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Transcutaneous Electrical Nerve Stimulation (TENS) and Low Back Pain (TENS and LBP)

Primary Purpose

Chronic Low-back Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TENS
Sponsored by
University of Hartford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low-back Pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Placebo Comparator

    No Intervention

    Arm Label

    Active TENS

    Placebo TENS

    No TENS

    Arm Description

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

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

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

    Outcomes

    Primary Outcome Measures

    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).
    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).

    Secondary Outcome Measures

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

    Full Information

    First Posted
    March 31, 2023
    Last Updated
    May 22, 2023
    Sponsor
    University of Hartford
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05812885
    Brief Title
    Transcutaneous Electrical Nerve Stimulation (TENS) and Low Back Pain
    Acronym
    TENS and LBP
    Official Title
    Transcutaneous Electrical Nerve Stimulation (TENS) and Chronic Low-Back Pain: A Randomized Crossover Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2023 (Anticipated)
    Primary Completion Date
    August 2024 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Hartford

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    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 are 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 images 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, and the pain may prevent 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 for its ability to activate descending inhibitory pathways (reduced in chronic low back pain patients) and to 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 that 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.
    Detailed 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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Low-back Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    Crossover Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    34 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Active TENS
    Arm Type
    Experimental
    Arm Description
    Active TENS: 100 Hz, 200 μs at maximal tolerable intensity
    Arm Title
    Placebo TENS
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo TENS: 100 Hz, 200 μs on for 45 seconds and then ramps off.
    Arm Title
    No TENS
    Arm Type
    No Intervention
    Arm Description
    Participants will wear a TENS unit that will be turned off to blind the outcome assessor
    Intervention Type
    Device
    Intervention Name(s)
    TENS
    Intervention Description
    Active TENS
    Primary Outcome Measure Information:
    Title
    Pain at Rest
    Description
    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).
    Time Frame
    3 weeks
    Title
    Pain With Movement
    Description
    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).
    Time Frame
    3 weeks
    Secondary Outcome Measure Information:
    Title
    Sit-to-Stand Test
    Description
    Five sit-to-stand repetitions will be completed in two trials with an average of two trials for scoring
    Time Frame
    3 weeks
    Title
    Repeated trunk flexion
    Description
    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
    Time Frame
    3 weeks
    Title
    Pressure Pain Threshold (PPT)
    Description
    A digital pressure algometer will measure the pain threshold to deep mechanical stimuli.
    Time Frame
    3 weeks
    Title
    Heat Pain Threshold (HPT)
    Description
    Superficial heat pain sensitivity will be assessed using a handheld thermode.
    Time Frame
    3 weeks
    Title
    Temporal Summation
    Description
    Temporal summation will be induced by a pressure algometer
    Time Frame
    3 weeks
    Title
    Conditioned pain modulation
    Description
    A cold pressor test will be used to assess the activation of the conditioned pain modulation.
    Time Frame
    3 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Richard E Liebano, PhD
    Phone
    860.768.5181
    Email
    liebano@hartford.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Transcutaneous Electrical Nerve Stimulation (TENS) and Low Back Pain

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