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

NCT04535622 | Completed

• 1 other identifier: 2019-03-157
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Macular Holes; Retinal Detachment

Keywords

face-down posture; musculoskeletal pain; vitrectomy

Outcome Measures

Primary Outcomes (1)

• 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).

  postoperative day 3

Secondary Outcomes (3)

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

  surgery day

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

  postoperative day 1

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

  postoperative day 2

Other Outcomes (1)

• Patients satisfaction on the exercise program

  postoperative day 3

Study Arms (2)

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.

Behavioral: A structured exercise

Control group

NO INTERVENTION

Patients are going to maintain face-down posture but no specific exercise instruction will be provided.

Interventions

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.

Exercise group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are getting vitrectomy for macular hole or retinal detachment and planning to maintain face-down posture.

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Retinal Perforations; Retinal Detachment; Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Se Woong Kang, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: September 2, 2020
• Study Start: September 3, 2020
• Primary Completion: December 14, 2020
• Study Completion: December 14, 2020
• Last Updated: December 16, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)