Percutaneous Neuromodulation and Therapeutic Exercise in Patients With Nonspecific Chronic Neck Pain

Not Applicable

Suspended

• Conditions: Chronic Pain; Neck Pain
• Interventions: Other: Percutaneous neuromodulation

• Registration Number: NCT06522893
• Lead Sponsor: Universidad de Almeria

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.

Study Timeline

• Study First Submitted: 2024-07-18
• Study First Submitted QC: 2024-07-22
• Study First Posted: 2024-07-26
• Status Verified: 2024-11
• Study Start: 2024-11-15
• Primary Completion: 2024-11-15
• Study Completion: 2024-11-15
• Last Update Submitted: 2024-11-15
• Last Update Posted: 2024-11-20

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 70

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Percutaneous neuromodulation	Percutaneous neuromodulation	Patients assigned to this group (n=35) will receive three weekly sessions of percutaneous neuromodulation for a total of 6 weeks, with each session lasting 30 minutes. For the treatment application, the patient will be positioned in a prone decubitus position, leaving the dorsal-cervical area exposed, and we will apply skin disinfectant (chlorhexidine). Subsequently, and under ultrasound guidance, we will perform the technique using a 30 x 40 mm acupuncture needle, which will be inserted at three vertebral levels and bilaterally; the greater occipital nerve and the posterior root of the C3 and C7 levels. Once the needles are correctly positioned, we will connect alligator clip electrodes segmentally, connecting them to an electrotherapy device (TensMed S82-Enraf Nonius) applying a TENS current. The parameters used will be set to low-frequency (2 Hz) symmetric biphasic pulsed current with a pulse width of 120 μs and an intensity described by the patient as "mild to moderate".
Therapeutic Exercise	Percutaneous neuromodulation	These participants (n=35) will engage in resistance training for the cervical flexor muscles, following a progressive exercise program in a supine position with the head comfortably supported, as described by Falla et al. (2008). Participants will perform these exercises with a frequency of 3 days a week for 6 weeks, with each session lasting 30 minutes.

Primary Outcome Measures

Name	Time	Method
Neck disability index	At baseline, at 6 weeks and at 2 months	The neck disability index consists of 10 questions addressing functional activities such as personal care, lifting, reading, work, driving, sleeping, recreational, pain intensity, concentration and headache.

Secondary Outcome Measures

Name	Time	Method
Treatment expectations	At baseline, at 6 weeks and at 2 months	Questionnaire on treatment expectations and the patient's perception level
Expectations regarding cervical pain	At baseline, at 6 weeks and at 2 months	Questionnaire on expectations regarding cervical pain
Pain (Visual Analog Scale)	At baseline, at 6 weeks and at 2 months	Pain will be assessed with the Visual Analog Scale (VAS), which assesses the pain intensity and degree of relief experienced by the patient (scored of 0 = no pain; 10 = unbearable pain).
McGill Pain Questionnaire	At baseline, at 6 weeks and at 2 months	The McGill Pain Questionnaire is a self-reporting measure of pain used for patients with a number of diagnoses. It assesses both quality and intensity of subjective pain. The MPQ is a multi-dimesional tool for pain assessment and it has three components, which are the sensory intensity, the cognitive evaluation of pain and the emotional impact of pain.
Quality of Life (SF-36 quality of life questionnaire)	At baseline, at 6 weeks and at 2 months	The SF-36 quality of life questionnaire assesses 8 domains including physical functioning, physical role, bodily pain, general health, vitality, social functioning, role-emotional, and mental health.
Quality of Sleep (Pittsburgh Quality of Sleep Questionnaire Index)	At baseline, at 6 weeks and at 2 months	The Pittsburgh Quality of Sleep Questionnaire Index (PSQI) will be used to study the quality of sleep. It comprises 24 items where the subjects respond to 19 of these items, and individual living in the same dwelling (or hospital room) responds to the remaining 5. Scores are obtained on each of 7 components of sleep quality: subjective quality, sleep latency, sleep duration, habitual sleep efficacy, sleep perturbations, use of hypnotic medication, and daily dysfunction.
Tampa scale for kinesiophobia	At baseline, at 6 weeks and at 2 months	The 17-item Tampa scale for kinesiophobia assesses fear of movement or of injury or reinjury.
Pain Catastrophizing Scale	At baseline, at 6 weeks and at 2 months	The Pain Catastrophizing Scale (PCS) is a self-assessment questionnaire to examine catastrophizing in clinical and nonclinical populations. Catastrophizing is commonly described as an exaggerated negative orientation toward noxious stimuli and plays an important role in experiencing and coping with pain. The PCS consists of 13 statements containing a number of thoughts and feelings one may experience when having pain. The items are divided into the categories of rumination, magnification and helplessness, with each item scored on a 5-point scale.
Cervical Range of Motion (Pro Motion Capture. Werium)	At baseline, at 6 weeks and at 2 months	Cervical range of motion is assessed with the patient sitting comfortably on a chair, with both feet flat on the floor, hips and knees at 90º of flexion, and buttocks positioned against the back of the chair.
Active and Latent Myofascial Trigger Points (Number of trigger Points)	At baseline, at 6 weeks and at 2 months	Myofascial Trigger Points will be explored in the following pairs of muscles: occipitofrontalis, splenius capitis, sternocleidomastoid, anterior scalene, middle scalene, posterior scalene, upper trapezius, middle trapezius, lower trapezius, supraspinatus, infraspinatus, and multifidus level C6.

Trial Locations

Locations (1)

Adelaida María Castro Sánchez; 🇪🇸 Almería, Almeria, Spain