ULNT1: Effectiveness of Scapula Mobilization on Mechanosensitivity of Upper Limb Neural Test 1 in Mechanical Neck Pain

Sponsor
Aitor Vaquero Garrido (Other)
Overall Status
Completed
CT.gov ID
NCT04168476
Collaborator
(none)
60
1
2
2.9
20.8

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Interscapular muscle release or scapular mobilization technique as described by Travell and Simons.
  • Other: Calcaneus abduction and adduction mobilization technique
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized prospective controlled trialRandomized prospective controlled trial
Masking:
Single (Participant)
Masking Description:
Single-blind clinical trial
Primary Purpose:
Treatment
Official Title:
Effectiveness of Scapula Mobilization Technique on Neural Mechanosensitivity of Upper Limb Neural Test 1 (ULNT1) in Subjects With Mechanical Neck Pain
Actual Study Start Date :
Dec 1, 2019
Actual Primary Completion Date :
Jan 1, 2020
Actual Study Completion Date :
Feb 27, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment group

Participants of this group were assessed by the examiner twice, pre and post intervention, having recorded two values for each of the following variables: Visual Analogue Scale Range of movement Hand grip strength. After a first assessment, scapula mobilization techniques were performed and participants reassessed.

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.

Placebo Comparator: Control group

Participants of this group were assessed by the examiner twice, pre and post intervention, having recorded two values for each of the following variables: Visual Analogue Scale Range of movement Hand grip strength. The procedure was a contralateral calcaneus abduction and adduction mobilization technique was carried out.

Other: 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.

Outcome Measures

Primary Outcome Measures

  1. Goniometer Test [Two minutes]

    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

Secondary Outcome Measures

  1. Neck pain [Two minutes]

    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

Other Outcome Measures

  1. Hand pressing force [Five minutes]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years to 79 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Aitor Vaquero Garrido Sevilla Spain 41009

Sponsors and Collaborators

  • Aitor Vaquero Garrido

Investigators

  • Study Chair: Aitor Vaquero Garrido, University of Seville

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Aitor Vaquero Garrido, Research Master, University of Seville
ClinicalTrials.gov Identifier:
NCT04168476
Other Study ID Numbers:
  • Upper Limb Neural Test 1
First Posted:
Nov 19, 2019
Last Update Posted:
Oct 19, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Aitor Vaquero Garrido, Research Master, University of Seville
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 19, 2020