Clinical trial NCT01578148: Noxipoint Therapy Versus Standard Physical Therapy Using Electrical Stimulation for Chronic Pain
Official title: Noxipoint Therapy vs. Standard Physical Therapy Using Electrical Stimulation for Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Pain
Neck Pain
Keywords: Cervical pain
Cervicalgia,
Cervicodynia
Neck ache
Neckache
Shoulder pain
Shoulder impingement syndrome
Lead sponsor: Pain Cure Center, California
Sponsor class: INDUSTRY
First posted: 2012-04-16
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Brief Pain Inventory (BPI) Severity of the Pain at Its Worst
timeFrame: One year
Secondary outcomes:
measure: BPI Severity of the pain in the other three occasions
timeFrame: One year
measure: BPI Interference of Function
timeFrame: One year
measure: Range of motion
timeFrame: One year
measure: Shoulder Pain and Disability Index (SPADI)
timeFrame: One year
measure: Neck Disability Index (NDI)
timeFrame: One year
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Pain Cure Center
state: California
Study officials:
affiliation: Pain Cure Center
name: Charles C Koo, PhD
role: STUDY_DIRECTOR
affiliation: Pain Cure Center
name: Charles C Koo, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: David Lewis, MD
role: PRINCIPAL_INVESTIGATOR
References: