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

Sponsor
Standard Process Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT05743855
Collaborator
(none)
25
Enrollment
3
Locations
2
Arms
36.1
Actual Duration (Months)
8.3
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Nutritional Supplement
  • Other: Placebo
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Supportive Care
Official Title:
The Effect of Co-therapy Chiropractic Plus Nutritional Supplement in Patients Experiencing Chronic Pain and Inflammation.
Actual Study Start Date :
Mar 28, 2019
Actual Primary Completion Date :
Nov 18, 2019
Actual Study Completion Date :
Apr 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Participants consume 1 serving of Placebo daily and attend weekly chiropractor sessions for 12 weeks.

Other: Placebo
Placebo + Chiropractic sessions
Other Names:
  • Chiropract sessions

    		•
    Experimental: Treatment Group

    Participants consume 1 serving of the Nutrional supplement daily and attend weekly chiropractor sessions for 12 weeks.

    Dietary Supplement: Nutritional Supplement
    Nutritional Supplement + Chiropract sessions
    Other Names:
  • Chiropract sessions

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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

    1. Inflammation Biomarkers [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Chronic pain (>3years)
    Exclusion Criteria:
    • GABA/opioid medication

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Randolph Chiropractic Health Center Charlotte North Carolina United States 28207
    2 Trull Chiropractic PA Kannapolis North Carolina United States 28083
    3 Combined Chiropractic & Acupuncture PLLC Mooresville North Carolina United States 28117

    Sponsors and Collaborators

    • Standard Process Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Standard Process Inc.
    ClinicalTrials.gov Identifier:
    NCT05743855
    Other Study ID Numbers:
    • Pro00032192
    First Posted:
    Feb 24, 2023
    Last Update Posted:
    Feb 24, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Inflammation
    Chronic Pain

    Study Results

    No Results Posted as of Feb 24, 2023