A dietary supplement for the management of patients with back pain

A dietary supplement for the management of patients with lumbar osteochondrosis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17230715

Enrollment

100

Registered

2021-04-28

Start date

2017-03-01

Completion date

Unknown

Last updated

2024-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar osteochondrosis Musculoskeletal Diseases Spinal osteochondrosis

Interventions

Randomization is performed in a 1:1 ratio in blocks of 10 and is generated via http://www.randomization.com. All packages will be labelled with the randomization number. Active intervention: The acti

Eligibility

Sex/Gender

All

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
Pain and function measured using the Oswestry Disability Index (ODI) at baseline and after the 3-month intervention	—

Secondary

Measure	Time frame
1. Intervertebral disc distances (IVDD) measured using magnetic resonance images (MRI) at baseline and after the 3-month intervention 2. Pain measured using the visual analogue scale (VAS) at baseline and after the 3-month intervention 3. Quality of life measured using the short form 12 (SF-12) at baseline and after the 3-month intervention 4. Nutritional status measured with a 60-item Food frequency questionnaire (FFQ) at baseline and after the 3-month intervention 5. Physical activity measured with the Global Physical Activity Questionnaire (GPAG) at baseline and after the 3-month intervention 6. Global satisfaction with the interventional procedure measured on a Likert scale with five categories ranging from very satisfied (4 points) to not satisfied at all (0 points) at baseline and after the 3-month intervention	—

Measure

Time frame

1. Intervertebral disc distances (IVDD) measured using magnetic resonance images (MRI) at baseline and after the 3-month intervention 2. Pain measured using the visual analogue scale (VAS) at baseline and after the 3-month intervention 3. Quality of life measured using the short form 12 (SF-12) at baseline and after the 3-month intervention 4. Nutritional status measured with a 60-item Food frequency questionnaire (FFQ) at baseline and after the 3-month intervention 5. Physical activity measured with the Global Physical Activity Questionnaire (GPAG) at baseline and after the 3-month intervention 6. Global satisfaction with the interventional procedure measured on a Likert scale with five categories ranging from very satisfied (4 points) to not satisfied at all (0 points) at baseline and after the 3-month intervention

—

Countries

Austria

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026