Shoulder Proprioceptive Training During Immobilization of the Wrist

Effects of Proprioceptive Training on Shoulder's Muscle Mass After Distal Radius Fracture. Randomized Clinical Trial.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Shoulder Pain; Wrist Fractures
• Intervention / Treatment: Other: Proprioceptive exercises

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.

• Study Type: Interventional
• Enrollment (Estimated): 28
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Patients that are undergoing immobilization period after a distal radius fracture.
Experimental: Experimental group; Patients that are undergoing immobilization period after a distal radius fracture.	Other: Proprioceptive exercises; Specific proprioceptive exercises for the shoulder that the patient has to do during the immobilization period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Change in shoulders muscle load	Electromyographic study of the shoulder's muscles	Begining of the injury, baseline, 4 weeks and 3 months
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Malaga

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): July 27, 2024
• Study Completion (Estimated): December 12, 2024

Study Registration Dates

• First Submitted: June 21, 2023
• First Submitted That Met QC Criteria: July 4, 2023
• First Posted (Actual): July 13, 2023

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Function; Proprioceptive exercises
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Fractures, Bone; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Arm Injuries; Wrist Injuries; Shoulder Pain; Wrist Fractures
• Other Study ID Numbers: RaqCan83

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No