NCT04351477

Brief Summary

The effect of mechanical massage chair on musculoskeletal pain improvement for endoscopists and endoscopy nurses

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 17, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

April 22, 2020

Status Verified

April 1, 2020

Enrollment Period

11 months

First QC Date

April 14, 2020

Last Update Submit

April 20, 2020

Conditions

Massage Therapy

Keywords

massage chairmulsculoskeletal pain

Outcome Measures

Primary Outcomes (1)

  • Visual analogue scale

    range: 0-10 (0: no pain; 10: worst possible pain)

    The change of VAS value at baseline, 1.5 week, 3 weeks during treatment, and 9 weeks after treatment

Secondary Outcomes (2)

  • Neck disability index (NDI)

    The change at baseline, 1.5 week, 3 weeks during treatment, and 9 weeks after treatment

  • Shoulder pain and disability index (SPADI)

    The change at baseline, 1.5 week, 3 weeks during treatment, and 9 weeks after treatment

Study Arms (2)

Massage chair group

EXPERIMENTAL

Use mechanical massage chair for 20 minutes/1 session, 3 sessions/week, for 3 weeks

Device: Massage chair

Control

NO INTERVENTION

No use of mechanical massage chair for 3 weeks

Interventions

Massage chairDEVICE

Mechanical massage chair

Also known as: Bodyfriend
Massage chair group

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Endoscopists or endoscopic nurses working at Seoul National University Hospital Gangnam Center

You may not qualify if:

  • Spine disease, skin disease, acute inflammation, electrical heart device, thromboembolism, fracture, osteoporosis, varicose vein
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Healthcare System Gangnam Center, Seoul National University Hospital

Seoul, South Korea

Location

Study Officials

  • Min-Sun Kwak, MD, PhD

    Seoul National University Hospital Gangnam Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Min-Sun Kwak, MD, PhD.

CONTACT

82-2-2112-5690rasberry0309@gmail.com

Su Jin Chung, MD, PhD.

CONTACT

82-2112-5751medjsj7@snuh.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
1. Randomization by allocation concealment 2. Open label, cross-over design
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Randomized, open-label, cross-over study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 14, 2020

First Posted

April 17, 2020

Study Start

June 1, 2020

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

April 22, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)