Comparison of Percutaneous Neuromodulation and Therapeutic Exercise in Patients With Nonspecific Chronic Neck Pain: A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Universidad de Almeria
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Neck disability index
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male and female patients aged between 30 and 65 years with chronic cervical pain.
- •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, and 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.)
- •Contraindications for transcutaneous electrical nerve stimulation (TENS).
Arms & Interventions
Percutaneous neuromodulation
Patients assigned to this group (n=50) will receive one 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 (C0-C1), and the posterior roots of vertebral levels C3-C4 and C7-T1, the spinal nerve, suprascapular nerve and dorsal. 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
Intervention: Percutaneous neuromodulation. (Other)
Therapeutic Exercise
These participants (n=50) 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.
Intervention: Therapeutic Exercise. (Other)
Outcomes
Primary Outcomes
Neck disability index
Time Frame: 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 Outcomes
- Pain (Visual Analog Scale)(At baseline, at 6 weeks and at 2 months.)
- McGill Pain Questionnaire(At baseline, at 6 weeks and at 2 months.)
- Quality of Life (SF-36 quality of life questionnaire)(At baseline, at 6 weeks and at 2 months.)
- Quality of Sleep (Pittsburgh Quality of Sleep Questionnaire Index)(At baseline, at 6 weeks and at 2 months.)
- Tampa scale for kinesiophobia(At baseline, at 6 weeks and at 2 months.)
- Pain Catastrophizing Scale(At baseline, at 6 weeks and at 2 months.)
- Treatment expectations(At baseline, at 6 weeks and at 2 months.)
- Expectations regarding cervical pain(At baseline, at 6 weeks and at 2 months.)
- Cervical Range of Motion (Pro Motion Capture. Werium)(At baseline, at 6 weeks and at 2 months.)
- Active and Latent Myofascial Trigger Points (Number of trigger Points)(At baseline, at 6 weeks and at 2 months.)
Investigators
Adelaida María Castro-Sánchez
Full Profesor
Universidad de Almeria