Assessing the Effects of HbA1c Reduction on Alleviating Nonspecific Back Pain

Sponsor

University of Baghdad (Other)

Overall Status

Completed

CT.gov ID

NCT06064058

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

12.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Back Pain Lower Back Chronic Back Pain Pre Diabetes Diabetes Back Pain, Low	Dietary Supplement: Ghazwan program Drug: Standard management	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Three Groups: Case Palcebo No placebo, no intervention groupThree Groups:Case Palcebo No placebo, no intervention group

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 30, 2023

Actual Primary Completion Date :

Aug 30, 2023

Actual Study Completion Date :

Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Interventional group 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 6-month lifestyle modification program, focusing on diet, sleep, exercise, and vitamin D and magnesium correction.
Placebo Comparator: Control group Ordinary painkillers given	Drug: Standard management Standard care with NSAIDs and acetaminophen for pain management
No Intervention: 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.

Arm

Intervention/Treatment

Experimental: Interventional group

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

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

Placebo Comparator: Control group

Ordinary painkillers given

Drug: Standard management

Standard care with NSAIDs and acetaminophen for pain management

No Intervention: 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.

Outcome Measures

Primary Outcome Measures

HBA1C [6 months]
Diabetes index

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dr. Ghazwan A. Hasan Clinic	Baghdad		Iraq

Sponsors and Collaborators

University of Baghdad

Investigators

Study Director: Hashim T Hashim, MBChB, University of Warith Al-Anbiyaa, College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hashim Talib Hashim, Doctor (MBChB), University of Baghdad

ClinicalTrials.gov Identifier:

NCT06064058

Other Study ID Numbers:

First Posted:

Oct 3, 2023

Last Update Posted:

Oct 5, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Hashim Talib Hashim, Doctor (MBChB), University of Baghdad

Back Pain

HBA1C

Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 5, 2023