Effects of Metformin on Low Back Pain

Low Back Pain Clinical Trial

Official title:

Metformin and Beyond: Individualizing Care for Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04055012
• Other study ID #: STUDY19010007
• Status: Completed
• Phase: Phase 2
• Start date: January 7, 2020
• Est. completion date: December 15, 2023

Study information

• Verified date: February 2024
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the current study is to determine the effects of metformin in non-diabetic patients with low back pain, and identify novel targets for future treatments

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 15, 2023
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 and above

• Diagnosed with axial low back pain (low back pain more severe than pain in other parts of the body, without radiation of pain into the lower extremities).

• Women of child bearing potential must have a negative serum pregnancy test at baseline.

Exclusion Criteria:

• Diagnosed with rheumatoid arthritis, lupus, other autoimmune/systemic inflammatory arthropathies

• Progressive lower extremity weakness or numbness

• Recent oral steroid use (within last 3 months)

• NSAID use

• Chronic kidney disease (eGFR <60)

• Diagnosis of diabetes mellitus

• Subjects must not be pregnant or breastfeeding, or planning to become pregnant or breastfeed during the course of the trial

• Unable to take an oral medication in a non crushable pill form

• Taking metformin presently or within the last 6 months

• History of allergy to metformin

• History of lactic acidosis

• Severe Hepatic dysfunction

• Currently taking a diabetic medication such as sitagliptin, saxagliptin, linagliptin, alogliptin, sitagliptin with metformin

• Currently taking a Carbonic anhydrase inhibitor such as topiramate, zonisamide, acetazolamide, dichlorphenamide, methazolamide

• Currently taking cimetidine

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Drug:
• Metformin
500mg tabs of Metformin Extended Release
• Placebo
Placebo Tabs

Locations

Country	Name	City	State
United States	UPMC Kaufmann Medical Building	Pittsburgh	Pennsylvania
United States	UPMC Wexford Spine Center	Wexford	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Gwendolyn Sowa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Numeric Pain Rating Scale	Scores range from 0 to 10 with a higher score indicating more severe pain	Up to 15 months
Primary	Change from baseline in Oswestry Disability Index	Scores range from 0% to 100% with higher percentage scores indicating greater disability	Up to 15 months
Secondary	Change from baseline in Connor-Davidson Resilience Scale 25	Scores range from 0 to 100 in which a higher score demonstrates greater resilience	Up to 15 months
Secondary	Change from baseline in 10 Meter Walk Test	Subject is timed walking at normal speed and also fastest speed possible. A faster time is associated with better outcome.	Up to 15 months
Secondary	Change from baseline in Fear Avoidance Questionnaire	Scores range from 0 to 96 in which a higher score indicates greater fear avoidance beliefs	Up to 15 months
Secondary	Change from baseline in Godin Leisure Time Questionnaire	Minimum score is 0 and there is no maximum score. A higher score indicates a more active individual.	Up to 15 months
Secondary	Change from baseline in Catastrophizing Scale	Score range from 0 to 36 with a higher score indicating a higher degree of catastrophizing	Up to 15 months
Secondary	Change from baseline in Generalized Anxiety Disorder-7	Scores range from 0 to 21 with a higher score indicating more anxiety	Up to 15 months
Secondary	Change from baseline in PROMIS (Patient-Reported Outcomes Measurement Information System) 16 Questionnaire	This questionnaire is scored on the T-score metric. A higher score indicates a greater amount of whatever concept that the question asks.	Up to 15 months
Secondary	Change from baseline in Patient Health Questionnaire-9	Scores range from 0 to 27 with higher scores indicating more depressive symptoms	Up to 15 months
Secondary	Change from baseline in EQ-5D-5L (EuroQol)	Scores range from 5 to 25 with higher scores indicating more problems. Scores on the visual analogue scale range from 0 to 100 with 100 being the best	Up to 15 months
Secondary	Change from baseline in McGill Pain Questionnaire	Scores range from 0 to 45 with a higher score indicating more pain.	Up to 15 months