Predictors of Response to Manual Physiotherapy Using Somatosensory Profiles in Patients With Cervicobrachial Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Deusto
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Subjects with unilateral cervicobrachial pain
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Manual physiotherapy and neurodynamic exercises
Other intervention* 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 movement and progressing to exercises involving more movement based on the patient's irritability.
Treatment groups
91 Participants
are divided into 1 treatment groupGroup A: Manual physiotherapy and neurodynamic exercisesExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Global rating of change scale
Is a self-administered questionnaire that aims to measure the degree of subjective improvement since the first intervention received. 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, the patient is the same.
Time frame
Pre-intervention and post-intervention at week 6 - Between intervention sessions, weekly. - Mid term: at week 14Secondary outcomes
1
Numeric Pain Rating Scale (NPRS)
Neck and arm pain over the last 24 hours will be assessed with the NPRS. 0 is considered as no pain and 10 as the worst pain imaginable.
Time frame
Pre-intervention and post-intervention at week 6 - Mid term: at week 142
Neck Disability Index
It is a unidimensional questionnaire consisting of 10 sections on different activities and measuring functionality.
Time frame
Pre-intervention and post-intervention at week 6 - Mid term: at week 143
Central Sensitization Inventory (CSI)
CSI is a 25-item questionnaire to assess the presence of signs and symptoms consistent with central sensitisation.
Time frame
Pre-intervention and post-intervention at week 64
Pain Detect Questionnaire (PD-Q)
Questionnaire consisting of temporal and spatial pain descriptors and sensory descriptors. The PD-Q classifies patients into 3 groups as follows: * The result is negative = The neuropathic pain component is unlikely (Score 0 to 12). * The result is unclear = The result is ambiguous, however, the neuropathic pain component may be present (Score 13 to 18). * The result is positive = Neuropathic pain is likely to be present (Score 19 to 38). The intensity of the most intense and average pain during the last 4 weeks is recorded on an NPRS as part of the PD-Q.
Time frame
Pre-intervention and post-intervention at week 6Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Deusto
Lead sponsor
University of the Basque Country (UPV/EHU)
Collaborator
Matia Foundation
Collaborator
Osakidetza
Collaborator
Source ClinicalTrials.gov