An interventional study of Manual physiotherapy and neurodynamic exercises in Cervical Radicular Pain, Cervical Radiculopathy and Cervical Pain, sponsored by University of Deusto. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-26.
Sponsored by University of Deusto · Not applicable, Interventional, and Treatment
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.
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.
483 studies on the registry are indexed under Radiculopathy; 145 are open to participants now.
This study's planned enrollment of 91 is above the median of 60 across 373 interventional studies indexed under Radiculopathy.
Browse Radiculopathy studies →University of Deusto is the lead sponsor of 20 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
The treatment applied forms part of the routine clinical practice and includes the following: * Cervical passive mobilisation techniques and techniques of the anatomical structures surrounding the nerve root. * Home neurodynamic sliders of the upper limb and cervical mobility exercises.
Other: 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 movement and progressing to exercises involving more movement based on the patient's irritability.
Also known as: Manual physiotherapy and exercise
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 14
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 14
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 14
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 6
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 6
Patient Specific Functional Scale (PSFS)
PSFS is a scale that measures a patient's functional status by asking about activities that are difficult to perform based on their condition and scoring the level of limitation of each activity.
Time frame: Pre-intervention and post-intervention at week 6
Tampa Scale of Kinesiophobia (TSK-11)
It is an 11-item questionnaire developed to identify fear of of movement.
Time frame: Pre-intervention and post-intervention at week 6
Patient Catastrophizing Scale
It is a 13-item questionnaire developed to identify catastrophising thoughts or feelings in relation to painful experiences.
Time frame: Pre-intervention and post-intervention at week 6
Scale for sleep quality
An increasing scale of 0-10 will be used to assess the quality of sleep. 0 is considered to be very poor sleep quality as a result of the pain, and 10 is considered to be no sleep disturbance.
Time frame: Pre-intervention and post-intervention at week 6
Hospital anxiety and depression scale
Is one of the most widely used tests to measure anxiety and depression in a general population of patients.
Time frame: Pre-intervention and post-intervention at week 6
Clinical examination
The clinical examination will include a detailed anamnesis considering items published by other studies.
Time frame: Pre-intervention and post-intervention at week 6
Sensitivity to touch
The sensitivity to touch of the different dermatomes involved in the upper extremity will be evaluated by means of a piece of cotton and with a toothpick by means of the neuropen. The sensitivity of the healthy limb will be compared with that affected in upper extremity dermatomes. The patient should tell us if there are alterations in sensitivity and if he perceives the stimulus in a more noticeable, similar or lesser way. Results will be noted as hyperesthesia, normoestesia, or hypoesthesia.
Time frame: Pre-intervention and post-intervention at week 6
Myotatic reflexes of the upper extremity
The reflex hammer will be used to evaluate the response of the roots of C5 and C6 by percussion in the biceps tendon and percussion in the triceps tendon for the evaluation of the roots of C6 and C7. The healthy and affected limb will be examined and compared for asymmetries indicating pathology
Time frame: Pre-intervention and post-intervention at week 6
Myotomes examination
The loss of strength will be manually examined that would indicate a loss of function of different nerve roots.
Time frame: Pre-intervention and post-intervention at week 6
Spurling test
It consists of performing a homolateral inclination that aims to reduce the intervertebral foramen along with a compression. The test is considered positive with reproduction of symptoms.
Time frame: Pre-intervention and post-intervention at week 6
Distraction test
It consists of slightly pulling the cervical spine with the patient in supine position. The reduction of symptoms during the test is considered positive.
Time frame: Pre-intervention and post-intervention at week 6
Extension + rotation test
With the patient in supine position, an extension and homolateral rotation is performed. The reproduction of the symptoms suggests facet involvement in the patient's clinical picture.
Time frame: Pre-intervention and post-intervention at week 6
Range of motion in rotation
The patient will be asked to perform a bilateral active rotation. Limitation of mobility to the symptomatological ipsilateral side will be considered positive.
Time frame: Pre-intervention and post-intervention at week 6
Examination of increased mechanosensitivity of nervous tissue
It will be evaluated using neurodynamic tests of the upper extremity (ULNT1, ULNT 2 and ULNT 3) and palpation of the median, radial and ulnar nerves. ULNTs are passive brachial plexus and nerve provocation tests to be evaluated performed supine, involving a sequence of movements that gradually add tension to the nerve trunk. The test will be considered positive with reproduction of arm symptoms at least partially and with the presence of structural differentiation. Structural differentiation involves modifying some of the movements of the sequence away from the area of onset of symptoms. It is a feature frequently used to involve nerve tissue in the symptoms reproduced.
Time frame: Pre-intervention and post-intervention at week 6
Pain mapping
The participant will be asked to draw, on an electronic body map, the location and intensity of their symptoms.
Time frame: Pre-intervention and post-intervention at week 6
Detection and thermal pain thresholds
Part of the QST protocol standardised by the German Research Network on Neuropathic Pain will be applied.This includes detection and thermal pain thresholds. The thermal thresholds will be measured using the MSA Thermotest (Somedic) with 9 cm thermode. The reference temperature will be set at 32°C. The cutting temperatures will be 5ºC and 50ºC. All thresholds will be obtained with ramp stimuli (1ºC/sec) that will stop voluntarily when the subject presses a button. Firstly, the cold and heat detection thresholds will be evaluated, and finally the measurement of the cold and heat pain thresholds. The average threshold temperature of 3 valid consecutive measurements will be calculated for each parameter.
Time frame: Pre-intervention and post-intervention at week 6
Vibration detection threshold
It will be measured with a Rydel-Seiffer tuning fork (64 Hz, 8/8 scale). The threshold will be determined as a threshold of disappearance of perception with 3 repetitions of stimuli. Measurements will be taken over bony prominences unless the area of maximum pain does not exhibit a bony surface, in which case, measurements will be taken over adjacent soft tissue.
Time frame: Pre-intervention and post-intervention at week 6
Pressure pain threshold
It will be determined with a pressure algometer with a contact surface of 1 cm2 and a ramp speed of 50kPa/s (Somedic). Subjects will be asked to press a button when the sensation changes from pressure to pressure pain. The average value of the measurements in triplicate shall be used for the analysis.
Time frame: Pre-intervention and post-intervention at week 6
Temporal summation of pain
It will be measured by a repetitive pinprick stimulus at a controlled intensity using the set of pinprick stimulators (MRC systems). The perceived magnitude of a single puncture stimulus (256mN) will be compared to that of a series of 10 puncture stimuli of the same force repeated at a rate of 1/sec.
Time frame: Pre-intervention and post-intervention at week 6
Conditioned pain modulation
The cold pressor test will be used to evaluate the efficacy of endogenous pain inhibitory mechanisms. Patients will immerse the healthy limb's hand in an insulated container filled with cold water. The pressure pain threshold (PPT) test will be applied as a test stimulus to determine the potential effect of conditioned pain modulation during the application of the cold stimulus.
Time frame: Pre-intervention and post-intervention at week 6
Offset Analgesia
Using the thermode, we will identify the value for the heat pain threshold to obtain a value of 5/10 in the NPRS and then raise it by 1°C to obtain a new supra-threshold NPRS value. After a few seconds the temperature will be lowered back to the initial value and we will assess for changes in pain perception in the NPRS.
Time frame: Pre-intervention and post-intervention at week 6
Magnetic resonance imaging and radiography
The patient will be asked for permission to access the tests performed as part of the medical diagnosis, in order to study whether the morphological changes produced by the aging of the patient (baseline situation) can be predictors of the response to treatment
Time frame: Pre-intervention
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started Apr 2023 (actual). Primary completion is estimated for Jul 2025, 27 months after the start.
Of 203 non-industry interventional studies with no phase under Radiculopathy, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 30. This study's planned 27 months is above that.
Counting every sponsor, half of 215 studies reached it within 12 months; a quarter within 5 and three quarters within 45.
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