Predictors of Response to Manual Physiotherapy Using Somatosensory Profiles in Patients With Cervicobrachial Pain

Официальное название

Prediction of Response to Manual Physiotherapy Using Somatosensory Profiles in Patients With Cervicobrachial Pain

Обзор

The goal of this clinical trial is to investigate about the characteristics that predict response to physiotherapy treatment in patients with nerve related neck arm pain. The main question to answer is whether there is a subgroup that responds better to physiotherapy treatment. Participants will be assessed for clinical and neurophysiological characteristics prior to treatment. Afterwards they will receive 6 sessions of manual physiotherapy treatment along with home nerve gliding exercises once a week. Baseline measurements will be taken again after treatment to know if there have been any changes.

Подробное описание

During the first visit, socio-demographic data will be collected. Then, participants will be assessed using the quantitative sensory testing (QST) to evaluate the excitability of the nervous system. In addition, questionnaires and scales will be used to obtain information on the psychosocial factors involved, neuropathic pain characteristics and on the disability caused by their situation.

Finally, various clinical tests will be carried out to obtain information on neck movement and irritability at closure of the intervertebral foramen, mechanosensitivity of the upper limb with neurodynamic testing and alterations in sensitivity, strength and myotatic reflexes. Also they will be asked for permission to access to their imaging tests.

Once the pre-treatment data has been obtained, the manual physiotherapy and exercise treatment will begin, which aims to reduce the irritability of the nervous system.

Once the treatment is completed, the initial measurements will be repeated along with a global rating of change scale to classify patients as responders vs. non-responders.

Вмешательства

• Другое Manual physiotherapy and neurodynamic exercises
  * Cervical passive mobilisation techniques and techniques of the anatomical structures surrounding the nerve. These techniques aim to open the nerve root foramen. They are gentle traction techniques and contralateral lateral glide mobilisation techniques. Interface techniques for scalenes will also be included. * Home exercises for cervical mobility and neurodynamic sliders of the upper extremity: Patients will be taught progressive upper extremity neurodynamic sliders, starting with gentle move

Первичные конечные точки

• Global rating of change scale [Срок оценки: Pre-intervention and post-intervention at week 6 - Between intervention sessions, weekly. - Mid term: at week 14]

Вторичные конечные точки (12)

• Numeric Pain Rating Scale (NPRS) [Срок оценки: Pre-intervention and post-intervention at week 6 - Mid term: at week 14]
• Neck Disability Index [Срок оценки: Pre-intervention and post-intervention at week 6 - Mid term: at week 14]
• Central Sensitization Inventory (CSI) [Срок оценки: Pre-intervention and post-intervention at week 6]
• Pain Detect Questionnaire (PD-Q) [Срок оценки: Pre-intervention and post-intervention at week 6]
• Patient Specific Functional Scale (PSFS) [Срок оценки: Pre-intervention and post-intervention at week 6]
• Tampa Scale of Kinesiophobia (TSK-11) [Срок оценки: Pre-intervention and post-intervention at week 6]
• Patient Catastrophizing Scale [Срок оценки: Pre-intervention and post-intervention at week 6]
• Scale for sleep quality [Срок оценки: Pre-intervention and post-intervention at week 6]
• Hospital anxiety and depression scale [Срок оценки: Pre-intervention and post-intervention at week 6]
• Clinical examination [Срок оценки: Pre-intervention and post-intervention at week 6]
• Sensitivity to touch [Срок оценки: Pre-intervention and post-intervention at week 6]
• Myotatic reflexes of the upper extremity [Срок оценки: Pre-intervention and post-intervention at week 6]

Критерии участия

Критерии включения

• Subjects with unilateral cervicobrachial pain

Критерии исключения

• Signs of severe disease, cervical myelopathy, tumour, rheumatic diseases or a neurological pathology of central origin.
• Cervicobrachial pain of traumatic origin or as a result of whiplash.
• Previous surgical intervention of the cervical spine.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• University of Deusto — San Sebastián

Публикации

• Schmid AB, Hailey L, Tampin B. Entrapment Neuropathies: Challenging Common Beliefs With Novel Evidence. J Orthop Sports Phys Ther. 2018 Feb;48(2):58-62. doi: 10.2519/jospt.2018.0603. PMID 29385943
• Bogduk N. On the definitions and physiology of back pain, referred pain, and radicular pain. Pain. 2009 Dec 15;147(1-3):17-9. doi: 10.1016/j.pain.2009.08.020. Epub 2009 Sep 16. No abstract available. PMID 19762151
• Vardeh D, Mannion RJ, Woolf CJ. Toward a Mechanism-Based Approach to Pain Diagnosis. J Pain. 2016 Sep;17(9 Suppl):T50-69. doi: 10.1016/j.jpain.2016.03.001. PMID 27586831

Идентификаторы

NCT: NCT06069362 · FST_DCB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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