Shoulder Proprioceptive Training During Immobilization of the Wrist

NCT ID: NCT05943340

Last Updated: 2023-10-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2024-12-12

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.

Conditions

Wrist Fractures; Shoulder Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control group

Patients that are undergoing immobilization period after a distal radius fracture.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Experimental group

Patients that are undergoing immobilization period after a distal radius fracture.

Group Type: EXPERIMENTAL

Proprioceptive exercises

Intervention Type: OTHER

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

Interventions

Proprioceptive exercises

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Malaga

OTHER

Sponsor Role: lead

Responsible Party

Leire Cruz-Gambero

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

RaqCan83

Identifier Type: -

Identifier Source: org_study_id