Neck Pain MusculoskeletalNCT07756229
Clinical and Brain Activity Assessment Before and After Physiotherapy in People With Chronic Non-specific Neck Pain
A study testing Manual physiotherapy and neck-specific exercise programme in people with Neck Pain Musculoskeletal and Chronic Neck Pain, run by Ander Cervantes Benítez at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neck Pain Musculoskeletal, Chronic Neck Pain
- What is being tested?
- Manual physiotherapy and neck-specific exercise programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 21 Mar 2024to Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Chronic non-specific neck pain (>3 months duration)
- Willing and able to sign informed consent for study participation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Ander Cervantes Benítez
San Sebastián, Guipuzcoa, 20012
Ander Cervantes Benítez, 34 943 32 66 00 ext. 5247, ander.cervantes@deusto.es
Ander Cervantes Benítez
About this study
Official title: Predictors of Response After Physiotherapy Treatment in People With Chronic Non-specific Neck Pain
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.
Read the 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.
- Conditions
- Neck Pain Musculoskeletal, Chronic Neck Pain
- Being tested
- Manual physiotherapy and neck-specific exercise programme
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual physiotherapy and neck-specific exercise programmeOther
Also called Manual therapy and neck exercise
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).
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy group | Experimental | Participants with chronic non-specific neck pain will receive a 6-week physiotherapy intervention consisting of six individual treatment sessions, including manual therapy directed at the cervical and thoracic regions, together with a home exercise program. Clinical and brain activity assessments will be performed before the intervention and approximately one week after completion of the intervention. Receives: Other: Manual physiotherapy and neck-specific exercise programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post-intervention (approximately 1 week after treatment completion and 12 weeks after the last treatment session)
Secondary outcomes (2)
Numeric Pain Rating Scale (NPRS)
11-point tool used to measure pain intensity from 0 (no pain) to 10 (worst pain imaginable)
Measured: Baseline and post-intervention (approximately 1 week after treatment completion and 12 weeks after the last treatment session)
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%.
Measured: Baseline and post-intervention (approximately 1 week after treatment completion and 12 weeks after the last treatment session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start21 Mar 2024
- Primary completionMar 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Neck Pain MusculoskeletalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ander Cervantes Benítez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ander Cervantes Benítez, University of Deusto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07756229
- Sponsor's protocol ID
- FST_CCNE
- Status last verified
- Jul 2026
- First submitted
- 31 Jul 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A final decision regarding individual participant data sharing has not yet been made. Pseudonymized individual participant data underlying the results reported in the main publications may be made available through an Open Science Framework repository upon publication. Data sharing will depend on participant consent, approval by the study investigators and relevant ethics bodies, and compliance with applicable data protection and institutional requirements.
Publications
Furman AJ, Meeker TJ, Rietschel JC, Yoo S, Muthulingam J, Prokhorenko M, Keaser ML, Goodman RN, Mazaheri A, Seminowicz DA. Cerebral peak alpha frequency predicts individual differences in pain sensitivity. Neuroimage. 2018 Feb 15;167:203-210. doi: 10.1016/j.neuroimage.2017.11.042. Epub 2017 Nov 21.
PubMed 29175204Chowdhury NS, Bi C, Furman AJ, Chiang AK, Skippen P, Si E, Millard SK, Margerison SM, Spies D, Keaser ML, Da Silva JT, Chen S, Schabrun SM, Seminowicz DA. A novel cortical biomarker signature predicts individual pain sensitivity. medRxiv [Preprint]. 2024 Nov 5:2024.06.16.24309005. doi: 10.1101/2024.06.16.24309005.
PubMed 39399054Bott FS, Zebhauser PT, Hohn VD, Turgut O, May ES, Tiemann L, Gil Avila C, Heitmann H, Nickel MM, Day MA, Adhia DB, Ashar YK, Wager TD, Granovsky Y, Yarnitsky D, Jensen MP, Gross J, Ploner M. Exploring electroencephalographic chronic pain biomarkers: a mega-analysis. EBioMedicine. 2025 Oct;120:105955. doi: 10.1016/j.ebiom.2025.105955. Epub 2025 Sep 30.
PubMed 41033105Heitmann H, Gil Avila C, Nickel MM, Ta Dinh S, May ES, Tiemann L, Hohn VD, Tolle TR, Ploner M. Longitudinal resting-state electroencephalography in patients with chronic pain undergoing interdisciplinary multimodal pain therapy. Pain. 2022 Sep 1;163(9):e997-e1005. doi: 10.1097/j.pain.0000000000002565. Epub 2021 Dec 15.
PubMed 35050961Zabala Mata J, Lascurain-Aguirrebena I, Dominguez Lopez E, Azkue JJ. Enhanced Pronociceptive and Disrupted Antinociceptive Mechanisms in Nonspecific Chronic Neck Pain. Phys Ther. 2021 Mar 3;101(3):pzaa223. doi: 10.1093/ptj/pzaa223.
PubMed 33351923Villanueva-Ruiz I, Falla D, Saez M, Araolaza-Arrieta M, Azkue JJ, Arbillaga-Etxarri A, Lersundi A, Lascurain-Aguirrebena I. Manual therapy and neck-specific exercise are equally effective for treating non-specific neck pain but only when exercise adherence is maximised: A randomised controlled trial. Musculoskelet Sci Pract. 2025 Jun;77:103319. doi: 10.1016/j.msksp.2025.103319. Epub 2025 Mar 21.
PubMed 40273517