Clinical trial NCT06522893: Percutaneous Neuromodulation and Therapeutic Exercise in Patients With Nonspecific Chronic Neck Pain
Official title: Comparison of Percutaneous Neuromodulation and Therapeutic Exercise in Patients With Nonspecific Chronic Neck Pain: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Neck Pain
Chronic Pain
Lead sponsor: Universidad de Almeria
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 70
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Male and female patients aged between 30 and 65 years with chronic cervical pain lasting 3 months or more and not receiving any other type of physiotherapy treatment.

Exclusion Criteria:

* Patients with sensory and/or coagulation disorders, history of spine surgery, cardiac complications, severe concurrent central or peripheral nervous system disease, epilepsy, needle phobia, disc pathology, or serious pathologies that may be the primary cause of chronic cervical pain (e.g., tumors, Arnold Chiari disease, vertigo syndrome, etc.) will be excluded, as they are contraindicated for transcutaneous electrical nerve stimulation (TENS).

Primary outcomes:
measure: Neck disability index
timeFrame: At baseline, at 6 weeks and at 2 months
Secondary outcomes:
measure: Pain (Visual Analog Scale)
timeFrame: At baseline, at 6 weeks and at 2 months
measure: McGill Pain Questionnaire
timeFrame: At baseline, at 6 weeks and at 2 months
measure: Quality of Life (SF-36 quality of life questionnaire)
timeFrame: At baseline, at 6 weeks and at 2 months
measure: Quality of Sleep (Pittsburgh Quality of Sleep Questionnaire Index)
timeFrame: At baseline, at 6 weeks and at 2 months
measure: Tampa scale for kinesiophobia
timeFrame: At baseline, at 6 weeks and at 2 months
measure: Pain Catastrophizing Scale
timeFrame: At baseline, at 6 weeks and at 2 months
measure: Treatment expectations
timeFrame: At baseline, at 6 weeks and at 2 months
measure: Expectations regarding cervical pain
timeFrame: At baseline, at 6 weeks and at 2 months
measure: Cervical Range of Motion (Pro Motion Capture. Werium)
timeFrame: At baseline, at 6 weeks and at 2 months
measure: Active and Latent Myofascial Trigger Points (Number of trigger Points)
timeFrame: At baseline, at 6 weeks and at 2 months
Other outcomes:
Locations:
city: Almería
country: Spain
facility: Adelaida María Castro Sánchez
state: Almeria
Study officials:
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