Effectiveness and safety assessment of orthopedic device for low back pain

Effectiveness and safety assessment of orthopedic device(LSM-01) for low back pain: a randomized, single-blinded, sham-controlled, parallel-group, pilot clinical trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0006425

Enrollment

Registered

2021-08-05

Start date

2021-08-02

Completion date

Unknown

Last updated

2021-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : Test device : orthopedic device(LSM-01) Control device : sham device(connection between the motor part and the roller is removed) Use in 45 degree lateral position, both gluteus mediu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) 19-70 year old male and female 2) Subject with lumbar pain above VAS 40mm and those who are taking analgesics for lumbar pain 3) Subject who voluntarily decides to participate in the study after hearing a sufficient explanation of the purpose of the test and the process and signs the informed consent form

Exclusion criteria

Exclusion criteria: 1) Those who have a history of vertebral fracture or spinal surgery, or have a scheduled surgery within the examination period 2) Those who have had severe back pain with a VAS of 75mm or more, lasting for 3 days or more within 3 months before participating in the trial 3) Those with neurological symptoms of sensory and motor paralysis or abnormal findings on L-spine x-ray and CT 4) Those who have pain in other parts of the body which is more severe than lower back pain 5) Those who cannot have friction due to skin diseases, inflammation, or wounds around the spine, pelvis, and hip joints 6) In case of concurrent treatment for back pain other than analgesic medication 7) Those with serious underlying diseases such as serious cardiovascular disease or tumor 8) Those with a history of alcohol or drug abuse 9) Those who cannot write measurement data for subjects by themselves or under the supervision of a guardian/researcher 10) Those who have participated in other interventional clinical trials within 30 days of trial participation 11) Any other researcher deemed inappropriate for this test

Design outcomes

Primary

Measure	Time frame
VAS(Visual Analogue Scale)	—

Secondary

Measure	Time frame
Pressure pain threshold (PPT);Oswestry Disability Index: ODI;PGIC(Patient Global Impression of change)	—

Countries

Korea, Republic of

Contacts

Public ContactGa-hyeon Jung

Cheonan Korean Medicine Hospital of Daejeon University

cherubss@naver.com+82-41-521-7579

Outcome results