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Assessing the Effects of HbA1c Reduction on Alleviating Nonspecific Back Pain

Assessing the Effects of HbA1c Reduction on Alleviating Nonspecific Back Pain in Prediabetic Non-obese Patients: A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06064058
Enrollment
90
Registered
2023-10-03
Start date
2023-01-30
Completion date
2023-09-01
Last updated
2023-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Back Pain, Back Pain, Low, Back Pain Lower Back Chronic, Diabetes, Pre Diabetes

Keywords

Back Pain, HBA1C

Brief 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. 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.

Interventions

DIETARY_SUPPLEMENTGhazwan program

6-month lifestyle modification program, focusing on diet, sleep, exercise, and vitamin D and magnesium correction.

Standard care with NSAIDs and acetaminophen for pain management

Sponsors

University of Baghdad
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

Three Groups: * Case * Palcebo * No placebo, no intervention group

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Not able to record data * previous spine surgeries * severe OA in knee * Spinal stenosis * Peripheral vascular diseases * Rheumatological diseases * Lumbar disc prolapse * uncooperative patient

Design outcomes

Primary

MeasureTime frameDescription
HBA1C6 monthsDiabetes index

Countries

Iraq

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026