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NCT Number: NCT05812885

Transcutaneous Electrical Nerve Stimulation (TENS) and Low Back Pain

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Hartford

West Hartford, Connecticut, 06117, United States

Location status: Recruiting

Location contact

Richard Liebano

CONTACT

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TENS

Device

Active TENS

Primary outcomes

  1. Pain at Rest

    Time frame: 3 weeks

    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).

  2. Pain With Movement

    Time frame: 3 weeks

    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).

Secondary outcomes

  1. Sit-to-Stand Test

    Time frame: 3 weeks

    Five sit-to-stand repetitions will be completed in two trials with an average of two trials for scoring

  2. Repeated trunk flexion

    Time frame: 3 weeks

    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

  3. Pressure Pain Threshold (PPT)

    Time frame: 3 weeks

    A digital pressure algometer will measure the pain threshold to deep mechanical stimuli.

  4. Heat Pain Threshold (HPT)

    Time frame: 3 weeks

    Superficial heat pain sensitivity will be assessed using a handheld thermode.

  5. Temporal Summation

    Time frame: 3 weeks

    Temporal summation will be induced by a pressure algometer

  6. Conditioned pain modulation

    Time frame: 3 weeks

    A cold pressor test will be used to assess the activation of the conditioned pain modulation.

Study contacts

Contact information is provided by the study sponsor or research team.

Richard E Liebano, PhD

CONTACT

[email protected]

860.768.5181

Richard E Liebano, PhD

CONTACT

[email protected]

8608105563

Sponsors and collaborators

Lead sponsor

University of Hartford

Other

Registry information

Official study title

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

Acronym: TENS and LBP

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 14, 2023
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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