Wrist FracturesNCT05943340
Shoulder Proprioceptive Training During Immobilization of the Wrist
A study testing Proprioceptive exercises in people with Wrist Fractures and Shoulder Pain, run by University of Malaga.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wrist Fractures, Shoulder Pain
- What is being tested?
- Proprioceptive exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 12 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
Read more
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.
Read the 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
- Being tested
- Proprioceptive exercises
- Keywords
- Proprioceptive exercises, Function
- Medical subject headings
- Wrist Fractures, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioceptive exercisesOther
Specific proprioceptive exercises for the shoulder that the patient has to do during the immobilization period.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Patients that are undergoing immobilization period after a distal radius fracture. |
| Experimental group | Experimental | Patients that are undergoing immobilization period after a distal radius fracture. Receives: Other: Proprioceptive exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in function related with daily living activities
Measured with QuickDash. 11 items, 0= no disability and 100=total disability
Measured: 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.
Measured: 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.
Measured: Begining of the injury, baseline, 4 weeks and 3 months
Secondary outcomes (7)
Change in range of motion of the shoulder
Active range of motion of the shoulder in all planes of motion
Measured: 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).
Measured: Begining of the injury, baseline, 4 weeks and 3 months
Change in shoulders muscle load
Electromyographic study of the shoulder's muscles
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Begining of the injury, baseline, 4 weeks and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start1 Dec 2023 (estimated)
- Primary completion27 Jul 2024 (estimated)
- Study completion12 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wrist FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leire Cruz-Gambero, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05943340
- Sponsor's protocol ID
- RaqCan83
- Status last verified
- Oct 2023
- First submitted
- 21 Jun 2023
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Proprioceptive Training on Shoulder's Muscle Mass After Distal Radius Fracture. Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT05943340
- Acronym / sponsor ID
- RaqCan83
- Conditions
- Wrist Fractures, Shoulder Pain
- Keywords
- Proprioceptive exercises, Function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 27 Jul 2024 (estimated)
- Study completion
- 12 Dec 2024 (estimated)
- First posted
- 13 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Patients that are undergoing immobilization period after a distal radius fracture. |
| Experimental group | Experimental | Other: Proprioceptive exercisesPatients that are undergoing immobilization period after a distal radius fracture. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proprioceptive exercisesSpecific proprioceptive exercises for the shoulder that the patient has to do during the immobilization period. | Other | Experimental group |
Primary outcome
Change in function related with daily living activities
Time frame: Begining 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 shoulder
Time frame: Begining 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.
Change in perception of Pain, referred to shoulder
Time frame: Begining of the injury, baseline, 4 weeks and 3 months
Pain measured with Numerical Rating Scale (NRS). 0= no pain and 10=worst pain.
7 secondary outcomes
Change in range of motion of the shoulder
Time frame: Begining of the injury, baseline, 4 weeks and 3 months
Change in Perception of Quality of life
Time frame: Begining of the injury, baseline, 4 weeks and 3 months
Change in shoulders muscle load
Time frame: Begining of the injury, baseline, 4 weeks and 3 months
Changes in catastrophizing pain
Time frame: Begining of the injury, baseline, 4 weeks and 3 months
Changes in kinesiophobia, fear of movement
Time frame: Begining of the injury, baseline, 4 weeks and 3 months
Changes in fear of movement
Time frame: Begining of the injury, baseline, 4 weeks and 3 months
Changes in self-efficacy related to pain
Time frame: Begining of the injury, baseline, 4 weeks and 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Proprioceptive exercises in people with Wrist Fractures and Shoulder Pain, run by University of Malaga.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in function related with daily living activities (time frame: Begining of the injury, baseline, 4 weeks and 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023.