Chronic Low Back PainNCT02890810
Predicting Analgesic Response to Acupuncture: A Practical Approach
A study testing Real Acupuncture with Electrical Stimulation and Simulated Acupuncture with Electrical Stimulation in people with Chronic Low Back Pain and Back Pain, run by Stanford University at 1 site in United States.
Trial summary
In this placebo controlled, patient and assessor blinded clinical trial, the investigators will administer electroacupuncture vs sham electroacupuncture to patients suffering from chronic low back pain, and monitor their symptoms as well as collecting objective outcome measures. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Chronic Low Back Pain, Back Pain
- What is being tested?
- Real Acupuncture with Electrical Stimulation and Simulated Acupuncture with Electrical Stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to 30 Jun 2020
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21-65
- English Fluency
- Chronic LBP for ≥ 6 Months
- Chronicity: cLBP "defined as a back pain problem that has persisted at least 3 months and has resulted in pain on at least half the days in the past 6 months."
- Location: "between the lower posterior margin of the rib cage and the horizontal gluteal fold
- Average pain over the last month ≥ 5/10
Who cannot join
- Radicular low back pain: defined as sharp (or burning) pain, with a defined territory, radiating down the limb, beyond the knee. Radicular pain may be accompanied by sensory and motor deficit along 1 or more dermatomes. Radicular back pain may also be accompanied by MRI evidence of intervertebral disc protrusion and compression of spinal cord and/or nerve roots.
- Pending litigation or Worker's compensation related to the low back pain.
- Currently pregnant or planning to become pregnant (in next 6 months)
- American Society of Anesthesiologist (ASA) class III or above physical status. ASA class III is defined as "a patient with severe systemic disease." Examples would include poorly controlled diabetes, hypertension, COPD or morbid obesity (BMI ≥ 40).
- Mental health conditions or treatment for mental health problems that would interfere with study procedures, at the discretion of the study team. For example, psychosis, untreated major depression, ongoing substance abuse, suicidal ideation. These will be assessed by the MINI.
- Medications: opioids ≥60mg morphine equivalent units/day, benzodiazepines, corticosteroids.
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- Prohibited interventions: during the study period, the following are not permitted
- Back surgeries
- Injections with local anesthetics or steroids to the back
- New chiropractic maneuvers
- New physical therapy programs
- New medications for back pain
- Bleeding disorders at the discretion of the study team.
- Previous acupuncture treatment in the past 10 years.
- Medical conditions that would interfere with study procedures (eg. Heart disease or pacemaker, active infection), per discretion of the team
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Systems Neuroscience and Pain Lab (SNAPL)
Palo Alto, California, 94304
About this study
Official title: Predicting Analgesic Response to Acupuncture: A Randomized, Placebo-Controlled, Subject and Assessor Blinded, 100-Subject Clinical Trial of Electro-Acupuncture in the Treatment of Chronic Low Back Pain
In this placebo controlled, patient and assessor blinded clinical trial, the investigators will administer electroacupuncture vs sham electroacupuncture to patients suffering from chronic low back pain, and monitor their symptoms as well as collecting objective outcome measures. The investigators objective is to identify predictors of pain reduction and functional improvement with electroacupuncture vs placebo.
- Conditions
- Chronic Low Back Pain, Back Pain
- Being tested
- Real Acupuncture with Electrical Stimulation, Simulated Acupuncture with Electrical Stimulation
- Keywords
- Acupuncture, Back Pain, Chronic Pain
- Medical subject headings
- Back Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real Acupuncture with Electrical StimulationOther
Also called Verum Electroacupuncture, Traditional acupuncture needles, ITO® ES-130® electrical stimulator
Acupuncture is a therapy commonly used in East Asian countries, where the practitioner insert thin needles at specific body sites in order to relieve pain and illnesses. Recent studies found low frequency electricity applied through acupuncture needles can lead to profound pain relief by increasing endorphin levels in the central nervous system. Electroacupuncture will thus be used as the active intervention to treat chronic low back pain in this clinical study.
Simulated Acupuncture with Electrical StimulationOther
Also called Sham Electroacupuncture / Placebo Electroacupuncture, Sterile Acupuncture Needles, ITO® ES-130® electrical stimulator
This intervention serves as the placebo control of the active intervention. Sterile acupuncture needles and the ITO electrical stimulators will be used in this intervention. But special care will be taken to have this intervention mimic the real treatment yet remaining as physiologically inert as possible.
| Study group | Role | What they receive |
|---|---|---|
| Verum Electroacupuncture | Experimental | Active Intervention Receives: Other: Real Acupuncture with Electrical Stimulation |
| Placebo Electroacupuncture | Placebo comparator | Validated Control Receives: Other: Simulated Acupuncture with Electrical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean back pain intensity by patient-report
Patient self-reported mean back pain intensity on 11 point (0-10) numerical rating scale (NRS).
Measured: 7 days
Roland Morris Disability Questionnaire
Validated functional outcome measure in chronic low back pain with 24 yes/no questions regarding physical function.
Measured: 1 day
Secondary outcomes (8)
Quantitative Sensory Testing
Standardized response to noxious thermal and mechanical stimuli up to 120 seconds.
Measured: Tests used are typically stable for 1-2 weeks
Physical exam to determine neurological function
Physical exam assessing neurological function (recorded as presence or absence of light touch sensation, and stretch reflexes at the knees and ankles) in up to 5min.
Measured: 1 month
Physical exam to assess lumbar facet irritation.
Physical exam assessing facet irritation via positive or negative response to lumbar facet maneuver in up to 5 minutes.
Measured: 1 month
Physical exam to assess lumbar spine range of motion
Physical exam assessing range of motion in lumbar spine (measured in degrees) in up to 5 minutes.
Measured: 1 month
Blood pressure
Blood pressure collected via OMRON electric blood pressure monitor, in mmHg up to 60 seconds.
Measured: 1 day
Heart Rate Variability
Heart rate variability (LF/HF) collected via non-invasive, HRVLive! device up to 10 minutes.
Measured: 1 month
Heart Rate Variability
Heart rate variability (BPM) collected via non-invasive, HRVLive! device up to 10 minutes.
Measured: 1 month
Heart Rate Variability
Heart rate variability (ECG) collected via non-invasive, HRVLive! device up to 10 minutes.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startJul 2016
- Primary completion31 Dec 2018
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Jiang-Ti Kong, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02890810
- Sponsor's protocol ID
- 34754
- Other IDs
- 1K23AT008477-01A1
- Status last verified
- Jan 2021
- First submitted
- 15 Jul 2016
- Last updated
- 25 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Kong JT, Puetz C, Tian L, Haynes I, Lee E, Stafford RS, Manber R, Mackey S. Effect of Electroacupuncture vs Sham Treatment on Change in Pain Severity Among Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Netw Open. 2020 Oct 1;3(10):e2022787. doi: 10.1001/jamanetworkopen.2020.22787.
PubMed 33107921
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Analgesic Response to Acupuncture: A Randomized, Placebo-Controlled, Subject and Assessor Blinded, 100-Subject Clinical Trial of Electro-Acupuncture in the Treatment of Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT02890810
- Acronym / sponsor ID
- 34754
- Conditions
- Chronic Low Back Pain, Back Pain
- Keywords
- Acupuncture, Back Pain, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Jul 2016 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 7 Sep 2016 (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.
In this placebo controlled, patient and assessor blinded clinical trial, the investigators will administer electroacupuncture vs sham electroacupuncture to patients suffering from chronic low back pain, and monitor their symptoms as well as collecting objective outcome measures. The investigators objective is to identify predictors of pain reduction and functional improvement with electroacupuncture vs placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verum Electroacupuncture | Experimental | Other: Real Acupuncture with Electrical StimulationActive Intervention |
| Placebo Electroacupuncture | Placebo comparator | Other: Simulated Acupuncture with Electrical StimulationValidated Control |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 21-65
- English Fluency
- Chronic LBP for ≥ 6 Months
- Average pain over the last month ≥ 5/10
Key exclusion criteria (15 listed)
- Radicular low back pain: defined as sharp (or burning) pain, with a defined territory, radiating down the limb, beyond the knee. Radicular pain may be accompanied by sensory and motor deficit along 1 or more dermatomes. Radicular back pain may also be accompanied by MRI evidence of intervertebral disc protrusion and compression of spinal cord and/or nerve roots.
- Pending litigation or Worker's compensation related to the low back pain.
- Currently pregnant or planning to become pregnant (in next 6 months)
- American Society of Anesthesiologist (ASA) class III or above physical status. ASA class III is defined as "a patient with severe systemic disease." Examples would include poorly controlled diabetes, hypertension, COPD or morbid obesity (BMI ≥ 40).
- Mental health conditions or treatment for mental health problems that would interfere with study procedures, at the discretion of the study team. For example, psychosis, untreated major depression, ongoing substance abuse, suicidal ideation. These will be assessed by the MINI.
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 |
|---|---|---|
| Real Acupuncture with Electrical StimulationAlso: Verum Electroacupuncture, Traditional acupuncture needles, ITO® ES-130® electrical stimulatorAcupuncture is a therapy commonly used in East Asian countries, where the practitioner insert thin needles at specific body sites in order to relieve pain and illnesses. Recent studies found low frequency electricity applied through acupuncture needles can lead to profound pain relief by increasing endorphin levels in the central nervous system. Electroacupuncture will thus be used as the active intervention to treat chronic low back pain in this clinical study. | Other | Verum Electroacupuncture |
| Simulated Acupuncture with Electrical StimulationAlso: Sham Electroacupuncture / Placebo Electroacupuncture, Sterile Acupuncture Needles, ITO® ES-130® electrical stimulatorThis intervention serves as the placebo control of the active intervention. Sterile acupuncture needles and the ITO electrical stimulators will be used in this intervention. But special care will be taken to have this intervention mimic the real treatment yet remaining as physiologically inert as possible. | Other | Placebo Electroacupuncture |
Primary outcome
Mean back pain intensity by patient-report
Time frame: 7 days
Patient self-reported mean back pain intensity on 11 point (0-10) numerical rating scale (NRS).
Roland Morris Disability Questionnaire
Time frame: 1 day
Validated functional outcome measure in chronic low back pain with 24 yes/no questions regarding physical function.
8 secondary outcomes
Quantitative Sensory Testing
Time frame: Tests used are typically stable for 1-2 weeks
Physical exam to determine neurological function
Time frame: 1 month
Physical exam to assess lumbar facet irritation.
Time frame: 1 month
Physical exam to assess lumbar spine range of motion
Time frame: 1 month
Blood pressure
Time frame: 1 day
Heart Rate Variability
Time frame: 1 month
Heart Rate Variability
Time frame: 1 month
Heart Rate Variability
Time frame: 1 month
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 25 Jan 2021.
- Background: PubMed 33107921Kong JT, Puetz C, Tian L, Haynes I, Lee E, Stafford RS, Manber R, Mackey S. Effect of Electroacupuncture vs Sham Treatment on Change in Pain Severity Among Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Netw Open. 2020 Oct 1;3(10):e2022787. doi: 10.1001/jamanetworkopen.2020.22787.
- Our study was featured by New York TimesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real Acupuncture with Electrical Stimulation and Simulated Acupuncture with Electrical Stimulation in people with Chronic Low Back Pain and Back Pain, run by Stanford University 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 6 inclusion and 15 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 25 Jan 2021. 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. Some participants in this study may receive a placebo. 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?
Mean back pain intensity by patient-report (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02890810, which also lists 1 linked publication.
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 25 Jan 2021.