Neck Pain Clinical Trial
Official title:
Proposal to Evaluate the Efficacy of the InterX 5000 in the Treatment of Chronic Neck and Shoulder Pain
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. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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