Knee Pain Intermittent
Conditions
Brief summary
Cis-9-cetylmyristoleate (CMO) is a naturally occurring fatty acid complex (FAC). Nutraceuticals containing CMO are used to improve knee pain despite the lack of placebo-controlled studies in humans. The aim of the double-blind controlled clinical trial is to explore the minimal effective dose of CMO for relieving knee joint pain.
Detailed description
Methods: Twenty-eight subjects, who are clinically or radiologically diagnosed as having mild degree arthritic knee joint pain, are randomized into 3 groups; Groups A, B, C that contained 100%, 80%, and 62.4% of fatty acid component with 12.5% of Cis-9-cetylmyristoleate (CMO), and control Group D (starch 100%). The pain intensity, functional disability state and change in the general status were assessed for a 12-week ingestion period.
Interventions
DIETARY_SUPPLEMENTJOINTRUS®
100% Fatty acid compound with 12.5% Cis-9-cetylmyristoleate
DIETARY_SUPPLEMENT80% dose of JOINTRUS®
80% Fatty acid compound with 12.5% Cis-9-cetylmyristoleate
DIETARY_SUPPLEMENT62.4% dose of JOINTRUS®
62.4% Fatty acid compound with 12.5% Cis-9-cetylmyristoleate
DIETARY_SUPPLEMENTStarch 100%
0% Fatty acid compound with 12.5% Cis-9-cetylmyristoleate
Sponsors
Seoul National University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* sub-healthy persons \>18 years of age and knee joint pain with a 0-10 numerical rating scale (NRS) pain score ≤ 4.
Exclusion criteria
* current medication use related to arthritis; * current use of FAC containing products; * clinical or radiological diagnosis as moderate degree arthritis accompanied by peri-articular spur formation, irregular joint margin, and/or subchondral cyst; * previous history of knee surgery; * pregnant, breastfeeding, or practicing contraception with reliable methods, or not accepting our guidelines during the research periods; * major pain other than knee joint pain; * current treatment of gastritis or gastric ulcer; * abnormal screening laboratory results; * major cardiac, renal disease, or disability that could affect adverse effect assessment or interfere with study completion when enrolled; * history of major procedures or operations that might affect study results; * enrollment in another clinical trial or human application testing; and * judged as unsuitable for human application testing.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CHANGE of Pain | change from baseline at 3 months | using the NRS score, composed of an 11-point scale from 0 (no pain) to 10 (the worst pain possible) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| difference in NRS pain score from baseline within groups | at 1-month follow-up, at 2-month follow-up, and at 3-month follow-up | — |
| change of the WOMAC score | change from baseline at 3 months | using the Korean version of WOMAC |
| Global Impression of Change | at 3-month follow-up | a scale ranging from 1 (very much improved) to 7 (very much worse). |
Outcome results
None listed