Shoulder Proprioceptive Training During Immobilization of the Wrist

NCT05943340 | Unknown

• 1 other identifier: RaqCan83
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Wrist Fractures; Shoulder Pain

Keywords

Proprioceptive exercises; Function

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Change in range of motion of the shoulder

  Begining of the injury, baseline, 4 weeks and 3 months

• Change in Perception of Quality of life

  Begining of the injury, baseline, 4 weeks and 3 months

• Change in shoulders muscle load

  Begining of the injury, baseline, 4 weeks and 3 months

• Changes in catastrophizing pain

  Begining of the injury, baseline, 4 weeks and 3 months

• Changes in kinesiophobia, fear of movement

  Begining of the injury, baseline, 4 weeks and 3 months

Study Arms (2)

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.

Other: Proprioceptive exercises

Interventions

Proprioceptive exercises OTHER

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

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaga: lead

MeSH Terms

Conditions

Wrist Fractures; Shoulder Pain

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be anonymized with a number and randomized with a web program (random.org)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: July 13, 2023
• Study Start: December 1, 2023
• Primary Completion: July 27, 2024
• Study Completion: December 12, 2024
• Last Updated: October 19, 2023

Record last verified: 2023-10