Dry Needling With Percutaneous Electrical Nerve Stimulation and Exercises for Non-specific Chronic Neck Pain

Not Applicable

Not yet recruiting

• Conditions: Neck Pain

• Registration Number: NCT07015281
• Lead Sponsor: Universidad de Almeria

Brief Summary

The aim of this study is to compare the effects of applying dry needling with percutaneous electrical nerve stimulation + exercises verus therapeutic execises in patients with non-specific chronic neck pain.

Detailed Description

Globally, neck pain is considered the fourth leading cause of years lived with disability. It is estimated that up to 70% of the world's population will experience neck pain at least once in their lifetime, and between 50% and 85% of cases will become chronic within a five-year period.

The point prevalence of neck pain in the adult population, aged 15-74 years, ranges from 5.9% to 38.7%. This prevalence has been observed to peak in the 50-74 age group. In 2017, the global age-standardized prevalence and incidence of neck pain were 3551.1 and 806.6 per 100,000 population, respectively.

Dry needling with percutaneous electrical nerve stimulation has positive short-term effects on pain intensity, pain-related disability, and mood in patients with chronic nonspecific neck pain, compared with no or minimal intervention. However, the long-term impact could not be assessed due to a lack of available studies. Furthermore, strong evidence has been found suggesting that dry needling with percutaneous electrical nerve stimulation may improve mental well-being and mood in patients with chronic neck pain, especially in those with pain induced by high levels of stress.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-03
• Study First Submitted QC: 2025-06-10
• Last Update Submitted: 2025-06-10
• Study First Posted: 2025-06-11
• Last Update Posted: 2025-06-11
• Study Start: 2025-08-01
• Primary Completion: 2025-10-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Men and women aged between 30 and 65 years.
• A diagnosis of non-specific neck pain,
• Acceptance and signing of informed consent for voluntary participation in the research study.
• Not currently receiving physiotherapy.

Exclusion Criteria

• Patients undergoing rehabilitative treatment for cervical pathologies.
• Patients with osteosynthesis material at the cervical level and/or cardiac, epileptic, or tumour-related complications.
• Patients who have undergone radiotherapy. in the last 6 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Neck Disability Index	At baseline, 6 weeks and 3 months (follow up).	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. Each item will be scored on a scale from 0 (no limitation). (severe limitation or inability to perform the activity). The total score will be calculated by summing the item scores, dividing by the maximum possible score of 50 (if all 10 questions are answered), and multiplying by 100 to generate a percentage. A score of 0% indicates full independence, while 100% represents complete dependence.

Secondary Outcome Measures

Name	Time	Method
Pain (Visual Analog Scale)	At baseline, 6 weeks and 3 months (follow up).	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).
Spinal Isometric Strength (SIS).	At baseline, 6 weeks and 3 months (follow up).	The investigators will measure the maximum isometric strength of the neck extensor muscles using a hand-held dynamometer (HHD). The patient will remain seated in a chair, with their feet flat on the floor, their hips and knees at 90º of flexion and the neck in the anatomical position, the patient will hold the HHD with both hands resting on their occiput, opposing the extension, and will be asked to perform a progressive isometric cervical extension for 3 seconds until reaching their maximum level of strength.
Quality of Sleep (Pittsburgh Quality of Sleep Questionnaire Index).	At baseline, 6 weeks and 3 months (follow up).	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. Using a four-point, Likert-type scale, respondents indicate how frequently they exhibit certain sleep behaviors (0 = "few," 1 = "sometimes," 2 = "often," and 3 = "almost always"). Scores on items belong to factors 2 and 5 (restoration after sleep and satisfaction with sleep) and are reversed before being tallied. Total scores can range from 0 to 84, with higher scores demoting more acute sleep problems.
Tampa scale for kinesiophobia.	At baseline, 6 weeks and 3 months (follow up).	The 17-item Tampa scale for kinesiophobia assesses fear of movement or of injury or reinjury. Participants rate their beliefs regarding kinesiophobia on a 4-point Likert scale, ranging from "strongly disagree" to "strongly agree".
Pain Catastrophizing Scale.	At baseline, 6 weeks and 3 months (follow up).	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. The PCS consists of 13 statements containing several thoughts and feelings one may experience when having pain.
Quality of Life (SF-36 quality of life questionnaire).	At baseline, 6 weeks and 3 months (follow up).	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. Scores range from 0 to 100% (with higher scores indicating greater health), reflecting the individual's self-perceived health-related quality of life.
Cervical Range of Motion (Pro Motion Capture. Werium).	At baseline, 6 weeks and 3 months (follow up).	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.
Neck Flexor Muscle Endurance Test (NFME).	At baseline, 6 weeks and 3 months (follow up).	To measure the isometric endurance of the neck flexors, the investigators will place the patient in a supine position and ask him/her to perform a double chin tuck, which he/she must maintain throughout the test. While maintaining this position, he/she must flex his/her neck until his/her head is 2.5 cm off the table and maintain this position for as long as possible. The evaluator will time the duration of the test, which will be terminated if the patient loses the position for more than one second or asks to end due to fatigue or pain.
Treatment expectations.	At baseline, 6 weeks and 3 months (follow up).	Questionnaire on treatment expectations and the patient's perception level.
Trigger points.	At baseline, 6 weeks and 3 months (follow up).	Trigger oints will be measured in the following pairs of cervical muscles billaterally (right and left): occipitofrontalis, splenius capitis, sternocleidomastoid, anterior scalene, middele scalene, posterior scalene, upper trapezius, middle trapezius, lower trapezius, supraspinatus, infraspinatus, and multifidus level C6.