Lumbar Disc HerniationNCT00480038
World Health Organization Disability Assessment Schedule (WHODAS-II) for Patients With Symptomatic Lumbar Disc Herniation
A study testing WHODAS II in people with Lumbar Disc Herniation, run by Kovacs Foundation at 2 sites in Spain.
Trial summary
The main purpose of this study is to determine the measurement characteristics of WHODAS II (World Health Organization Disability Assessment Schedule), as well as to analyze its correlation with symptomatic lumbar disc herniation (Visual Analog Scale, VAS), disability (Spanish version of the Roland Morris… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lumbar Disc Herniation
- What is being tested?
- WHODAS II
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesSpain
- Study dates
- Apr 2007to Apr 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients seen for symptomatic lumbar disc herniation
- Radiated pain concordant with nerve root
- With or without motor restriction
- Able to read and write
- Signed the informed consent form
Who cannot join
- Central nervous system pathology (with or without treatment)
- Diagnosis of rheumatic inflammatory disease or fibromyalgia
- Red flags for underlying systemic disease
- Criteria for diagnosis of symptomatic spinal stenosis
- Symptoms suggesting saddle anesthesia, cauda equina, loss of sphincter tone or paraparesis
- Motor deficit that progresses or does not improve in 6 weeks
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Fundación Kovacs
Palma de Mallorca, Balearic Islands, 07012
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008
About this study
Official title: WHODAS-II for Patients With Symptomatic Lumbar Disc Herniation
The main purpose of this study is to determine the measurement characteristics of WHODAS II (World Health Organization Disability Assessment Schedule), as well as to analyze its correlation with symptomatic lumbar disc herniation (Visual Analog Scale, VAS), disability (Spanish version of the Roland Morris Questionnaire, RMQ), fear avoidance beliefs and attitudes (Spanish version of the FAB Questionnaire, FABQ) and quality of life (SF-12). Measurements will be taken at baseline and 6 days later (day 7).
- Conditions
- Lumbar Disc Herniation
- Being tested
- WHODAS II
- Keywords
- symptomatic, lumbar disc herniation, disability, fear avoidance beliefs, quality of life
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WHODAS IIOther
To determine the measurement characteristics of WHODAS II (World Health Organization Disability Assessment Schedule)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Measurement characteristics of WHODAS II (World Health Organization Disability Assessment Schedule) Receives: Other: WHODAS II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement characteristics of WHODAS-II
Measured: At baseline and at 7 days
Secondary outcomes (1)
Correlation between WHODAS-II and VAS, RMQ, FABQ and SF-12 in symptomatic lumbar herniated disc
Measured: At baseline and at 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2007 (estimated)
- Study startApr 2007
- Primary completionApr 2011
- Study completionApr 2011
Why it stopped: Recruitment was so slow, that it made the study impossible. Organizational changes made it impossible for recruiting centers to continue recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kovacs Foundation
- Sponsor type
- University, hospital or other
- Investigators
- Francisco M Kovacs, MD, PhD, Study director, Kovacs Foundation, Palma de Mallorca, SpainJosé Luis Peña, MD, Principal investigator, Hospital Universitario Marqués de Valdecilla, Santander, Cantabria, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00480038
- Sponsor's protocol ID
- FK-R-18
- Status last verified
- Jun 2011
- First submitted
- 28 May 2007
- Last updated
- 28 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bombardier C. Outcome assessments in the evaluation of treatment of spinal disorders. Introduction. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3097-9. doi: 10.1097/00007632-200012150-00002. No abstract available.
PubMed 11124723Chwastiak LA, Von Korff M. Disability in depression and back pain: evaluation of the World Health Organization Disability Assessment Schedule (WHO DAS II) in a primary care setting. J Clin Epidemiol. 2003 Jun;56(6):507-14. doi: 10.1016/s0895-4356(03)00051-9.
PubMed 12873644van Tubergen A, Landewe R, Heuft-Dorenbosch L, Spoorenberg A, van der Heijde D, van der Tempel H, van der Linden S. Assessment of disability with the World Health Organisation Disability Assessment Schedule II in patients with ankylosing spondylitis. Ann Rheum Dis. 2003 Feb;62(2):140-5. doi: 10.1136/ard.62.2.140.
PubMed 12525383
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WHODAS-II for Patients With Symptomatic Lumbar Disc Herniation
- ClinicalTrials.gov ID
- NCT00480038
- Acronym / sponsor ID
- FK-R-18
- Conditions
- Lumbar Disc Herniation
- Keywords
- symptomatic, lumbar disc herniation, disability, fear avoidance beliefs, quality of life
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment was so slow, that it made the study impossible. Organizational changes made it impossible for recruiting centers to continue recruitment
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Kovacs FoundationUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 30 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to determine the measurement characteristics of WHODAS II (World Health Organization Disability Assessment Schedule), as well as to analyze its correlation with symptomatic lumbar disc herniation (Visual Analog Scale, VAS), disability (Spanish version of the Roland Morris Questionnaire, RMQ), fear avoidance beliefs and attitudes (Spanish version of the FAB Questionnaire, FABQ) and quality of life (SF-12). Measurements will be taken at baseline and 6 days later (day 7).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: WHODAS IIMeasurement characteristics of WHODAS II (World Health Organization Disability Assessment Schedule) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients seen for symptomatic lumbar disc herniation
- Radiated pain concordant with nerve root
- With or without motor restriction
- Able to read and write
- Signed the informed consent form
Key exclusion criteria (6 listed)
- Central nervous system pathology (with or without treatment)
- Diagnosis of rheumatic inflammatory disease or fibromyalgia
- Red flags for underlying systemic disease
- Criteria for diagnosis of symptomatic spinal stenosis
- Symptoms suggesting saddle anesthesia, cauda equina, loss of sphincter tone or paraparesis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WHODAS IITo determine the measurement characteristics of WHODAS II (World Health Organization Disability Assessment Schedule) | Other | 1 |
Primary outcome
Measurement characteristics of WHODAS-II
Time frame: At baseline and at 7 days
1 secondary outcome
Correlation between WHODAS-II and VAS, RMQ, FABQ and SF-12 in symptomatic lumbar herniated disc
Time frame: At baseline and at 7 days
Results and safety
The study was stopped early (reason given: Recruitment was so slow, that it made the study impossible. Organizational changes made it impossible for recruiting centers to continue recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2011.
- Background: PubMed 11124723Bombardier C. Outcome assessments in the evaluation of treatment of spinal disorders. Introduction. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3097-9. doi: 10.1097/00007632-200012150-00002. No abstract available.
- Background: PubMed 12873644Chwastiak LA, Von Korff M. Disability in depression and back pain: evaluation of the World Health Organization Disability Assessment Schedule (WHO DAS II) in a primary care setting. J Clin Epidemiol. 2003 Jun;56(6):507-14. doi: 10.1016/s0895-4356(03)00051-9.
- Background: PubMed 12525383van Tubergen A, Landewe R, Heuft-Dorenbosch L, Spoorenberg A, van der Heijde D, van der Tempel H, van der Linden S. Assessment of disability with the World Health Organisation Disability Assessment Schedule II in patients with ankylosing spondylitis. Ann Rheum Dis. 2003 Feb;62(2):140-5. doi: 10.1136/ard.62.2.140.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francisco M Kovacs, MD, PhD study director
Kovacs Foundation, Palma de Mallorca, Spain
José Luis Peña, MD principal investigator
Hospital Universitario Marqués de Valdecilla, Santander, Cantabria, Spain
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WHODAS II in people with Lumbar Disc Herniation, run by Kovacs Foundation at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment was so slow, that it made the study impossible. Organizational changes made it impossible for recruiting centers to continue recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement characteristics of WHODAS-II (time frame: At baseline and at 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00480038, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2011.