Transcutaneous Electrical Nerve Stimulation (TENS) and Chronic Low-Back Pain: A Randomized Crossover Trial

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Low back pain is a significant public health problem, is very prevalent, and is often characterized by the persistence of symptoms. Unfortunately, substantial improvements in people with chronic low back pain are rare, causing most people to live with the pain. People with chronic low back pain may have an exaggerated pain response to nociceptive input into tissues that may also cause symptoms distant from the site of the primary symptoms. Historically, these symptoms were thought to be related to pathoanatomic changes to the muscles, ligaments, or joints. However, the severity of these structural changes weakly correlates with the clinical presentation and, in most cases, is not directly related to diagnostic image findings. Patients with chronic musculoskeletal pain, in general, show signs of local/central sensitization. The central sensitization may appear to be directly correlated with the intensity and duration of pain. Therefore, it is essential to reduce pain intensity and minimize the duration of pain to prevent this from happening. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• people who have experienced back pain for at least 3 months

• 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

Locations
United States
Connecticut
University of Hartford
RECRUITING
West Hartford
Contact Information
Primary
Richard E Liebano, PhD
liebano@hartford.edu
860.768.5181
Backup
Richard E Liebano, PhD
liebano@hartford.edu
8608105563
Time Frame
Start Date: 2023-11-15
Estimated Completion Date: 2025-07
Participants
Target number of participants: 34
Treatments
Experimental: Active TENS
Active TENS: 100 Hz, 200 μs at maximal tolerable intensity
Placebo_comparator: Placebo TENS
Placebo TENS: 100 Hz, 200 μs on for 45 seconds and then ramps off.
No_intervention: No TENS
Participants will wear a TENS unit that will be turned off to blind the outcome assessor
Related Therapeutic Areas
Sponsors
Leads: University of Hartford

This content was sourced from clinicaltrials.gov

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