Cervical Pain, Neck Pain, Shoulder Pain
Conditions
Keywords
neck pain, shoulder pain, cervical pain, chronic, recurrent
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.
Interventions
DEVICEInactive InterX 5000
Patients will receive will receive InterX placebo treatment 3 times a week for 4 weeks.
DEVICEInterX 5000 Treatment
Patients will receive will receive InterX treatment 3 times a week for 4 weeks.
Sponsors
Canadian Memorial Chiropractic College
Neuro Resource Group
Hamilton Health Sciences Corporation
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 66 Years
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)
Design outcomes
Primary
| Measure | 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 |
Countries
Canada
Outcome results
None listed