Joint Pain
Conditions
Brief summary
Joint pain is reported by about 1/3 of U.S. adults, and increases with age reaching 50% prevalence among the elderly \[1\]. Joint pain is associated with substantial activity limitation, work disability, sleep disturbance, negative mood (e.g., depression, anxiety, stress), and reduced quality of life (2, 3). Conventional treatment of joint pain with non-steroidal anti-inflammatory drugs (NSAIDs) and other analgesics is associated with gastrointestinal and cardiovascular side effects, and other adverse health effects \[4\]. Use of alternative supplements is reported by about 50% of people with knee osteoarthritis, and well-designed human trials are needed to identify effective analgesic alternatives \[5\]. The most widely used and studied joint pain supplements include those related to chondroprotection such as glucosamine, chondroitin, collagen hydrolysates, and hyaluronic acid \[6-9\]. Further research is needed examining the effects of other herbal supplementation on joint pain and overall health. Preliminary research reveals Q-ActinTM supplementation may be an effective intervention to reduce OA-related pain compared with standard treatments. Q-ActinTM is a cucumber extract with the anti-inflammatory iminosugar idoBR1 standardised to over 1%. Study Purpose To conduct a 8 week randomized double-blind placebo-controlled trial to examine the effectiveness of daily use of Q-ActinTM supplementation compared to placebo on joint pain, stiffness, function, mood, sleep, daytime activity, and health-related quality of life in adults with a history (\>3 months) of mild to moderate joint pain.
Detailed description
To conduct a 8 week randomized double-blind placebo-controlled trial to examine the effectiveness of daily use of Q-ActinTM supplementation compared to placebo on joint pain, stiffness, function, mood, sleep, daytime activity, and health-related quality of life in adults with a history (\>3 months) of mild to moderate joint pain. Assessments will be completed at Day 0 (Baseline), Week 2, Week 4, and Week 8. The primary outcome will be on joint pain, stiffness, and function (as assessed by the WOMAC). Secondary outcomes will be sleep quality, physical activity, daytime fatigue, mood, anxiety, perceived stress, pain severity, tolerance and limitations, and health-related quality of life. Adults (N = 80) will be randomized to one of the following conditions: * Q-ActinTM (n = 40) * Placebo control (n = 40)
Interventions
cucumber extract
Sponsors
Study design
Eligibility
Inclusion criteria
Inclusion and
Exclusion criteria
Participants (N = 80) will meet the inclusion criteria if they: are healthy adults (age range between 35 to 70 years), chose to sign Sterling IRB approved consent forms, and willing to forego use of all supplement products with claims regarding joint health during the study period. Our goal is to have 80 participants complete the intervention. To control for potential dropout we will recruit 90 participants for this trial. Other inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Joint pain | 8 weeks | WOMAC |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mood, sleep, daytime activity, pain perceptions, daytime fatigue, anxiety, perceived stress, pain perceptions, health-related quality of life. | 8 weeks | POMS, PSQI, Oura Ring, Daytime Fatigue Scale, Perceived Stress Scale, Trait Anxiety Scale, Pain Severity Scale, Health-related Quality of Life Scale |