Assessing the Effects of HbA1c Reduction on Alleviating Nonspecific Back Pain

University of Baghdad

Status: Completed

Conditions: Back Pain; Diabetes; Back Pain, Low; Back Pain Lower Back Chronic; Pre Diabetes

Treatments: Drug: Standard management; Dietary Supplement: Ghazwan program

Study type: Interventional

Funder types: Other

Identifiers

NCT06064058

001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 3 patient groups, including a placebo group

Interventional group

Experimental group

Description:

This group were assigned to 6-month lifestyle modification program, focusing on diet, sleep, exercise, and vitamin D and magnesium correction.

Treatment:

Dietary Supplement: Ghazwan program

Control group

Placebo Comparator group

Description:

Ordinary painkillers given

Treatment:

Drug: Standard management

No Placebo, no intervention group

No Intervention group

Description:

Nothing was given to them neither 6-month lifestyle modification program, focusing on diet, sleep, exercise, and vitamin D and magnesium correction nor painkillers.