A Phase 2 interventional study of Inactive InterX 5000 and InterX 5000 Treatment in Neck Pain, Shoulder Pain and Cervical Pain, sponsored by Hamilton Health Sciences Corporation. Completed at 2 sites in Canada. Open to participants aged 18 Years to 66 Years. Per ClinicalTrials.gov, last updated 2010-06-25.
Sponsored by Hamilton Health Sciences Corporation · Phase 2, Interventional, and Treatment
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.
Electrical stimulation modalities of various types have been used as a therapeutic intervention for years in a wide variety of applications. Individuals with neck and shoulder pain represent a significant segment of the pain population seeking relief. However, there is a paucity of data from quality studies published in mainstream peer-reviewed journals supporting the effectiveness of this intervention. No well-designed prospective, randomized, controlled trials investigating the efficacy or effectiveness of this intervention in patients with chronic neck and shoulder pain have been reported. The need for such work is becoming increasingly important considering the progressively greater demands for evidence-based medicine to justify reimbursement for care.
707 studies on the registry are indexed under Shoulder Pain; 152 are open to participants now.
This study's planned enrollment of 80 is above the median of 60 across 561 interventional studies indexed under Shoulder Pain.
Browse Shoulder Pain studies →Hamilton Health Sciences Corporation is the lead sponsor of 237 studies on the registry; 35 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
InterX treatment plus rehabilitation exercises
Device: InterX 5000 Treatment
Inactive InterX treatment plus rehabilitation exercises
Device: Inactive InterX 5000
Patients will receive will receive InterX placebo treatment 3 times a week for 4 weeks.
Patients will receive will receive InterX treatment 3 times a week for 4 weeks.
Visual Analog Scale
Time frame: 4 weeks
Neck Disability Index (NDI)
Time frame: 4 weeks
Medical Outcomes Study Short-Form 36 (SF-36) Health Survey
Time frame: 4 weeks
Short-Form McGill Questionnaire
Time frame: 4 weeks
Biomarkers (inflammatory cytokines and SP)
Time frame: 4 weeks
Functional Impairment Test-Hand, and Neck, Shoulder, Arm (FIT-HaNSA)
Time frame: 4 weeks
Cervical Range of Motion (CROM)
Time frame: 4 weeks
Grip strength
Time frame: 4 weeks
Vibration threshold
Time frame: 4 weeks
Pain Tolerance and Threshold - Pressure
Time frame: 4 weeks
Pain Threshold and Tolerance - Current Perception
Time frame: 4 weeks
Current Perception Threshold
Time frame: 4 weeks
Neck Walk Index (NWI)
Time frame: 4 weeks
Muscle Fatigue
Time frame: 4 weeks
This study is completed, as verified in Jun 2010. You cannot join it, but the record below documents what was studied.
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Hamilton Health Sciences Corporation