Transcutaneous Electrical Nerve Stimulation (TENS) and Low Back Pain
NCT ID: NCT05812885
Last Updated: 2024-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
34 participants
INTERVENTIONAL
2023-11-15
2025-07-31
Brief Summary
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Pain relief for chronic low back pain patients should be aimed at treatments that reduce central excitability and increase central inhibition. Research into chronic low back pain treatment has demonstrated strong evidence that different types of exercise decrease pain and improve quality of life. However, exercise itself may be painful, preventing a person from exercising. Thus, treatments aimed at decreasing pain will improve a person's ability to exercise and participate in activities of daily living.
One treatment aimed at reducing central excitability and increasing central inhibition is transcutaneous electrical nerve stimulation (TENS). TENS is a "non-pharmacological" treatment for pain that is inexpensive, safe, and easy to use. Prior studies show that TENS utilizes opioid receptors both spinally and supraspinally to inhibit nociceptive dorsal horn neurons, reduce excitatory neurotransmitter release, and reduce hyperalgesia. Thus, TENS may be particularly useful in people with chronic low back pain because it can activate descending inhibitory pathways (reduced in chronic low back pain patients) and inhibit central excitability (increased in chronic low back pain patients).
Previous studies that have investigated the effects of TENS on pain in low back pain patients have failed to use proper intensities of current, and the assessment of pain was not performed during the peak of the analgesic response. Previous studies show inadequate intensities do not reduce pain or increase pressure pain thresholds. Further, TENS typically does not affect resting pain, while changes in pressure pain thresholds and pain with movement are reduced. Thus, the current study proposes to assess the effects of TENS on measures of pain, function, and descending inhibition using the maximal tolerable intensity of TENS applied to a large area of the trunk.
Detailed Description
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The following tools will be used to measure pain (Numeric Rating Scale), central excitability (pressure pain thresholds, temporal summation and CPM) and function (sit-to-stand test and repeated trunk flexion).
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Active TENS
Active TENS: 100 Hz, 200 μs at maximal tolerable intensity
TENS
Active TENS
Placebo TENS
Placebo TENS: 100 Hz, 200 μs on for 45 seconds and then ramps off.
TENS
Active TENS
No TENS
Participants will wear a TENS unit that will be turned off to blind the outcome assessor
No interventions assigned to this group
Interventions
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TENS
Active TENS
Eligibility Criteria
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Inclusion Criteria
* and have reported a minimal pain level of 3 on the 0-10 Pain Numerical Rating Scale (NRS)
* age from 18-60
* TENS naive or have not used TENS for 5 years.
* Both men and women may participate in the study
Exclusion Criteria
* nerve root disorders confirmed by neurological tests;
* neurological diseases
* severe cardiorespiratory disease
* pregnancy
* skin infection or lesions or change in sensation at the TENS application site
* cancer
* cardiac pacemaker
* allergy to electrodes
* use of opioids.
18 Years
60 Years
ALL
No
Sponsors
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University of Hartford
OTHER
Responsible Party
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Richard Liebano
Associate Professor
Principal Investigators
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Richard E Liebano, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Hartford
Locations
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University of Hartford
West Hartford, Connecticut, United States
Countries
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Central Contacts
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Facility Contacts
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Richard Liebano
Role: primary
References
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Liebano RE, Sluka KA, Roy J, Savinelli M, Dailey DL, Riley SP. Effects of transcutaneous electrical nerve stimulation on pain, function, and descending inhibition in people with non-specific chronic low-back pain: a study protocol for a randomized crossover trial. Trials. 2024 Apr 6;25(1):242. doi: 10.1186/s13063-024-08089-7.
Other Identifiers
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23-03-187
Identifier Type: -
Identifier Source: org_study_id