Assessing the Effects of HbA1c Reduction on Alleviating Nonspecific Back Pain

Not Applicable

Completed

• Conditions: Back Pain Lower Back Chronic; Back Pain; Pre Diabetes; Diabetes; Back Pain, Low
• Interventions: Dietary Supplement: Ghazwan program; Drug: Standard management

• Registration Number: NCT06064058
• Lead Sponsor: University of Baghdad

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.

Study Timeline

• Study Start: 2023-01-30
• Primary Completion: 2023-08-30
• Study Completion: 2023-09-01
• Study First Submitted: 2023-09-24
• Study First Submitted QC: 2023-09-28
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-02
• Study First Posted: 2023-10-03
• Last Update Posted: 2023-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional group	Ghazwan program	This group were assigned to 6-month lifestyle modification program, focusing on diet, sleep, exercise, and vitamin D and magnesium correction.
Control group	Standard management	Ordinary painkillers given

Primary Outcome Measures

Name	Time	Method
HBA1C	6 months	Diabetes index

Trial Locations

Locations (1)

Dr. Ghazwan A. Hasan Clinic; 🇮🇶 Baghdad, Iraq