Shoulder Pain Clinical Trial
Official title:
The Effectiveness of Augmented Reality Combined With Scapular Repositioning Exercises in Patients With Chronic Shoulder Pain and Scapular Dyskinesis: a Randomized Clinical Trial
Verified date | November 2022 |
Source | University of Alcala |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Spain | Ruben Fernandez-Matias | Alcalá De Henares |
Lead Sponsor | Collaborator |
---|---|
Ruben Fernandez Matias |
Spain,
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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