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.

Study Overview

• Status: Completed
• Conditions: Neck Pain; Shoulder Pain; Cervical Pain
• Intervention / Treatment: Device: InterX 5000 Treatment; Device: Inactive InterX 5000

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8S 1C7
      • McMaster University
    • Toronto, Ontario, Canada, M2H 3J1
      • Canadian Memorial Chiropractic College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	4 weeks
Neck Walk Index (NWI)	4 weeks
Muscle Fatigue	4 weeks

Collaborators and Investigators

• Sponsor: Hamilton Health Sciences Corporation
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: December 21, 2007
• First Submitted That Met QC Criteria: December 21, 2007
• First Posted (Estimate): January 7, 2008

Study Record Updates

• Last Update Posted (Estimate): June 25, 2010
• Last Update Submitted That Met QC Criteria: June 24, 2010
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Keywords: neck pain; chronic; shoulder pain; recurrent; cervical pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Neck Pain; Shoulder Pain
• Other Study ID Numbers: NRG