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Shoulder Proprioceptive Training During Immobilization of the Wrist

Primary Purpose

Wrist Fractures, Shoulder Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Proprioceptive exercises
Sponsored by
University of Malaga
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wrist Fractures focused on measuring Proprioceptive exercises, Function

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control group

    Experimental group

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Change in function related with daily living activities
    Measured with QuickDash. 11 items, 0= no disability and 100=total disability
    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.
    Change in perception of Pain, referred to shoulder
    Pain measured with Numerical Rating Scale (NRS). 0= no pain and 10=worst pain.

    Secondary Outcome Measures

    Change in range of motion of the shoulder
    Active range of motion of the shoulder in all planes of motion
    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).
    Change in shoulders muscle load
    Electromyographic study of the shoulder's muscles
    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.
    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.
    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.
    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.

    Full Information

    First Posted
    June 21, 2023
    Last Updated
    October 18, 2023
    Sponsor
    University of Malaga
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05943340
    Brief Title
    Shoulder Proprioceptive Training During Immobilization of the Wrist
    Official Title
    Effects of Proprioceptive Training on Shoulder's Muscle Mass After Distal Radius Fracture. Randomized Clinical Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2023 (Anticipated)
    Primary Completion Date
    July 27, 2024 (Anticipated)
    Study Completion Date
    December 12, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Malaga

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Wrist Fractures, Shoulder Pain
    Keywords
    Proprioceptive exercises, Function

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Masking Description
    Participants will be anonymized with a number and randomized with a web program (random.org)
    Allocation
    Randomized
    Enrollment
    28 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    Patients that are undergoing immobilization period after a distal radius fracture.
    Arm Title
    Experimental group
    Arm Type
    Experimental
    Arm Description
    Patients that are undergoing immobilization period after a distal radius fracture.
    Intervention Type
    Other
    Intervention Name(s)
    Proprioceptive exercises
    Intervention Description
    Specific proprioceptive exercises for the shoulder that the patient has to do during the immobilization period.
    Primary Outcome Measure Information:
    Title
    Change in function related with daily living activities
    Description
    Measured with QuickDash. 11 items, 0= no disability and 100=total disability
    Time Frame
    Begining of the injury, baseline, 4 weeks and 3 months
    Title
    Change in disability related with shoulder
    Description
    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.
    Time Frame
    Begining of the injury, baseline, 4 weeks and 3 months
    Title
    Change in perception of Pain, referred to shoulder
    Description
    Pain measured with Numerical Rating Scale (NRS). 0= no pain and 10=worst pain.
    Time Frame
    Begining of the injury, baseline, 4 weeks and 3 months
    Secondary Outcome Measure Information:
    Title
    Change in range of motion of the shoulder
    Description
    Active range of motion of the shoulder in all planes of motion
    Time Frame
    Begining of the injury, baseline, 4 weeks and 3 months
    Title
    Change in Perception of Quality of life
    Description
    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).
    Time Frame
    Begining of the injury, baseline, 4 weeks and 3 months
    Title
    Change in shoulders muscle load
    Description
    Electromyographic study of the shoulder's muscles
    Time Frame
    Begining of the injury, baseline, 4 weeks and 3 months
    Title
    Changes in catastrophizing pain
    Description
    Measured with Pain Catastrophizing Scale (PCS).13 items. Total punctuation goes from 0 to 52, where more points means more catastrophism level.
    Time Frame
    Begining of the injury, baseline, 4 weeks and 3 months
    Title
    Changes in kinesiophobia, fear of movement
    Description
    Measured with Tampa Scale for Kinesiophobia (TSK). Punctuation goes from 17 to 68, from 36 points means presence of kinesiophobia.
    Time Frame
    Begining of the injury, baseline, 4 weeks and 3 months
    Title
    Changes in fear of movement
    Description
    Measured with "Fear Avoidance Beliefs Q questionnarie" (FAB). 16 ítems. Punctuation goes from 0 to 96 points. More points means more fear and avoidance.
    Time Frame
    Begining of the injury, baseline, 4 weeks and 3 months
    Title
    Changes in self-efficacy related to pain
    Description
    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.
    Time Frame
    Begining of the injury, baseline, 4 weeks and 3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

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    Shoulder Proprioceptive Training During Immobilization of the Wrist

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