Proposal to Evaluate the Efficacy of the InterX 5000 in the Treatment of Chronic Neck and Shoulder Pain
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 80
- Locations
- 4
- Primary Endpoint
- Short-Form McGill Questionnaire
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 66 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
Short-Form McGill Questionnaire
Time Frame: 4 weeks
Biomarkers (inflammatory cytokines and SP)
Time Frame: 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
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
Secondary Outcomes
No secondary outcomes reported