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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:
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
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Visual Analog Scale [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Neck Disability Index (NDI) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Medical Outcomes Study Short-Form 36 (SF-36) Health Survey [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Short-Form McGill Questionnaire [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Biomarkers (inflammatory cytokines and SP) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Functional Impairment Test-Hand, and Neck, Shoulder, Arm (FIT-HaNSA) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Cervical Range of Motion (CROM) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Grip strength [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Vibration threshold [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Pain Tolerance and Threshold - Pressure [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Pain Threshold and Tolerance - Current Perception [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Current Perception Threshold [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Neck Walk Index (NWI) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Muscle Fatigue [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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
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

No publications provided

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
Health Authority: Canada: Ethics Review Committee

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 May 16, 2013