Assessing the Effects of HbA1c Reduction on Alleviating Nonspecific Back Pain

NCT06064058 | Completed DMC

• 1 other identifier: 001
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Back Pain; HBA1C

Outcome Measures

Primary Outcomes (1)

• HBA1C

  Diabetes index

  6 months

Study Arms (3)

Interventional group

EXPERIMENTAL

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

Dietary Supplement: Ghazwan program

Control group

PLACEBO COMPARATOR

Ordinary painkillers given

Drug: Standard management

No Placebo, no intervention group

NO INTERVENTION

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

Interventions

Ghazwan program DIETARY_SUPPLEMENT

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

Interventional group

Standard management DRUG

Standard care with NSAIDs and acetaminophen for pain management

Control group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Not able to record data
• previous spine surgeries
• severe OA in knee
• Spinal stenosis
• Peripheral vascular diseases
• Rheumatological diseases
• Lumbar disc prolapse
• uncooperative patient

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

Dr. Ghazwan A. Hasan Clinic

Baghdad, Iraq

Location

MeSH Terms

Conditions

Back Pain; Glucose Intolerance; Diabetes Mellitus; Low Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Hashim T Hashim, MBChB

  University of Warith Al-Anbiyaa, College of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor (MBChB)

Model Details: Three Groups: * Case * Palcebo * No placebo, no intervention group

Study Record Dates

• First Submitted: September 24, 2023
• First Posted: October 3, 2023
• Study Start: January 30, 2023
• Primary Completion: August 30, 2023
• Study Completion: September 1, 2023
• Last Updated: October 5, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)