Low Back PainNCT02611583
TENS Treatment Plus Ibuprofen for the Treatment of Acute Back Pain in the ED
A study testing TENS in people with Low Back Pain, run by Albert Einstein Healthcare Network at 1 site in United States.
Trial summary
Patients presenting to the ED with a chief complaint of acute low back pain and whom the providing physician feels symptomatic treatment is appropriate in the ED will be screened for inclusion in the study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low 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
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2016to 24 Jun 2016
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Albert Einstein Healthcare Network
Philadelphia, Pennsylvania, 19141
About this study
Official title: 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
Patients presenting to the ED with a chief complaint of acute low back pain and whom the providing physician feels symptomatic treatment is appropriate in the ED will be screened for inclusion in the study. The purpose of the study is to compare Transcutaneous Electrical Nerve Stimulation (TENS) as an adjunct to ibuprofen in the treatment of acute low back pain in the emergency department. Therefore, the aim of this prospective, randomized, double blind study is to evaluate the efficacy of ED administered TENS in acute low back pain patients during their ED visit.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- TENS
- Keywords
- TENS
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENSDevice
Transcutaneous Electrical Nerve Stimulation
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen and TENS plus | Active comparator | Patients will receive 45 minutes of TENS therapy. All patients will receive ibuprofen. Receives: Device: TENS |
| Ibuprofen and Sham TENS plus | Placebo comparator | Patients will receive 45 minutes of sham TENS therapy. All patients will receive ibuprofen. Receives: Device: TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in visual analog scale (VAS)
Patients will have a baseline and 45 minutes VAS performed
Measured: 0 minutes, 45 minutes
Secondary outcomes (2)
Treatment failure
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
Measured: 45 minutes
Adverse events
Any reactions to TENS application
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2015 (estimated)
- Study start24 Jun 2016
- Primary completion24 Jun 2016
- Study completion24 Jun 2016
Why it stopped: Never initiated due to lack of funding and IRB Approval
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Low 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein Healthcare Network
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Dominici, Albert Einstein Healthcare Network
- Investigators
- Paul G Dominici, MD, Principal investigator, Albert Einstein Healthcare Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02611583
- Sponsor's protocol ID
- HN4810
- Status last verified
- Mar 2017
- First submitted
- 19 Nov 2015
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 6219588Patrick 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.
PubMed 24994051Thorsteinsson 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.
PubMed 353652Marchand 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.
PubMed 8378107Bertalanffy 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.
PubMed 15995091
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02611583
- Acronym / sponsor ID
- HN4810
- Conditions
- Low Back Pain
- Keywords
- TENS
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Never initiated due to lack of funding and IRB Approval
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Albert Einstein Healthcare NetworkUniversity, hospital or other
- Study start
- 24 Jun 2016 (actual)
- Primary completion
- 24 Jun 2016 (actual)
- Study completion
- 24 Jun 2016 (actual)
- First posted
- 23 Nov 2015 (estimated)
- 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.
Patients presenting to the ED with a chief complaint of acute low back pain and whom the providing physician feels symptomatic treatment is appropriate in the ED will be screened for inclusion in the study. The purpose of the study is to compare Transcutaneous Electrical Nerve Stimulation (TENS) as an adjunct to ibuprofen in the treatment of acute low back pain in the emergency department. Therefore, the aim of this prospective, randomized, double blind study is to evaluate the efficacy of ED administered TENS in acute low back pain patients during their ED visit.
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 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 |
|---|---|---|
| Ibuprofen and TENS plus | Active comparator | Device: TENSPatients will receive 45 minutes of TENS therapy. All patients will receive ibuprofen. |
| Ibuprofen and Sham TENS plus | Placebo comparator | Device: TENSPatients will receive 45 minutes of sham TENS therapy. All patients will receive ibuprofen. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
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 |
|---|---|---|
| TENSTranscutaneous Electrical Nerve Stimulation | Device | Ibuprofen and Sham TENS plus, Ibuprofen and TENS plus |
Primary outcome
Change in visual analog scale (VAS)
Time frame: 0 minutes, 45 minutes
Patients will have a baseline and 45 minutes VAS performed
2 secondary outcomes
Treatment failure
Time frame: 45 minutes
Adverse events
Time frame: 60 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
- Background: PubMed 6219588Cypress 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.
- Background: PubMed 24994051Patrick 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.
- Background: PubMed 353652Thorsteinsson 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.
- Background: PubMed 8378107Marchand 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.
- Background: PubMed 15995091Bertalanffy 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.
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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.
Paul G Dominici, MD principal investigator
Albert Einstein Healthcare Network
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 Low Back Pain, run by Albert Einstein Healthcare Network 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 14 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: withdrawn, as of the sponsor's last update on 10 May 2017. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in visual analog scale (VAS) (time frame: 0 minutes, 45 minutes). 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 NCT02611583, which also lists 5 linked publications.
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 10 May 2017.