None
Conditions
Sponsors
TTC Co., Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Males and females at the ages of 20 to 60 (2) Subjects who have continuous low back pain for 3 months or more (3) Subjects who have habit of sleeping on bedding alone (4) Subjects with narrow values on low back range of motion
Exclusion criteria
Exclusion criteria: Subjects (1) which low back pain is weaker than pain in other joints (2) who are suspected gouty attack with hyperuricemia (3) who have positive rheumatoid factors on the screening test or may have rheumatic pain (4) who have performed arthroplasty or need it (5) who regularly take health food which may affect this study from three month before the screening test to the end of the study (6) who regularly take medicine (7) who have been performed intra-articular hyaluronic acid or steroid drug injection within a year before the screening test (8) who get an intense exercise to make excessive load on the body (9) who have a history of the disorder related to bone and joint such as fracture and sprain within a year before the screening test (10) who regularly use a cane, supporter or corset (11) who periodically conduct actions that may affect the evaluation of effectiveness (12) who have under treatment that may affect the evaluation of effectiveness (13) who have nervous system diseases or severe diseases such as, malignant tumors, diabetes, liver diseases, kidney diseases, heart diseases, etc. and have a history of serious disorder (14) who has under treatment or a history of mental diseases or is strongly suspected of mental diseases (15) who work night and day shift or who work manual labor (16) who drink alcohol in large quantities (17) who regularly smoke or who started smoking cessation one year before screening test (18) who have possibilities for emerging allergy onset related to the study (19) who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination (20) who have participated in other clinical study within a month before the screening test or who intend to participate in study period (21) who intend to become pregnant or lactating (22) who are judged as unsuitable due to lifestyle questionnaire (23) who are judged as unsuitable for the study by investigator for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| JLEQ Low back range of motion | — |
Secondary
| Measure | Time frame |
|---|---|
| Trunk muscle strength Core temperature VAS (Joint pain of knee, elbow, ankle, shoulder, neck, back and hip and finger) | — |
Countries
Japan
Contacts
Public ContactKotoha Isobe
TTC Co., Ltd. Clinical Research Planning Department
Outcome results
None listed