Clinical and Brain Activity Assessment Before and After Physiotherapy in People With Chronic Non-specific Neck Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAnder Cervantes Benítez
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Chronic non-specific neck pain (>3 months duration)
Willing and able to sign informed consent for study participation
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Manual physiotherapy and neck-specific exercise programme
Other interventionThe 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).
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Physiotherapy groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Global Rating of Change (GROC) scale
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.
Time frame
Post-intervention (approximately 1 week after treatment completion and 12 weeks after the last treatment session)Secondary outcomes
1
Numeric Pain Rating Scale (NPRS)
11-point tool used to measure pain intensity from 0 (no pain) to 10 (worst pain imaginable)
Time frame
Baseline and post-intervention (approximately 1 week after treatment completion and 12 weeks after the last treatment session)2
Neck Disability Index (NDI)
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%.
Time frame
Baseline and post-intervention (approximately 1 week after treatment completion and 12 weeks after the last treatment session)Other outcomes
1
Electroencephalographic spectral characteristics
Spectral characteristics will be derived from 64-channel electroencephalography recorded while participants are seated comfortably with their eyes closed in a quiet environment and instructed to remain relaxed and minimize movement. Mean peak alpha frequency will be reported in hertz (Hz) at baseline and post-intervention.
Time frame
Baseline and post-intervention (approximately 1 week after treatment completion)2
Pain Catastrophizing Scale (PCS)
The Pain Catastrophizing Scale consists of 13 items scored from 0 to 4. The total score ranges from 0 to 52, with higher scores indicating greater pain catastrophizing.
Time frame
Baseline and post-intervention (approximately 1 week after treatment completion)3
Hospital Anxiety and Depression Scale (HADS)
Anxiety and depressive symptoms will be assessed using the 14-item Hospital Anxiety and Depression Scale. The anxiety and depression subscale scores will be summed to obtain a total score ranging from 0 to 42, with higher scores indicating greater psychological distress.
Time frame
Baseline and post-intervention (approximately 1 week after treatment completion)4
Central Sensitization Inventory (CSI)
Symptoms associated with central sensitization will be assessed using Part A of the 25-item Central Sensitization Inventory. The total score ranges from 0 to 100, with higher scores indicating greater symptom severity.
Time frame
Baseline and post-intervention (approximately 1 week after treatment completion)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Ander Cervantes Benítez
Lead sponsor
University of Deusto
Sponsor institution
Source ClinicalTrials.gov