A dietary supplement for the management of patients with back pai

Not Applicable

Completed

• Conditions: umbar osteochondrosis; Musculoskeletal Diseases; Spinal osteochondrosis

• Registration Number: ISRCTN17230715
• Lead Sponsor: Austrian Research group for Regenerative and Orthopedic Medicine (AURROM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-28
• Study Completion: 2021-12-31
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Female and male patients aged between 18 and 75 years of age
2. Patients with symptomatic (VAS =4) MRI-confirmed lumbar osteochondrosis

Exclusion Criteria

1. Patients with asymptomatic (VAS = 3) MRI-confirmed (Pfirrmann grades 1 and 5 lumbar osteochondrosis
2. Patients with pathologies including
2.1. Rheumatoid osteoarthritis
2.2. Fibromyalgia
2.3. Scoliosis
2.4. Neurological deficit
2.5. Morbid adiposity (body mass index, BMI =40)
2.6. Any other current or past clinically significant disease (comorbidity) that, in the opinion of the orthopaedic consultant, might confound the results of the study or poses an additional risk to the subject during participation in the study (e.g. renal, neoplastic, epigastric disease)
3. Previous surgeries of intervertebral disc(s), hip(s)
4. Allergies/intolerances against any component of the dietary supplement (e.g. shellfish)
5. Pregnant or lactating women
6. Not fluent (read/understand) in German (consent, questionnaires, and study forms are in German)
7. Not able to undergo MRI (e.g. claustrophobia, pacemaker)

Study & Design

• Study Type: Interventional
• Study Design: Not specified