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

Primary Purpose

Neck Pain, Shoulder Pain, Cervical Pain

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Inactive InterX 5000

InterX 5000 Treatment

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring neck pain, shoulder pain, cervical pain, chronic, recurrent

Eligibility Criteria

18 Years - 66 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

McMaster University
Canadian Memorial Chiropractic College

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

InterX treatment plus rehabilitation exercises

Inactive InterX treatment plus rehabilitation exercises

Outcomes

Primary Outcome Measures

Visual Analog Scale

Neck Disability Index (NDI)

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

Short-Form McGill Questionnaire

Biomarkers (inflammatory cytokines and SP)

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

Cervical Range of Motion (CROM)

Grip strength

Vibration threshold

Pain Tolerance and Threshold - Pressure

Pain Threshold and Tolerance - Current Perception

Current Perception Threshold

Neck Walk Index (NWI)

Muscle Fatigue

Secondary Outcome Measures

Full Information

NCT ID

NCT00587626

First Posted

December 21, 2007

Last Updated

June 24, 2010

Sponsor

Hamilton Health Sciences Corporation

Collaborators

Canadian Memorial Chiropractic College, Neuro Resource Group

1. Study Identification

Unique Protocol Identification Number

NCT00587626

Brief Title

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

2. Study Status

Record Verification Date

June 2010

Overall Recruitment Status

Completed

Study Start Date

August 2007 (undefined)

Primary Completion Date

August 2009 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Hamilton Health Sciences Corporation

Collaborators

Canadian Memorial Chiropractic College, Neuro Resource Group

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neck Pain, Shoulder Pain, Cervical Pain

Keywords

neck pain, shoulder pain, cervical pain, chronic, recurrent

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

InterX treatment plus rehabilitation exercises

Arm Title

Arm Type

Placebo Comparator

Arm Description

Inactive InterX treatment plus rehabilitation exercises

Intervention Type

Device

Intervention Name(s)

Inactive InterX 5000

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

InterX 5000 Treatment

Intervention Description

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

Primary Outcome Measure Information:

Title

Visual Analog Scale

Time Frame

4 weeks

Title

Neck Disability Index (NDI)

Time Frame

4 weeks

Title

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

Time Frame

4 weeks

Title

Short-Form McGill Questionnaire

Time Frame

4 weeks

Title

Biomarkers (inflammatory cytokines and SP)

Time Frame

4 weeks

Title

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

Time Frame

4 weeks

Title

Cervical Range of Motion (CROM)

Time Frame

4 weeks

Title

Grip strength

Time Frame

4 weeks

Title

Vibration threshold

Time Frame

4 weeks

Title

Pain Tolerance and Threshold - Pressure

Time Frame

4 weeks

Title

Pain Threshold and Tolerance - Current Perception

Time Frame

4 weeks

Title

Current Perception Threshold

Time Frame

4 weeks

Title

Neck Walk Index (NWI)

Time Frame

4 weeks

Title

Muscle Fatigue

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

66 Years

Accepts Healthy Volunteers

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)

Overall Study Officials: