NCT02611583

Brief 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. 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 23, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

June 24, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2016

Completed
Last Updated

May 10, 2017

Status Verified

March 1, 2017

Enrollment Period

Same day

First QC Date

November 19, 2015

Last Update Submit

May 8, 2017

Conditions

Low Back Pain

Keywords

TENS

Outcome Measures

Primary Outcomes (1)

  • Change in visual analog scale (VAS)

    Patients will have a baseline and 45 minutes VAS performed

    0 minutes, 45 minutes

Secondary Outcomes (2)

  • Treatment failure

    45 minutes

  • Adverse events

    60 minutes

Study Arms (2)

Ibuprofen and TENS plus

ACTIVE COMPARATOR

Patients will receive 45 minutes of TENS therapy. All patients will receive ibuprofen.

Device: TENS

Ibuprofen and Sham TENS plus

PLACEBO COMPARATOR

Patients will receive 45 minutes of sham TENS therapy. All patients will receive ibuprofen.

Device: TENS

Interventions

TENSDEVICE

Transcutaneous Electrical Nerve Stimulation

Ibuprofen and Sham TENS plusIbuprofen and TENS plus

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Albert Einstein Healthcare Network

Philadelphia, Pennsylvania, 19141, United States

Location

Related Publications (5)

  • 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.

    PMID: 6219588BACKGROUND

  • 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.

    PMID: 24994051BACKGROUND

  • 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.

    PMID: 353652BACKGROUND

  • 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.

    PMID: 8378107BACKGROUND

  • 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.

    PMID: 15995091BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Officials

  • Paul G Dominici, MD

    Albert Einstein Healthcare Network

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 19, 2015

First Posted

November 23, 2015

Study Start

June 24, 2016

Primary Completion

June 24, 2016

Study Completion

June 24, 2016

Last Updated

May 10, 2017

Record last verified: 2017-03

Locations

US(1)