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

NCT01578148 | Completed DMC

• 1 other identifier: NT-01-2012
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Pain; Neck Pain

Keywords

Cervical pain; Cervicalgia,; Cervicodynia; Neck ache; Neckache; Shoulder pain; Shoulder impingement syndrome

Outcome Measures

Primary Outcomes (1)

• Brief Pain Inventory (BPI) Severity of the Pain at Its Worst

  BPI will be evaluated as the score change from the baseline. As a supplemental measure, the baseline of individual patients will also be normalized to 100%, with the change being a percentile of the baseline.

  One year

Secondary Outcomes (5)

• BPI Severity of the pain in the other three occasions

  One year

• BPI Interference of Function

  One year

• Range of motion

  One year

• Shoulder Pain and Disability Index (SPADI)

  One year

• Neck Disability Index (NDI)

  One year

Study Arms (2)

Noxipoint Therapy

EXPERIMENTAL

Procedure: Noxipoint Therapy

Physical Therapy

ACTIVE COMPARATOR

Procedure: Physical Therapy

Interventions

Noxipoint Therapy 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.

Also known as: Koo's Pain Cure Therapy

Noxipoint Therapy

Physical Therapy 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

Also known as: PT

Physical Therapy

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Pain Cure Center, California: lead

Study Sites (1)

Pain Cure Center

Palo Alto, California, 94306, United States

Location

MeSH Terms

Conditions

Shoulder Pain; Neck Pain; Shoulder Impingement Syndrome

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Shoulder Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Charles C Koo, PhD

  Pain Cure Center

  STUDY DIRECTOR

• Charles C Koo, PhD

  Pain Cure Center

  PRINCIPAL INVESTIGATOR

• David Lewis, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 13, 2012
• First Posted: April 16, 2012
• Study Start: April 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: April 24, 2013

Record last verified: 2013-04

Locations

US (1)