search
Back to results

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

Primary Purpose

Neck Pain, Musculoskeletal Diseases

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Interscapular muscle release or scapular mobilization technique as described by Travell and Simons.
Calcaneus abduction and adduction mobilization technique
Sponsored by
Aitor Vaquero Garrido
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Median Nerve, Hand Strength, Brachial plexus, Physical Therapy Modalities, Neck Pain

Eligibility Criteria

22 Years - 79 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Aitor Vaquero Garrido

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 15, 2019
Last Updated
October 14, 2020
Sponsor
Aitor Vaquero Garrido
search

1. Study Identification

Unique Protocol Identification Number
NCT04168476
Brief Title
Effectiveness of Scapula Mobilization on Mechanosensitivity of Upper Limb Neural Test 1 in Mechanical Neck Pain
Acronym
ULNT1
Official Title
Effectiveness of Scapula Mobilization Technique on Neural Mechanosensitivity of Upper Limb Neural Test 1 (ULNT1) in Subjects With Mechanical Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
February 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Aitor Vaquero Garrido

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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Musculoskeletal Diseases
Keywords
Median Nerve, Hand Strength, Brachial plexus, Physical Therapy Modalities, Neck Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized prospective controlled trial
Masking
Participant
Masking Description
Single-blind clinical trial
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Interscapular muscle release or scapular mobilization technique as described by Travell and Simons.
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Calcaneus abduction and adduction mobilization technique
Intervention Description
Abduction and adduction mobilization of the calcaneus is carried out in the opposite side of the upper extremity measured.
Primary Outcome Measure Information:
Title
Goniometer Test
Description
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
Time Frame
Two minutes
Secondary Outcome Measure Information:
Title
Neck pain
Description
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
Time Frame
Two minutes
Other Pre-specified Outcome Measures:
Title
Hand pressing force
Description
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.
Time Frame
Five minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aitor Vaquero Garrido
Organizational Affiliation
University of Seville
Official's Role
Study Chair
Facility Information:
Facility Name
Aitor Vaquero Garrido
City
Sevilla
ZIP/Postal Code
41009
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs