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Assessing the Effects of HbA1c Reduction on Alleviating Nonspecific Back Pain

Primary Purpose

Back Pain Lower Back Chronic, Back Pain, Pre Diabetes

Status
Completed
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
Ghazwan program
Standard management
Sponsored by
University of Baghdad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Back Pain Lower Back Chronic focused on measuring Back Pain, HBA1C

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Dr. Ghazwan A. Hasan Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

Interventional group

Control group

No Placebo, no intervention group

Arm Description

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

Ordinary painkillers given

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

Outcomes

Primary Outcome Measures

HBA1C
Diabetes index

Secondary Outcome Measures

Full Information

First Posted
September 24, 2023
Last Updated
October 2, 2023
Sponsor
University of Baghdad
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1. Study Identification

Unique Protocol Identification Number
NCT06064058
Brief Title
Assessing the Effects of HbA1c Reduction on Alleviating Nonspecific Back Pain
Official Title
Assessing the Effects of HbA1c Reduction on Alleviating Nonspecific Back Pain in Prediabetic Non-obese Patients: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
January 30, 2023 (Actual)
Primary Completion Date
August 30, 2023 (Actual)
Study Completion Date
September 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Baghdad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain Lower Back Chronic, Back Pain, Pre Diabetes, Diabetes, Back Pain, Low
Keywords
Back Pain, HBA1C

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Three Groups: Case Palcebo No placebo, no intervention group
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interventional group
Arm Type
Experimental
Arm Description
This group were assigned to 6-month lifestyle modification program, focusing on diet, sleep, exercise, and vitamin D and magnesium correction.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Ordinary painkillers given
Arm Title
No Placebo, no intervention group
Arm Type
No Intervention
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Ghazwan program
Intervention Description
6-month lifestyle modification program, focusing on diet, sleep, exercise, and vitamin D and magnesium correction.
Intervention Type
Drug
Intervention Name(s)
Standard management
Intervention Description
Standard care with NSAIDs and acetaminophen for pain management
Primary Outcome Measure Information:
Title
HBA1C
Description
Diabetes index
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hashim T Hashim, MBChB
Organizational Affiliation
University of Warith Al-Anbiyaa, College of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Dr. Ghazwan A. Hasan Clinic
City
Baghdad
Country
Iraq

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Assessing the Effects of HbA1c Reduction on Alleviating Nonspecific Back Pain

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