Chronic Low Back PainPhase 3DISCINCT00567736
Efficacy of Disci/Rhus Toxicodendron Comp.®, in Patients With Chronic Low Back Pain
A Phase 3 study testing Disci/Rhus toxicodendron comp.® in people with Chronic Low Back Pain, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The aim of the study is to evaluate the efficacy of Disci/Rhus toxicodendron. comp.® in patients with chronic low back pain compared to waiting list group, or placebo. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Disci/Rhus toxicodendron comp.®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2007to Jan 2009
- Phase
- Phase 3
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients, 30 to 75 years
- Willingness of following the study protocol
- Clinical diagnosis of chronic low back pain
- Low back pain since at least 3 months
- Average pain intensity of at least 40 mm on VAS (0-100 mm) in the last 7 days
- In the last 4 weeks only oral NSAD and muscle relaxation treatment
- Effective oral contraception in woman
- Informed consent
Who cannot join
- Previous treatment with DISCI comp.
- Treatment with other than NSAID
- Routine use of pain drugs for other diseases
- Protrusio or prolapse of one or more intervertebral discs with neurological symptoms
- Previous spine surgery
- (Suspicious) infectious spondylopathy
Show all 24Show fewer
- Low back pain because of malignant or infectious disease
- Other causes of back pain symptoms (e.g. M. Bechterev, M. Reiter)
- Congenital deformity of spine (without minor lordosis or kyphosis or scoliosis
- (Suspicious) osteoporosis with compression fracture
- (Suspicious) spinal stenosis
- Spondylolysis or spondylolisthesis
- Physiotherapy in the last four weeks or planed during trial
- Begin of a new treatment for low back pain
- Complementary treatment in the last four weeks or planed during trial
- Patients who are not able to cooperate in a sufficient way
- Patients with alcohol or substance abuse
- Participation in another clinical trial
- Severe chronical or acute disease which does not allow study participation
- Patients with bleeding disorders or oral anticoagulation treatment
- Pregnancy and breast feeding
- Patients with application for pension
- Patients involved in planning or coordination of the study
- Hypersensitivity against drug components
Trial locations and contacts
1 site in 1 country.
Germany1 site
o Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center
Berlin, 10117
About this study
Official title: Prospective Randomized Controlled Multicentre Trial for Patients With Chronic Low Back Pain Comparing Disci/Rhus Toxicodendron Comp.®, Placebo and Waiting List Group
The aim of the study is to evaluate the efficacy of Disci/Rhus toxicodendron. comp.® in patients with chronic low back pain compared to waiting list group, or placebo.
Read the detailed description
Chronic low back pain is a significant health problem in industrialized countries. Use of complementary medicine is increasing in patients with low back pain. Until now there is no evidence for the efficacy of Disci/Rhus toxicodendron. comp.® in patients with chronic low back pain.
- Conditions
- Chronic Low Back Pain
- Being tested
- Disci/Rhus toxicodendron comp.®, placebo solution
- Keywords
- low back pain, complementary therapies
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disci/Rhus toxicodendron comp.®Drug
s.c. application 10 ml (1 ampul) in 5 to 10 parts on different back pain sites verum group 12 treatments: 8 in the first 4 weeks and 4 in the next 4 weeks
placebo solutionDrug
s.c. application 10 ml (1 ampul) in 5 to 10 parts on different back pain sites 12 treatments: 8 in the first 4 weeks and 4 in the next 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Disci/Rhus toxicodendron comp.® Receives: Drug: Disci/Rhus toxicodendron comp.® |
| 2 | Placebo comparator | placebo solution Receives: Drug: placebo solution |
| 3 | No intervention | waiting list group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale (0-100 mm) low back pain
Measured: once after 8 weeks
Secondary outcomes (11)
Back function (back function scale FFbHR)
Measured: once at week 8 and 26
visual analogue scale (0-100 mm) low back pain
Measured: once after week 26
days with medication
Measured: week 4 to 8
quality of life (SF-36)
Measured: once at week 8 and 26
pain disability scale (PDI)
Measured: once at week 8 and 26
emotional pain scale (SES)
Measured: once at week 8 and 26
influence of patient expectancy
Measured: once at week 8 and 26
influence of physician expectancy
Measured: once at week 8 and 26
Responder rate 36% VAS pain intensity
Measured: once at week 8 and 26
numbers of days with absence from work
Measured: between week 4 and 8
days with physician visits because of low back pain
Measured: between week 4 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2007 (estimated)
- Study startAug 2007
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- WALA Heilmittel GmbH
- Investigators
- Claudia M Witt, MD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00567736
- Sponsor's protocol ID
- DISCI-07
- Other IDs
- EudraCT-Nr. 2006-006390-24
- Acronym
- DISCI
- Status last verified
- Aug 2009
- First submitted
- 4 Dec 2007
- Last updated
- 11 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Pach D, Brinkhaus B, Roll S, Wegscheider K, Icke K, Willich SN, Witt CM. Efficacy of injections with Disci/Rhus toxicodendron compositum for chronic low back pain--a randomized placebo-controlled trial. PLoS One. 2011;6(11):e26166. doi: 10.1371/journal.pone.0026166. Epub 2011 Nov 8.
PubMed 22087222
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Multicentre Trial for Patients With Chronic Low Back Pain Comparing Disci/Rhus Toxicodendron Comp.®, Placebo and Waiting List Group
- ClinicalTrials.gov ID
- NCT00567736
- Acronym / sponsor ID
- DISCI / DISCI-07
- Conditions
- Chronic Low Back Pain
- Keywords
- low back pain, complementary therapies
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- WALA Heilmittel GmbH
- Study start
- Aug 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 5 Dec 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 aim of the study is to evaluate the efficacy of Disci/Rhus toxicodendron. comp.® in patients with chronic low back pain compared to waiting list group, or placebo.
Detailed description
Chronic low back pain is a significant health problem in industrialized countries. Use of complementary medicine is increasing in patients with low back pain. Until now there is no evidence for the efficacy of Disci/Rhus toxicodendron. comp.® in patients with chronic low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Disci/Rhus toxicodendron comp.®Disci/Rhus toxicodendron comp.® |
| 2 | Placebo comparator | Drug: placebo solutionplacebo solution |
| 3 | No intervention | –waiting list group |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male and female patients, 30 to 75 years
- Willingness of following the study protocol
- Clinical diagnosis of chronic low back pain
- Low back pain since at least 3 months
- Average pain intensity of at least 40 mm on VAS (0-100 mm) in the last 7 days
Key exclusion criteria (24 listed)
- Previous treatment with DISCI comp.
- Treatment with other than NSAID
- Routine use of pain drugs for other diseases
- Protrusio or prolapse of one or more intervertebral discs with neurological symptoms
- Previous spine surgery
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 |
|---|---|---|
| Disci/Rhus toxicodendron comp.®s.c. application 10 ml (1 ampul) in 5 to 10 parts on different back pain sites verum group 12 treatments: 8 in the first 4 weeks and 4 in the next 4 weeks | Drug | 1 |
| placebo solutions.c. application 10 ml (1 ampul) in 5 to 10 parts on different back pain sites 12 treatments: 8 in the first 4 weeks and 4 in the next 4 weeks | Drug | 2 |
Primary outcome
Visual analogue scale (0-100 mm) low back pain
Time frame: once after 8 weeks
11 secondary outcomes
Back function (back function scale FFbHR)
Time frame: once at week 8 and 26
visual analogue scale (0-100 mm) low back pain
Time frame: once after week 26
days with medication
Time frame: week 4 to 8
quality of life (SF-36)
Time frame: once at week 8 and 26
pain disability scale (PDI)
Time frame: once at week 8 and 26
emotional pain scale (SES)
Time frame: once at week 8 and 26
influence of patient expectancy
Time frame: once at week 8 and 26
influence of physician expectancy
Time frame: once at week 8 and 26
Responder rate 36% VAS pain intensity
Time frame: once at week 8 and 26
numbers of days with absence from work
Time frame: between week 4 and 8
days with physician visits because of low back pain
Time frame: between week 4 and 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2012.
- Results publication: PubMed 22087222Pach D, Brinkhaus B, Roll S, Wegscheider K, Icke K, Willich SN, Witt CM. Efficacy of injections with Disci/Rhus toxicodendron compositum for chronic low back pain--a randomized placebo-controlled trial. PLoS One. 2011;6(11):e26166. doi: 10.1371/journal.pone.0026166. Epub 2011 Nov 8.
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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.
Claudia M Witt, MD principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Disci/Rhus toxicodendron comp.® in people with Chronic Low Back Pain, run by Charite University, Berlin, Germany at 1 site in Germany.
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 8 inclusion and 24 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: finished, as of the sponsor's last update on 11 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Visual analogue scale (0-100 mm) low back pain (time frame: once after 8 weeks). 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 NCT00567736, which also lists 1 linked publication.
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 11 Jul 2012.