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

Neck Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00587626
• Other study ID #: NRG
• Status: Completed
• Phase: Phase 2
• First received: December 21, 2007
• Last updated: June 24, 2010
• Start date: August 2007
• Est. completion date: December 2009

Study information

• Verified date: June 2010
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 66 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Pain
• Neck Pain
• Shoulder Pain

Intervention

Device:
• Inactive InterX 5000
Patients will receive will receive InterX placebo treatment 3 times a week for 4 weeks.
• InterX 5000 Treatment
Patients will receive will receive InterX treatment 3 times a week for 4 weeks.

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario
Canada	Canadian Memorial Chiropractic College	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation	Canadian Memorial Chiropractic College, Neuro Resource Group

Country where clinical trial is conducted

Canada, 

Outcome

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