TENS for Back Pain Emergency Department

Stony Brook University

Status: Completed

Conditions: Back Pain

Treatments: Device: TENS; Device: SHAM TENS

Study type: Interventional

Funder types: Other

Identifiers

NCT04227067

IRB2019-00435

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• Pregnant patients
• Minors
• Prisoners
• Neurological deficits

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups

TENS

Active Comparator group

Description:

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.

Treatment:

Device: TENS

SHAM TENS

Sham Comparator group

Description:

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.

Treatment:

Device: SHAM TENS