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

NCT ID: NCT01578148

Last Updated: 2013-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2013-02-28

Brief 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.

Detailed Description

View http://paincurecenter.com/Clinical_Outcome.html for the observational study mentioned in the Brief Summary above. For more detailed cases, please view http://paincurecenter.com/uploads/Nocipoint_therapy_clinical_study_w_o_ID_2011-2012.pdf

Conditions

Shoulder Pain; Neck Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Noxipoint Therapy

Group Type: EXPERIMENTAL

Noxipoint Therapy

Intervention Type: PROCEDURE

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.

Physical Therapy

Group Type: ACTIVE_COMPARATOR

Physical Therapy

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: 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

Intervention Type: PROCEDURE

Other Intervention Names

Koo's Pain Cure Therapy; PT

Eligibility Criteria

Inclusion Criteria

• 18-64 years old male or female
• Having chronic pain (ICD-9: 338.21, 338.29) in the neck/upper back (ICD-9: 723.1), or the shoulder (ICD-9: 719.41)
• Pain duration over 6 months, with at least one month of history of other therapy treatments (Physical therapy, steroid injection, acupuncture, analgesic medicine, and/or massage therapy)

Exclusion Criteria

• Patients with BPI Severity at its Worst below 5
• Traumatic injury from external impact force
• Pain caused by traumatic bone fractures
• History of traumatic cervical injury
• History of osteoporosis
• Pain related to systemic inflammatory conditions including polymyalgia rheumatic, systemic lupus erythematosis
• Signs of psychosomatic illness
• Severe rheumatoid arthritis undergoing active treatment including DMARD biologics
• Steroid injection on pain site within 4 weeks
• Language and/or cognitive inability to complete the assessment questionnaires
• Previous TENS for pain relief
• For safety reasons, patients wearing cardiac pace makers, implanted defibrillator, or pregnant women

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pain Cure Center, California

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles C Koo, PhD

Role: STUDY_DIRECTOR

Pain Cure Center

Charles C Koo, PhD

Role: PRINCIPAL_INVESTIGATOR

Pain Cure Center

David Lewis, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Pain Cure Center

Palo Alto, California, United States

Countries

United States

Other Identifiers

NT-01-2012

Identifier Type: -

Identifier Source: org_study_id