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Efficacy of Exercise Program for Facedown Posture-related Pain After Retinal Surgery

NCT ID: NCT04535622

Last Updated: 2020-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-03

Study Completion Date

2020-12-14

Brief Summary

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The purpose of this study is to evaluate the effects of a structured exercise program on musculoskeletal pain of patients in face-down posture after retinal surgery.

Detailed Description

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After being informed about the study, patients who are planning to get vitrectomy for macular hole or retinal detachment are going to be randomly assigned into two groups; exercise group and control group. All patients are going be admitted to the hospital prior to the surgery. After the surgery is done, the patients are going to maintain a face-down position in the ward until postoperative day 3. After returning to the ward after surgery and completed the pain scoring forms, exercise training is going to be conducted for patients assigned to the exercise group by a physical therapist. Three times of daily self-exercise sessions are going to be performed according to the training provided to the patients. Pain score will be measured on the first, second and the third postoperative days. Patients will be discharged on the third postoperative days.

Conditions

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Macular Holes Retinal Detachment

Keywords

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face-down posture musculoskeletal pain vitrectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
Due to the nature of the interventions participants and researchers cannot be blinded to group allocation. The treating healthcare professionals (i.e. the Research Nurse and Clinical Research Fellow) will also not be masked due to nature of the service. The surgeon will be masked to allocation. The data manager and trial statistician will be masked to allocation throughout the study.

Study Groups

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Exercise group

A structured exercise instruction for facedown posture-related pain will be provided to the patients, and patients will go through three times of self-exercise sessions everyday according to the training provided.

Group Type EXPERIMENTAL

A structured exercise

Intervention Type BEHAVIORAL

Exercise training will be conducted by a physical therapist which will take about 10 to 15 minutes. Patient education will include how to keep face down in various postures, and how to actively exercise the related muscles and joints while maintaining face-down posture through video clip and brochure. Patients will go through three times of self-exercise sessions everyday according to the training provided to the patients. Active exercise for the FDP patients will include exercise in a hands and knees position, limb exercise in an FDP, and exercise in a standing position. The exercises were performed within the range of individual muscle strength and fitness.

Control group

Patients are going to maintain face-down posture but no specific exercise instruction will be provided.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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A structured exercise

Exercise training will be conducted by a physical therapist which will take about 10 to 15 minutes. Patient education will include how to keep face down in various postures, and how to actively exercise the related muscles and joints while maintaining face-down posture through video clip and brochure. Patients will go through three times of self-exercise sessions everyday according to the training provided to the patients. Active exercise for the FDP patients will include exercise in a hands and knees position, limb exercise in an FDP, and exercise in a standing position. The exercises were performed within the range of individual muscle strength and fitness.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Patients who are getting vitrectomy for macular hole or retinal detachment and planning to maintain face-down posture.

Exclusion Criteria

* Pre-existing musculoskeletal disorder.
* low visiual acuity in the opposite eye (best-corrected visual acuity less than 20/200 by snellen chart) making patients hard to get the exercise training.
* Patients with posture prescriptions other than the prone position
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Se Woong, Kang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Se Woong Kang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2019-03-157

Identifier Type: -

Identifier Source: org_study_id