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

Noxipoint Therapy vs. Standard Physical Therapy Using Electrical Stimulation for Chronic Pain

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.

Study Overview

• Status: Completed
• Conditions: Neck Pain; Shoulder Pain
• Intervention / Treatment: Procedure: Noxipoint Therapy; Procedure: Physical Therapy

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

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94306
      • Pain Cure Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: 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.; 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/orShoulder exercise: Range of motion exercises to include walking the arm on the wall, rotation of the upper arm for about 15 minutesHot/cold pack to the pain area for about 15 minutes; Other Names: PT
Experimental: Noxipoint Therapy	Procedure: Noxipoint Therapy; Patients will be treated with a TENS device, following Noxipoint Therapy guidelines: 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").; 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.; Repeat (a) to (b) above for each identified injured muscle group until all pain areas are eliminated or when the session time is up.; Instruct the subject not to use the newly recovered muscle/tissue too much an estimated rest period depending on his/her age.; Other Names: Koo's Pain Cure Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
BPI Severity of the pain in the other three occasions	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.	One year
BPI Interference of Function	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.	One year
Range of motion	This measure will be taken whenever possible.	One year
Shoulder Pain and Disability Index (SPADI)	SPADI will be taken from shoulder pain patients whenever possible. This is optional.	One year
Neck Disability Index (NDI)	NDI will be taken from neck pain patients whenever possible. This is optional.	One year

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

Helpful Links

• Observational study results

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: April 13, 2012
• First Submitted That Met QC Criteria: April 13, 2012
• First Posted (Estimate): April 16, 2012

Study Record Updates

• Last Update Posted (Estimate): April 24, 2013
• Last Update Submitted That Met QC Criteria: April 23, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Shoulder pain; Shoulder impingement syndrome; Cervical pain; Cervicodynia; Neckache; Cervicalgia,; Neck ache
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Chronic Pain; Neck Pain; Shoulder Pain
• Other Study ID Numbers: NT-01-2012