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

NCT07756229 | Recruiting

• 1 other identifier: FST_CCNE
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Neck Pain; Neck Pain Musculoskeletal

Outcome Measures

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.

  Post-intervention (approximately 1 week after treatment completion and 12 weeks after the last treatment session)

Secondary Outcomes (2)

• Numeric Pain Rating Scale (NPRS)

  Baseline and post-intervention (approximately 1 week after treatment completion and 12 weeks after the last treatment session)

• Neck Disability Index (NDI)

  Baseline and post-intervention (approximately 1 week after treatment completion and 12 weeks after the last treatment session)

Other Outcomes (12)

• Electroencephalographic spectral characteristics

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

• Pain Catastrophizing Scale (PCS)

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

• Hospital Anxiety and Depression Scale (HADS)

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

Study Arms (2)

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.

Other: Manual physiotherapy and neck-specific exercise programme

Healthy control group

NO INTERVENTION

Healthy participants without chronic neck pain will undergo baseline clinical, psychophysical, and electroencephalographic assessments for comparison with participants with chronic non-specific neck pain. They will not receive the physiotherapy intervention or undergo a post-intervention assessment.

Interventions

Manual physiotherapy and neck-specific exercise programme OTHER

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

Physiotherapy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ander Cervantes Benítez: lead

Study Sites (1)

Ander Cervantes Benítez

San Sebastián, Guipuzcoa, 20012, Spain

RECRUITING

Related Publications (6)

• 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.

  PMID: 29175204 BACKGROUND

• 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.

  PMID: 39399054 BACKGROUND

• 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.

  PMID: 41033105 BACKGROUND

• 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.

  PMID: 35050961 BACKGROUND

• 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.

  PMID: 33351923 BACKGROUND

• 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.

  PMID: 40273517 BACKGROUND

MeSH Terms

Interventions

Musculoskeletal Manipulations

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer, Department of Physiotherapy, Faculty of Health Sciences

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: August 10, 2026
• Study Start: March 21, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 10, 2026

Record last verified: 2026-07

Locations

ES (1)