Proposal to Evaluate the Efficacy of the InterX 5000 in the Treatment of Chronic Neck and Shoulder Pain

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.

Official Title

Proposal to Evaluate the Efficacy of the InterX 5000 in the Treatment of Chronic Neck and Shoulder Pain.

Conditions

• Neck Pain
• Shoulder Pain
• Cervical Pain

Study Type

Interventional

Study Design

Treatment, Randomised, Double Blind (Subject, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study.

Further Details

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]
• 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]

Study Start

August 2007

Eligibility & Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Genders Eligible for Study: Both
• Accepts 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 facture
• previous electrical stimulation treatment for this episode
• recent cervicalspinal 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)

Total Enrolment

80

Contact Details

John J Triano, DC, PhD    
416-482-2340    
jtriano@cmcc.ca

Location: 

Canadian Memorial Chiropractic College
Toronto, Ontario
Canada, M2H 3J1