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

• Visual Analog Scale [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
• Neck Disability Index (NDI) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
• Medical Outcomes Study Short-Form 36 (SF-36) Health Survey [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
• Short-Form McGill Questionnaire [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
• Biomarkers (inflammatory cytokines and SP) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
• Functional Impairment Test-Hand, and Neck, Shoulder, Arm (FIT-HaNSA) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
• Cervical Range of Motion (CROM) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
• Grip strength [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
• Vibration threshold [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
• Pain Tolerance and Threshold - Pressure [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
• Pain Threshold and Tolerance - Current Perception [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
• Current Perception Threshold [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
• Neck Walk Index (NWI) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
• Muscle Fatigue [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

• Visual Analog Scale [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
• Neck Disability Index (NDI) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
• Medical Outcomes Study Short-Form 36 (SF-36) Health Survey [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
• Short-Form McGill Questionnaire [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
• Biomarkers (inflammatory cytokines and SP) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
• Functional Impairment Test-Hand, and Neck, Shoulder, Arm (FIT-HaNSA) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
• Cervical Range of Motion (CROM) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
• Grip strength [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
• Vibration threshold [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
• Pain Tolerance and Threshold - Pressure [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
• Pain Threshold and Tolerance - Current Perception [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
• Current Perception Threshold [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
• Neck Walk Index (NWI) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
• Muscle Fatigue [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

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.

• Neck Pain
• Shoulder Pain
• Cervical Pain

• Device: Inactive InterX 5000
  Patients will receive will receive InterX placebo treatment 3 times a week for 4 weeks.
• Device: InterX 5000 Treatment
  Patients will receive will receive InterX treatment 3 times a week for 4 weeks.

• Active Comparator: 1
  InterX treatment plus rehabilitation exercises
  Intervention: Device: InterX 5000 Treatment
• Placebo Comparator: 2
  Inactive InterX treatment plus rehabilitation exercises
  Intervention: Device: Inactive InterX 5000

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 Memorial Chiropractic College
• Neuro Resource Group