Efficacy of the InterX 5000 in the Treatment of Chronic Neck Pain

Neck Pain Clinical Trial

Official title:

Evaluation of the Efficacy of the InterX 5000 in the Treatment of Chronic Neck and Shoulder Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01382537
• Other study ID #: 072131
• Status: Completed
• Phase: N/A
• First received: September 21, 2009
• Last updated: July 24, 2014
• Start date: January 2008
• Est. completion date: April 2010

Study information

• Verified date: July 2014
• Source: Canadian Memorial Chiropractic College
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study will focus on the efficacy of treating 80 patients who have functional limitations in activity because of chronic/recurrent neck or shoulder pain.

Hypothesis 1: InterX therapy alone will have a moderate effect to reduce pain during weeks 1-2.

Hypothesis 2: Functional gains will be greater in patients receiving InterX therapy compared to those who received placebo treatment.

Hypothesis 3: Chronic neck and shoulder pain is more prevalent in patients who exhibit radiographic evidence of degenerative spondylosis/arthrosis of the cervical spine.

Description:

Evaluation of subjects will be conducted at baseline (interval 0) and at 2, 4, 6 and 12 week time periods. At 26 weeks, the patient will be contacted to obtain follow-up questionnaires on pain and function. After informed consent, participants will be randomly assigned to a treatment group and a sham group using the InterX5002, hand held electrical stimulation unit. Treatment will be administered three times per week for six weeks.

During the interval of weeks 1-2 patients will have either the InterX treatment/sham alone. Weeks 3-4 will advance the patient adding a standardized rehabilitation exercise program typical for chronic neck patients. During weeks 5-6, the patient will be scheduled for treatment and will use a self-administered InterX treatment ("home" Flex) unit mimicking home care but accounting for compliance issues through attendance being monitored.

Baseline and follow-up assessments will consist of pain scores, NDI, neck fatigue testing, shoulder and arm reach tasks and walking on a treadmill at 2 MPH for 5 minutes (Neck-walk Index, NWI). Neck fatigue testing will consist of prone positioning and extensor muscle exertion against resistance to tolerance at 60% MVC. Myoelectric sensors will be taped to the skin to record muscle activity during fatigue and reach task testing. Electromagnetic sensors will be taped to a swimmers cap worn by the patient and on the skin at T1 over the spine at the shoulder level and S1 at the pelvis during the walk on the treadmill and on the shoulder and arm during reach testing.

Venipuncture will be performed at the evaluation intervals to collect blood samples for quantifying circulating inflammatory cytokines.

Analysis will focus on change in pain scores and inflammatory cytokines over the first two weeks for Hypothesis H1. Primary functional outcomes including neck fatigue and progression through neck rehabilitation exercise will be tested for Hypothesis2. The third hypothesis will be tested in two ways. First, quantification of degenerative changes (e.g.disc narrowing & osteophyte formation) on x-ray (AP & Lat screening views) will be contrasted to incidence in the published literature. Second, pain levels at baseline will be stratified into quartiles and compared to quantitative tally of degenerative changes. This data will serve as a basis for determining whether future studies using degenerative change criteria are warranted. Myoelectric activity, fatigue and head-pelvic position data will be used descriptively to assess functional differences from baseline to completion of treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• males or females

• ages 18-65

• chronic or recurrent neck or shoulder pain

• pain of at least 3 months duration

• willing to sign consent form

• able/willing to comply with treatment schedule

Exclusion Criteria:

• age over 65 years

• clinically significant herniated disc

• spinal fracture

• previous electrical stimulation treatment for this episode

• recent cervical spine or shoulder surgery

• implanted instrumentation/prostheses

• epilepsy

• pregnancy

• recent (3 months) chemotherapy/radiotherapy

• phlebitis

• cortisone use (30 days)

• hypersensitivity to tape used with EMG

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neck Pain
• Shoulder Pain

Intervention

Device:
• InterX 5000
A computer driven electrical stimulation unit that contains a cutaneous impedance sensor.
• InterX 5000
Placebo treatment

Locations

Country	Name	City	State
Canada	Canadian Memorial Chiropractic College	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Canadian Memorial Chiropractic College	McMaster University

Country where clinical trial is conducted

Canada, 

References & Publications (5)

Brennan PC, Triano JJ, McGregor M, Kokjohn K, Hondras MA, Brennan DC. Enhanced neutrophil respiratory burst as a biological marker for manipulation forces: duration of the effect and association with substance P and tumor necrosis factor. J Manipulative Physiol Ther. 1992 Feb;15(2):83-9. — View Citation

Godfrey CM, Morgan PP, Schatzker J. A randomized trial of manipulation for low-back pain in a medical setting. Spine (Phila Pa 1976). 1984 Apr;9(3):301-4. — View Citation

Hurley DA, McDonough SM, Dempster M, Moore AP, Baxter GD. A randomized clinical trial of manipulative therapy and interferential therapy for acute low back pain. Spine (Phila Pa 1976). 2004 Oct 15;29(20):2207-16. — View Citation

Pope MH, Phillips RB, Haugh LD, Hsieh CY, MacDonald L, Haldeman S. A prospective randomized three-week trial of spinal manipulation, transcutaneous muscle stimulation, massage and corset in the treatment of subacute low back pain. Spine (Phila Pa 1976). 1994 Nov 15;19(22):2571-7. — View Citation

Teodorczyk-Injeyan JA, Injeyan HS, Ruegg R. Spinal manipulative therapy reduces inflammatory cytokines but not substance P production in normal subjects. J Manipulative Physiol Ther. 2006 Jan;29(1):14-21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale	Pain scores on the Visual Analog Scale.	10 minutes	No
Primary	Neck Disability Index	Neck Disability Index pain scores.	15 minutes	No
Primary	Shoulder Pain and Disability Index	Shoulder Pain and Disability Index scores.	60 minutes	No
Primary	Medical Outcomes Study Short-Form (SF-36)	Change in Medical Outcomes Study Short-Form (SF-36) score.	15 minutes	No
Primary	Neck Walk Index	Change in Neck Walk Index score.	20 minutes	No
Primary	Upper Limb Coordination During and Overhead Reach	Change in range of motion.	20 minutes	No
Primary	Task Limitation (TL)/Upper Limb Function - FIT-HaNSA Protocol	Change in FIT-HaNSA score.	20 min	No
Primary	EMG testing	Mean frequency shifts. Change in percentage of maximum voluntary contraction.	30 minutes	No
Secondary	Blood and serum biomarkers	Change in cytokine counts.	20 minutes	No