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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Noxipoint Therapy | Experimental |
| |
| Physical Therapy | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Noxipoint Therapy | Procedure | Patients will be treated with a TENS device, following Noxipoint Therapy guidelines:
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pain Cure Center | Palo Alto | California | 94306 | United States |
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| ID | Term |
|---|---|
| D020069 | Shoulder Pain |
| D019547 | Neck Pain |
| D019534 | Shoulder Impingement Syndrome |
| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| 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:
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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 |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000070599 | Shoulder Injuries |
| D014947 | Wounds and Injuries |