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

NCT01382537 | Completed

• 1 other identifier: 072131
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neck Pain; Shoulder Pain

Keywords

Neck; Chronic; Musculoskeletal; Shoulder

Outcome Measures

Primary Outcomes (8)

• Visual Analog Scale

  Pain scores on the Visual Analog Scale.

  10 minutes

• Neck Disability Index

  Neck Disability Index pain scores.

  15 minutes

• Shoulder Pain and Disability Index

  Shoulder Pain and Disability Index scores.

  60 minutes

• Medical Outcomes Study Short-Form (SF-36)

  Change in Medical Outcomes Study Short-Form (SF-36) score.

  15 minutes

• Neck Walk Index

  Change in Neck Walk Index score.

  20 minutes

• Upper Limb Coordination During and Overhead Reach

  Change in range of motion.

  20 minutes

• Task Limitation (TL)/Upper Limb Function - FIT-HaNSA Protocol

  Change in FIT-HaNSA score.

  20 min

• EMG testing

  Mean frequency shifts. Change in percentage of maximum voluntary contraction.

  30 minutes

Secondary Outcomes (1)

• Blood and serum biomarkers

  20 minutes

Study Arms (2)

A

ACTIVE COMPARATOR

Device: InterX 5000

B

PLACEBO COMPARATOR

Device: InterX 5000

Interventions

InterX 5000 DEVICE

A computer driven electrical stimulation unit that contains a cutaneous impedance sensor.

A

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Canadian Memorial Chiropractic College: lead
• McMaster University: collaborator

Study Sites (1)

Canadian Memorial Chiropractic College

Toronto, Ontario, Canada

Location

Related Publications (6)

• 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.

  PMID: 1373431 BACKGROUND

• 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. doi: 10.1097/00007632-198404000-00015.

  PMID: 6233718 BACKGROUND

• 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. doi: 10.1097/01.brs.0000142234.15437.da.

  PMID: 15480130 BACKGROUND

• 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. doi: 10.1097/00007632-199411001-00013.

  PMID: 7855683 BACKGROUND

• 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. doi: 10.1016/j.jmpt.2005.10.002.

  PMID: 16396725 BACKGROUND

• Teodorczyk-Injeyan JA, Triano JJ, McGregor M, Woodhouse L, Injeyan HS. Effect of Interactive Neurostimulation Therapy on Inflammatory Response in Patients With Chronic and Recurrent Mechanical Neck Pain. J Manipulative Physiol Ther. 2015 Oct;38(8):545-54. doi: 10.1016/j.jmpt.2015.08.006. Epub 2015 Oct 4.

  PMID: 26435087 DERIVED

MeSH Terms

Conditions

Neck Pain; Shoulder Pain; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. John J. Triano

Study Record Dates

• First Submitted: September 21, 2009
• First Posted: June 27, 2011
• Study Start: January 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: July 25, 2014

Record last verified: 2014-07

Locations

CA (1)