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

Not Applicable

Completed

• Conditions: Chronic Pain; Inflammatory Response
• Interventions: Dietary Supplement: Nutritional Supplement; Other: Placebo

• Registration Number: NCT05743855
• Lead Sponsor: Standard Process Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-28
• Primary Completion: 2019-11-18
• Study Completion: 2022-04-01
• Study First Submitted: 2023-01-16
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-23
• Study First Posted: 2023-02-24
• Last Update Submitted: 2023-03-28
• Last Update Posted: 2023-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Chronic pain (>3years)

Exclusion Criteria

• GABA/opioid medication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group	Nutritional Supplement	Participants consume 1 serving of the Nutrional supplement daily and attend weekly chiropractor sessions for 12 weeks.
Placebo	Placebo	Participants consume 1 serving of Placebo daily and attend weekly chiropractor sessions for 12 weeks.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (3)

Randolph Chiropractic Health Center; 🇺🇸 Charlotte, North Carolina, United States

Trull Chiropractic PA; 🇺🇸 Kannapolis, North Carolina, United States

Combined Chiropractic & Acupuncture PLLC; 🇺🇸 Mooresville, North Carolina, United States