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NCT05743855 Clinical Trial

The Effect of Chiropractic Plus Nutritional Supplement in Patients With Chronic Pain and Inflammation.

Chronic Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05743855
Other study ID # Pro00032192
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 28, 2019
Est. completion date April 1, 2022

Study information
Verified date February 2023
Source Standard Process Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date April 1, 2022
Est. primary completion date November 18, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Chronic pain (>3years) Exclusion Criteria: - GABA/opioid medication

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Nutritional Supplement
Nutritional Supplement + Chiropract sessions
Other:
• Placebo
Placebo + Chiropractic sessions

Locations
Country Name City State
United States Randolph Chiropractic Health Center Charlotte North Carolina
United States Trull Chiropractic PA Kannapolis North Carolina
United States Combined Chiropractic & Acupuncture PLLC Mooresville North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Standard Process Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in Pain level using the Brief Pain Inventory (BPI) after 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. Baseline and 12 weeks
Primary Change from baseline in Pain intensity using the 11-Point Numeric Rating Scale (11-NRS) after 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". Baseline and 12 weeks
Secondary Reactive oxygen species (ROS) status Reactive oxygen species (ROS) status in the peripheral blood mononuclear cells was used to assess participant's inflammation biomarkers. At baseline and after 12 weeks
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