An interventional study of TENS in Chronic Low-back Pain, sponsored by University of Hartford. Recruiting at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-12-04.
Sponsored by University of Hartford · Not applicable, Interventional, and Treatment
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.
The study will be a simple crossover design with the following three treatments (1) active TENS, (2) placebo TENS or (3) no treatment control randomly assigned. Each subject will receive all 3 interventions in random order.
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).
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's planned enrollment of 34 is below the median of 60 across 1,941 interventional studies indexed under Back Pain.
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Exclusion Criteria:
Active TENS: 100 Hz, 200 μs at maximal tolerable intensity
Device: TENS
Placebo TENS: 100 Hz, 200 μs on for 45 seconds and then ramps off.
Device: TENS
Participants will wear a TENS unit that will be turned off to blind the outcome assessor
Active TENS
Pain at Rest
Pain at Rest Difference Score Pre-intervention and Post Intervention measured by the Numeric Pain Rating Scale. It starts with the absence of pain (0) and reaches the worst pain imaginable (10).
Time frame: 3 weeks
Pain With Movement
Pain With Movement Difference Score Pre-intervention and Post Intervention measured by the Numeric Pain Rating Scale. It starts with the absence of pain (0) and reaches the worst pain imaginable (10).
Time frame: 3 weeks
Sit-to-Stand Test
Five sit-to-stand repetitions will be completed in two trials with an average of two trials for scoring
Time frame: 3 weeks
Repeated trunk flexion
From a neutral standing position, the subject will be required to flex to the limit of the range and return to the upright position as fast as tolerable.This activity will be repeated 10 times, and the total procedure will be timed with a stopwatch
Time frame: 3 weeks
Pressure Pain Threshold (PPT)
A digital pressure algometer will measure the pain threshold to deep mechanical stimuli.
Time frame: 3 weeks
Heat Pain Threshold (HPT)
Superficial heat pain sensitivity will be assessed using a handheld thermode.
Time frame: 3 weeks
Temporal Summation
Temporal summation will be induced by a pressure algometer
Time frame: 3 weeks
Conditioned pain modulation
A cold pressor test will be used to assess the activation of the conditioned pain modulation.
Time frame: 3 weeks
Plan to share: No
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