Assessing the Effects of HbA1c Reduction on Alleviating Nonspecific Back Pain

NCT ID: NCT06064058

Last Updated: 2023-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-30
• Study Completion Date: 2023-09-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Interventional group

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

Group Type: EXPERIMENTAL

Ghazwan program

Intervention Type: DIETARY_SUPPLEMENT

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

Control group

Ordinary painkillers given

Group Type: PLACEBO_COMPARATOR

Standard management

Intervention Type: DRUG

Standard care with NSAIDs and acetaminophen for pain management

No Placebo, no intervention group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Ghazwan program

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

Intervention Type: DIETARY_SUPPLEMENT

Standard management

Standard care with NSAIDs and acetaminophen for pain management

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Baghdad

OTHER

Sponsor Role: lead

Responsible Party

Hashim Talib Hashim

Doctor (MBChB)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hashim T Hashim, MBChB

Role: STUDY_DIRECTOR

University of Warith Al-Anbiyaa, College of Medicine

Locations

Dr. Ghazwan A. Hasan Clinic

Baghdad, , Iraq

Countries

Iraq

Other Identifiers

001

Identifier Type: -

Identifier Source: org_study_id