- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02611583
TENS Treatment Plus Ibuprofen for the Treatment of Acute Back Pain in the ED
Double-blind, Randomized, Placebo Controlled Trial of Transcutaneous Electrical Nerve Stimulation (TENS) Treatment Plus Ibuprofen for the Treatment of Acute Back Pain in the Emergency Department
Study Overview
Detailed Description
The study is a double blind, randomized, placebo controlled trial. One group will receive ibuprofen and TENS. The comparison group will receive ibuprofen and sham TENS. The study primary endpoint is change in pain level on Visual Analog Scale score at 45-60 minutes after TENS start.
This is a two-arm, double blind, randomized control trial evaluating the patient perceived improvement in back pain. Patients will first fill out a Visual Analog Scale (VAS).
Patients will be randomized to one of two arms. Ibuprofen 800 mg, plus sham TENS for 45 minutes Ibuprofen 800 mg, plus TENS for 45 minutes
Patients will be given a 2nd VAS scale up to 15 minutes after the end of the TENS session. After the second VAS the patients will be finished with the study procedures and can be continued to be cared as per the discretion of their treating physician.
Our intention is to detect a 20% reduction in pain by VAS with a common standard deviation equal to the difference at the p = 0.05 level with a power of 80% using an analysis of variance (ANOVA). The calculated sample size required 28 patients per group. Considering the uncertain dropout rate, the investigators decided to enroll at least 66 patients. Baseline characteristics will be calculated to determine if groups are equal. A two-way repeated-measures ANOVA will be used to test both a trial effect and a group effect (SPSS 20, SPSS Inc., Chicago, IL). Data will be presented as means with standard deviations with 95% confidence intervals. A p< 0.05 was considered statistically significant.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19141
- Albert Einstein Healthcare Network
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients 18 years to 65 years of age presenting to the emergency room with a primary complaint of low back pain.
- Patient is receiving 800mg dose of ibuprofen as part of their treatment regimen for back pain
- Back pain new in the last 48 hours
- Deemed by the treating physician to have musculoskeletal back pain, and no central/peripheral nervous system pathology as the cause of their pain.
Exclusion Criteria:
- Allergy to ibuprofen.
- Hypotension (MAP <65 or Systolic BP <100), fever, tachycardia
- Paresthesias, isolated motor weakness, or objective sensory deficit on physical exam
- Radicular symptoms
- Urinary incontinence or retention
- Bowel incontinence
- Unexplained weight loss of >15 lbs in the last 3 months.
- Multiple primary complaints in the ED.
- Received Analgesia other than Ibuprofen as part of their ED work up.
- Taken prescription strength pain medication within the last 12 hours for any condition.
- History of active malignancy, HIV, organ transplantation, active hemodialysis
- Currently pregnant
- Nursing home residents
- Currently in police custody
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Ibuprofen and TENS plus
Patients will receive 45 minutes of TENS therapy.
All patients will receive ibuprofen.
|
Transcutaneous Electrical Nerve Stimulation
|
Placebo Comparator: Ibuprofen and Sham TENS plus
Patients will receive 45 minutes of sham TENS therapy.
All patients will receive ibuprofen.
|
Transcutaneous Electrical Nerve Stimulation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in visual analog scale (VAS)
Time Frame: 0 minutes, 45 minutes
|
Patients will have a baseline and 45 minutes VAS performed
|
0 minutes, 45 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment failure
Time Frame: 45 minutes
|
Patients requiring rescue medication after 45 minute treatment will be considered treatment failures and will receive further non study related treatment at the discretion of the treating physician
|
45 minutes
|
Adverse events
Time Frame: 60 minutes
|
Any reactions to TENS application
|
60 minutes
|
Collaborators and Investigators
Investigators
- Principal Investigator: Paul G Dominici, MD, Albert Einstein Healthcare Network
Publications and helpful links
General Publications
- Marchand S, Charest J, Li J, Chenard JR, Lavignolle B, Laurencelle L. Is TENS purely a placebo effect? A controlled study on chronic low back pain. Pain. 1993 Jul;54(1):99-106. doi: 10.1016/0304-3959(93)90104-W.
- Patrick N, Emanski E, Knaub MA. Acute and chronic low back pain. Med Clin North Am. 2014 Jul;98(4):777-89, xii. doi: 10.1016/j.mcna.2014.03.005.
- Cypress BK. Characteristics of physician visits for back symptoms: a national perspective. Am J Public Health. 1983 Apr;73(4):389-95. doi: 10.2105/ajph.73.4.389.
- Thorsteinsson G, Stonnington HH, Stillwell KG, Elveback LR. The placebo effect of transcutaneous electrical stimulation. Pain. 1978 Jun;5(1):31-41. doi: 10.1016/0304-3959(78)90022-2.
- Bertalanffy A, Kober A, Bertalanffy P, Gustorff B, Gore O, Adel S, Hoerauf K. Transcutaneous electrical nerve stimulation reduces acute low back pain during emergency transport. Acad Emerg Med. 2005 Jul;12(7):607-11. doi: 10.1197/j.aem.2005.01.013.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HN4810
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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