NCT05812885 Transcutaneous Electrical Nerve Stimulation (TENS) and Low Back Pain
| NCT ID | NCT05812885 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Hartford |
| Condition | Chronic Low-back Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 34 participants |
| Start Date | 2023-11-15 |
| Primary Completion | 2025-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 34 participants in total. It began in 2023-11-15 with a primary completion date of 2025-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Serious spinal disorders, such as fractures, tumors, or inflammatory arthritis disease * 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.
Contact & Investigator
Richard E Liebano, PhD
PRINCIPAL INVESTIGATOR
University of Hartford
Frequently Asked Questions
Who can join the NCT05812885 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Chronic Low-back Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05812885 currently recruiting?
Yes, NCT05812885 is actively recruiting participants. Contact the research team at liebano@hartford.edu for enrollment information.
Where is the NCT05812885 trial being conducted?
This trial is being conducted at West Hartford, United States.
Who is sponsoring the NCT05812885 clinical trial?
NCT05812885 is sponsored by University of Hartford. The principal investigator is Richard E Liebano, PhD at University of Hartford. The trial plans to enroll 34 participants.