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

Neck Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01578148
• Other study ID #: NT-01-2012
• Status: Completed
• Phase: N/A
• First received: April 13, 2012
• Last updated: April 23, 2013
• Start date: April 2012
• Est. completion date: February 2013

Study information

• Verified date: April 2013
• Source: Pain Cure Center, California
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain
• Neck Pain
• Shoulder Pain

Intervention

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.
• 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/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

Locations

Country	Name	City	State
United States	Pain Cure Center	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Pain Cure Center, California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Range of motion	This measure will be taken whenever possible.	One year	No
Secondary	Shoulder Pain and Disability Index (SPADI)	SPADI will be taken from shoulder pain patients whenever possible. This is optional.	One year	No
Secondary	Neck Disability Index (NDI)	NDI will be taken from neck pain patients whenever possible. This is optional.	One year	No