total of all reporting groups

Baseline Measures
   H-Wave Device   TENS   Sham Electrotherapy   Total 
Overall Participants Analyzed 
[Units: Participants]
 39   36   38   113 
Age 
[Units: Years]
Mean (Standard Deviation)
 48.8  (12.1)   48.5  (11.5)   45.5  (12.0)   47.6  (11.9) 
Gender 
[Units: Participants]
       
Female   16   9   16   41 
Male   23   27   22   72 
Ethnicity (NIH/OMB) 
[Units: Participants]
       
Hispanic or Latino   1   0   2   3 
Not Hispanic or Latino   38   36   36   110 
Unknown or Not Reported   0   0   0   0 
Number of participants currently working at enrollment 
[Units: Participants]
       
Yes   29   28   31   88 
No   10   8   7   25 
Number of participants who have ever seen a Chiropractor for LBP 
[Units: Participants]
       
Yes   23   23   25   71 
No   16   13   13   42 
Number of participants who have seen a Physician for their current LBP 
[Units: Participants]
       
Yes   23   28   27   78 
No   16   8   11   35 
Number of participants who have been to a chronic pain clinic for their current LBP 
[Units: Participants]
       
Yes   5   5   1   11 
No   34   31   37   102 
Participants of participants who have ever had a MRI for their current LBP 
[Units: Participants]
       
Yes   17   17   17   51 
No   22   19   21   62 
Number of participants that have ever smoked greater than 100 cigarettes - lifetime 
[Units: Participants]
       
Yes   9   4   9   22 
No   30   32   29   91 
Number of participants who have ever seen a physical therapist for LBP 
[Units: Participants]
       
Yes   17   18   22   57 
NO   22   18   16   56 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Oswestry Disability Index at 1 Week   [ Time Frame: 1 week ]

2.  Primary:   Change From Baseline in Oswestry Disability Index at 4 Weeks   [ Time Frame: Week 4 ]

3.  Primary:   Change From Baseline in Oswestry Disability Index at 8 Weeks   [ Time Frame: Week 8 ]

4.  Primary:   Change From Baseline in Oswestry Disability Index at 12 Weeks   [ Time Frame: Week 12 ]

5.  Secondary:   Change From Baseline in VAS Pain Score at 1 Week   [ Time Frame: Week 1 ]

6.  Secondary:   Change From Baseline in VAS Pain Score at 4 Weeks   [ Time Frame: Week 4 ]

7.  Secondary:   Change From Baseline in VAS Pain Score at 8 Weeks   [ Time Frame: Week 8 ]

8.  Secondary:   Change From Baseline in VAS Pain Score at 12 Weeks   [ Time Frame: Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Matthew A Hughes, MD, MPH
Organization: University of Utah School of Medicine
phone: 8015814800
e-mail: matthew.hughes@hsc.utah.edu


Publications:

Responsible Party: Matt Hughes, MD, MPH, University of Utah
ClinicalTrials.gov Identifier: NCT01658735     History of Changes
Other Study ID Numbers: IRB_00052918
Study First Received: July 30, 2012
Results First Received: February 9, 2015
Last Updated: February 24, 2015
Health Authority: United States: Institutional Review Board