SupplementationBackinNCT05597189
Clinical Study for Palliative/Preventive Treatment of Chronic Back Pain
A study testing Experimental product in people with Supplementation and Back Pain, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial summary
Randomized, controlled, double-blind, double-blind clinical trial, with three parallel arms depending on the product consumed (experimental product dose 1 and dose 2 and placebo product) and single-center, to measure the efficacy of a botanical supplement on the prevention of non-joint pain. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Supplementation, Back Pain
- What is being tested?
- Experimental product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 1 siteSpain
- Study dates
- 26 Sep 2022to 31 Jul 2023
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women between 20 and 65 years of age.
- The subjects must have localized myofascial pain in the back area (cervical, dorsal and lumbar), with an evolution time of at least 3 months.
- The pain must present an initial score of at least 30 mm in the pain evaluation by means of the VAS scale.
- The pain must be episodic.
- BMI 18.5 - 29.9 kg/m2.
- Subjects should not be treated with narcotic drugs or steroidal anti-inflammatory drugs. steroidal anti-inflammatory drugs or immunosuppressants.
Who cannot join
- Severe or terminal illnesses.
- Subjects with pain associated with trauma.
- Subjects with pain associated with chronic conditions (rheumatoid arthritis, herniated discs, ankylosing herniated disc, ankylosing spondylitis, etc.).
- Subjects with known allergy to any of the components of the investigational product. the investigational product.
- Subjects undergoing physiotherapy treatment during the course of the study. development of the study.
- Pregnant or lactating women.
- Inability to understand the informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study of Palliative / Preventive Treatment of Chronic Back Pain by Taking a Dietary Supplement Based on Botanical Extracts
Randomized, controlled, double-blind, double-blind clinical trial, with three parallel arms depending on the product consumed (experimental product dose 1 and dose 2 and placebo product) and single-center, to measure the efficacy of a botanical supplement on the prevention of non-joint pain.
Read the detailed description
Subjects who meet the selection criteria will be randomly assigned to each of the study groups (investigational product dose 1 or dose 2, or placebo, depending on the group to which they have been assigned).
The product to be consumed is a Botanical Extract. Participants will consume the product for 84 days. It should be taken half an hour before breakfast, two capsules per day.
The study subjects will have to make 5 visits to the laboratory. On the first and last visit, they will have their blood drawn, their sleep quality will be evaluated and they will complete a series of questionnaires to evaluate their quality of life and type of back pain. In the rest of the visits they will only have to take the tests on paper.
- Conditions
- Supplementation, Back Pain
- Being tested
- Experimental product, Control product consumption
- Keywords
- botanical extracts
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental productDietary supplement
Botanical extract
Control product consumptionOther
Product with identical characteristics to the experimental product.
| Study group | Role | What they receive |
|---|---|---|
| Botanical extracts high dose | Experimental | Consumption for 84 days. Subjects should consume two capsules half an hour before breakfast. Receives: Dietary Supplement: Experimental product |
| Botanical extracts low dose | Experimental | Consumption for 84 days. Subjects should consume two capsules half an hour before breakfast. Receives: Dietary Supplement: Experimental product |
| Control group | Placebo comparator | Consumption for 84 days. Subjects should consume two capsules half an hour before breakfast. Receives: Other: Control product consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain from baseline at 12 weeks
Visual analog scale from 0 to 10. The higher the value, the more pain.
Measured: The evolution of pain after consumption during 12 weeks will be measured.
Secondary outcomes (16)
Change in concomitant analgesic medication
The change in the need for the use of analgesic medications will be evaluated
Measured: The test will be measured at baseline and after 12 weeks of consumption. It will also be evaluated on a daily basis
Evaluation of back pain: Promis-29 test
Back pain will be measured with the Promis-29 v2.0 test. This is a 29-item test that measures the degree of pain.
Measured: Day 1, at 4, 8 and 12 weeks later
Evaluation of back pain: Cornell
The Cornell Musculoskeletal Discomfort Questionnaires (CMDQ) assesses musculoskeletal symptomatology in workers who perform sedentary and standing work. sedentary work and standing work.
Measured: Day 1, at 4, 8 and 12 weeks later
Level of functionality: Roland Morris test
The Roland-Morris questionnaire is used to reliably determine the degree of physical degree of physical disability derived from non-specific low back pain.
Measured: Day 1, at 4, 8 and 12 weeks later
Quality of life questionnaire
SF-36 test health questionnaire
Measured: Day 1, at 4, 8 and 12 weeks later
Wellbeing / wellness
WHOQOL BREF test
Measured: Day 1, at 4, 8 and 12 weeks later
Depression
Beck depression. Test to measure the level of depression of the subjects
Measured: Day 1, at 4, 8 and 12 weeks later
Anxiety questionnaire
Test STAI, to measure the level of anxiety of the subjects
Measured: Day 1, at 4, 8 and 12 weeks later
Perceived stress
Remor, 2001. Test to measure the level of stress of the subjects
Measured: Day 1, at 4, 8 and 12 weeks later
Sleep quality
Measured by Pittsburgh test
Measured: It will be measured twice, once at baseline or at the end of the study after 12 weeks of use
Body composition
It is a control variable. Measured by bioimpedance
Measured: The test will be measured at baseline and after 12 weeks of consumption.
Physical activity
It is a control variable. Measured by accelerometry, with Actigraph wGT3X-BT
Measured: The test will be measured at baseline and after 12 weeks of consumption. It will be measured during 3 weekdays and one weekend day.
Sleep efficiency
Measured by accelerometry, with Actigraph wGT3X-BT
Measured: The test will be measured at baseline and after 12 weeks of consumption. It will be measured during 3 weekdays and one weekend day.
C Reactive Protein (PCR)
It is a blood test that measures inflammation levels.
Measured: It will be measured twice, once at baseline or at the end of the study after 12 weeks.
Interleukin 6 (IL-6)
It is a blood test that measures inflammation levels.
Measured: It will be measured twice, once at baseline or at the end of the study after 12 weeks.
Liver safety variables
It is a blood test that measures the presence of some enzymes, proteins and bilirubin in the blood, with the aim of determining if there is any alteration in the liver. Enzyme GPT, GOT, Gamma GT, LDH, alkaline phosphatase and bilirubin (UI/L)
Measured: It will be measured twice, once at baseline or at the end of the study 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 posted27 Oct 2022
- Study start26 Sep 2022
- Primary completion26 Jun 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SupplementationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Javier López Román, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05597189
- Sponsor's protocol ID
- UCAMCFE-00028
- Acronym
- Backin
- Status last verified
- Sep 2022
- First submitted
- 24 Oct 2022
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Palliative / Preventive Treatment of Chronic Back Pain by Taking a Dietary Supplement Based on Botanical Extracts
- ClinicalTrials.gov ID
- NCT05597189
- Acronym / sponsor ID
- Backin / UCAMCFE-00028
- Conditions
- Supplementation, Back Pain
- Keywords
- botanical extracts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 26 Sep 2022 (actual)
- Primary completion
- 26 Jun 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 27 Oct 2022 (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.
Randomized, controlled, double-blind, double-blind clinical trial, with three parallel arms depending on the product consumed (experimental product dose 1 and dose 2 and placebo product) and single-center, to measure the efficacy of a botanical supplement on the prevention of non-joint pain.
Detailed description
Subjects who meet the selection criteria will be randomly assigned to each of the study groups (investigational product dose 1 or dose 2, or placebo, depending on the group to which they have been assigned).
The product to be consumed is a Botanical Extract. Participants will consume the product for 84 days. It should be taken half an hour before breakfast, two capsules per day.
The study subjects will have to make 5 visits to the laboratory. On the first and last visit, they will have their blood drawn, their sleep quality will be evaluated and they will complete a series of questionnaires to evaluate their quality of life and type of back pain. In the rest of the visits they will only have to take the tests on paper.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Botanical extracts high dose | Experimental | Dietary Supplement: Experimental productConsumption for 84 days. Subjects should consume two capsules half an hour before breakfast. |
| Botanical extracts low dose | Experimental | Dietary Supplement: Experimental productConsumption for 84 days. Subjects should consume two capsules half an hour before breakfast. |
| Control group | Placebo comparator | Other: Control product consumptionConsumption for 84 days. Subjects should consume two capsules half an hour before breakfast. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women between 20 and 65 years of age.
- The subjects must have localized myofascial pain in the back area (cervical, dorsal and lumbar), with an evolution time of at least 3 months.
- The pain must present an initial score of at least 30 mm in the pain evaluation by means of the VAS scale.
- The pain must be episodic.
- BMI 18.5 - 29.9 kg/m2.
Key exclusion criteria (7 listed)
- Severe or terminal illnesses.
- Subjects with pain associated with trauma.
- Subjects with pain associated with chronic conditions (rheumatoid arthritis, herniated discs, ankylosing herniated disc, ankylosing spondylitis, etc.).
- Subjects with known allergy to any of the components of the investigational product. the investigational product.
- Subjects undergoing physiotherapy treatment during the course of the study. development of the study.
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 |
|---|---|---|
| Experimental productBotanical extract | Dietary supplement | Botanical extracts high dose, Botanical extracts low dose |
| Control product consumptionProduct with identical characteristics to the experimental product. | Other | Control group |
Primary outcome
Change in Pain from baseline at 12 weeks
Time frame: The evolution of pain after consumption during 12 weeks will be measured.
Visual analog scale from 0 to 10. The higher the value, the more pain.
16 secondary outcomes
Change in concomitant analgesic medication
Time frame: The test will be measured at baseline and after 12 weeks of consumption. It will also be evaluated on a daily basis
Evaluation of back pain: Promis-29 test
Time frame: Day 1, at 4, 8 and 12 weeks later
Evaluation of back pain: Cornell
Time frame: Day 1, at 4, 8 and 12 weeks later
Level of functionality: Roland Morris test
Time frame: Day 1, at 4, 8 and 12 weeks later
Quality of life questionnaire
Time frame: Day 1, at 4, 8 and 12 weeks later
Wellbeing / wellness
Time frame: Day 1, at 4, 8 and 12 weeks later
Depression
Time frame: Day 1, at 4, 8 and 12 weeks later
Anxiety questionnaire
Time frame: Day 1, at 4, 8 and 12 weeks later
Perceived stress
Time frame: Day 1, at 4, 8 and 12 weeks later
Sleep quality
Time frame: It will be measured twice, once at baseline or at the end of the study after 12 weeks of use
Body composition
Time frame: The test will be measured at baseline and after 12 weeks of consumption.
Physical activity
Time frame: The test will be measured at baseline and after 12 weeks of consumption. It will be measured during 3 weekdays and one weekend day.
Sleep efficiency
Time frame: The test will be measured at baseline and after 12 weeks of consumption. It will be measured during 3 weekdays and one weekend day.
C Reactive Protein (PCR)
Time frame: It will be measured twice, once at baseline or at the end of the study after 12 weeks.
Interleukin 6 (IL-6)
Time frame: It will be measured twice, once at baseline or at the end of the study after 12 weeks.
Liver safety variables
Time frame: It will be measured twice, once at baseline or at the end of the study 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 27 Nov 2023.
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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 Experimental product in people with Supplementation and Back Pain, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
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 6 inclusion and 7 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 27 Nov 2023. 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 Spain. 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 in Pain from baseline at 12 weeks (time frame: The evolution of pain after consumption during 12 weeks will be measured.). 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 27 Nov 2023.