Proposal to Evaluate the Efficacy of the InterX 5000 in the Treatment of Chronic Neck and Shoulder Pain
CompletedPhase 2NCT00587626
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Brief summary (from the registry)
The purpose of the proposed study is to evaluate the efficacy of the InterX 5000 in relieving chronic neck and shoulder pain. This study will focus on the efficacy of treating patients who have functional limitations in activity because of chronic/recurrent neck or shoulder pain. H1: InterX therapy will have a moderate effect to reduce pain. H2: Functional gains will be greater in patients receiving InterX therapy compared to those who received placebo treatment. H3: Chronic neck and shoulder pain is more prevalent in patients who exhibit radiographic evidence of degenerative spondylosis/arthrosis of the cervical spine.
Study details
- Official title
- Proposal to Evaluate the Efficacy of the InterX 5000 in the Treatment of Chronic Neck and Shoulder Pain
- Conditions
- Interventions
- Device: Inactive InterX 5000
- Device: InterX 5000 Treatment
- Sponsor
- Hamilton Health Sciences Corporation
- Collaborators
- Canadian Memorial Chiropractic College; Neuro Resource Group
- Organization
- McMaster University
- Start date
- 2007-08
- Primary completion
- 2009-08
- Sex
- All
- Age range
- from 18 Years to 66 Years
- Results posted
- No results posted in this snapshot
- Countries
- Canada
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * chronic or recurrent neck or shoulder pain of at least 3 months duration with or without arm pain * willing to sign consent for study participation * able/willing to comply with treatment schedule Exclusion Criteria: * clinically significant herniated disc (defined as positive radicular arm pain aggravated by head position change or neural stretch signs from provocative arm movement, this will not exclude patients with any imaged herniation as this is a common finding in all populations) * spinal fracture * previous electrical stimulation treatment for this episode * recent cervical spinal or shoulder surgery or implanted instrumentation/prostheses. * patients with cardiac pacemaker or spinal cord stimulator, epilepsy, pregnancy, recent (3 months) chemotherapy/radiotherapy, phlebitis, cortisone use (30 days)
Canadian sites (2)
| Facility | City | Province |
|---|---|---|
| McMaster University | Hamilton | Ontario |
| Canadian Memorial Chiropractic College | Toronto | Ontario |
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00587626