Back to resultsTENS for Back Pain Emergency Department
Primary Purpose
Back Pain
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TENS
SHAM TENS
Sponsored by
About this trial
This is an interventional treatment trial for Back Pain focused on measuring TENS, back pain, ibuprofen
Eligibility Criteria
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
Sites / Locations
- Stony Brook University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
TENS
SHAM TENS
Arm 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.
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.
Outcomes
Primary Outcome Measures
Pain severity
Pain severity graded on a verbal numeric pain scales from none (0) to most (10)
Secondary Outcome Measures
Use of rescue medications
The percentage of patients that were administered an additional analgesic medication after the application of TENS
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04227067
Brief Title
TENS for Back Pain Emergency Department
Official Title
The Use of TENS for the Treatment of Back Pain in the Emergency Department
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 20, 2020 (Actual)
Primary Completion Date
January 30, 2023 (Anticipated)
Study Completion Date
January 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stony Brook University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain
Keywords
TENS, back pain, ibuprofen
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TENS
Arm Type
Active Comparator
Arm 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.
Arm Title
SHAM TENS
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
TENS
Intervention Description
An electrical impulse is delivered to the skin around the painful area using pads attached to an electric generator.
Intervention Type
Device
Intervention Name(s)
SHAM TENS
Intervention Description
A TENS generator without batteries is used. The pads are attached to the generator and to the skin around the painful area.
Primary Outcome Measure Information:
Title
Pain severity
Description
Pain severity graded on a verbal numeric pain scales from none (0) to most (10)
Time Frame
30 minutes after application of TENS unit
Secondary Outcome Measure Information:
Title
Use of rescue medications
Description
The percentage of patients that were administered an additional analgesic medication after the application of TENS
Time Frame
30 minutes after application of the TENS unit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adam J Singer, MD
Phone
6314447856
Email
adam.singer@stonybrook.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Singer, MD
Organizational Affiliation
Stony Brook University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stony Brook University Hospital
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam J Singer, MD
Phone
631-444-7856
Email
adam.singer@stonybrook.edu
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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TENS for Back Pain Emergency Department
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