- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04351477
Mechanical Massage Chair on Musculoskeletal Pain Improvement
April 20, 2020 updated by: Su Jin Chung, Seoul National University Hospital
The Effect of Mechanical Massage Chair on Musculoskeletal Pain Improvement for Endoscopists and Endoscopy Nurses
The effect of mechanical massage chair on musculoskeletal pain improvement for endoscopists and endoscopy nurses
Study Overview
Detailed Description
Randomized, open-label, cross-over study
- 1st phase Massage chair group (20 minutes/session, 3 sessions/week, 3 weeks), vs. control (no use of massage chair)
- Wash-out period (9 weeks)
2nd phase (cross-over) Massage chair group (20 minutes/session, 3 sessions/week, 3 weeks), vs. control (no use of massage chair)
- Msculoskeletal pain questionnaires (VAS, NDI, SPADI)
1) 1st phase: at baseline, 1.5 wk, 3 wk 2) 2nd phase: at baseline, 1.5 wk, 3 wk, 9wk after the end of treatment
Study Type
Interventional
Enrollment (Anticipated)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Min-Sun Kwak, MD, PhD.
- Phone Number: 82-2-2112-5690
- Email: rasberry0309@gmail.com
Study Contact Backup
- Name: Su Jin Chung, MD, PhD.
- Phone Number: 82-2112-5751
- Email: medjsj7@snuh.org
Study Locations
-
-
-
Seoul, Korea, Republic of
- Healthcare System Gangnam Center, Seoul National University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Endoscopists or endoscopic nurses working at Seoul National University Hospital Gangnam Center
Exclusion Criteria:
- Spine disease, skin disease, acute inflammation, electrical heart device, thromboembolism, fracture, osteoporosis, varicose vein
- Pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Massage chair group
Use mechanical massage chair for 20 minutes/1 session, 3 sessions/week, for 3 weeks
|
Mechanical massage chair
Other Names:
|
No Intervention: Control
No use of mechanical massage chair for 3 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual analogue scale
Time Frame: The change of VAS value at baseline, 1.5 week, 3 weeks during treatment, and 9 weeks after treatment
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neck disability index (NDI)
Time Frame: The change at baseline, 1.5 week, 3 weeks during treatment, and 9 weeks after treatment
|
range: 0-50 score (0: no pain or no disability, 50: worst pain or disability)
|
The change at baseline, 1.5 week, 3 weeks during treatment, and 9 weeks after treatment
|
Shoulder pain and disability index (SPADI)
Time Frame: The change at baseline, 1.5 week, 3 weeks during treatment, and 9 weeks after treatment
|
range: 0-100% (0: no pain or no disability, 100: worst pain or disability)
|
The change at baseline, 1.5 week, 3 weeks during treatment, and 9 weeks after treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Min-Sun Kwak, MD, PhD, Seoul National University Hospital Gangnam Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
June 1, 2020
Primary Completion (Anticipated)
April 30, 2021
Study Completion (Anticipated)
April 30, 2021
Study Registration Dates
First Submitted
April 14, 2020
First Submitted That Met QC Criteria
April 16, 2020
First Posted (Actual)
April 17, 2020
Study Record Updates
Last Update Posted (Actual)
April 22, 2020
Last Update Submitted That Met QC Criteria
April 20, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20200413
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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