Proposal to Evaluate the Efficacy of the InterX 5000 in the Treatment of Chronic Neck and Shoulder Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Proposal to Evaluate the Efficacy of the InterX 5000 in the Treatment of Chronic Neck and Shoulder Pain

Conditions
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Neck Pain, Shoulder Pain, Cervical Pain

Intervention / Treatment
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* Device: Inactive InterX 5000
* Device: InterX 5000 Treatment


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 66 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>InterX treatment plus rehabilitation exercises | Device: InterX 5000 Treatment<br>* Patients will receive will receive InterX treatment 3 times a week for 4 weeks.<br>|
| Placebo Comparator: 2<br>Inactive InterX treatment plus rehabilitation exercises | Device: Inactive InterX 5000<br>* Patients will receive will receive InterX placebo treatment 3 times a week for 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale |  | 4 weeks | 
| Neck Disability Index (NDI) |  | 4 weeks | 
| Medical Outcomes Study Short-Form 36 (SF-36) Health Survey |  | 4 weeks | 
| Short-Form McGill Questionnaire |  | 4 weeks | 
| Biomarkers (inflammatory cytokines and SP) |  | 4 weeks | 
| Functional Impairment Test-Hand, and Neck, Shoulder, Arm (FIT-HaNSA) |  | 4 weeks | 
| Cervical Range of Motion (CROM) |  | 4 weeks | 
| Grip strength |  | 4 weeks | 
| Vibration threshold |  | 4 weeks | 
| Pain Tolerance and Threshold - Pressure |  | 4 weeks | 
| Pain Threshold and Tolerance - Current Perception |  | 4 weeks | 
| Current Perception Threshold |  | 4 weeks | 
| Neck Walk Index (NWI) |  | 4 weeks | 
| Muscle Fatigue |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neck pain, shoulder pain, cervical pain, chronic, recurrent