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Shoulder Proprioceptive Training During Immobilization of the Wrist

Not Applicable
Not yet recruiting
Conditions
Shoulder Pain
Wrist Fractures
Interventions
Other: Proprioceptive exercises
Registration Number
NCT05943340
Lead Sponsor
University of Malaga
Brief 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.

Detailed 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 & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
28
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

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Experimental groupProprioceptive exercisesPatients that are undergoing immobilization period after a distal radius fracture.
Primary Outcome Measures
NameTimeMethod
Change in perception of Pain, referred to shoulderBegining of the injury, baseline, 4 weeks and 3 months

Pain measured with Numerical Rating Scale (NRS). 0= no pain and 10=worst pain.

Change in function related with daily living activitiesBegining of the injury, baseline, 4 weeks and 3 months

Measured with QuickDash. 11 items, 0= no disability and 100=total disability

Change in disability related with shoulderBegining of the injury, baseline, 4 weeks and 3 months

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.

Secondary Outcome Measures
NameTimeMethod
Change in range of motion of the shoulderBegining of the injury, baseline, 4 weeks and 3 months

Active range of motion of the shoulder in all planes of motion

Change in shoulders muscle loadBegining of the injury, baseline, 4 weeks and 3 months

Electromyographic study of the shoulder's muscles

Changes in kinesiophobia, fear of movementBegining of the injury, baseline, 4 weeks and 3 months

Measured with Tampa Scale for Kinesiophobia (TSK). Punctuation goes from 17 to 68, from 36 points means presence of kinesiophobia.

Changes in fear of movementBegining of the injury, baseline, 4 weeks and 3 months

Measured with "Fear Avoidance Beliefs Q questionnarie" (FAB). 16 ítems. Punctuation goes from 0 to 96 points. More points means more fear and avoidance.

Change in Perception of Quality of lifeBegining of the injury, baseline, 4 weeks and 3 months

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).

Changes in catastrophizing painBegining of the injury, baseline, 4 weeks and 3 months

Measured with Pain Catastrophizing Scale (PCS).13 items. Total punctuation goes from 0 to 52, where more points means more catastrophism level.

Changes in self-efficacy related to painBegining of the injury, baseline, 4 weeks and 3 months

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.

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