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

Sponsor

Samsung Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT04535622

Collaborator

(none)

Enrollment

Location

Arms

3.4

Actual Duration (Months)

20.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Macular Holes Retinal Detachment	Behavioral: A structured exercise	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Sep 3, 2020

Actual Primary Completion Date :

Dec 14, 2020

Actual Study Completion Date :

Dec 14, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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).

Other Outcome Measures

Patients satisfaction on the exercise program [postoperative day 3]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

Samsung Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Se Woong, Kang, Professor, Samsung Medical Center

ClinicalTrials.gov Identifier:

NCT04535622

Other Study ID Numbers:

2019-03-157

First Posted:

Sep 2, 2020

Last Update Posted:

Dec 16, 2020

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Se Woong, Kang, Professor, Samsung Medical Center

face-down posture

musculoskeletal pain

vitrectomy

Additional relevant MeSH terms:

Retinal Detachment

Retinal Perforations

Study Results

No Results Posted as of Dec 16, 2020