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Completed

NCT Number: NCT06064058

Assessing the Effects of HbA1c Reduction on Alleviating Nonspecific Back Pain

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.

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Key information

Conditions

Back Pain Lower Back Chronic Back Pain Back Pain, Low Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Low Back Pain Metabolic Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Pain Pathological Conditions, Signs and Symptoms Pre Diabetes Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Ghazwan A. Hasan Clinic

Baghdad, Iraq

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ghazwan program

Dietary Supplement

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

standard management

Drug

Standard care with NSAIDs and acetaminophen for pain management

Primary outcomes

  1. HBA1C

    Time frame: 6 months

    Diabetes index

Sponsors and collaborators

Lead sponsor

University of Baghdad

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 3, 2023
Registry last updated
Oct 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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