Back to resultsThe Effect of Chiropractic Plus Nutritional Supplement in Patients With Chronic Pain and Inflammation.
Primary Purpose
Chronic Pain, Inflammatory Response
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nutritional Supplement
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Pain
Eligibility Criteria
Inclusion Criteria: Chronic pain (>3years) Exclusion Criteria: GABA/opioid medication
Sites / Locations
- Randolph Chiropractic Health Center
- Trull Chiropractic PA
- Combined Chiropractic & Acupuncture PLLC
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Treatment Group
Arm Description
Participants consume 1 serving of Placebo daily and attend weekly chiropractor sessions for 12 weeks.
Participants consume 1 serving of the Nutrional supplement daily and attend weekly chiropractor sessions for 12 weeks.
Outcomes
Primary Outcome Measures
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.
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".
Secondary Outcome Measures
Reactive oxygen species (ROS) status
Reactive oxygen species (ROS) status in the peripheral blood mononuclear cells was used to assess participant's inflammation biomarkers.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05743855
Brief Title
The Effect of Chiropractic Plus Nutritional Supplement in Patients With Chronic Pain and Inflammation.
Official Title
The Effect of Co-therapy Chiropractic Plus Nutritional Supplement in Patients Experiencing Chronic Pain and Inflammation.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
March 28, 2019 (Actual)
Primary Completion Date
November 18, 2019 (Actual)
Study Completion Date
April 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Standard Process Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Inflammatory Response
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants consume 1 serving of Placebo daily and attend weekly chiropractor sessions for 12 weeks.
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Participants consume 1 serving of the Nutrional supplement daily and attend weekly chiropractor sessions for 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutritional Supplement
Other Intervention Name(s)
Chiropract sessions
Intervention Description
Nutritional Supplement + Chiropract sessions
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Chiropract sessions
Intervention Description
Placebo + Chiropractic sessions
Primary Outcome Measure Information:
Title
Change from baseline in Pain level using the Brief Pain Inventory (BPI) after 12 weeks.
Description
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.
Time Frame
Baseline and 12 weeks
Title
Change from baseline in Pain intensity using the 11-Point Numeric Rating Scale (11-NRS) after 12 weeks.
Description
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".
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Reactive oxygen species (ROS) status
Description
Reactive oxygen species (ROS) status in the peripheral blood mononuclear cells was used to assess participant's inflammation biomarkers.
Time Frame
At baseline and after 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Chronic pain (>3years)
Exclusion Criteria:
GABA/opioid medication
Facility Information:
Facility Name
Randolph Chiropractic Health Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Trull Chiropractic PA
City
Kannapolis
State/Province
North Carolina
ZIP/Postal Code
28083
Country
United States
Facility Name
Combined Chiropractic & Acupuncture PLLC
City
Mooresville
State/Province
North Carolina
ZIP/Postal Code
28117
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Chiropractic Plus Nutritional Supplement in Patients With Chronic Pain and Inflammation.
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