Transcutaneous Electrical Nerve Stimulation (TENS) and Low Back Pain

NCT05812885 | Recruiting FDA Device

• 1 other identifier: 23-03-187
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  3 weeks

Secondary Outcomes (6)

• Sit-to-Stand Test

  3 weeks

• Repeated trunk flexion

  3 weeks

• Pressure Pain Threshold (PPT)

  3 weeks

• Heat Pain Threshold (HPT)

  3 weeks

• Temporal Summation

  3 weeks

Study Arms (3)

Active TENS

EXPERIMENTAL

Active TENS: 100 Hz, 200 μs at maximal tolerable intensity

Device: TENS

Placebo TENS

PLACEBO COMPARATOR

Placebo TENS: 100 Hz, 200 μs on for 45 seconds and then ramps off.

Device: TENS

No TENS

NO INTERVENTION

Participants will wear a TENS unit that will be turned off to blind the outcome assessor

Interventions

TENS DEVICE

Active TENS

Active TENS; Placebo TENS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Hartford: lead

Study Sites (1)

University of Hartford

West Hartford, Connecticut, 06117, United States

RECRUITING

Related Publications (1)

• Liebano RE, Sluka KA, Roy J, Savinelli M, Dailey DL, Riley SP. Effects of transcutaneous electrical nerve stimulation on pain, function, and descending inhibition in people with non-specific chronic low-back pain: a study protocol for a randomized crossover trial. Trials. 2024 Apr 6;25(1):242. doi: 10.1186/s13063-024-08089-7.

  PMID: 38582874 DERIVED

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Richard E Liebano, PhD

  University of Hartford

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard E Liebano, PhD

CONTACT

860.768.5181; liebano@hartford.edu

Richard E Liebano, PhD

CONTACT

8608105563; liebano@hartford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Crossover Assignment

Study Record Dates

• First Submitted: March 31, 2023
• First Posted: April 14, 2023
• Study Start: November 15, 2023
• Primary Completion: May 1, 2025
• Study Completion: July 1, 2025
• Last Updated: December 4, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)