Macular HolesNCT04535622
Efficacy of Exercise Program for Facedown Posture-related Pain After Retinal Surgery
A study testing A structured exercise in people with Macular Holes and Retinal Detachment, run by Samsung Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Macular Holes, Retinal Detachment
- What is being tested?
- A structured exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Sep 2020to 14 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are getting vitrectomy for macular hole or retinal detachment and planning to maintain face-down posture.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Macular Holes, Retinal Detachment
- Being tested
- A structured exercise
- Keywords
- face-down posture, musculoskeletal pain, vitrectomy
- Medical subject headings
- Retinal Perforations, Retinal Detachment, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A structured exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | 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. Receives: Behavioral: A structured exercise |
| Control group | No intervention | Patients are going to maintain face-down posture but no specific exercise instruction will be provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: postoperative day 3
Secondary outcomes (3)
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).
Measured: 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).
Measured: 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).
Measured: postoperative day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2020
- Study start3 Sep 2020
- Primary completion14 Dec 2020
- Study completion14 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular HolesStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Se Woong, Kang, Samsung Medical Center
- Investigators
- Se Woong Kang, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04535622
- Sponsor's protocol ID
- 2019-03-157
- Status last verified
- Dec 2020
- First submitted
- 26 Aug 2020
- Last updated
- 16 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Evaluate Effect of a Structured Rehabilitation Exercise Program on Facedown Posture-related Pain After Retinal Surgery
- ClinicalTrials.gov ID
- NCT04535622
- Acronym / sponsor ID
- 2019-03-157
- Conditions
- Macular Holes, Retinal Detachment
- Keywords
- face-down posture, musculoskeletal pain, vitrectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 3 Sep 2020 (actual)
- Primary completion
- 14 Dec 2020 (actual)
- Study completion
- 14 Dec 2020 (actual)
- First posted
- 2 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Behavioral: A structured exerciseA 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. |
| Control group | No intervention | –Patients are going to maintain face-down posture but no specific exercise instruction will be provided. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who are getting vitrectomy for macular hole or retinal detachment and planning to maintain face-down posture.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A structured exerciseExercise 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. | Behavioural | Exercise group |
Primary outcome
Final pain score at back neck, shoulder, and lower back
Time frame: 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).
3 secondary outcomes
pain score at back neck, shoulder, and lower back right on surgery day
Time frame: surgery day
pain score at back neck, shoulder, and lower back on postoperative day 1
Time frame: postoperative day 1
pain score at back neck, shoulder, and lower back on postoperative day 2
Time frame: postoperative day 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Se Woong Kang, MD, PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A structured exercise in people with Macular Holes and Retinal Detachment, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Final pain score at back neck, shoulder, and lower back (time frame: postoperative day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2020.