Recruiting

TENS & Low Back Pain

Sponsor:

University of Hartford

Code:

NCT05812885

Conditions

Chronic Low-back Pain

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

TENS

Study Details

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.

Conditions

Chronic Low-back Pain

Study ID

NCT05812885

Start date

Nov 15, 2023

Status verified date

Dec, 2024

Completion date

Jul, 2025

Anticipated

Primary completion date

May, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

34 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Interventions

TENS

Active TENS

Primary outcome measure

  • Pain at Rest [ Time Frame: 3 weeks ]
  • Pain With Movement [ Time Frame: 3 weeks ]

Central Contacts and Locations

Central contacts

Richard E Liebano, PhD

860.768.5181liebano@hartford.edu

Richard E Liebano, PhD

8608105563liebano@hartford.edu

Locations

University of Hartford

Recruiting

West Hartford, Connecticut, United States, 06117

More Information

Sponsor

University of Hartford

Last update posted

Dec 4, 2024

Last verified

Dec, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Hartford on 2024-12-04.