Transcutaneous Electrical Nerve Stimulation (TENS) and Low Back Pain

Chronic Low-back Pain Clinical Trial

— TENS and LBP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05812885
• Other study ID #: 23-03-187
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: University of Hartford
• Contact: Richard E Liebano, PhD
• Phone: 860.768.5181
• Email: liebano[@]hartford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: December 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain

Intervention

Device:
• TENS
Active TENS

Locations

Country	Name	City	State
United States	University of Hartford	West Hartford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
University of Hartford

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Sit-to-Stand Test	Five sit-to-stand repetitions will be completed in two trials with an average of two trials for scoring	3 weeks
Secondary	Repeated trunk flexion	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 weeks
Secondary	Pressure Pain Threshold (PPT)	A digital pressure algometer will measure the pain threshold to deep mechanical stimuli.	3 weeks
Secondary	Heat Pain Threshold (HPT)	Superficial heat pain sensitivity will be assessed using a handheld thermode.	3 weeks
Secondary	Temporal Summation	Temporal summation will be induced by a pressure algometer	3 weeks
Secondary	Conditioned pain modulation	A cold pressor test will be used to assess the activation of the conditioned pain modulation.	3 weeks