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

Not Applicable

Completed

• Conditions: Macular Holes; Retinal Detachment
• Interventions: Behavioral: A structured exercise

• Registration Number: NCT04535622
• Lead Sponsor: Samsung Medical Center

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-08-26
• Study First Submitted QC: 2020-08-27
• Study First Posted: 2020-09-02
• Study Start: 2020-09-03
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-13
• Primary Completion: 2020-12-14
• Study Completion: 2020-12-14
• Last Update Posted: 2020-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise group	A structured exercise	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.

Primary Outcome Measures

Name	Time	Method
Final pain score at back neck, shoulder, and lower back	postoperative day 3	Pain score (numerical rating scale) at back neck, shoulder, and lower back at postoperative day 3 (discharge day). Possible scores range from 0 (no pain) to 10 (worst possible pain).

Secondary Outcome Measures

Name	Time	Method
pain score at back neck, shoulder, and lower back right on surgery day	surgery day	Pain score based on numerical rating scale at back neck, shoulder, and lower back at postoperative day 1. Possible scores range from 0 (no pain) to 10 (worst possible pain).
pain score at back neck, shoulder, and lower back on postoperative day 1	postoperative day 1	Pain score based on numerical rating scale at back neck, shoulder, and lower back at postoperative day 2. Possible scores range from 0 (no pain) to 10 (worst possible pain).
pain score at back neck, shoulder, and lower back on postoperative day 2	postoperative day 2	Pain score based on numerical rating scale at back neck, shoulder, and lower back at postoperative day 2. Possible scores range from 0 (no pain) to 10 (worst possible pain).

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of