Shoulder PainNCT01578148
Noxipoint Therapy Versus Standard Physical Therapy Using Electrical Stimulation for Chronic Pain
A study testing Noxipoint Therapy and Physical Therapy in people with Shoulder Pain and Neck Pain, run by Pain Cure Center, California at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Shoulder Pain, Neck Pain
- What is being tested?
- Noxipoint Therapy and Physical Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Noxipoint Therapy vs. Standard Physical Therapy Using Electrical Stimulation for Chronic Pain
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.
Read the 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
- Conditions
- Shoulder Pain, Neck Pain
- Being tested
- Noxipoint Therapy, Physical Therapy
- Keywords
- Cervical pain, Cervicalgia,, Cervicodynia, Neck ache, Neckache, Shoulder pain, Shoulder impingement syndrome
- Medical subject headings
- Shoulder Pain, Neck Pain, Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noxipoint TherapyProcedure or surgery
Also called Koo's Pain Cure 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 TherapyProcedure or surgery
Also called PT
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
| Study group | Role | What they receive |
|---|---|---|
| Noxipoint Therapy | Experimental | Not described Receives: Procedure: Noxipoint Therapy |
| Physical Therapy | Active comparator | Not described Receives: Procedure: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year
Secondary outcomes (5)
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.
Measured: One year
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.
Measured: One year
Range of motion
This measure will be taken whenever possible.
Measured: One year
Shoulder Pain and Disability Index (SPADI)
SPADI will be taken from shoulder pain patients whenever possible. This is optional.
Measured: One year
Neck Disability Index (NDI)
NDI will be taken from neck pain patients whenever possible. This is optional.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pain Cure Center, California
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charles C Koo, PhD, Study director, Pain Cure CenterCharles C Koo, PhD, Principal investigator, Pain Cure CenterDavid Lewis, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01578148
- Sponsor's protocol ID
- NT-01-2012
- Status last verified
- Apr 2013
- First submitted
- 13 Apr 2012
- Last updated
- 24 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noxipoint Therapy vs. Standard Physical Therapy Using Electrical Stimulation for Chronic Pain
- ClinicalTrials.gov ID
- NCT01578148
- Acronym / sponsor ID
- NT-01-2012
- Conditions
- Shoulder Pain, Neck Pain
- Keywords
- Cervical pain, Cervicalgia,, Cervicodynia, Neck ache, Neckache, Shoulder pain, Shoulder impingement syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Pain Cure Center, CaliforniaIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 16 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Noxipoint Therapy | Experimental | Procedure: Noxipoint Therapy |
| Physical Therapy | Active comparator | Procedure: Physical Therapy |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Noxipoint TherapyAlso: Koo's Pain Cure TherapyPatients will be treated with a TENS device, following Noxipoint Therapy guidelines: 1. 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"). 2. 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. 3. Repeat (a) to (b) above for each identified injured muscle group until all pain areas are eliminated or when the session time is up. 4. Instruct the subject not to use the newly recovered muscle/tissue too much an estimated rest period depending on his/her age. | Procedure or surgery | Noxipoint Therapy |
| Physical TherapyAlso: PTThe 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: 1. 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. 2. 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 | Procedure or surgery | Physical Therapy |
Primary outcome
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.
5 secondary outcomes
BPI Severity of the pain in the other three occasions
Time frame: One year
BPI Interference of Function
Time frame: One year
Range of motion
Time frame: One year
Shoulder Pain and Disability Index (SPADI)
Time frame: One year
Neck Disability Index (NDI)
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles C Koo, PhD study director
Pain Cure Center
Charles C Koo, PhD principal investigator
Pain Cure Center
David Lewis, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Noxipoint Therapy and Physical Therapy in people with Shoulder Pain and Neck Pain, run by Pain Cure Center, California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Pain Inventory (BPI) Severity of the Pain at Its Worst (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2013.