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

P

Pain Cure Center, California

Status

Completed

Conditions

Shoulder Pain
Neck Pain

Treatments

Procedure: Noxipoint Therapy
Procedure: Physical Therapy

Study type

Interventional

Funder types

Industry

Identifiers

NCT01578148
NT-01-2012

Details and patient eligibility

About

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.

Full 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

Enrollment

34 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

34 participants in 2 patient groups

Noxipoint Therapy
Experimental group
Treatment:
Procedure: Noxipoint Therapy
Physical Therapy
Active Comparator group
Treatment:
Procedure: Physical Therapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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