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

A Randomized Controlled Trial to Evaluate Effect of a Structured Rehabilitation Exercise Program on Facedown Posture-related Pain After Retinal Surgery

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.

Study Overview

• Status: Completed
• Conditions: Retinal Detachment; Macular Holes
• Intervention / Treatment: Behavioral: A structured exercise

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
No Intervention: Control group; Patients are going to maintain face-down posture but no specific exercise instruction will be provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Final pain score at back neck, shoulder, and lower back	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).	postoperative day 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain score at back neck, shoulder, and lower back right on 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).	surgery day
pain score at back neck, shoulder, and lower back on 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).	postoperative day 1
pain score at back neck, shoulder, and lower back on 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).	postoperative day 2

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients satisfaction on the exercise program	4 questionnaire items are as follow: The rehabilitation program help patients recover health. Answer: [1: strongly disagree 2: disagree 3: neither agree nor disagree 4: agree 5: strongly disagree]; I want this exercise program the next time I have retinal surgery Answer: [1: strongly disagree 2: disagree 3: neither agree nor disagree 4: agree 5: strongly disagree]; I would recommend this program to other patients getting retinal surgery Answer: [1: strongly disagree 2: disagree 3: neither agree nor disagree 4: agree 5: strongly disagree]; Overall satisfaction Answer: [1: very disappointed 2: disappointed 3: neither satisfied nor disappointed 4: satisfied 5: very satisfied]	postoperative day 3

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Principal Investigator: Se Woong Kang, MD, PhD, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2020
• Primary Completion (Actual): December 14, 2020
• Study Completion (Actual): December 14, 2020

Study Registration Dates

• First Submitted: August 26, 2020
• First Submitted That Met QC Criteria: August 27, 2020
• First Posted (Actual): September 2, 2020

Study Record Updates

• Last Update Posted (Actual): December 16, 2020
• Last Update Submitted That Met QC Criteria: December 13, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: vitrectomy; musculoskeletal pain; face-down posture
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Perforations; Retinal Detachment
• Other Study ID Numbers: 2019-03-157

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No