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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Neck Pain; Shoulder Pain; Cervical Pain	Device: Inactive InterX 5000; Device: InterX 5000 Treatment	Phase 2

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	80 participants
Allocation:	Randomized
Intervention Model:	Single Group Assignment
Masking:	Double (Participant, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Proposal to Evaluate the Efficacy of the InterX 5000 in the Treatment of Chronic Neck and Shoulder Pain
Study Start Date :	August 2007
Actual Primary Completion Date :	August 2009
Actual Study Completion Date :	December 2009

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: 1; InterX treatment plus rehabilitation exercises	Device: InterX 5000 Treatment; Patients will receive will receive InterX treatment 3 times a week for 4 weeks.
Placebo Comparator: 2; Inactive InterX treatment plus rehabilitation exercises	Device: Inactive InterX 5000; Patients will receive will receive InterX placebo treatment 3 times a week for 4 weeks.

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

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 ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 66 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

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Locations

Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8S 1C7
Canadian Memorial Chiropractic College
Toronto, Ontario, Canada, M2H 3J1

Sponsors and Collaborators

Hamilton Health Sciences Corporation

Canadian Memorial Chiropractic College

Neuro Resource Group

Investigators

Principal Investigator:	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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Linda J. Woodhouse, McMaster University
ClinicalTrials.gov Identifier:	NCT00587626 History of Changes
Other Study ID Numbers:	NRG
First Posted:	January 7, 2008
Last Update Posted:	June 25, 2010
Last Verified:	June 2010

Keywords provided by McMaster University:

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

Additional relevant MeSH terms:

Neck Pain; Shoulder Pain; Pain; Neurologic Manifestations; Nervous System Diseases	Signs and Symptoms; Arthralgia; Joint Diseases; Musculoskeletal Diseases