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

NCT ID: NCT06069362

Last Updated: 2025-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-20

Study Completion Date

2025-07-20

Brief Summary

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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

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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.

Conditions

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Cervical Radicular Pain Cervical Radiculopathy Cervical Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single arm clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Manual physiotherapy and neurodynamic exercises

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.

Group Type EXPERIMENTAL

Manual physiotherapy and neurodynamic exercises

Intervention Type OTHER

* 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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Manual physiotherapy and exercise

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of the Basque Country (UPV/EHU)

OTHER

Sponsor Role collaborator

Matia Foundation

OTHER

Sponsor Role collaborator

Osakidetza

OTHER

Sponsor Role collaborator

University of Deusto

OTHER

Sponsor Role lead

Responsible Party

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Xabat Casado

Physiotherapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xabat Casado, PhD cand

Role: PRINCIPAL_INVESTIGATOR

University of Deusto

Locations

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University of Deusto

San Sebastián, Gipuzkoa, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Xabat Casado, PhD Cand

Role: CONTACT

943326600 ext. 5247

Facility Contacts

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Xabat Casado, PhD cand

Role: primary

943326600 ext. 5247

References

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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.

Reference Type BACKGROUND
PMID: 29385943 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19762151 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27586831 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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FST_DCB

Identifier Type: -

Identifier Source: org_study_id

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