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

Hamilton Health Sciences (HHS)

Status and phase

Completed

Phase 2

Conditions

Shoulder Pain

Cervical Pain

Neck Pain

Treatments

Device: InterX 5000 Treatment

Device: Inactive InterX 5000

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00587626

NRG

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 66 years old

Volunteers

No 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)