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

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. Physical Therapy group (PT)
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.

Subjects will be evaluated before and after the first treatment session and followed up at about 4 weeks, 8 weeks, and 12 weeks after the first treatment.

Outcome measures are (1) the pain scale in the Brief Pain Index, (2) cervical Range of Motion (ROM), (3) Quality of Life (QoL) measured with the Interference of Pain to Life section in the Brief Pain Index (BPI) and (4) ultrasound elastogram. Pain scale, ROM and QoL measures will be taken before and after the first treatment session, and at 4 weeks, 8 weeks and 12 weeks after the first session. Elastogram will be taken before the first treatment, and about four weeks after the first treatment.

Statistics: The effects of PT and NT will be compared based on two-sample hypothesis testing methods. All the estimated P-values are two tailed.

Conditions

• Cervical Pain

Interventions

PROCEDURE

Noxipoint Therapy (NT)

• 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.

PROCEDURE

Physical therapy(PT)

•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.

Sponsors & Collaborators

• Pain Cure Center, California

  collaborator INDUSTRY

• National Taiwan University Hospital

  lead OTHER

Principal Investigators

• Tyng-Guey Wang, MD · National Taiwan University

• Charles C Koo, PhD · National Taiwan University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-04-30

Primary Completion

2014-10-31

Completion

2014-10-31

Countries

• Taiwan