Plain English Summary
Background and study aims
Lumbar osteochondrosis is a disease of the lumbar (lower) spine caused by wear and tear on the intervertebral discs, vertebrae, vertebral joints or ligaments. Treatment is usually through pain and exercise therapy. The aim of this study is to investigate the 3-month intake of a dietary supplement as an accompanying measure to medical treatment. The food supplement, which has been sold in pharmacies for several years, is a combination of certain nutrients (collagen type II, hyaluronic acid, glucosamine, bamboo extract, L-lysine, and vitamin C) that occur naturally in the intervertebral disc and are intended to improve back pain or at least contribute to the maintenance of the spinal column function.
Who can participate?
Patients aged 18 to 75 with back pain, diagnosed with painful osteochondrosis
What does the study involve?
Participants are randomly allocated to take supplement or placebo (dummy) capsules daily with a glass of water (2 capsules during breakfast and 2 capsules during dinner) for 3 months. The research assistant contacts participants at least once during the 3-month intervention period to provide support if needed. Participants complete questionnaires and undergo MRI scans at the start of the study and after the 3-month supplementation.
What are the possible benefits and risks of participating?
The benefits of participating include being provided with free supplements for 3 months. The risks are very minimal and include potential side effects of the supplement's ingredients.
Where is the study run from?
The study is run by the Department of Nutritional Sciences, the University of Vienna with the OrthoCare and HealthPi Medical Center (Vienna, Austria)
When is the study starting and how long is it expected to run for?
April 2016 to December 2021
Who is funding the study?
The Austrian Research group for Orthopedic Medicine (AURROM) (Austria)
Who is the main contact?
Philipp R. Heuberer, MD and Brenda Laky, MSc, PhD
brenda.laky@meduniwien.ac.at
Study website
Contact information
Type
Scientific
Contact name
Dr Brenda Laky
ORCID ID
http://orcid.org/0000-0003-1198-4132
Contact details
Center of Clinical Research
University Clinic of Dentistry
Medical University of Vienna
Sensengasse 2a
Vienna
1090
Austria
+43 (0) 664 8498 120
brenda.laky@meduniwien.ac.at
Additional identifiers
EudraCT/CTIS number
Nil known
IRAS number
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
A dietary supplement for the management of patients with lumbar osteochondrosis
Acronym
NutS4IVDs
Study hypothesis
A 3-month supplementation with a combination of specific dietary compounds including collagen type II, hyaluronic acid, glucosamine, bamboo extract, L-lysine, and vitamin C improve pain and function in the management of patients with lumbar osteochondrosis.
Ethics approval(s)
Approved 10/01/2017, ethics committee of the Medical University of Vienna (Borschkegasse 8b/E06, 1090 Vienna, Austria; +43 (1)40400 21360; ethik-kom@meduniwien.ac.at), ref: 1998/2016; protocol version 1.0
Study design
Randomized double-blind placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Other
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a participant information sheet
Condition
Lumbar osteochondrosis
Intervention
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 active study dietary supplement capsules (Vertebene Bandscheibenkapseln, Natural Products & Drugs GmbH, Spital a.d. Drau, Austria) are composed of a mix of the following nutritional compounds: collagen hydrolysate, collagen type II, mucopolysaccharides, hyaluronic acid, glucosamine, bamboo extract, L-lysine hydrochloride, and vitamin C.
Comparator:
The same company (Natural Products & Drugs GmbH, Austria) producing the active capsules provide the control capsules (placebos). Cellulose is used as an inactive filler for the placebo capsules.
Patients in both groups are advised to take 2 x 2 capsules daily with a glass of water (2 capsules during breakfast and 2 capsules during dinner) for 3 months. The research assistant contacts participants at least once during the 3-month intervention period to provide support if needed. At baseline and follow-up (once after the intervention), all participants are asked to complete the subjective questionnaire and the lumbar magnetic resonance image are collected.
Intervention type
Supplement
Primary outcome measure
Pain and function measured using the Oswestry Disability Index (ODI) at baseline and after the 3-month intervention
Secondary outcome measures
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
Overall study start date
26/04/2016
Overall study end date
31/12/2021
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
100
Total final enrolment
50
Participant 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)
Recruitment start date
01/03/2017
Recruitment end date
01/09/2021
Locations
Countries of recruitment
Austria
Study participating centre
HealthPi Medical Center
Wollzeile 1
Vienna
1010
Austria
Sponsor information
Organisation
Austrian Research group for Regenerative and Orthopedic Medicine (AURROM)
Sponsor details
Hartmanngasse 15/9
Vienna
1050
Austria
+43 (0)68110 599 809
info@aurrom.org
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Austrian Research group for Regenerative and Orthopedic Medicine (AURROM)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
All dietary supplements and placebos are donated by Natural Products & Drugs GmbH; however, they will not be involved in any other part of the study.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal. The study protocol will be available after it has been published.
Intention to publish date
31/12/2023
Individual participant data (IPD) sharing plan
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.
IPD sharing plan summary
Other
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|