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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pain Cure Center, California
ClinicalTrials.gov Identifier:
NCT01578148
First received: April 13, 2012
Last updated: April 23, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention
Shoulder Pain
Neck Pain
 Procedure: Noxipoint Therapy
Procedure: Physical Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Noxipoint Therapy vs. Standard Physical Therapy Using Electrical Stimulation for Chronic Pain

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pain Cure Center, California:

Primary Outcome Measures:
  • Brief Pain Inventory (BPI) Severity of the Pain at Its Worst [ Time Frame: One year ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • BPI Severity of the pain in the other three occasions [ Time Frame: One year ] [ Designated as safety issue: No ]
    Besides the Severity of the Pain at Its Worst, there are three other pain measures in BPI. This measure will be used as a supporting measure fo the Primary Measure.

  • BPI Interference of Function [ Time Frame: One year ] [ Designated as safety issue: No ]
    This measure is used to indicate the impact of the subject's quality of life. However, the standard questions include the therapy's functional impact on walking, which is not likely to be influenced by neck/shoulder pains in any case and thus may not be relevant. Thus, a supplemental measure excluding the impact on walking will be provided as a supplemental observation.

  • Range of motion [ Time Frame: One year ] [ Designated as safety issue: No ]
    This measure will be taken whenever possible.

  • Shoulder Pain and Disability Index (SPADI) [ Time Frame: One year ] [ Designated as safety issue: No ]
    SPADI will be taken from shoulder pain patients whenever possible. This is optional.

  • Neck Disability Index (NDI) [ Time Frame: One year ] [ Designated as safety issue: No ]
    NDI will be taken from neck pain patients whenever possible. This is optional.


Enrollment: 34
Study Start Date: April 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Noxipoint Therapy 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.
Other Name: Koo's Pain Cure Therapy
Active Comparator: Physical Therapy 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
Other Name: PT

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

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01578148

Locations
United States, California
Pain Cure Center
Palo Alto, California, United States, 94306
Sponsors and Collaborators
Pain Cure Center, California
Investigators
Study Director: Charles C Koo, PhD Pain Cure Center
Principal Investigator: Charles C Koo, PhD Pain Cure Center
Principal Investigator: David Lewis, MD Stanford University
  More Information

Additional Information:
Observational study results  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pain Cure Center, California
ClinicalTrials.gov Identifier: NCT01578148     History of Changes
Other Study ID Numbers: NT-01-2012
Study First Received: April 13, 2012
Last Updated: April 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Pain Cure Center, California:
Cervical pain
Cervicalgia,
Cervicodynia
Neck ache
 Neckache
Shoulder pain
Shoulder impingement syndrome

Additional relevant MeSH terms:
Neck Pain
Shoulder Pain
Pain
Neurologic Manifestations
Nervous System Diseases
 Signs and Symptoms
Arthralgia
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 16, 2013