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Completed

NCT Number: NCT00587626

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.

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Key information

Conditions

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

Age range

18 year–66 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

McMaster University, Hamilton, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Inactive InterX 5000

Device

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

InterX 5000 Treatment

Device

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

Primary outcomes

  1. Visual Analog Scale

    Time frame: 4 weeks

  2. Neck Disability Index (NDI)

    Time frame: 4 weeks

  3. Medical Outcomes Study Short-Form 36 (SF-36) Health Survey

    Time frame: 4 weeks

  4. Short-Form McGill Questionnaire

    Time frame: 4 weeks

  5. Biomarkers (inflammatory cytokines and SP)

    Time frame: 4 weeks

  6. Functional Impairment Test-Hand, and Neck, Shoulder, Arm (FIT-HaNSA)

    Time frame: 4 weeks

  7. Cervical Range of Motion (CROM)

    Time frame: 4 weeks

  8. Grip strength

    Time frame: 4 weeks

  9. Vibration threshold

    Time frame: 4 weeks

  10. Pain Tolerance and Threshold - Pressure

    Time frame: 4 weeks

  11. Pain Threshold and Tolerance - Current Perception

    Time frame: 4 weeks

  12. Current Perception Threshold

    Time frame: 4 weeks

  13. Neck Walk Index (NWI)

    Time frame: 4 weeks

  14. Muscle Fatigue

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Hamilton Health Sciences Corporation

Other

Collaborators

  • Canadian Memorial Chiropractic College
  • Neuro Resource Group

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jan 7, 2008
Registry last updated
Jun 25, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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