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Clinical Trials/NCT05743855
NCT05743855
Completed
Not Applicable

The Effect of Co-therapy Chiropractic Plus Nutritional Supplement in Patients Experiencing Chronic Pain and Inflammation.

Standard Process Inc.3 sites in 1 country25 target enrollmentMarch 28, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
Standard Process Inc.
Enrollment
25
Locations
3
Primary Endpoint
Change from baseline in Pain level using the Brief Pain Inventory (BPI) after 12 weeks.
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 28, 2019
End Date
April 1, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Chronic pain (\>3years)

Exclusion Criteria

  • GABA/opioid medication

Outcomes

Primary Outcomes

Change from baseline in Pain level using the Brief Pain Inventory (BPI) after 12 weeks.

Time Frame: 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.

Time Frame: 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 Outcomes

  • Reactive oxygen species (ROS) status(At baseline and after 12 weeks)

Study Sites (3)

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