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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT05088668
Other study ID # 25072021
Secondary ID
Status Suspended
Phase N/A
First received
Last updated
Start date October 27, 2021
Est. completion date December 1, 2028

Study information

Verified date November 2022
Source University of Alcala
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to analyze whether an Augmented Reality based scapular stabilization exercise program is more effective than conventional programs in patients with chronic shoulder pain and Scapular Dyskinesis.


Recruitment information / eligibility

Status Suspended
Enrollment 52
Est. completion date December 1, 2028
Est. primary completion date May 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Unilateral mechanical shoulder pain of nonspecific origin (non-traumatic) lasting at least 3 months. - Weakness in flexion, abduction and/or external rotation isometric strength testing. - Presence of scapular dyskinesis according to Kibler, Scapular Assistance Test, and Scapular Reposition Test. Exclusion Criteria: - Previous shoulder surgery. - History of shoulder fracture or glenohumeral luxation. - History of acromioclavicular joint injury. - Presence of massive rotator cuff rears. - Presence of frozen shoulder. - Cervical hernias or radiculopathy. - Fibromyalgia. - Neuropathic pain. - Cervical and/or vestibular problems with dizziness, unsteadiness, or vertigo. - Medical contraindication for performing exercise (cardio-vascular or cardio-pulmonar diseases, systemic diseases, metabolic diseases in non-controlled acute state). - Blindness. - Actually being treated with physical therapy for shoulder pain.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Augmented reality
The subjects will perform scapular repositioning exercise using glasses of augmented reality to see their scapular movement simultaneously. Furthermore, they will also see at the same time a video record of an "ideal" scapular movement, and will me encouraged to simulate that "ideal" scapular movement.
Scapular repositioning exercise
Subjects will perform scapular repositioning exercises for improving scapular movement.

Locations

Country Name City State
Spain Ruben Fernandez-Matias Alcalá De Henares

Sponsors (1)

Lead Sponsor Collaborator
Ruben Fernandez Matias

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in pain intensity Pain intensity measured with a visual analogue scale which ranges from 0 (no pain) to 10 (worst imaginable pain). Baseline, change from baseline at 1-month, change from baseline at 2-months, change from baseline at 3-months, and change from baseline at 6-months
Secondary Change in shoulder disability Shoulder disability measured with Shoulder Pain and Disability Index (SPADI), which ranges from 0 (no disability) to 100 (maximum degree of disability). Baseline, change from baseline at 1-month, change from baseline at 2-months, change from baseline at 3-months, and change from baseline at 6-months
Secondary Change in arm disability Arm disability measured with Disabilities of the Arm, Shoulder, and Hand (Quick-DASH), which ranges from 0 (no disability) to 100 (maximum degree of disability). Baseline, change from baseline at 1-month, change from baseline at 2-months, change from baseline at 3-months, and change from baseline at 6-months
Secondary Change in kinesiophobia Kinesiophobia measured with Tampa Scale of Kinesiophobia (TSK-11), which ranges from 0 (no kinesiophobia) to 100 (maximum degree of kinesiophobia) Baseline, change from baseline at 1-month, change from baseline at 2-months, change from baseline at 3-months, and change from baseline at 6-months
Secondary Change in catastrophism Pain catastrophism measured with Pain Catastrophism Scale (PCS), which ranges from 0 (no catastrophism) to 100 (severe catastrophism). Baseline, change from baseline at 1-month, change from baseline at 2-months, change from baseline at 3-months, and change from baseline at 6-months
Secondary Change in shoulder range of motion Shoulder range of motion in abduction, flexion, internal and external rotation, measured with a goniometer Baseline, 1-month, 2-months, 3-months, and 6-months
Secondary Change in surface electromiography Electromiographic activity of serratus anterior, upper trapezius, lower trapezius, and deltoid medimum muscles. Percent of electromiographic activity as a function of maximum voluntary isometric contraction, as well as latency of muscle activation during scaption will be recorded. Baseline, change from baseline at 1-month, change from baseline at 2-months, change from baseline at 3-months, and change from baseline at 6-months
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