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Efficacy of the InterX 5000 in the Treatment of Chronic Neck Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01382537
Recruitment Status : Completed
First Posted : June 27, 2011
Last Update Posted : July 25, 2014
Sponsor:
Collaborator:
McMaster University
Information provided by (Responsible Party):
John J Triano, Canadian Memorial Chiropractic College

Brief Summary:

This study will focus on the efficacy of treating 80 patients who have functional limitations in activity because of chronic/recurrent neck or shoulder pain.

Hypothesis 1: InterX therapy alone will have a moderate effect to reduce pain during weeks 1-2.

Hypothesis 2: Functional gains will be greater in patients receiving InterX therapy compared to those who received placebo treatment.

Hypothesis 3: Chronic neck and shoulder pain is more prevalent in patients who exhibit radiographic evidence of degenerative spondylosis/arthrosis of the cervical spine.


Condition or disease Intervention/treatment Phase
Neck Pain Shoulder Pain Device: InterX 5000 Not Applicable

Detailed Description:

Evaluation of subjects will be conducted at baseline (interval 0) and at 2, 4, 6 and 12 week time periods. At 26 weeks, the patient will be contacted to obtain follow-up questionnaires on pain and function. After informed consent, participants will be randomly assigned to a treatment group and a sham group using the InterX5002, hand held electrical stimulation unit. Treatment will be administered three times per week for six weeks.

During the interval of weeks 1-2 patients will have either the InterX treatment/sham alone. Weeks 3-4 will advance the patient adding a standardized rehabilitation exercise program typical for chronic neck patients. During weeks 5-6, the patient will be scheduled for treatment and will use a self-administered InterX treatment ("home" Flex) unit mimicking home care but accounting for compliance issues through attendance being monitored.

Baseline and follow-up assessments will consist of pain scores, NDI, neck fatigue testing, shoulder and arm reach tasks and walking on a treadmill at 2 MPH for 5 minutes (Neck-walk Index, NWI). Neck fatigue testing will consist of prone positioning and extensor muscle exertion against resistance to tolerance at 60% MVC. Myoelectric sensors will be taped to the skin to record muscle activity during fatigue and reach task testing. Electromagnetic sensors will be taped to a swimmers cap worn by the patient and on the skin at T1 over the spine at the shoulder level and S1 at the pelvis during the walk on the treadmill and on the shoulder and arm during reach testing.

Venipuncture will be performed at the evaluation intervals to collect blood samples for quantifying circulating inflammatory cytokines.

Analysis will focus on change in pain scores and inflammatory cytokines over the first two weeks for Hypothesis H1. Primary functional outcomes including neck fatigue and progression through neck rehabilitation exercise will be tested for Hypothesis2. The third hypothesis will be tested in two ways. First, quantification of degenerative changes (e.g.disc narrowing & osteophyte formation) on x-ray (AP & Lat screening views) will be contrasted to incidence in the published literature. Second, pain levels at baseline will be stratified into quartiles and compared to quantitative tally of degenerative changes. This data will serve as a basis for determining whether future studies using degenerative change criteria are warranted. Myoelectric activity, fatigue and head-pelvic position data will be used descriptively to assess functional differences from baseline to completion of treatment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy of the InterX 5000 in the Treatment of Chronic Neck and Shoulder Pain
Study Start Date : January 2008
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: A Device: InterX 5000
A computer driven electrical stimulation unit that contains a cutaneous impedance sensor.

Placebo Comparator: B Device: InterX 5000
Placebo treatment




Primary Outcome Measures :
  1. Visual Analog Scale [ Time Frame: 10 minutes ]
    Pain scores on the Visual Analog Scale.

  2. Neck Disability Index [ Time Frame: 15 minutes ]
    Neck Disability Index pain scores.

  3. Shoulder Pain and Disability Index [ Time Frame: 60 minutes ]
    Shoulder Pain and Disability Index scores.

  4. Medical Outcomes Study Short-Form (SF-36) [ Time Frame: 15 minutes ]
    Change in Medical Outcomes Study Short-Form (SF-36) score.

  5. Neck Walk Index [ Time Frame: 20 minutes ]
    Change in Neck Walk Index score.

  6. Upper Limb Coordination During and Overhead Reach [ Time Frame: 20 minutes ]
    Change in range of motion.

  7. Task Limitation (TL)/Upper Limb Function - FIT-HaNSA Protocol [ Time Frame: 20 min ]
    Change in FIT-HaNSA score.

  8. EMG testing [ Time Frame: 30 minutes ]
    Mean frequency shifts. Change in percentage of maximum voluntary contraction.


Secondary Outcome Measures :
  1. Blood and serum biomarkers [ Time Frame: 20 minutes ]
    Change in cytokine counts.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • males or females
  • ages 18-65
  • chronic or recurrent neck or shoulder pain
  • pain of at least 3 months duration
  • willing to sign consent form
  • able/willing to comply with treatment schedule

Exclusion Criteria:

  • age over 65 years
  • clinically significant herniated disc
  • spinal fracture
  • previous electrical stimulation treatment for this episode
  • recent cervical spine or shoulder surgery
  • implanted instrumentation/prostheses
  • epilepsy
  • pregnancy
  • recent (3 months) chemotherapy/radiotherapy
  • phlebitis
  • cortisone use (30 days)
  • hypersensitivity to tape used with EMG

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01382537


Locations
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Canada, Ontario
Canadian Memorial Chiropractic College
Toronto, Ontario, Canada
Sponsors and Collaborators
Canadian Memorial Chiropractic College
McMaster University
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: John J Triano, Dr. John J. Triano, Canadian Memorial Chiropractic College
ClinicalTrials.gov Identifier: NCT01382537    
Other Study ID Numbers: 072131
First Posted: June 27, 2011    Key Record Dates
Last Update Posted: July 25, 2014
Last Verified: July 2014
Keywords provided by John J Triano, Canadian Memorial Chiropractic College:
Neck
Chronic
Musculoskeletal
Shoulder
Additional relevant MeSH terms:
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Shoulder Pain
Neck Pain
Pain
Neurologic Manifestations
Arthralgia
Joint Diseases
Musculoskeletal Diseases