Assessing the Effects of HbA1c Reduction on Alleviating Nonspecific Back Pain

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06064058
• Other study ID #: 001
• Status: Completed
• Phase: N/A
• Start date: January 30, 2023
• Est. completion date: September 1, 2023

Study information

• Verified date: October 2023
• Source: University of Baghdad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 1, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Back Pain Lower Back Chronic
• Back Pain, Low
• Diabetes
• Diabetes Mellitus
• Low Back Pain
• Pre Diabetes
• Prediabetic State

Intervention

Dietary Supplement:
• Ghazwan program
6-month lifestyle modification program, focusing on diet, sleep, exercise, and vitamin D and magnesium correction.

Drug:
• Standard management
Standard care with NSAIDs and acetaminophen for pain management

Locations

Country	Name	City	State
Iraq	Dr. Ghazwan A. Hasan Clinic	Baghdad

Sponsors (1)

Lead Sponsor	Collaborator
University of Baghdad

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HBA1C	Diabetes index	6 months