Percutaneous Neuromodulation and Therapeutic Exercise in Patients With Nonspecific Chronic Neck Pain
NCT Number: NCT06522893
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Neck Pain|Chronic Pain
Interventions: OTHER: Percutaneous neuromodulation
Sponsor: Universidad de Almeria
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-22
Completion Date: 2024-11-01
Locations: Adelaida María Castro Sánchez, Almería, Almeria, 04120, Spain

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.

Primary Outcome Measures: Neck disability index, 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., Change from baseline disability at two months
Secondary Outcome Measures: Pain (Visual Analog Scale), 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)., Change from baseline disability at two months|McGill Pain Questionnaire, 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., Change from baseline disability at two months|Quality of Life (SF-36 quality of life questionnaire), 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., Change from baseline disability at two months|Quality of Sleep (Pittsburgh Quality of Sleep Questionnaire Index), 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., Change from baseline disability at two months|Tampa scale for kinesiophobia, The 17-item Tampa scale for kinesiophobia assesses fear of movement or of injury or reinjury., Change from baseline disability at two months|Pain Catastrophizing Scale, 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., Change from baseline disability at two months|Treatment expectations, Questionnaire on treatment expectations and the patient's perception level, Change from baseline disability at two months|Expectations regarding cervical pain, Questionnaire on expectations regarding cervical pain, Change from baseline disability at two months|Cervical Range of Motion (Pro Motion Capture. Werium), 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., Change from baseline disability at two months|Active and Latent Myofascial Trigger Points (Number of trigger Points), 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., Change from baseline disability at two months