Back Pain Lower Back ChronicNCT06064058
Assessing the Effects of HbA1c Reduction on Alleviating Nonspecific Back Pain
A study testing Ghazwan program and Standard management in people with Back Pain Lower Back Chronic and Back Pain, run by University of Baghdad at 1 site in Iraq.
Trial summary
Prediabetes, characterized by elevated HbA1c levels, is a common precursor to type 2 diabetes mellitus. Recent studies have suggested a potential link between prediabetes and nonspecific back pain. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Back Pain Lower Back Chronic, Back Pain, Pre Diabetes
- What is being tested?
- Ghazwan program and Standard management
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteIraq
- Study dates
- 30 Jan 2023to 1 Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Poor sleep (less than 6 hours per day)
- chronic back pain
- Multiple joint pain
- non-specific back pain
- HBA1C more than 5.7
- ability to record the data
Who cannot join
- Not able to record data
- previous spine surgeries
- severe OA in knee
- Spinal stenosis
- Peripheral vascular diseases
- Rheumatological diseases
- Lumbar disc prolapse
- uncooperative patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Effects of HbA1c Reduction on Alleviating Nonspecific Back Pain in Prediabetic Non-obese Patients: A Randomized Controlled Trial
Prediabetes, characterized by elevated HbA1c levels, is a common precursor to type 2 diabetes mellitus. Recent studies have suggested a potential link between prediabetes and nonspecific back pain. This randomized controlled trial aimed to assess whether reducing HbA1c levels through lifestyle interventions and, along with the correction of vitamin D and magnesium, can alleviate nonspecific back pain in prediabetic patients.
Read the detailed description
The study included 40 patients from an outpatient clinic in Baghdad, evenly divided into intervention and control groups. The intervention group underwent a 6-month lifestyle modification program, focusing on diet, sleep, exercise, and vitamin D and magnesium correction. HbA1c levels were measured, and back pain severity was assessed (through what assessment method ?). The control group received standard care with NSAIDs and acetaminophen for pain management. Assessments were conducted at baseline and at various intervals over a total period of 6 months to evaluate changes in HbA1c levels and back pain intensity.
This randomized controlled trial provides evidence that reducing HbA1c levels through lifestyle modifications, along with the correction of vitamin D and magnesium, can lead to a reduction in nonspecific back pain intensity and improved functional outcomes in prediabetic patients.
- Conditions
- Back Pain Lower Back Chronic, Back Pain, Pre Diabetes, Diabetes, Back Pain, Low
- Being tested
- Ghazwan program, Standard management
- Keywords
- Back Pain, HBA1C
- Medical subject headings
- Back Pain, Glucose Intolerance, Diabetes Mellitus, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ghazwan programDietary supplement
6-month lifestyle modification program, focusing on diet, sleep, exercise, and vitamin D and magnesium correction.
Standard managementDrug
Standard care with NSAIDs and acetaminophen for pain management
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | This group were assigned to 6-month lifestyle modification program, focusing on diet, sleep, exercise, and vitamin D and magnesium correction. Receives: Dietary Supplement: Ghazwan program |
| Control group | Placebo comparator | Ordinary painkillers given Receives: Drug: Standard management |
| No Placebo, no intervention group | No intervention | Nothing was given to them neither 6-month lifestyle modification program, focusing on diet, sleep, exercise, and vitamin D and magnesium correction nor painkillers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HBA1C
Diabetes index
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start30 Jan 2023
- Primary completion30 Aug 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back Pain Lower Back ChronicStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe sponsor's other registered studies.
- 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
- Three Groups: * Case * Palcebo * No placebo, no intervention group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hashim Talib Hashim, University of Baghdad
- Investigators
- Hashim T Hashim, MBChB, Study director, University of Warith Al-Anbiyaa, College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06064058
- Sponsor's protocol ID
- 001
- Status last verified
- Oct 2023
- First submitted
- 24 Sep 2023
- Last updated
- 5 Oct 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 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effects of HbA1c Reduction on Alleviating Nonspecific Back Pain in Prediabetic Non-obese Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06064058
- Acronym / sponsor ID
- 001
- Conditions
- Back Pain Lower Back Chronic, Back Pain, Pre Diabetes, Diabetes, Back Pain, Low
- Keywords
- Back Pain, HBA1C
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 3 Oct 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.
Prediabetes, characterized by elevated HbA1c levels, is a common precursor to type 2 diabetes mellitus. Recent studies have suggested a potential link between prediabetes and nonspecific back pain. This randomized controlled trial aimed to assess whether reducing HbA1c levels through lifestyle interventions and, along with the correction of vitamin D and magnesium, can alleviate nonspecific back pain in prediabetic patients.
Detailed description
The study included 40 patients from an outpatient clinic in Baghdad, evenly divided into intervention and control groups. The intervention group underwent a 6-month lifestyle modification program, focusing on diet, sleep, exercise, and vitamin D and magnesium correction. HbA1c levels were measured, and back pain severity was assessed (through what assessment method ?). The control group received standard care with NSAIDs and acetaminophen for pain management. Assessments were conducted at baseline and at various intervals over a total period of 6 months to evaluate changes in HbA1c levels and back pain intensity.
This randomized controlled trial provides evidence that reducing HbA1c levels through lifestyle modifications, along with the correction of vitamin D and magnesium, can lead to a reduction in nonspecific back pain intensity and improved functional outcomes in prediabetic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Three Groups: * Case * Palcebo * No placebo, no intervention group
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Dietary Supplement: Ghazwan programThis group were assigned to 6-month lifestyle modification program, focusing on diet, sleep, exercise, and vitamin D and magnesium correction. |
| Control group | Placebo comparator | Drug: Standard managementOrdinary painkillers given |
| No Placebo, no intervention group | No intervention | –Nothing was given to them neither 6-month lifestyle modification program, focusing on diet, sleep, exercise, and vitamin D and magnesium correction nor painkillers. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Poor sleep (less than 6 hours per day)
- chronic back pain
- Multiple joint pain
- non-specific back pain
- HBA1C more than 5.7
Key exclusion criteria (8 listed)
- Not able to record data
- previous spine surgeries
- severe OA in knee
- Spinal stenosis
- Peripheral vascular diseases
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 |
|---|---|---|
| Ghazwan program6-month lifestyle modification program, focusing on diet, sleep, exercise, and vitamin D and magnesium correction. | Dietary supplement | Interventional group |
| Standard managementStandard care with NSAIDs and acetaminophen for pain management | Drug | Control group |
Primary outcome
HBA1C
Time frame: 6 months
Diabetes index
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 5 Oct 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.
Hashim T Hashim, MBChB study director
University of Warith Al-Anbiyaa, College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ghazwan program and Standard management in people with Back Pain Lower Back Chronic and Back Pain, run by University of Baghdad at 1 site in Iraq.
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 8 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 5 Oct 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 Iraq. 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?
HBA1C (time frame: 6 months). 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 5 Oct 2023.