Innovations in the management of musculoskeletal pain with alpha-lipoic acid

Phase 2

Completed

• Conditions: Fibromyalgia; Musculoskeletal Diseases

• Registration Number: ISRCTN58259979
• Lead Sponsor: Physicians Services Incorporated Foundation

Brief Summary

2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/28351829 2021 results in https://pubmed.ncbi.nlm.nih.gov/32773602/ (added 21/05/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-15
• Study Completion: 2018-12-30
• Last Update Posted: 7 June 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

1. Aged 18 and older
2. Meeting the 2010 American College of Rheumatology diagnostic criteria for fibromyalgia
3. Experienced at least moderate daily pain (Numerical Rating Scale = 4/10) for at least 3 months prior to study entry
4. AST (aspartate aminotransferase)/ALT (alanine aminotransferase) no greater than 20% the upper limit of normal
5. Serum creatinine no greater than 50% the upper limit of normal
6. Necessary abilities, visual acuity and language skills for pain diary completion and telephone communication with study nurses

Exclusion Criteria

1. Any major organ system disease
2. Major poorly controlled psychiatric disorder
3. Severe depression or suicidal ideation
4. Active substance abuse disorder
5. Lactose intolerance
6. Hypersensitivity to ALA
7. Painful condition more than 50% as severe as their fibromyalgia pain
8. Unwillingness to use a highly effective form of contraception (women of childbearing potential)

Study & Design

• Study Type: Interventional
• Study Design: Not specified