Back PainNCT04227067
TENS for Back Pain Emergency Department
A study testing TENS in people with Back Pain, run by Stony Brook University at 1 site in United States.
Trial summary
In this study we will see if application of TENS for a period of 30 minutes in addition to ibuprofen reduces the pain of emergency department patients with back pain compared with ibuprofen and a sham TENS unit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Back Pain
- What is being tested?
- TENS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2020to 12 Feb 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults age 18 years or greater
- Able to consent
- Back pain of less than 2 weeks duration
- Pain severity of at least 5/10 on a verbal numeric scale from 0 (none) to 10 (worst)
Who cannot join
- Pregnant patients
- Minors
- Prisoners
- Neurological deficits
Trial locations and contacts
1 site in 1 country.
United States1 site
Stony Brook University Hospital
Stony Brook, New York, 11794
About this study
Official title: The Use of TENS for the Treatment of Back Pain in the Emergency Department
In this study we will see if application of TENS for a period of 30 minutes in addition to ibuprofen reduces the pain of emergency department patients with back pain compared with ibuprofen and a sham TENS unit.
Read the detailed description
Adult patients presenting to the emergency department with moderate to severe back pain of relatively short duration without neurological deficits will be eligible for inclusion in the study. After signing informed consent the patients will rate their pain severity and receive a 400 mg dose of ibuprofen and then randomly be assigned to either TENS or sham TENS for 30 minutes. At the end of the study period patients will again be asked to rate their pain severity and indicate whether their pain got better or worse. We will also ask them to try and guess which treatment they received and whether they require any medications for their pain.
- Conditions
- Back Pain
- Being tested
- TENS, SHAM TENS
- Keywords
- TENS, back pain, ibuprofen
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENSDevice
An electrical impulse is delivered to the skin around the painful area using pads attached to an electric generator.
SHAM TENSDevice
A TENS generator without batteries is used. The pads are attached to the generator and to the skin around the painful area.
| Study group | Role | What they receive |
|---|---|---|
| TENS | Active comparator | A TENS device consists of an electric pulse generator and pads that are attached to the skin on around the area of maximal pain. We will use the conventional mode, which provides nerve stimulation with a pulse width of 60 microseconds and a pulse rate of 60 pulses per second. The channel intensity will be gradually increased until the intensity is noticeable but not painful. Receives: Device: TENS |
| SHAM TENS | Sham comparator | In the SHAM TENS group the TENS pads will be attached to the pulse generator and the patients skin around the painful area. The investigator will turn the knobs on but the batteries will be removed from the device. Receives: Device: SHAM TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain severity
Pain severity graded on a verbal numeric pain scales from none (0) to most (10)
Measured: 30 minutes after application of TENS unit
Secondary outcomes (1)
Use of rescue medications
The percentage of patients that were administered an additional analgesic medication after the application of TENS
Measured: 30 minutes after application of the TENS unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start20 Jan 2020
- Primary completion12 Feb 2024
- Study completion12 Feb 2024
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 Back 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Singer, Stony Brook University
- Investigators
- Adam Singer, MD, Principal investigator, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04227067
- Sponsor's protocol ID
- IRB2019-00435
- Status last verified
- Feb 2024
- First submitted
- 10 Jan 2020
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Otterness K, McMahon B, Ma M, Thode HC Jr, Singer AJ. The use of TENS for the treatment of back pain in the emergency department: A randomized controlled trial. Acad Emerg Med. 2025 Aug;32(8):828-835. doi: 10.1111/acem.70013. Epub 2025 Apr 9.
PubMed 40202296
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of TENS for the Treatment of Back Pain in the Emergency Department
- ClinicalTrials.gov ID
- NCT04227067
- Acronym / sponsor ID
- IRB2019-00435
- Conditions
- Back Pain
- Keywords
- TENS, back pain, ibuprofen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 12 Feb 2024 (actual)
- Study completion
- 12 Feb 2024 (actual)
- First posted
- 13 Jan 2020 (actual)
- 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 study we will see if application of TENS for a period of 30 minutes in addition to ibuprofen reduces the pain of emergency department patients with back pain compared with ibuprofen and a sham TENS unit.
Detailed description
Adult patients presenting to the emergency department with moderate to severe back pain of relatively short duration without neurological deficits will be eligible for inclusion in the study. After signing informed consent the patients will rate their pain severity and receive a 400 mg dose of ibuprofen and then randomly be assigned to either TENS or sham TENS for 30 minutes. At the end of the study period patients will again be asked to rate their pain severity and indicate whether their pain got better or worse. We will also ask them to try and guess which treatment they received and whether they require any medications for their pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TENS | Active comparator | Device: TENSA TENS device consists of an electric pulse generator and pads that are attached to the skin on around the area of maximal pain. We will use the conventional mode, which provides nerve stimulation with a pulse width of 60 microseconds and a pulse rate of 60 pulses per second. The channel intensity will be gradually increased until the intensity is noticeable but not painful. |
| SHAM TENS | Sham comparator | Device: SHAM TENSIn the SHAM TENS group the TENS pads will be attached to the pulse generator and the patients skin around the painful area. The investigator will turn the knobs on but the batteries will be removed from the device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults age 18 years or greater
- Able to consent
- Back pain of less than 2 weeks duration
- Pain severity of at least 5/10 on a verbal numeric scale from 0 (none) to 10 (worst)
Key exclusion criteria (4 listed)
- Pregnant patients
- Minors
- Prisoners
- Neurological deficits
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 |
|---|---|---|
| TENSAn electrical impulse is delivered to the skin around the painful area using pads attached to an electric generator. | Device | TENS |
| SHAM TENSA TENS generator without batteries is used. The pads are attached to the generator and to the skin around the painful area. | Device | SHAM TENS |
Primary outcome
Pain severity
Time frame: 30 minutes after application of TENS unit
Pain severity graded on a verbal numeric pain scales from none (0) to most (10)
1 secondary outcome
Use of rescue medications
Time frame: 30 minutes after application of the TENS unit
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 13 Feb 2024.
- Derived from this study: PubMed 40202296Otterness K, McMahon B, Ma M, Thode HC Jr, Singer AJ. The use of TENS for the treatment of back pain in the emergency department: A randomized controlled trial. Acad Emerg Med. 2025 Aug;32(8):828-835. doi: 10.1111/acem.70013. Epub 2025 Apr 9.
- Individual participant dataSharing planned: Undecided
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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.
Adam Singer, MD principal investigator
Stony Brook 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 TENS in people with Back Pain, run by Stony Brook 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 4 inclusion and 4 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 13 Feb 2024. 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?
Pain severity (time frame: 30 minutes after application of TENS unit). 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 NCT04227067, 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 13 Feb 2024.