The Effect of Chiropractic Plus Nutritional Supplement in Patients With Chronic Pain and Inflammation.
The Effect of Co-therapy Chiropractic Plus Nutritional Supplement in Patients Experiencing Chronic Pain and Inflammation.
1 other identifier
interventional
25
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable chronic-pain
Started Mar 2019
Longer than P75 for not_applicable chronic-pain
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 18, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2022
CompletedFirst Submitted
Initial submission to the registry
January 16, 2023
CompletedFirst Posted
Study publicly available on registry
February 24, 2023
CompletedMarch 31, 2023
February 1, 2023
8 months
January 16, 2023
March 28, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (1)
Reactive oxygen species (ROS) status
At baseline and after 12 weeks
Study Arms (2)
Placebo
PLACEBO COMPARATORParticipants consume 1 serving of Placebo daily and attend weekly chiropractor sessions for 12 weeks.
Treatment Group
EXPERIMENTALParticipants consume 1 serving of the Nutrional supplement daily and attend weekly chiropractor sessions for 12 weeks.
Interventions
Nutritional Supplement + Chiropract sessions
Eligibility Criteria
You may qualify if:
- Chronic pain (\>3years)
You may not qualify if:
- GABA/opioid medication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Randolph Chiropractic Health Center
Charlotte, North Carolina, 28207, United States
Trull Chiropractic PA
Kannapolis, North Carolina, 28083, United States
Combined Chiropractic & Acupuncture PLLC
Mooresville, North Carolina, 28117, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2023
First Posted
February 24, 2023
Study Start
March 28, 2019
Primary Completion
November 18, 2019
Study Completion
April 1, 2022
Last Updated
March 31, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share