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

Cervical Radiculopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06069362
• Other study ID #: FST_DCB
• Status: Recruiting
• Phase: N/A
• Start date: April 20, 2023
• Est. completion date: February 20, 2025

Study information

• Verified date: May 2024
• Source: University of Deusto
• Contact: Xabat Casado, PhD Cand
• Phone: 943326600
• Email: xabat.casado[@]deusto.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 91
• Est. completion date: February 20, 2025
• Est. primary completion date: December 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Pain
• Cervical Radicular Pain
• Cervical Radiculopathy
• Neck Pain
• Radiculopathy

Intervention

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.

Locations

Country	Name	City	State
Spain	University of Deusto	San Sebastián	Gipuzkoa

Sponsors (4)

Lead Sponsor	Collaborator
University of Deusto	Matia Foundation, Osakidetza, University of the Basque Country (UPV/EHU)

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Pre-intervention and post-intervention at week 6 - Between intervention sessions, weekly. - Mid term: at week 14
Secondary	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.	Pre-intervention and post-intervention at week 6 - Mid term: at week 14
Secondary	Neck Disability Index	It is a unidimensional questionnaire consisting of 10 sections on different activities and measuring functionality.	Pre-intervention and post-intervention at week 6 - Mid term: at week 14
Secondary	Central Sensitization Inventory (CSI)	CSI is a 25-item questionnaire to assess the presence of signs and symptoms consistent with central sensitisation.	Pre-intervention and post-intervention at week 6
Secondary	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.	Pre-intervention and post-intervention at week 6
Secondary	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.	Pre-intervention and post-intervention at week 6
Secondary	Tampa Scale of Kinesiophobia (TSK-11)	It is an 11-item questionnaire developed to identify fear of of movement.	Pre-intervention and post-intervention at week 6
Secondary	Patient Catastrophizing Scale	It is a 13-item questionnaire developed to identify catastrophising thoughts or feelings in relation to painful experiences.	Pre-intervention and post-intervention at week 6
Secondary	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.	Pre-intervention and post-intervention at week 6
Secondary	Hospital anxiety and depression scale	Is one of the most widely used tests to measure anxiety and depression in a general population of patients.	Pre-intervention and post-intervention at week 6
Secondary	Clinical examination	The clinical examination will include a detailed anamnesis considering items published by other studies.	Pre-intervention and post-intervention at week 6
Secondary	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.	Pre-intervention and post-intervention at week 6
Secondary	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	Pre-intervention and post-intervention at week 6
Secondary	Myotomes examination	The loss of strength will be manually examined that would indicate a loss of function of different nerve roots.	Pre-intervention and post-intervention at week 6
Secondary	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.	Pre-intervention and post-intervention at week 6
Secondary	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.	Pre-intervention and post-intervention at week 6
Secondary	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.	Pre-intervention and post-intervention at week 6
Secondary	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.	Pre-intervention and post-intervention at week 6
Secondary	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.	Pre-intervention and post-intervention at week 6
Secondary	Pain mapping	The participant will be asked to draw, on an electronic body map, the location and intensity of their symptoms.	Pre-intervention and post-intervention at week 6
Secondary	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.	Pre-intervention and post-intervention at week 6
Secondary	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.	Pre-intervention and post-intervention at week 6
Secondary	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.	Pre-intervention and post-intervention at week 6
Secondary	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.	Pre-intervention and post-intervention at week 6
Secondary	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.	Pre-intervention and post-intervention at week 6
Secondary	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.	Pre-intervention and post-intervention at week 6
Secondary	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	Pre-intervention