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Proposal to Evaluate the Efficacy of the InterX 5000 in the Treatment of Chronic Neck and Shoulder Pain
This study has been completed.
Sponsor:
Hamilton Health Sciences Corporation
Collaborators:
Canadian Memorial Chiropractic College
Neuro Resource Group
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00587626
First received: December 21, 2007
Last updated: June 24, 2010
Last verified: June 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Neck Pain Shoulder Pain Cervical Pain | Device: Inactive InterX 5000 Device: InterX 5000 Treatment | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double Blind (Participant, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Proposal to Evaluate the Efficacy of the InterX 5000 in the Treatment of Chronic Neck and Shoulder Pain |
Resource links provided by NLM:
Further study details as provided by McMaster University:
Primary Outcome Measures:
- 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 ]
- Short-Form McGill Questionnaire [ Time Frame: 4 weeks ]
- Biomarkers (inflammatory cytokines and SP) [ 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 ]
| Estimated Enrollment: | 80 |
| Study Start Date: | August 2007 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
InterX treatment plus rehabilitation exercises
|
Device: InterX 5000 Treatment
Patients will receive will receive InterX treatment 3 times a week for 4 weeks.
|
|
Placebo Comparator: 2
Inactive InterX treatment plus rehabilitation exercises
|
Device: Inactive InterX 5000
Patients will receive will receive InterX placebo treatment 3 times a week for 4 weeks.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 66 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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)
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00587626
Please refer to this study by its ClinicalTrials.gov identifier: NCT00587626
Locations
| Canada, Ontario | |
| McMaster University | |
| Hamilton, Ontario, Canada, L8S 1C7 | |
| Canadian Memorial Chiropractic College | |
| Toronto, Ontario, Canada, M2H 3J1 | |
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Canadian Memorial Chiropractic College
Neuro Resource Group
Investigators
| Principal Investigator: | 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 |
More Information
| Responsible Party: | Linda J. Woodhouse, McMaster University |
| ClinicalTrials.gov Identifier: | NCT00587626 History of Changes |
| Other Study ID Numbers: |
NRG |
| Study First Received: | December 21, 2007 |
| Last Updated: | June 24, 2010 |
Keywords provided by McMaster University:
|
neck pain shoulder pain cervical pain chronic recurrent |
Additional relevant MeSH terms:
|
Neck Pain Shoulder Pain Pain Neurologic Manifestations Nervous System Diseases |
Signs and Symptoms Arthralgia Joint Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on July 21, 2017