Ignite Creation Date:
2024-05-06 @ 6:52 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05812885
Status:
RECRUITING
Last Update Posted:
2023-11-30
First Post:
2023-03-31
Brief Title:
Transcutaneous Electrical Nerve Stimulation TENS and Low Back Pain
Sponsor:
University of Hartford
Organization:
University of Hartford
Study Overview
Official Title:
Transcutaneous Electrical Nerve Stimulation TENS and Chronic Low-Back Pain A Randomized Crossover Trial
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TENS and LBP
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 localcentral 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 persons 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
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 persons 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None