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

Phase 2

Completed

• Conditions: Neck Pain; Shoulder Pain; Cervical Pain
• Interventions: Device: InterX 5000 Treatment; Device: Inactive InterX 5000

• Registration Number: NCT00587626
• Lead Sponsor: Hamilton Health Sciences Corporation

Brief Summary

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.

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 Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2007-12-21
• Study First Posted: 2008-01-07
• Primary Completion: 2009-08
• Study Completion: 2009-12
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-24
• Last Update Posted: 2010-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	InterX 5000 Treatment	InterX treatment plus rehabilitation exercises
2	Inactive InterX 5000	Inactive InterX treatment plus rehabilitation exercises

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

McMaster University; 🇨🇦 Hamilton, Ontario, Canada

Canadian Memorial Chiropractic College; 🇨🇦 Toronto, Ontario, Canada