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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05943340
Other study ID # RaqCan83
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 1, 2023
Est. completion date December 12, 2024

Study information

Verified date October 2023
Source University of Malaga
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Distal radius fracture (DRF) in one of the most frequent injuries in the upper limb, corresponding to 1/6 of the total fractures of the body. It appears mostly in >50 years old women (due to osteoporosis and menopause) but it is also frequent in middle age men as a consequence of a big trauma during sport activities or working. This injury can be treated conservative of surgically, but regardless of the treatment, it always has a period of immobilization between 3 to 6 weeks. During the immobilization period, proximal structures suffer changes in mobility. Shoulder's ROM has to increased in order to compensate the immobilization of the wrist. Previous studies shown that there is a relation between time of immobilization and shoulder pain. Shoulder pain can significantly affect daily living activities as driving, dressing or even eating. Also, pain does not appear only on it's own, but with other psychological factors as catastrophism, lower self-efficacy, fear of movement and avoidance. These factors could be crucial to predict disability in these patients, hence they should not be ignored during the rehabilitation process. Our hypothesis is that the implementation of a proprioceptive shoulder exercise program during the period of immobilization may help and/or prevent shoulder pain secondary to immobilization.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Proprioceptive exercises
Specific proprioceptive exercises for the shoulder that the patient has to do during the immobilization period.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Malaga

Outcome

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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