Clinical trial NCT00587626: Proposal to Evaluate the Efficacy of the InterX 5000 in the Treatment of Chronic Neck and Shoulder Pain
Official title: Proposal to Evaluate the Efficacy of the InterX 5000 in the Treatment of Chronic Neck and Shoulder Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neck Pain
Shoulder Pain
Cervical Pain
Keywords: neck pain
shoulder pain
cervical pain
chronic
recurrent
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Canadian Memorial Chiropractic College
name: Neuro Resource Group
First posted: 2008-01-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Visual Analog Scale
timeFrame: 4 weeks
measure: Neck Disability Index (NDI)
timeFrame: 4 weeks
measure: Medical Outcomes Study Short-Form 36 (SF-36) Health Survey
timeFrame: 4 weeks
measure: Short-Form McGill Questionnaire
timeFrame: 4 weeks
measure: Biomarkers (inflammatory cytokines and SP)
timeFrame: 4 weeks
measure: Functional Impairment Test-Hand, and Neck, Shoulder, Arm (FIT-HaNSA)
timeFrame: 4 weeks
measure: Cervical Range of Motion (CROM)
timeFrame: 4 weeks
measure: Grip strength
timeFrame: 4 weeks
measure: Vibration threshold
timeFrame: 4 weeks
measure: Pain Tolerance and Threshold - Pressure
timeFrame: 4 weeks
measure: Pain Threshold and Tolerance - Current Perception
timeFrame: 4 weeks
measure: Current Perception Threshold
timeFrame: 4 weeks
measure: Neck Walk Index (NWI)
timeFrame: 4 weeks
measure: Muscle Fatigue
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
city: Toronto
country: Canada
facility: Canadian Memorial Chiropractic College
state: Ontario
Study officials:
affiliation: McMaster University
name: Linda J Woodhouse, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Canadian Memorial Chiropractic College
name: John J Triano, DC, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Vickie Galea, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Canadian Memorial Chiropractic College
name: H Stephen Injeyan, PhD, DC
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Joy MacDermid, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Canadian Memorial Chiropractic College
name: Marion McGregor, DC, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Michael Pierrynowski, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Canadian Memorial Chiropractic College
name: Richard Ruegg, PhD, DC
role: PRINCIPAL_INVESTIGATOR
affiliation: Canadian Memorial Chiropractic College
name: Julita A Teodorczyk-Injeyan, PhD
role: PRINCIPAL_INVESTIGATOR
References: