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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:
ClinicalTrials.gov Identifier:
NCT00587626
First Posted: January 7, 2008
Last Update Posted: June 25, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Canadian Memorial Chiropractic College
Neuro Resource Group
Information provided by:
McMaster University
  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 (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

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: December 21, 2007
First Posted: January 7, 2008
Last Update Posted: June 25, 2010
Last Verified: June 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