Chronic Neck Pain, Neck Pain Musculoskeletal
Conditions
Brief summary
The goal of this clinical trial is to investigate whether electroencephalographic features are associated with the multidimensional clinical characteristics of adults with chronic non-specific neck pain and whether clinical and brain function measures change following physiotherapy. Participants with chronic non-specific neck pain will receive six weekly treatment sessions consisting of a manual physiotherapy and neck-specific exercise programme, including a home exercise programme. Clinical, psychophysical, and 64-channel electroencephalographic assessments will be performed at baseline and approximately one week after completion of the intervention. Clinical outcomes will also be reassessed 12 weeks after the last treatment session. Electroencephalographic recordings will be obtained while participants are seated comfortably and instructed to remain relaxed. EEG-derived measures will be examined in relation to pain intensity, neck-related disability, psychological and cognitive-affective factors, sleep quality, and psychophysical pain responses. Healthy participants without chronic neck pain will undergo a comparable baseline assessment to provide reference data for the interpretation of brain function in the clinical group.
Detailed description
This non-randomized interventional study aims to investigate clinical and electroencephalographic characteristics in individuals with chronic non-specific neck pain and to examine changes following a physiotherapy intervention. A healthy control group will also be assessed to provide reference data for comparison with participants with chronic non-specific neck pain. Participants with chronic non-specific neck pain will undergo a baseline assessment including clinical questionnaires, pain mapping, quantitative sensory testing, and 64-channel electroencephalographic recordings. Following the baseline assessment, participants with chronic non-specific neck pain will receive six weekly physiotherapy sessions. The intervention will include passive mobilizations of the cervical and thoracic spine, soft tissue mobilizations, and a neck-specific home exercise programme involving neck flexor and extensor training. The clinical, psychophysical, and electroencephalographic assessments will be repeated approximately one week after completion of the intervention. Perceived recovery, pain intensity, and neck-related disability will also be evaluated approximately 12 weeks after the final treatment session. The study will examine baseline differences between participants with chronic non-specific neck pain and healthy controls and changes in clinical and electroencephalographic outcomes following physiotherapy.
Interventions
OTHERManual physiotherapy and neck-specific exercise programme
The physiotherapy intervention will consist of six weekly sessions combining manual physiotherapy and a neck-specific exercise programme. Manual physiotherapy will include passive mobilisations of the cervical and thoracic spine and soft tissue techniques. The exercise programme will include daily home exercises targeting cervical mobility and neuromuscular control, including neck flexor and neck extensor training. The intervention is based on the protocol described by Villanueva-Ruiz et al. (2025).
Sponsors
Ander Cervantes Benítez
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Chronic non-specific neck pain (\>3 months duration) * Willing and able to sign informed consent for study participation
Exclusion criteria
* Concomitant neurological or psychiatric disease apart from depression (especially severe mental disorder or psychopathology) * Regular (daily) intake of benzodiazepines * Signs of severe disease, cervical myelopathy, tumour, rheumatic diseases or a neurological pathology of central origin * Neck pain of traumatic origin or as a result of whiplash * Previous surgical intervention of the cervical spine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global Rating of Change (GROC) scale | Post-intervention (approximately 1 week after treatment completion and 12 weeks after the last treatment session) | It is a single-item patient-reported outcome that aims to quantify a patient's perceived improvement or deterioration over time. The questionnaire is scored with 7 positive items to assess the patient's subjective improvement progressively. It also presents 7 negative items to assess whether the patient has worsened. The 0 is defined as no improvement or worsening. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Pain Rating Scale (NPRS) | Baseline and post-intervention (approximately 1 week after treatment completion and 12 weeks after the last treatment session) | 11-point tool used to measure pain intensity from 0 (no pain) to 10 (worst pain imaginable) |
| Neck Disability Index (NDI) | Baseline and post-intervention (approximately 1 week after treatment completion and 12 weeks after the last treatment session) | The Neck Disability Index consists of 10 items assessing disability related to neck pain. Each item is scored from 0 to 5, giving a total score from 0 to 50. Higher scores indicate greater neck-related disability. The score may also be expressed as a percentage from 0% to 100%. |
Countries
Spain
Outcome results
None listed