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OpenTrials
Completed

NCT Number: NCT05743855

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

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.

Completed

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Key information

Conditions

Chronic Pain Inflammatory Response Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Randolph Chiropractic Health Center, Charlotte, North Carolina, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chronic pain (>3years)

Exclusion criteria

  • GABA/opioid medication

Treatment and study plan

Nutritional Supplement

Dietary Supplement

Nutritional Supplement + Chiropract sessions

Other names: Chiropract sessions

Placebo

Other

Placebo + Chiropractic sessions

Other names: Chiropract sessions

Primary outcomes

  1. Change from baseline in Pain level using the Brief Pain Inventory (BPI) after 12 weeks.

    Time frame: 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.

    Time frame: 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 outcomes

  1. Reactive oxygen species (ROS) status

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Standard Process Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2022
First posted
Feb 24, 2023
Registry last updated
Mar 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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