Noxipoint Therapy Versus Standard Physical Therapy Using Electrical Stimulation for Chronic Pain
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01578148|
Recruitment Status : Completed
First Posted : April 16, 2012
Last Update Posted : April 24, 2013
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 or disease||Intervention/treatment||Phase|
|Shoulder Pain Neck Pain||Procedure: Noxipoint Therapy Procedure: Physical Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Noxipoint Therapy vs. Standard Physical Therapy Using Electrical Stimulation for Chronic Pain|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||February 2013|
|Experimental: Noxipoint Therapy||
Procedure: Noxipoint Therapy
Patients will be treated with a TENS device, following Noxipoint Therapy guidelines:
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:
Other Name: PT
- Brief Pain Inventory (BPI) Severity of the Pain at Its Worst [ Time Frame: One year ]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.
- BPI Severity of the pain in the other three occasions [ Time Frame: One year ]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 ]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 ]This measure will be taken whenever possible.
- Shoulder Pain and Disability Index (SPADI) [ Time Frame: One year ]SPADI will be taken from shoulder pain patients whenever possible. This is optional.
- Neck Disability Index (NDI) [ Time Frame: One year ]NDI will be taken from neck pain patients whenever possible. This is optional.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01578148
|United States, California|
|Pain Cure Center|
|Palo Alto, California, United States, 94306|
|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|