Efficacy of Exercise Program for Facedown Posture-related Pain After Retinal Surgery
Primary Purpose
Macular Holes, Retinal Detachment
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
A structured exercise
Sponsored by
About this trial
This is an interventional supportive care trial for Macular Holes focused on measuring face-down posture, musculoskeletal pain, vitrectomy
Eligibility Criteria
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
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Exercise group
Control group
Arm Description
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.
Patients are going to maintain face-down posture but no specific exercise instruction will be provided.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
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).
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).
Full Information
NCT ID
NCT04535622
First Posted
August 26, 2020
Last Updated
December 13, 2020
Sponsor
Samsung Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04535622
Brief Title
Efficacy of Exercise Program for Facedown Posture-related Pain After Retinal Surgery
Official Title
A Randomized Controlled Trial to Evaluate Effect of a Structured Rehabilitation Exercise Program on Facedown Posture-related Pain After Retinal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
September 3, 2020 (Actual)
Primary Completion Date
December 14, 2020 (Actual)
Study Completion Date
December 14, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Holes, Retinal Detachment
Keywords
face-down posture, musculoskeletal pain, vitrectomy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients are going to maintain face-down posture but no specific exercise instruction will be provided.
Intervention Type
Behavioral
Intervention Name(s)
A structured exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Final pain score at back neck, shoulder, and lower back
Description
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).
Time Frame
postoperative day 3
Secondary Outcome Measure Information:
Title
pain score at back neck, shoulder, and lower back right on surgery day
Description
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).
Time Frame
surgery day
Title
pain score at back neck, shoulder, and lower back on postoperative day 1
Description
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).
Time Frame
postoperative day 1
Title
pain score at back neck, shoulder, and lower back on postoperative day 2
Description
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).
Time Frame
postoperative day 2
Other Pre-specified Outcome Measures:
Title
Patients satisfaction on the exercise program
Description
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]
Time Frame
postoperative day 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Se Woong Kang, MD, PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Exercise Program for Facedown Posture-related Pain After Retinal Surgery
We'll reach out to this number within 24 hrs