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Completed

NCT Number: NCT04535622

Efficacy of Exercise Program for 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.

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Key information

Conditions

Macular Holes Eye Diseases Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Retinal Detachment Retinal Diseases Retinal Perforations Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

A structured exercise

Behavioral

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 outcomes

  1. 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).

Secondary outcomes

  1. pain score at back neck, shoulder, and lower back right on surgery day

    Time frame: 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).

  2. pain score at back neck, shoulder, and lower back on postoperative day 1

    Time frame: 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).

  3. pain score at back neck, shoulder, and lower back on postoperative day 2

    Time frame: 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 outcomes

  1. Patients satisfaction on the exercise program

    Time frame: 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]

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 2, 2020
Registry last updated
Dec 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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