The Effect of Noxipoint Therapy Versus Physical Therapy With TENS on Chronic Neck Pain

NCT01844167 | Completed DMC

• 1 other identifier: 201302023RINB
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic cervical pain is a common problem in rehabilitation clinic, but the treatment is time consuming and the effect unsatisfactory. Noxipoint® Therapy, developed by Dr. Charles C. Koo, is a unique electrical stimulation precisely on corresponding "Noxipoints®" of each injured soft tissue, with specific duration and intensity of TENS that induce C-fiber nerve ending sensation. Each application typically last for 2 to 5 minutes. Based on observations of the clinical application, Noxipoint® Therapy appears to relieve chronic neck and shoulder pain significantly with lasting effect, and effectively improves the range of motion. However, large-scale double-blinded, randomized control study on the therapy is not available yet. The purpose of this study is to compare the effect of Noxipoint® Therapy and physical therapy (including the current TENS application) on patients with chronic neck pain. This study is a prospective stratified randomized control trial. Eighty subjects with chronic cervical pain will be recruited from the Rehabilitation Department or the Physical Therapy Center of National Taiwan University Hospital (NTUH). The qualified subjects will be stratified and randomly allocated into two arms, 40 persons in each:

1. 1.Physical Therapy group (PT)
2. 2.Noxipoint Therapy group (NT) Subjects in either group will be treated for up to 6 sessions within 3 weeks, about 1.5 hours per session. The treatment will terminate after six sessions or earlier if the patient shows no symptoms.

Conditions

Cervical Pain

Keywords

noxipoint; physical therapy; cervical pain; trigger point; neck pain; TENS; transcutaneous electrical nerve stimulation

Outcome Measures

Primary Outcomes (1)

• Change of Brief Pain Index (BPI) At Its Worst from baseline to 4 weeks

  BPI At Its Worst will be assessed before the first treatment and followed up at 4 weeks after the start.

  About 4 weeks after the initial treatment

Secondary Outcomes (12)

• Change of the normalized Range of motion(ROM) of the neck from baseline to follow-up at 4 weeks

  About 4 weeks after the initial session

• Change of BPI Average from baseline to the follow-up at 4 weeks

  4 weeks after the initial treatment

• Change of BPI-Right-Now from baseline to the follow-up at 4 weeks

  4 weeks after the initial treatment

• Change of BPI-Average from baseline to the follow-up at 8 weeks

  8 weeks after the initial treatment

• Change of BPI-Right-Now from baseline to the follow-up at 8 weeks

  8 weeks after the initial treatment

Study Arms (2)

Physical therapy arm (PT)

ACTIVE COMPARATOR

* The TENS device used: FDA K071951 * Patients will be treated with standard physical therapy, including the electrical stimulation. Manual therapy, cold/heat therapy or exercise will be applied at the discretion of the physical therapist for about 60 minutes in each session. Patient education and self-care instructions will be provided. TENS will also be performed in each session for about 30 minutes based on the typical PT guidelines, which will serve both as a part of the standard of care and as a placebo equivalent. It will typically be set at Normal/Modulate mode and 120 Hertz rate.

Procedure: Noxipoint Therapy (NT)

Noxipoint Therapy arm (NT)

EXPERIMENTAL

Patients will be treated with TENS following Noxipoint Therapy guidelines as highlighted below: * The TENS device used: FDA K071951 * TENS is calibrated to allow for maximum range in the specifications. * A pair of electrode pads is placed at the corresponding pair of Noxipoints of the injured muscle/soft tissue, for about 2- 5 minutes during each application. * The electrical stimulation is set to induce the C-fiber response based on the feedback of the patient. * If the corresponding pain is not eliminated or reduced after a couple of applications on correct Noxipoints, apply an ice pack for about 10-15 minutes on site before and during the next Noxipoint stimulation.

Procedure: Physical therapy(PT)

Interventions

Noxipoint Therapy (NT) PROCEDURE

• For severe chronic neck pain patients, cervical braces are recommended within the first 2-3 days of each treatment session. The patient has to avoid using the treated tissues/muscles during the "Rest Period": Similar to all other cells, the muscle cell healing or regeneration takes time. Patients are instructed not to use the newly recovered muscle/tissue during the "Rest Period", which is about three days if they are forty or younger, plus about one extra day for every 10 additional years of age. If the patient has extensive injured muscles, take two more days of rest. Ice packs may be used during or soon after the session to prevent Delayed Onset of Muscle Soreness (DOMS) from the TENS stimulation.

Also known as: Charles Koo's Pain Cure Therapy

Physical therapy arm (PT)

Physical therapy(PT) PROCEDURE

•Placebo effect consideration: TENS is included in both arms to obfuscate the process. Using TENS in the PT arm serves both as a sham-therapy-equivalent to what is used in the NT arm to neutralize placebo bias, and as a meaningful therapeutic remedy. The subject is thus blinded. Placebo effect consideration: TENS is included in both arms to obfuscate the process. Using TENS in the PT arm serves both as a sham-therapy-equivalent to what is used in the NT arm to neutralize placebo bias, and as a meaningful therapeutic remedy. The subject is thus blinded.

Noxipoint Therapy arm (NT)

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 70 years of age
• Diagnosed as chronic cervical pain syndrome (ICD9: 723.1)
• Having no less than 6 months of the pain history
• The pain level \>＝ 5 in BPI
• with trigger points.

You may not qualify if:

• cervical spondylosis
• local corticoid injection within last two weeks
• signs of psychosomatic illness
• unwilling to be randomized
• pregnant woman

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Pain Cure Center, California: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipai, Taiwan

Location

MeSH Terms

Conditions

Neck Pain

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Tyng-Guey Wang, MD

  National Taiwan University

  PRINCIPAL INVESTIGATOR

• Charles C Koo, PhD

  National Taiwan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2013
• First Posted: May 1, 2013
• Study Start: April 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: December 2, 2014

Record last verified: 2014-12

Locations

TW (1)