Clinical trial NCT06069362: Predictors of Response to Manual Physiotherapy Using Somatosensory Profiles in Patients With Cervicobrachial Pain
Official title: Prediction of Response to Manual Physiotherapy Using Somatosensory Profiles in Patients With Cervicobrachial Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Radicular Pain
Cervical Radiculopathy
Cervical Pain
Keywords: Cervicobrachial pain
Nerve related neck arm pain
Lead sponsor: University of Deusto
Sponsor class: OTHER
Collaborators: name: University of the Basque Country (UPV/EHU)
name: Matia Foundation
name: Osakidetza
First posted: 2023-10-05
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm clinical trial
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Subjects with unilateral cervicobrachial pain

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Global rating of change scale
timeFrame: Pre-intervention and post-intervention at week 6 - Between intervention sessions, weekly. - Mid term: at week 14
Secondary outcomes:
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: Pre-intervention and post-intervention at week 6 - Mid term: at week 14
measure: Neck Disability Index
timeFrame: Pre-intervention and post-intervention at week 6 - Mid term: at week 14
measure: Central Sensitization Inventory (CSI)
timeFrame: Pre-intervention and post-intervention at week 6
measure: Pain Detect Questionnaire (PD-Q)
timeFrame: Pre-intervention and post-intervention at week 6
measure: Patient Specific Functional Scale (PSFS)
timeFrame: Pre-intervention and post-intervention at week 6
measure: Tampa Scale of Kinesiophobia (TSK-11)
timeFrame: Pre-intervention and post-intervention at week 6
measure: Patient Catastrophizing Scale
timeFrame: Pre-intervention and post-intervention at week 6
measure: Scale for sleep quality
timeFrame: Pre-intervention and post-intervention at week 6
measure: Hospital anxiety and depression scale
timeFrame: Pre-intervention and post-intervention at week 6
measure: Clinical examination
timeFrame: Pre-intervention and post-intervention at week 6
measure: Sensitivity to touch
timeFrame: Pre-intervention and post-intervention at week 6
measure: Myotatic reflexes of the upper extremity
timeFrame: Pre-intervention and post-intervention at week 6
measure: Myotomes examination
timeFrame: Pre-intervention and post-intervention at week 6
measure: Spurling test
timeFrame: Pre-intervention and post-intervention at week 6
measure: Distraction test
timeFrame: Pre-intervention and post-intervention at week 6
measure: Extension + rotation test
timeFrame: Pre-intervention and post-intervention at week 6
measure: Range of motion in rotation
timeFrame: Pre-intervention and post-intervention at week 6
measure: Examination of increased mechanosensitivity of nervous tissue
timeFrame: Pre-intervention and post-intervention at week 6
measure: Pain mapping
timeFrame: Pre-intervention and post-intervention at week 6
measure: Detection and thermal pain thresholds
timeFrame: Pre-intervention and post-intervention at week 6
measure: Vibration detection threshold
timeFrame: Pre-intervention and post-intervention at week 6
measure: Pressure pain threshold
timeFrame: Pre-intervention and post-intervention at week 6
measure: Temporal summation of pain
timeFrame: Pre-intervention and post-intervention at week 6
measure: Conditioned pain modulation
timeFrame: Pre-intervention and post-intervention at week 6
measure: Offset Analgesia
timeFrame: Pre-intervention and post-intervention at week 6
measure: Magnetic resonance imaging and radiography
timeFrame: Pre-intervention
Other outcomes:
Locations:
city: San Sebastián
country: Spain
facility: University of Deusto
state: Gipuzkoa
Study officials:
affiliation: University of Deusto
name: Xabat Casado, PhD cand
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.