Low Back PainNCT04134013
Nutrient Nutritional Advise for Low Back Pain Patients Seeking Chiropractic Care
A study testing Combination: Nutrition AND Chiropractic Adjustment and Chiropractic Adjustment: Spinal Manipulation Therapy in people with Low Back Pain and Nutrition Poor, run by Parker University at 1 site in United States.
Trial summary
The nutritional intervention will reduce LBP and cause 10% weight loss. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Nutrition Poor
- What is being tested?
- Combination: Nutrition AND Chiropractic Adjustment and Chiropractic Adjustment: Spinal Manipulation Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2019to 26 Nov 2020
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI 25-40, Experiencing LBP (VAS>4, mechanical, chronic), not pregnant
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nutrition Plus Chiropractic Care for Low Back Pain: a Randomized Clinical Trial
The nutritional intervention will reduce LBP and cause 10% weight loss.
Read the detailed description
This feasibility study will assess a two-armed low-back pain (LBP) randomized, prospective clinical trial with nutritional offerings provided for one-arm.
- Conditions
- Low Back Pain, Nutrition Poor
- Being tested
- Combination: Nutrition AND Chiropractic Adjustment, Chiropractic Adjustment: Spinal Manipulation Therapy
- Keywords
- Chiropractic manipulation, spinal manipulation therapy, osteopathic manipulation
- Medical subject headings
- Low Back Pain, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination: Nutrition AND Chiropractic AdjustmentDietary supplement
LBP chiropractic adjustment per protocol, nutrition counseling/ 4 Nutrient offerings (Vitamin Booster, Shake + 2 other offerings)
Chiropractic Adjustment: Spinal Manipulation TherapyOther
LBP chiropractic adjustment per protocol
| Study group | Role | What they receive |
|---|---|---|
| Nutrition and Chiropractic | Experimental | LBP chiropractic adjustment per protocol and 4 Nutrient offerings (Vitamin Booster, Shake + 2 other offerings) Receives: Dietary Supplement: Combination: Nutrition AND Chiropractic Adjustment |
| Chiropractic Adjustment ONLY | Active comparator | LBP chiropractic adjustment per protocol Receives: Other: Chiropractic Adjustment: Spinal Manipulation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low back pain evaluation using NPRS
Reduces Low Back Pain
Measured: Maximum six weeks of care
Weight loss being measured using scale in pounds
Promotes weight loss
Measured: Beginning of study and re-evaluation at the end of six weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2019
- Study start14 Oct 2019
- Primary completion23 Nov 2019
- Study completion26 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized into one of two arms: 1) nutrition+chiropractic or 2) chiropractic only
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parker University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04134013
- Sponsor's protocol ID
- Parker19_04
- Status last verified
- Jun 2021
- First submitted
- 16 Oct 2019
- Last updated
- 14 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition Plus Chiropractic Care for Low Back Pain: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04134013
- Acronym / sponsor ID
- Parker19_04
- Conditions
- Low Back Pain, Nutrition Poor
- Keywords
- Chiropractic manipulation, spinal manipulation therapy, osteopathic manipulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Parker UniversityUniversity, hospital or other
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- 23 Nov 2019 (actual)
- Study completion
- 26 Nov 2020 (actual)
- First posted
- 21 Oct 2019 (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.
The nutritional intervention will reduce LBP and cause 10% weight loss.
Detailed description
This feasibility study will assess a two-armed low-back pain (LBP) randomized, prospective clinical trial with nutritional offerings provided for one-arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized into one of two arms: 1) nutrition+chiropractic or 2) chiropractic only
| Arm | Type | Receives |
|---|---|---|
| Nutrition and Chiropractic | Experimental | Dietary Supplement: Combination: Nutrition AND Chiropractic AdjustmentLBP chiropractic adjustment per protocol and 4 Nutrient offerings (Vitamin Booster, Shake + 2 other offerings) |
| Chiropractic Adjustment ONLY | Active comparator | Other: Chiropractic Adjustment: Spinal Manipulation TherapyLBP chiropractic adjustment per protocol |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI 25-40, Experiencing LBP (VAS>4, mechanical, chronic), not pregnant
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Combination: Nutrition AND Chiropractic AdjustmentLBP chiropractic adjustment per protocol, nutrition counseling/ 4 Nutrient offerings (Vitamin Booster, Shake + 2 other offerings) | Dietary supplement | Nutrition and Chiropractic |
| Chiropractic Adjustment: Spinal Manipulation TherapyLBP chiropractic adjustment per protocol | Other | Chiropractic Adjustment ONLY |
Primary outcome
Low back pain evaluation using NPRS
Time frame: Maximum six weeks of care
Reduces Low Back Pain
Weight loss being measured using scale in pounds
Time frame: Beginning of study and re-evaluation at the end of six weeks.
Promotes weight loss
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 14 Jan 2022.
- Nutrient FoodsLink provided by the sponsor.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combination: Nutrition AND Chiropractic Adjustment and Chiropractic Adjustment: Spinal Manipulation Therapy in people with Low Back Pain and Nutrition Poor, run by Parker University at 1 site 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 0 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 14 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Low back pain evaluation using NPRS (time frame: Maximum six weeks of care). 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 14 Jan 2022.