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

NCT00587626 | Completed Phase 2

• 1 other identifier: NRG
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Neck Pain; Shoulder Pain; Cervical Pain

Keywords

neck pain; shoulder pain; cervical pain; chronic; recurrent

Outcome Measures

Primary Outcomes (14)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

InterX treatment plus rehabilitation exercises

Device: InterX 5000 Treatment

2

PLACEBO COMPARATOR

Inactive InterX treatment plus rehabilitation exercises

Device: Inactive InterX 5000

Interventions

Inactive InterX 5000 DEVICE

Patients will receive will receive InterX placebo treatment 3 times a week for 4 weeks.

2

InterX 5000 Treatment DEVICE

Patients will receive will receive InterX treatment 3 times a week for 4 weeks.

1

Eligibility Criteria

• Age: 18 Years - 66 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• Canadian Memorial Chiropractic College: collaborator
• Neuro Resource Group: collaborator

Study Sites (2)

McMaster University

Hamilton, Ontario, L8S 1C7, Canada

Location

Canadian Memorial Chiropractic College

Toronto, Ontario, M2H 3J1, Canada

Location

MeSH Terms

Conditions

Neck Pain; Shoulder Pain; Bronchiolitis Obliterans Syndrome; Recurrence

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Disease Attributes; Pathologic Processes

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 7, 2008
• Study Start: August 1, 2007
• Primary Completion: August 1, 2009
• Study Completion: December 1, 2009
• Last Updated: June 25, 2010

Record last verified: 2010-06

Locations

CA (2)