Macular Holes, Retinal Detachment
Conditions
Keywords
face-down posture, musculoskeletal pain, vitrectomy
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.
Interventions
BEHAVIORALA 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.
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Patients satisfaction on the exercise program | postoperative day 3 | 4 questionnaire items are as follow: 1. The rehabilitation program help patients recover health. Answer: \[1: strongly disagree 2: disagree 3: neither agree nor disagree 4: agree 5: strongly disagree\] 2. I want this exercise program the next time I have retinal surgery Answer: \[1: strongly disagree 2: disagree 3: neither agree nor disagree 4: agree 5: strongly disagree\] 3. I would recommend this program to other patients getting retinal surgery Answer: \[1: strongly disagree 2: disagree 3: neither agree nor disagree 4: agree 5: strongly disagree\] 4. Overall satisfaction Answer: \[1: very disappointed 2: disappointed 3: neither satisfied nor disappointed 4: satisfied 5: very satisfied\] |
Countries
South Korea
Outcome results
None listed