Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06522893
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
Percutaneous Neuromodulation and Therapeutic Exercise in Patients With Nonspecific Chronic Neck Pain
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison of Percutaneous Neuromodulation and Therapeutic Exercise in Patients With Nonspecific Chronic Neck Pain A Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to compare the effects of applying percutaneous neuromodulation with performing only therapeutic exercise in patients with non-specific chronic neck pain
Detailed Description:
Neck pain is highly prevalent affecting 203 million people worldwide in 2020 and ranking eleventh in terms of years lived with disability More than 50 of individuals will not recover from an acute episode and will experience recurrent neck pain within 1 to 5 years leading to a persistent and chronic problem Chronic neck pain can originate from a traumatic episode such as whiplash or it may not have a traumatic origin In the latter case in the absence of an identifiable pathoanatomic cause it is classified as nonspecific chronic neck pain NSNP The GBD 2021 study acknowledges that the burden of neck pain has not been reduced in the past three decades and projects a significant increase in this absolute burden by 2050 Several studies have highlighted the urgency of prioritizing future research on preventing and treating this condition
Clinical practice guidelines for the management of NSNP advocate for the use of exercise Specifically it has been shown that specific neck exercises are more effective than other types of alternative exercises in reducing pain and disability in patients with NSNP In recent years treatment based on percutaneous neuromodulation PNM has gained popularity and has become an alternative to conventional treatment for soft tissue injuries noted for its low incidence of significant side effects PNM involves the percutaneous electrical stimulation of a peripheral nerve either along its pathway or in a muscle using a puncture needle that utilizes low or medium-frequency electrical currents Additionally the advent of ultrasound technology has provided new opportunities to improve the safety of this invasive approach
The primary goal of PNM is to relieve pain and restore the normal functioning of the nervous system reducing chronic and neuropathic pain associated with central sensitization and improving neuromuscular function and motor control Although the physiological mechanism explaining pain inhibition and the analgesic effect remains incomplete various hypotheses have been proposed to expand current knowledge Among the most cited models is the gate control theory which suggests that the electrical stimulation of large-diameter afferent nerve fibers inhibits pain transmission through small-diameter fibers to the central nervous system at the spinal cord level producing what is known as neuromodulation However few studies investigate the effects of PNM so more evidence is needed to draw solid conclusions
Clinical practice guidelines for the management of NSNP advocate for the use of exercise Specifically it has been shown that specific neck exercises are more effective than other types of alternative exercises in reducing pain and disability in patients with NSNP In recent years treatment based on percutaneous neuromodulation PNM has gained popularity and has become an alternative to conventional treatment for soft tissue injuries noted for its low incidence of significant side effects PNM involves the percutaneous electrical stimulation of a peripheral nerve either along its pathway or in a muscle using a puncture needle that utilizes low or medium-frequency electrical currents Additionally the advent of ultrasound technology has provided new opportunities to improve the safety of this invasive approach
The primary goal of PNM is to relieve pain and restore the normal functioning of the nervous system reducing chronic and neuropathic pain associated with central sensitization and improving neuromuscular function and motor control Although the physiological mechanism explaining pain inhibition and the analgesic effect remains incomplete various hypotheses have been proposed to expand current knowledge Among the most cited models is the gate control theory which suggests that the electrical stimulation of large-diameter afferent nerve fibers inhibits pain transmission through small-diameter fibers to the central nervous system at the spinal cord level producing what is known as neuromodulation However few studies investigate the effects of PNM so more evidence is needed to draw solid conclusions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None