Chronic Pain, Inflammatory Response
Conditions
Brief summary
Evaluating the effect of a combined therapy of chiropractic sessions plus nutritional supplement containing hemp, omega-3 fatty acids, and broccoli extract oil in patients experiencing chronic pain and inflammation.
Interventions
DIETARY_SUPPLEMENTNutritional Supplement
Nutritional Supplement + Chiropract sessions
OTHERPlacebo
Placebo + Chiropractic sessions
Sponsors
Standard Process Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Chronic pain (\>3years)
Exclusion criteria
* GABA/opioid medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Pain level using the Brief Pain Inventory (BPI) after 12 weeks. | Baseline and 12 weeks | The BPI is a validated self-reporting instrument assessing pain. Possible score range 0-10 with higher scores indicating higher pain levels. The instrument contains 9 items. |
| Change from baseline in Pain intensity using the 11-Point Numeric Rating Scale (11-NRS) after 12 weeks. | Baseline and 12 weeks | The 11-NRS is a validated self-reporting instrument assessing pain level. Possible score ranges from '0' representing no pain to '10' representing worst pain imaginable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reactive oxygen species (ROS) status | At baseline and after 12 weeks | Reactive oxygen species (ROS) status in the peripheral blood mononuclear cells was used to assess participant's inflammation biomarkers. |
Countries
United States
Outcome results
None listed