Massage TherapyNCT04351477
Mechanical Massage Chair on Musculoskeletal Pain Improvement
A study testing Massage chair in people with Massage Therapy, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The effect of mechanical massage chair on musculoskeletal pain improvement for endoscopists and endoscopy nurses Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Massage Therapy
- What is being tested?
- Massage chair
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2020to 30 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Endoscopists or endoscopic nurses working at Seoul National University Hospital Gangnam Center
Who cannot join
- Spine disease, skin disease, acute inflammation, electrical heart device, thromboembolism, fracture, osteoporosis, varicose vein
- Pregnancy
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Healthcare System Gangnam Center, Seoul National University Hospital
Seoul
About this study
Official title: 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
Read the 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)
- 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
- Conditions
- Massage Therapy
- Being tested
- Massage chair
- Keywords
- massage chair, mulsculoskeletal pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Massage chairDevice
Also called Bodyfriend
Mechanical massage chair
| Study group | Role | What they receive |
|---|---|---|
| Massage chair group | Experimental | Use mechanical massage chair for 20 minutes/1 session, 3 sessions/week, for 3 weeks Receives: Device: Massage chair |
| Control | No intervention | No use of mechanical massage chair for 3 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale
range: 0-10 (0: no pain; 10: worst possible pain)
Measured: 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)
range: 0-50 score (0: no pain or no disability, 50: worst pain or disability)
Measured: The change at baseline, 1.5 week, 3 weeks during treatment, and 9 weeks after treatment
Shoulder pain and disability index (SPADI)
range: 0-100% (0: no pain or no disability, 100: worst pain or disability)
Measured: The change at baseline, 1.5 week, 3 weeks during treatment, and 9 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start1 Jun 2020 (estimated)
- Primary completion30 Apr 2021 (estimated)
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Massage TherapyStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, open-label, cross-over study
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Su Jin Chung, Seoul National University Hospital
- Investigators
- Min-Sun Kwak, MD, PhD, Principal investigator, Seoul National University Hospital Gangnam Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04351477
- Sponsor's protocol ID
- 20200413
- Status last verified
- Apr 2020
- First submitted
- 14 Apr 2020
- Last updated
- 22 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mechanical Massage Chair on Musculoskeletal Pain Improvement for Endoscopists and Endoscopy Nurses
- ClinicalTrials.gov ID
- NCT04351477
- Acronym / sponsor ID
- 20200413
- Conditions
- Massage Therapy
- Keywords
- massage chair, mulsculoskeletal pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 17 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
- 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, open-label, cross-over study
| Arm | Type | Receives |
|---|---|---|
| Massage chair group | Experimental | Device: Massage chairUse mechanical massage chair for 20 minutes/1 session, 3 sessions/week, for 3 weeks |
| Control | No intervention | –No use of mechanical massage chair for 3 weeks |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Endoscopists or endoscopic nurses working at Seoul National University Hospital Gangnam Center
Key exclusion criteria (2 listed)
- Spine disease, skin disease, acute inflammation, electrical heart device, thromboembolism, fracture, osteoporosis, varicose vein
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Massage chairAlso: BodyfriendMechanical massage chair | Device | Massage chair group |
Primary outcome
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)
2 secondary outcomes
Neck disability index (NDI)
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min-Sun Kwak, MD, PhD principal investigator
Seoul National University Hospital Gangnam Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Massage chair in people with Massage Therapy, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min-Sun Kwak, MD, PhD. (82-2-2112-5690, rasberry0309@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale (time frame: The change of VAS value at baseline, 1.5 week, 3 weeks during treatment, and 9 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2020.