Chronic PainNCT05743855
The Effect of Chiropractic Plus Nutritional Supplement in Patients With Chronic Pain and Inflammation.
A study testing Nutritional Supplement in people with Chronic Pain and Inflammatory Response, run by Standard Process Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain, Inflammatory Response
- What is being tested?
- Nutritional Supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 3 sitesUnited States
- Study dates
- 28 Mar 2019to 1 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Chronic pain (>3years)
Who cannot join
- GABA/opioid medication
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Randolph Chiropractic Health Center
Charlotte, North Carolina, 28207
Trull Chiropractic PA
Kannapolis, North Carolina, 28083
Combined Chiropractic & Acupuncture PLLC
Mooresville, North Carolina, 28117
About this study
Official title: The Effect of Co-therapy Chiropractic Plus Nutritional Supplement in Patients Experiencing 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.
- Conditions
- Chronic Pain, Inflammatory Response
- Being tested
- Nutritional Supplement, Placebo
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional SupplementDietary supplement
Also called Chiropract sessions
Nutritional Supplement + Chiropract sessions
PlaceboOther
Also called Chiropract sessions
Placebo + Chiropractic sessions
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants consume 1 serving of Placebo daily and attend weekly chiropractor sessions for 12 weeks. Receives: Other: Placebo |
| Treatment Group | Experimental | Participants consume 1 serving of the Nutrional supplement daily and attend weekly chiropractor sessions for 12 weeks. Receives: Dietary Supplement: Nutritional Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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".
Measured: Baseline and 12 weeks
Secondary outcomes (1)
Reactive oxygen species (ROS) status
Reactive oxygen species (ROS) status in the peripheral blood mononuclear cells was used to assess participant's inflammation biomarkers.
Measured: At baseline and after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start28 Mar 2019
- Primary completion18 Nov 2019
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Standard Process Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05743855
- Sponsor's protocol ID
- Pro00032192
- Status last verified
- Feb 2023
- First submitted
- 16 Jan 2023
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Co-therapy Chiropractic Plus Nutritional Supplement in Patients Experiencing Chronic Pain and Inflammation.
- ClinicalTrials.gov ID
- NCT05743855
- Acronym / sponsor ID
- Pro00032192
- Conditions
- Chronic Pain, Inflammatory Response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Standard Process Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Mar 2019 (actual)
- Primary completion
- 18 Nov 2019 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 24 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboParticipants consume 1 serving of Placebo daily and attend weekly chiropractor sessions for 12 weeks. |
| Treatment Group | Experimental | Dietary Supplement: Nutritional SupplementParticipants consume 1 serving of the Nutrional supplement daily and attend weekly chiropractor sessions for 12 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic pain (>3years)
Key exclusion criteria (1 listed)
- GABA/opioid medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional SupplementAlso: Chiropract sessionsNutritional Supplement + Chiropract sessions | Dietary supplement | Treatment Group |
| PlaceboAlso: Chiropract sessionsPlacebo + Chiropractic sessions | Other | Placebo |
Primary outcome
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.
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".
1 secondary outcome
Reactive oxygen species (ROS) status
Time frame: At baseline and after 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional Supplement in people with Chronic Pain and Inflammatory Response, run by Standard Process Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Pain level using the Brief Pain Inventory (BPI) after 12 weeks. (time frame: Baseline and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2023.