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

Retinal Detachment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04535622
• Other study ID #: 2019-03-157
• Status: Completed
• Phase: N/A
• Start date: September 3, 2020
• Est. completion date: December 14, 2020

Study information

• Verified date: December 2020
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 14, 2020
• Est. primary completion date: December 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Macular Holes
• Retinal Detachment
• Retinal Perforations

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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
Secondary	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