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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TENS | Device | An electrical impulse is delivered to the skin around the painful area using pads attached to an electric generator. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain severity | Pain severity graded on a verbal numeric pain scales from none (0) to most (10) | 30 minutes after application of TENS unit |
| Measure | Description | Time Frame |
|---|---|---|
| Use of rescue medications | The percentage of patients that were administered an additional analgesic medication after the application of TENS | 30 minutes after application of the TENS unit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adam Singer, MD | Stony Brook University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stony Brook University Hospital | Stony Brook | New York | 11794 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40202296 | Derived | 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. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 8, 2024 | Dec 3, 2024 | 5 |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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| SHAM TENS | Device | A TENS generator without batteries is used. The pads are attached to the generator and to the skin around the painful area. |
|
| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |