Noxipoint Therapy Versus Standard Physical Therapy Using Electrical Stimulation for Chronic Pain

Summary

The purpose of this study is to validate the efficacy of Noxipoint(TM) therapy on chronic pain, and compare it with standard physical therapy using electrical stimulation on patients with chronic pain.

Invented by Dr. Charlie Koo at Stanford University, Noxipoint Therapy is a specific procedure with precise location, duration and intensity of TENS stimulation within the general FDA guidelines. The therapy substantially relieves general muscular/tendon pain and persistently restores the muscle and tendon function. The surface locations of nociceptors at the free nerve ending (i.e., "Noxipoints") are focused on in the stimulation therapy. Multiple clinical uses of Noxipoint Therapy confirmed the consistent efficacy of such stimulation at Noxipoints. An observational study of Noxipoint therapy within the FDA-approved use of TENS demonstrated an encouraging 93% success rate in eliminating the chronic pain, such as frozen shoulder pain, within 2-3 sessions. It is an order-of-magnitude improvement over the non-specific application of TENS and any other modalities in pain treatment. A unique neuro-immuno-signaling pathway that implicates the activation of adult stem cells, such as satellite cells in muscles, is implicated based on such a high success rate.

Conditions

• Shoulder Pain
• Neck Pain

Interventions

PROCEDURE

Noxipoint Therapy

Patients will be treated with a TENS device, following Noxipoint Therapy guidelines: 1. Find the cause of the pain via Noxipoint: For each injured muscle/tissue, it is discovered that there are always a pair of points at the skin surface locations of its nociceptors that are painful at light press (named "Noxipoints"). 2. Stimulate the corresponding pair of Nocipoints following a narrowly defined combination of intensity/ frequency (inducing the C-fiber response) and duration (about 1.5-3 minutes) of TENS at the two targeted Noxipoints. 3. Repeat (a) to (b) above for each identified injured muscle group until all pain areas are eliminated or when the session time is up. 4. Instruct the subject not to use the newly recovered muscle/tissue too much an estimated rest period depending on his/her age.

PROCEDURE

Physical Therapy

The 1.5-hour physical therapy in the control arm are provided both as standard of care and sham device comparison to Nocipoint Therapy, following these guidelines: 1. TENS stimulation (45 minutes): • Electrodes will be placed around the patient-identified general pain area on the neck /shoulder for TENS. Rotate the electrode pads around the pain area and stimulate again. 2. Other modalities of PT per the therapist's choice: * Infrared treatment on the pain areas (about 15 minutes) * Manual therapy to cervical and/or rotator cuff areas (about 15 minutes). * Exercise and training: * Neck exercises: Range of motion exercises to include foraminal opening for about 15 minutes, and/or * Shoulder exercise: Range of motion exercises to include walking the arm on the wall, rotation of the upper arm for about 15 minutes * Hot/cold pack to the pain area for about 15 minutes

Sponsors & Collaborators

• Pain Cure Center, California

  lead INDUSTRY

Principal Investigators

• Charles C Koo, PhD · Pain Cure Center

• Charles C Koo, PhD · Pain Cure Center

• David Lewis, MD · Stanford University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-04-30

Primary Completion

2013-02-28

Completion

2013-02-28

Countries

• United States

Study Locations