Back to resultsMechanical Massage Chair on Musculoskeletal Pain Improvement
Primary Purpose
Massage Therapy
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Massage chair
Sponsored by
About this trial
This is an interventional other trial for Massage Therapy focused on measuring massage chair, mulsculoskeletal pain
Eligibility Criteria
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
Sites / Locations
- Healthcare System Gangnam Center, Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Massage chair group
Control
Arm Description
Use mechanical massage chair for 20 minutes/1 session, 3 sessions/week, for 3 weeks
No use of mechanical massage chair for 3 weeks
Outcomes
Primary Outcome Measures
Visual analogue scale
range: 0-10 (0: no pain; 10: worst possible pain)
Secondary Outcome Measures
Neck disability index (NDI)
range: 0-50 score (0: no pain or no disability, 50: worst pain or disability)
Shoulder pain and disability index (SPADI)
range: 0-100% (0: no pain or no disability, 100: worst pain or disability)
Full Information
NCT ID
NCT04351477
First Posted
April 14, 2020
Last Updated
April 20, 2020
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04351477
Brief Title
Mechanical Massage Chair on Musculoskeletal Pain Improvement
Official Title
The Effect of Mechanical Massage Chair on Musculoskeletal Pain Improvement for Endoscopists and Endoscopy Nurses
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2020 (Anticipated)
Primary Completion Date
April 30, 2021 (Anticipated)
Study Completion Date
April 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The effect of mechanical massage chair on musculoskeletal pain improvement for endoscopists and endoscopy nurses
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Massage Therapy
Keywords
massage chair, mulsculoskeletal pain
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized, open-label, cross-over study
Masking
None (Open Label)
Masking Description
Randomization by allocation concealment
Open label, cross-over design
Allocation
Randomized
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Massage chair group
Arm Type
Experimental
Arm Description
Use mechanical massage chair for 20 minutes/1 session, 3 sessions/week, for 3 weeks
Arm Title
Control
Arm Type
No Intervention
Arm Description
No use of mechanical massage chair for 3 weeks
Intervention Type
Device
Intervention Name(s)
Massage chair
Other Intervention Name(s)
Bodyfriend
Intervention Description
Mechanical massage chair
Primary Outcome Measure Information:
Title
Visual analogue scale
Description
range: 0-10 (0: no pain; 10: worst possible pain)
Time Frame
The change of VAS value at baseline, 1.5 week, 3 weeks during treatment, and 9 weeks after treatment
Secondary Outcome Measure Information:
Title
Neck disability index (NDI)
Description
range: 0-50 score (0: no pain or no disability, 50: worst pain or disability)
Time Frame
The change at baseline, 1.5 week, 3 weeks during treatment, and 9 weeks after treatment
Title
Shoulder pain and disability index (SPADI)
Description
range: 0-100% (0: no pain or no disability, 100: worst pain or disability)
Time Frame
The change at baseline, 1.5 week, 3 weeks during treatment, and 9 weeks after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min-Sun Kwak, MD, PhD.
Phone
82-2-2112-5690
Email
rasberry0309@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Su Jin Chung, MD, PhD.
Phone
82-2112-5751
Email
medjsj7@snuh.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min-Sun Kwak, MD, PhD
Organizational Affiliation
Seoul National University Hospital Gangnam Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Healthcare System Gangnam Center, Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Mechanical Massage Chair on Musculoskeletal Pain Improvement
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