Chronic Low Back PainPhase 4NCT01166048
Comparison of the Efficacy of Duloxetine With Placebo in Patients With Chronic Low Back Pain With a Radicular Component
A Phase 4 study testing Duloxetine in people with Chronic Low Back Pain, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Objective: The objective of this study is to compare the efficacy of duloxetine in the treatment of patients with chronic low back pain with a radicular component to placebo. Study hypothesis: Duloxetine is a new substance now in use for the treatment of neuropathic pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Duloxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteAustria
- Study dates
- May 2010to Jun 2014
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Low back pain ( below L1)
- Chronic pain, >6 months
- Visual Analogue Scale (VAS) ≥ 5
- Back pain with radicular component defined as pain with a burning, tingling sensation within the anatomic distribution of the nerve root and diagnosed by painDETECT questionnaire
- Failed back surgery
Who cannot join
- Current mood disorder (dysthymia, bipolar mood disorder)
- Major Depression > 12 months (Beck Depression Inventory Score ≥ 18)
- History of a psychoactive substance use disorder within the preceding 12 months
- Major coexisting medical illness (e.g. severe heart failure, pulmonary hypertension, renal insufficiency)
- Glaucoma
- Acute myocardial infarction
Show all 26Show fewer
- uncontrolled hypertension
- Prostate hyperplasia
- History of convulsion
- Pregnancy; women of childbearing age will be required to use contraceptives during the duration of the study. Furthermore a pregnancy test will be performed prior to the beginning of the study and once a month during the study period.
- Participation in a clinical trial in the 3 weeks preceding the study
- Allergy to study medication
- Use of the following medication:
- opioids except for tramadol,
- benzodiazepines other than indicated at low doses for sleep disorders
- antineuropathic medication including except for that specified in the study protocol
- muscle relaxants
- antidepressants other than indicated at low doses for sleep disorders
- NSAID, Paracetamol
- non-selective MAO-Inhibitors
- Fluvoxamine, Ciprofloxacin, Enoxacin
- Selective Serotonin-reuptake Inhibitors (SSRI)
- if tapering of these drugs is impossible before inclusion.
- Impaired kidney function (Creatinine > 1.5mg/dl)
- Impaired hepatic function (GOT, GPT >2 fold standard levels)
- Patients who are not able to understand the study measures and are not able to complete pain assessment forms.
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Special Anesthesia and Pain Therapy, Medical University of Vienna, AKH Vienna
Vienna, State of Vienna, 1090
About this study
Official title: Randomized Double-blind Study Comparing the Efficacy of Duloxetine With Placebo in Patients With Chronic Low Back Pain With a Radicular Component
Objective:
The objective of this study is to compare the efficacy of duloxetine in the treatment of patients with chronic low back pain with a radicular component to placebo.
Read more
Study hypothesis:
Duloxetine is a new substance now in use for the treatment of neuropathic pain. It has proven its efficacy in diabetic peripheral neuropathy and fibromyalgia in several trials. The investigators therefore hypothesize that duloxetine will be efficacious in patients with chronic low back pain and a radicular component.
Study Rationale:
Chronic low back pain is an extremely common diagnosis. However, therapeutic options for the condition are limited and therapy remains difficult. Duloxetine has proven its efficacy in patients with neuropathic pain and may also be useful in chronic low back pain. If the investigators are able to show a benefit for patients in the duloxetine arm, the substance may constitute a further treatment alternative in chronic low back pain.
Study Design:
Prospective, randomized, double-blind placebo-controlled cross over study. Patients will be administered duloxetine for 4 weeks followed by a 2 week wash-out phase after which they will be medicated with placebo for 4 weeks. A second group of patients will receive the medication in reversed order. The primary study endpoint is constituted the weekly mean of VAS-Score in the last week of each treatment period. Secondary endpoints are defined as use of rescue medication, Beck Depression Inventory score, Health related Quality of Life SF-36 score and side effects/adverse events.
- Conditions
- Chronic Low Back Pain
- Being tested
- Duloxetine
- Keywords
- Chronic Low Back Pain, Radicular component, neuropathic pain, duloxetine, CLBP
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuloxetineDrug
Patients will receive 120mg of Duloxetine for the duration of 2 weeks after a dosage titration of 2 weeks according to the following scheme: (p=placebo)
day: 1 2 3 4 5 6 7: p-30mg p-30mg p-30mg p-30 mg p-30mg p-30mg p-60mg
day: 8 9 10 11 12 13 14: p-60 mg p-60 mg p-60mg p-60mg p-60mg p-60mg 60-60mg
DuloxetineDrug
2 weeks of titration of duloxetine to 120mg, (1-0-1), 2 weeks of continuation on 120mg/day.
| Study group | Role | What they receive |
|---|---|---|
| Milk powder pill | Placebo comparator | Patients will receive 2 placebo pills per day for a period of 4 weeks. Receives: Drug: Duloxetine |
| Duloxetine | Experimental | In the experimental arm of the study patients will receive duloxetine, which will be titrated up to a dosage of 120mg over a period of two weeks and continued at this dosage for two weeks. Receives: Drug: Duloxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly mean pain intensity in study phase I (Visual analogue score, units 1-10)
Operationally a VAS is a horizontal line, 100 mm in length, anchored by word descriptors at each end (left= no pain, right=worst imaginable pain).The patient marks the current subjective pain intensity on the scale. This is converted to a numeric value by measurement from the left side of the scale. (Units 1-10)
Measured: Week 4 of study period
Weekly mean pain intensity in study phase II (Visual analogue score, units 1-10)
Measured: Week 10 of study period
Secondary outcomes (8)
Use of rescue medication in study phase I
Patients will be allowed Metamizol (500mg up to 3g per day) and Tramadol drops (20 ggt. up to 6 times per day) as rescue medication. Rescue medication will be recorded daily in a patient diary. Use of rescue medication will be scored as follows: 0=no rescue medication; 1=metamizol; 2=tramadol
Measured: Use of rescue medication in week 4 of study period
Beck Depression Inventory score in phase I of study period
Subjects will be asked to perform the Beck Depression Inventory at screening and at week 4.
Measured: Beck Depression Inventory score at week 4 of study period
Health related Quality of Life SF-36 score in phase I of study period
Subjects will be asked to fill out the Health related Quality of Life SF-36 questionnaire at screening and at the end of each treatment period (placebo and verum)
Measured: Health related Quality of Life SF-36 score at week 4 of study period.
painDetect score in phase I of study period
Subjects will be asked to complete the painDetect questionnaire at screening and the end of each treatment period (placebo and verum).
Measured: painDetect score at week 4 of study period.
Use of rescue medication in phase II of study period
Measured: Use of rescue medication in week 10 of study period.
Beck Depression Inventory score in phase II of study period
Measured: Beck Depression Inventory score at week 10 of study period.
Health related Quality of Life SF-36 score in phase II of study period.
Measured: Health related Quality of Life SF-36 score at week 10 of study period.
painDetect score in phase II of study period
Measured: painDetect score at week 10 of study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2010 (estimated)
- Study startMay 2010
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibylle Pramhas, Medical University of Vienna
- Investigators
- Matthias Oehmke, MD, Principal investigator, Department of Special Anesthesia and Pain Therapy, Medical University of Vienna, AKH Vienna,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01166048
- Sponsor's protocol ID
- SPDP-01
- Status last verified
- Jul 2014
- First submitted
- 18 May 2010
- Last updated
- 31 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-blind Study Comparing the Efficacy of Duloxetine With Placebo in Patients With Chronic Low Back Pain With a Radicular Component
- ClinicalTrials.gov ID
- NCT01166048
- Acronym / sponsor ID
- SPDP-01
- Conditions
- Chronic Low Back Pain
- Keywords
- Chronic Low Back Pain, Radicular component, neuropathic pain, duloxetine, CLBP
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 20 Jul 2010 (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.
Objective:
The objective of this study is to compare the efficacy of duloxetine in the treatment of patients with chronic low back pain with a radicular component to placebo.
Study hypothesis:
Duloxetine is a new substance now in use for the treatment of neuropathic pain. It has proven its efficacy in diabetic peripheral neuropathy and fibromyalgia in several trials. The investigators therefore hypothesize that duloxetine will be efficacious in patients with chronic low back pain and a radicular component.
Study Rationale:
Chronic low back pain is an extremely common diagnosis. However, therapeutic options for the condition are limited and therapy remains difficult. Duloxetine has proven its efficacy in patients with neuropathic pain and may also be useful in chronic low back pain. If the investigators are able to show a benefit for patients in the duloxetine arm, the substance may constitute a further treatment alternative in chronic low back pain.
Study Design:
Prospective, randomized, double-blind placebo-controlled cross over study. Patients will be administered duloxetine for 4 weeks followed by a 2 week wash-out phase after which they will be medicated with placebo for 4 weeks. A second group of patients will receive the medication in reversed order. The primary study endpoint is constituted the weekly mean of VAS-Score in the last week of each treatment period. Secondary endpoints are defined as use of rescue medication, Beck Depression Inventory score, Health related Quality of Life SF-36 score and side effects/adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Milk powder pill | Placebo comparator | Drug: DuloxetinePatients will receive 2 placebo pills per day for a period of 4 weeks. |
| Duloxetine | Experimental | Drug: DuloxetineIn the experimental arm of the study patients will receive duloxetine, which will be titrated up to a dosage of 120mg over a period of two weeks and continued at this dosage for two weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Low back pain ( below L1)
- Chronic pain, >6 months
- Visual Analogue Scale (VAS) ≥ 5
- Back pain with radicular component defined as pain with a burning, tingling sensation within the anatomic distribution of the nerve root and diagnosed by painDETECT questionnaire
- Failed back surgery
Key exclusion criteria (26 listed)
- Current mood disorder (dysthymia, bipolar mood disorder)
- Major Depression > 12 months (Beck Depression Inventory Score ≥ 18)
- History of a psychoactive substance use disorder within the preceding 12 months
- Major coexisting medical illness (e.g. severe heart failure, pulmonary hypertension, renal insufficiency)
- Glaucoma
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 |
|---|---|---|
| DuloxetinePatients will receive 120mg of Duloxetine for the duration of 2 weeks after a dosage titration of 2 weeks according to the following scheme: (p=placebo) day: 1 2 3 4 5 6 7: p-30mg p-30mg p-30mg p-30 mg p-30mg p-30mg p-60mg day: 8 9 10 11 12 13 14: p-60 mg p-60 mg p-60mg p-60mg p-60mg p-60mg 60-60mg | Drug | Milk powder pill |
| Duloxetine2 weeks of titration of duloxetine to 120mg, (1-0-1), 2 weeks of continuation on 120mg/day. | Drug | Duloxetine, Milk powder pill |
Primary outcome
Weekly mean pain intensity in study phase I (Visual analogue score, units 1-10)
Time frame: Week 4 of study period
Operationally a VAS is a horizontal line, 100 mm in length, anchored by word descriptors at each end (left= no pain, right=worst imaginable pain).The patient marks the current subjective pain intensity on the scale. This is converted to a numeric value by measurement from the left side of the scale. (Units 1-10)
Weekly mean pain intensity in study phase II (Visual analogue score, units 1-10)
Time frame: Week 10 of study period
8 secondary outcomes
Use of rescue medication in study phase I
Time frame: Use of rescue medication in week 4 of study period
Beck Depression Inventory score in phase I of study period
Time frame: Beck Depression Inventory score at week 4 of study period
Health related Quality of Life SF-36 score in phase I of study period
Time frame: Health related Quality of Life SF-36 score at week 4 of study period.
painDetect score in phase I of study period
Time frame: painDetect score at week 4 of study period.
Use of rescue medication in phase II of study period
Time frame: Use of rescue medication in week 10 of study period.
Beck Depression Inventory score in phase II of study period
Time frame: Beck Depression Inventory score at week 10 of study period.
Health related Quality of Life SF-36 score in phase II of study period.
Time frame: Health related Quality of Life SF-36 score at week 10 of study period.
painDetect score in phase II of study period
Time frame: painDetect score at week 10 of study period.
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 31 Jul 2014.
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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.
Matthias Oehmke, MD principal investigator
Department of Special Anesthesia and Pain Therapy, Medical University of Vienna, AKH Vienna,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Duloxetine in people with Chronic Low Back Pain, run by Medical University of Vienna at 1 site in Austria.
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 26 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 31 Jul 2014. 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 Austria. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Weekly mean pain intensity in study phase I (Visual analogue score, units 1-10) (time frame: Week 4 of study period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jul 2014.