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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04168476
Other study ID # Upper Limb Neural Test 1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2019
Est. completion date February 27, 2020

Study information

Verified date October 2020
Source University of Seville
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Between 45% and 70% of the general population suffers neck pain at some point in their lives, making it one of the most frequent reasons for taking sick leave. Given its importance in physiotherapy at clinical level, we seek to observe how a scapular mobilization technique might influence the neural mechanosensitivity of the median nerve as measured by Upper Limb Neural Test 1 (ULNT1) on subjects with neck pain. Hypotheses and objectives. Performing a scapular mobilization technique on subjects with neck pain and a positive ULNT1 improves the patient's response to said test. It also decreases the patient's neck pain as measured using a Visual Analog Scale (VAS) for pain and increases grip strength. Material and method. A single-blind clinical trial was performed on subjects randomly assigned to either a treatment group or control group. The sample consisted of 60 subjects (N = 60) -30 in the treatment group (n = 30) and the other 30 as a control (n = 30) -and was made up of patients with neck pain and a positive ULNT1. A scapular mobilization was performed on the first group and on the second, a calcaneus abduction adduction on the opposite side from the positive ULNT1 as a placebo.


Description:

Mechanical cervicalgia is a very frequent and important clinical picture in physiotherapy consultations. It can be considered as a pluripatology as it covers somatic, functional, psychological and social aspects. This ailment is suffered by between 45 and 70% of the general population during some period of life and is one of the most frequent justifications of work leave and the main cause of permanent disability. Mechanical cervicalgia significantly decreases the quality of life of those who suffer from it: it frequently produces a significant disability when generating pain, functional deficit, headaches, movement restriction, vertiginous syndromes, nausea and / or vomiting, etc. This leads to reduced work time and increased health system costs, causing a strong economic and social impact. For example, Borghouts JA and Cols point out that in the Netherlands in 1996 these costs were approximately 686 million dollars, which constituted 1% of total health expenditure and 0.1% of its Gross Domestic Product (GDP) . In Spain, referrals to the cervicalgia physiotherapy service represent 10% of the total of all health demands; in Britain this percentage reaches 15% and in Canada 30%. Likewise, it should be considered that the direct cost caused by cervicalgia to the health system in our country, specifically to the Primary Care consultation, constitutes 2% of the total, and in some centers this figure reaches up to 12% if they are considered diagnostic tests, pharmaceutical expenses and visits to the specialist.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date February 27, 2020
Est. primary completion date January 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 22 Years to 79 Years
Eligibility Inclusion Criteria: - Adults with mechanical cervicalgia and a positive median neurodynamic test (ULNT1) reproducing the patient's cervical pain. - Sign the informed consent. Exclusion Criteria: - Do not sign informed consent. - Patients who, due to previous malformations or injuries, are not able to be positioned in the position described for the ULNT1 test. - Congenital malformations of the cervical spine and / or upper limb. - Previous spine surgery. - Neurological pathologies diagnosed, such as diabetic polyneuritis or others. - Refusal to participate in the study.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Interscapular muscle release or scapular mobilization technique as described by Travell and Simons.
Patient is sidelying with the testing side up. The auditor stands in front of the patient, reaches over the patient's shoulder to grasp the upper portion of the vertebral border of the scapula, and the other arm reaches under the patient's humerus to grasp the lower portion of the vertebral border of the scapula. The auditor then slowly moves the scapula into elevation/depression, internal/external rotation/abduction and adduction. To standardize the technique and be able to reproduce it in each participant, a set of 10 repetitions for each movement was performed in the same order.
Calcaneus abduction and adduction mobilization technique
Abduction and adduction mobilization of the calcaneus is carried out in the opposite side of the upper extremity measured.

Locations

Country Name City State
Spain Aitor Vaquero Garrido Sevilla

Sponsors (1)

Lead Sponsor Collaborator
Aitor Vaquero Garrido

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Other Hand pressing force To measure the grip force of the hand we use the Dynamometer hydraulic baseline (SP-5030J1). We always place the subject in the same position to ensure that the conditions were the same, seated subject, shoulder adducted and in neutral rotation, 90º bend of the elbow, neutral position of the forearm, wrist in slight dorsal flexion (always between 0º and 30º) and a cubital deviation between 0º and 15º. Five minutes
Primary Goniometer Test The axis of the Goniometer is placed On the elbow joint. The stationary arm is lined up with the arm and the moveable arm along the forearm. The subject is asked to perform elbow extension and the angle is measured.
Improvement of this angle 10º. Inmediately after the intervention
Two minutes
Secondary Neck pain Improvement of this 0,5 Newtons. Using a visual pain scale, with values between 0 and 10, the subject marks the intensity level of the neck pain. Inmediately after the intervention Two minutes
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