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| Name | Class |
|---|---|
| Canadian Memorial Chiropractic College | OTHER |
| Neuro Resource Group | INDUSTRY |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | InterX treatment plus rehabilitation exercises |
|
| 2 | Placebo Comparator | Inactive InterX treatment plus rehabilitation exercises |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inactive InterX 5000 | Device | Patients will receive will receive InterX placebo treatment 3 times a week for 4 weeks. |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linda J Woodhouse, PhD | McMaster University | Principal Investigator |
| John J Triano, DC, PhD | Canadian Memorial Chiropractic College | Principal Investigator |
| Vickie Galea, PhD | McMaster University | Principal Investigator |
| H Stephen Injeyan, PhD, DC | Canadian Memorial Chiropractic College | Principal Investigator |
| Joy MacDermid, PhD | McMaster University | Principal Investigator |
| Marion McGregor, DC, PhD | Canadian Memorial Chiropractic College | Principal Investigator |
| Michael Pierrynowski, PhD | McMaster University | Principal Investigator |
| Richard Ruegg, PhD, DC | Canadian Memorial Chiropractic College | Principal Investigator |
| Julita A Teodorczyk-Injeyan, PhD | Canadian Memorial Chiropractic College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McMaster University | Hamilton | Ontario | L8S 1C7 | Canada | ||
| Canadian Memorial Chiropractic College |
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| ID | Term |
|---|---|
| D019547 | Neck Pain |
| D020069 | Shoulder Pain |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| InterX 5000 Treatment | Device | Patients will receive will receive InterX treatment 3 times a week for 4 weeks. |
|
| 4 weeks |
| Neck Walk Index (NWI) | 4 weeks |
| Muscle Fatigue | 4 weeks |
| Toronto |
| Ontario |
| M2H 3J1 |
| Canada |
| D018771 | Arthralgia |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |