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

Primary Purpose

Cervical Radicular Pain, Cervical Radiculopathy, Cervical Pain

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Manual physiotherapy and neurodynamic exercises
Sponsored by
University of Deusto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Radicular Pain focused on measuring Cervicobrachial pain, Nerve related neck arm pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of DeustoRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Manual physiotherapy and neurodynamic exercises

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
September 22, 2023
Last Updated
September 29, 2023
Sponsor
University of Deusto
Collaborators
University of the Basque Country (UPV/EHU), Matia Foundation, Osakidetza
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1. Study Identification

Unique Protocol Identification Number
NCT06069362
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 20, 2023 (Actual)
Primary Completion Date
April 20, 2024 (Anticipated)
Study Completion Date
October 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Deusto
Collaborators
University of the Basque Country (UPV/EHU), Matia Foundation, Osakidetza

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Radicular Pain, Cervical Radiculopathy, Cervical Pain
Keywords
Cervicobrachial pain, Nerve related neck arm pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single arm clinical trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
91 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Manual physiotherapy and neurodynamic exercises
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Manual physiotherapy and neurodynamic exercises
Other Intervention Name(s)
Manual physiotherapy and exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Global rating of change scale
Description
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
Secondary Outcome Measure Information:
Title
Numeric Pain Rating Scale (NPRS)
Description
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
Title
Neck Disability Index
Description
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
Title
Central Sensitization Inventory (CSI)
Description
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
Title
Pain Detect Questionnaire (PD-Q)
Description
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
Title
Patient Specific Functional Scale (PSFS)
Description
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
Title
Tampa Scale of Kinesiophobia (TSK-11)
Description
It is an 11-item questionnaire developed to identify fear of of movement.
Time Frame
Pre-intervention and post-intervention at week 6
Title
Patient Catastrophizing Scale
Description
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
Title
Scale for sleep quality
Description
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
Title
Hospital anxiety and depression scale
Description
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
Title
Clinical examination
Description
The clinical examination will include a detailed anamnesis considering items published by other studies.
Time Frame
Pre-intervention and post-intervention at week 6
Title
Sensitivity to touch
Description
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
Title
Myotatic reflexes of the upper extremity
Description
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
Title
Myotomes examination
Description
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
Title
Spurling test
Description
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
Title
Distraction test
Description
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
Title
Extension + rotation test
Description
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
Title
Range of motion in rotation
Description
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
Title
Examination of increased mechanosensitivity of nervous tissue
Description
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
Title
Pain mapping
Description
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
Title
Detection and thermal pain thresholds
Description
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
Title
Vibration detection threshold
Description
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
Title
Pressure pain threshold
Description
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
Title
Temporal summation of pain
Description
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
Title
Conditioned pain modulation
Description
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
Title
Offset Analgesia
Description
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
Title
Magnetic resonance imaging and radiography
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xabat Casado, PhD Cand
Phone
943326600
Ext
5247
Email
xabat.casado@deusto.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xabat Casado, PhD cand
Organizational Affiliation
University of Deusto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Deusto
City
San Sebastián
State/Province
Gipuzkoa
ZIP/Postal Code
20012
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xabat Casado, PhD cand
Phone
943326600
Ext
5247
Email
xabat.casado@deusto.es
First Name & Middle Initial & Last Name & Degree
Xabat Casado, Phd Cand

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29385943
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.
Results Reference
background
PubMed Identifier
19762151
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.
Results Reference
background
PubMed Identifier
27586831
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.
Results Reference
background

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

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