ClinicalTrials.gg
RecruitingNCT07756229Updated Sep 25, 2026

Clinical and Brain Activity Assessment Before and After Physiotherapy in People With Chronic Non-specific Neck Pain

An interventional study of Manual physiotherapy and neck-specific exercise programme in Neck Pain Musculoskeletal and Chronic Neck Pain, sponsored by Ander Cervantes Benítez. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Ander Cervantes Benítez · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 4 months after the study started (first participant enrolled Mar 2024, registered Jul 2026).
  • Started Mar 2024; still recruiting 2 years 7 months later.
Updated Sep 25, 2026Interventions changedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 44 studies in Musculoskeletal Pain with a site in Spain — 11 open to participants now, 16 under way, none of them phase 3. Musculoskeletal Pain · Spain.

Planned enrollment
8th of 29
100 · median 66
Started
2024
with 3 others
No phase
26 of 44
8 open now
Primary completion
2027-03
later than 11 of 15 live
Registered
43rd of 44
by date

Among the 44 studies in Musculoskeletal Pain with a site in Spain, this one is the 8th largest by planned enrollment of the 29 interventional ones, is one of 4 that started in 2024, is one of 26 with no phase, reaches primary completion later than 11 of the 15 other live ones, and was the 43rd registered.

By phase

44 studies; the count open now beside each. This study's row is marked.

No phasethis study26 · 8 open
Observational15 · 3 open
Phase 42 · 0 open
Phase 1/21 · 0 open

By the year they started

First in 2013; this study’s year is marked. 4 started in 2024.

Size and results

Median enrollment 66 across the 29 interventional studies, 200 across the 15 observational. Of the 23 that completed or were terminated, 1 (4%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 44 studies in Musculoskeletal Pain with a site in Spain, or all of them as a file.
02

Study 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.

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.

03

Conditions studied

  • Neck Pain Musculoskeletal
  • Chronic Neck Pain
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Chronic non-specific neck pain (>3 months duration)
  • Willing and able to sign for study participation

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Physiotherapy group

    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.

    Other: Manual physiotherapy and neck-specific exercise programme

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).

    Also known as: Manual therapy and neck exercise

06

What researchers measure

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)

  5. Tampa Scale for Kinesiophobia-11

    Fear of movement will be assessed using the 11-item Tampa Scale for Kinesiophobia. The total score ranges from 11 to 44, with higher scores indicating greater kinesiophobia.

    Time frame: Baseline and post-intervention (approximately 1 week after treatment completion)

  6. Sleep quality

    Sleep quality will be assessed using a single 0-to-10 numerical rating scale, where 0 indicates the worst possible sleep quality and 10 indicates the best possible sleep quality.

    Time frame: Baseline and post-intervention (approximately 1 week after treatment completion)

  7. Pain mapping

    Participants will indicate the location and extent of their pain using a digital body chart. Total pain extent will be calculated as the percentage of the body chart area marked as painful.

    Time frame: Baseline and post-intervention (approximately 1 week after treatment completion)

  8. Pressure pain threshold

    Pressure pain threshold will be assessed using a pressure algometer with a 1-cm² contact surface. Participants will be instructed to press a button when the sensation first changes from pressure to pain. Measurements will be performed at the most painful cervical location and at the contralateral hand. Three measurements will be obtained at each anatomical location, and the mean of the three measurements will be used for analysis. Values from the cervical location and the hand will be reported separately. Results will be reported in kilopascals.

    Time frame: Baseline and post-intervention (approximately 1 week after treatment completion)

  9. Cold pain threshold

    Cold pain threshold will be assessed as part of a quantitative sensory testing protocol using the MSA Thermotest (Somedic) with a 9-cm² contact thermode. The baseline temperature will be set at 32°C, and the minimum safety limit will be 5°C. Temperature will decrease at a rate of 1°C/s. Participants will press a button when the cold sensation first becomes painful, immediately stopping the stimulus. Three valid consecutive measurements will be obtained, and their mean temperature will be used for analysis. Results will be reported in degrees Celsius.

    Time frame: Baseline and post-intervention (approximately 1 week after treatment completion)

  10. Heat pain threshold

    Heat pain threshold will be assessed as part of a quantitative sensory testing protocol using the MSA Thermotest (Somedic) with a 9-cm² contact thermode. The baseline temperature will be set at 32°C, and the maximum safety limit will be 50°C. Temperature will increase at a rate of 1°C/s. Participants will press a button when the heat sensation first becomes painful, immediately stopping the stimulus. Three valid consecutive measurements will be obtained, and their mean temperature will be used for analysis. Results will be reported in degrees Celsius.

    Time frame: Baseline and post-intervention (approximately 1 week after treatment completion)

  11. Temporal summation of pain

    Mechanical temporal summation of pain will be assessed using calibrated pinprick stimulators (MRC Systems). Participants will rate the perceived pain intensity of a single 256-mN pinprick stimulus and the overall pain intensity elicited by a series of 10 pinprick stimuli of the same force applied at a rate of 1 stimulus per second. Pain intensity will be rated using a numerical rating scale ranging from 0, no pain, to 10, worst imaginable pain. The temporal summation ratio will be calculated by dividing the pain rating for the series of 10 stimuli by the pain rating for the single stimulus. When the pain rating for the single stimulus is 0, a value of 1 will be used as the denominator to avoid division by zero. Higher ratios indicate greater temporal summation of pain.

    Time frame: Baseline and post-intervention (approximately 1 week after treatment completion)

  12. Conditioned pain modulation

    Conditioned pain modulation will be assessed using the cold pressor test as the conditioning stimulus and pressure pain threshold as the test stimulus. Participants will immerse the foot contralateral to the most painful cervical location in an insulated container filled with cold water, initially set at 10°C, for up to 2 minutes. The water temperature may be adjusted to achieve a pain intensity of approximately 5 out of 10. Immediately after removal of the conditioning stimulus, pressure pain threshold will be measured three times at the cervical location, with 15 seconds between measurements, and the mean of the three measurements will be used for analysis. The conditioned pain modulation response will be calculated as the absolute change in pressure pain threshold between the pre-conditioning and post-conditioning measurements and reported in kilopascals (kPa). Higher positive values indicate greater endogenous pain inhibition.

    Time frame: Baseline and post-intervention (approximately 1 week after treatment completion)

07

Study locations

1 of 1 sites recruiting
  • Ander Cervantes Benítez
    San Sebastián, Guipuzcoa 20012, Spain
    Recruiting
    • Ander Cervantes Benítez · Contactander.cervantes@deusto.es · 34 943 32 66 00
    • Ander Cervantes Benítez · Sub investigator
08

References and documents

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 29175204 ↗
  • Chowdhury 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 39399054 ↗
  • Bott 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 41033105 ↗
  • Heitmann 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 35050961 ↗
  • Zabala 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 33351923 ↗
  • Villanueva-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 ↗

Individual participant data

Plan to share: 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.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2024 (actual). Primary completion is estimated for Mar 2027, 36 months after the start.

Of 224 non-industry interventional studies with no phase under Musculoskeletal Pain, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 34. This study's planned 36 months is above that.

Counting every sponsor, half of 237 studies reached it within 13 months; a quarter within 5 and three quarters within 32.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 31, 2026
First posted
Aug 10, 2026
StartActual
Mar 21, 2024
Primary completionEst.
Mar 2027
CompletionEst.
Dec 2027
Last update
Sep 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Interventions
Arms removed: Healthy control group
Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    Interventions Arms removed: Healthy control group
    + 1 other change: design details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07756229
Lead sponsor
Ander Cervantes Benítez
Responsible party
Ander Cervantes Benítez (Lecturer, Department of Physiotherapy, Faculty of Health Sciences, University of Deusto) — Sponsor-investigator
First posted
Aug 10, 2026
Start date
Mar 21, 2024
Primary completion
Mar 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Sep 25, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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