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

NCT06069362 | Recruiting

• 1 other identifier: FST_DCB
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Radicular Pain; Cervical Radiculopathy; Cervical Pain

Keywords

Cervicobrachial pain; Nerve related neck arm pain

Outcome Measures

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.

  Pre-intervention and post-intervention at week 6 - Between intervention sessions, weekly. - Mid term: at week 14

Secondary Outcomes (26)

• Numeric Pain Rating Scale (NPRS)

  Pre-intervention and post-intervention at week 6 - Mid term: at week 14

• Neck Disability Index

  Pre-intervention and post-intervention at week 6 - Mid term: at week 14

• Central Sensitization Inventory (CSI)

  Pre-intervention and post-intervention at week 6

• Pain Detect Questionnaire (PD-Q)

  Pre-intervention and post-intervention at week 6

• Patient Specific Functional Scale (PSFS)

  Pre-intervention and post-intervention at week 6

Study Arms (1)

Manual physiotherapy and neurodynamic exercises

EXPERIMENTAL

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

Interventions

Manual physiotherapy and neurodynamic exercises 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.

Also known as: Manual physiotherapy and exercise

Manual physiotherapy and neurodynamic exercises

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with unilateral cervicobrachial pain

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Deusto: lead
• University of the Basque Country (UPV/EHU): collaborator
• Matia Foundation: collaborator
• Osakidetza: collaborator

Study Sites (1)

University of Deusto

San Sebastián, Gipuzkoa, 20012, Spain

RECRUITING

Related Publications (3)

• 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.

  PMID: 29385943 BACKGROUND

• 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.

  PMID: 19762151 BACKGROUND

• 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.

  PMID: 27586831 BACKGROUND

MeSH Terms

Conditions

Radiculopathy; Neck Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Xabat Casado, PhD cand

  University of Deusto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xabat Casado, PhD Cand

CONTACT

943326600; xabat.casado@deusto.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Model Details: Single arm clinical trial

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: October 5, 2023
• Study Start: April 20, 2023
• Primary Completion: July 20, 2025
• Study Completion: July 20, 2025
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)