NCT05812885 · University of Hartford
Transcutaneous Electrical Nerve Stimulation (TENS) and Low Back Pain
(TENS and LBP)
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- skin infection or lesions or change in sensation at the TENS application site
- cardiac pacemaker
- allergy to electrodes
- use of opioids.
Where
- West Hartford, Connecticut
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 4, 2024 · Source of record for eligibility and locations