Shoulder Pain Clinical Trial
Official title:
Effects of Proprioceptive Training on Shoulder's Muscle Mass After Distal Radius Fracture. Randomized Clinical Trial.
Verified date | October 2023 |
Source | University of Malaga |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this randomized clinical trial is to compare how a program of proprioceptive exercises for the shoulder could influence in pain, functionality, quality of life and shoulder muscle overload in people that are undergoing a immobilization period after a wrist fracture. The main questions it aims to answer are: - Study the relationship between shoulder muscle overload and shoulder pain. - Evaluate the effect of a proprioceptive program on pain and patient's satisfaction. Intervention will be: - Control group: participants of this group are not going to receive any protocol of exercises during the immobilization period. - Experimental group: participants of this group are going to receive a protocol of proprioceptive shoulder exercises to do during the immobilization period. Researchers will compare control and experimental group to see if a implantation of a proprioceptive program for the shoulder has benefits on pain, function, quality of life and muscle overload.
Status | Not yet recruiting |
Enrollment | 28 |
Est. completion date | December 12, 2024 |
Est. primary completion date | July 27, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adult (equal or more than 18 y/o). - Suffering a distal radius fracture and being in the first week of the immobilization period. - Agree and sign informed consent. Exclusion Criteria: - Not had suffered a distal radius fracture and/or not being on the immobilization period. - Suffer any mental, cognitive, neurological or musculoskeletal disorder. - Previous injury or pathology of the shoulder diagnosed as fractures, instability, shoulder pain or capsulitis. - Previous shoulder surgery. - Have cervical pathology/impairment. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of Malaga |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in function related with daily living activities | Measured with QuickDash. 11 items, 0= no disability and 100=total disability | Begining of the injury, baseline, 4 weeks and 3 months | |
Primary | Change in disability related with shoulder | Measured with Shoulder Pain and Disability Index (SPADI). 13 items, with 2 subscales (pain and disability). Pain subscale goes from 0-50 points and disability subscale goes from 0 to 80 points. Total punctuation is expressed as a percentage. More points indicates more disability. | Begining of the injury, baseline, 4 weeks and 3 months | |
Primary | Change in perception of Pain, referred to shoulder | Pain measured with Numerical Rating Scale (NRS). 0= no pain and 10=worst pain. | Begining of the injury, baseline, 4 weeks and 3 months | |
Secondary | Change in range of motion of the shoulder | Active range of motion of the shoulder in all planes of motion | Begining of the injury, baseline, 4 weeks and 3 months | |
Secondary | Change in Perception of Quality of life | EuroQol-5D. It has 5 dimensions, mobility, self-care, daily activities, pain and anxiety and depression. Patient determines the level of agreement with the affirmations (3 options). | Begining of the injury, baseline, 4 weeks and 3 months | |
Secondary | Change in shoulders muscle load | Electromyographic study of the shoulder's muscles | Begining of the injury, baseline, 4 weeks and 3 months | |
Secondary | Changes in catastrophizing pain | Measured with Pain Catastrophizing Scale (PCS).13 items. Total punctuation goes from 0 to 52, where more points means more catastrophism level. | Begining of the injury, baseline, 4 weeks and 3 months | |
Secondary | Changes in kinesiophobia, fear of movement | Measured with Tampa Scale for Kinesiophobia (TSK). Punctuation goes from 17 to 68, from 36 points means presence of kinesiophobia. | Begining of the injury, baseline, 4 weeks and 3 months | |
Secondary | Changes in fear of movement | Measured with "Fear Avoidance Beliefs Q questionnarie" (FAB). 16 ítems. Punctuation goes from 0 to 96 points. More points means more fear and avoidance. | Begining of the injury, baseline, 4 weeks and 3 months | |
Secondary | Changes in self-efficacy related to pain | Measured with Chronic Pain Self-efficacy Scale (CPSES). 19 items. Punctuation goes from 0 to 60 points. High scores indicate greater levels of confidence in dealing with pain. | Begining of the injury, baseline, 4 weeks and 3 months |
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