- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04168476
Effectiveness of Scapula Mobilization on Mechanosensitivity of Upper Limb Neural Test 1 in Mechanical Neck Pain (ULNT1)
Effectiveness of Scapula Mobilization Technique on Neural Mechanosensitivity of Upper Limb Neural Test 1 (ULNT1) in Subjects With Mechanical Neck Pain
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Sevilla, Spain, 41009
- Aitor Vaquero Garrido
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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:
|
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:
|
Abduction and adduction mobilization of the calcaneus is carried out in the opposite side of the upper extremity measured.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Goniometer Test
Time Frame: 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 |
Two minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neck pain
Time Frame: 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
|
Two minutes
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hand pressing force
Time Frame: 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.
|
Five minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Aitor Vaquero Garrido, University of Seville
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Upper Limb Neural Test 1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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