Low Back PainPhase 2NCT03364075
Genetic Variants Associated With Low Back Pain and Their Response to Treatment With Duloxetine or Propranolol
A Phase 2 study testing Duloxetine, Propranolol and Genotype for SNPs associated to Serotonin and COMT in people with Low Back Pain, run by Mark Ware at 1 site in Canada.
Trial summary
This study is a randomized, double-blind, placebo controlled, three period crossover clinical trial. The main purpose of this study is to determine if Chronic Low Back Pain patients presenting with either localized or widespread painful symptoms respond differently to treatment with Duloxetine or Propranolol, and if… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Duloxetine, Propranolol and Genotype for SNPs associated to Serotonin and COMT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2017to 31 May 2018
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Uncontrolled medical or psychiatric conditions.
- History of major depressive disorder, psychotic disorder or schizophrenia, and/or manic episodes within the past year.
- Pregnancy and/or breast-feeding. Patients who are unsure of their status will also be excluded from participating
- Pain due to cancer.
- Disability compensation or litigation.
- Neurologic signs of lumbosacral radiculopathy within the past 6 months: lower extremity muscle weakness/sensory loss in a dermatomal distribution, abnormal deep tendon reflexes.
Show all 18Show fewer
- Radiographic and/or electrophysiology evidence of radicular compression in the past 6 months.
- Clinical signs of lumbar stenosis within the past 6 months: numbness, weakness, and/or discomfort radiating from the spine down to the buttocks and legs while walking or in prolonged standing and relieved with sitting or lying.
- Clinical signs of back pain that requires an urgent/alternative intervention: new onset bowel/bladder incontinence, saddle anaesthesia, foot drop, unexplained weight loss, fever.
- Radiographic evidence of spinal stenosis, high-grade spondylolisthesis (grade 3 or 4), acute spinal fracture, tumour, abscess or acute pathology in the low back/abdominal area in the past 6 months.
- Low back surgery (lumbosacral spine) within the past 12 months, or history of more than 1 low back surgery.
- Minimally invasive procedures aimed to reduce pain in the lumbosacral area within the past month (Medial Branch Blocks/Ablations, Epidural Steroid Injections, Trigger point injections, Sacroiliac Joint Injections, Greater Trochanteric/Acetabulofemoral Joint Injections).
- Known hypersensitivity to Beta Blockers or SNRIs.
- Currently taking SNRIs, Beta Blockers, Opioids at a daily dose superior to 30mg of Morphine Oral Equivalent, Tricyclic Antidepressants, Methylene Blue, Linezolid, Monoamine Oxidase Inhibitors (such as Selegiline, Isoniazid, Procarbazine), Thioridazine, CYP1A2 inhibitors (Fluvoxamine, Verapamil, Cimetidine, Fluoroquinolone antibiotics such as Ciprofloxacin).
- Active alcoholism within the past 6 months.
- Psychoactive recreational drug abuse within the past 6 months including MDMA, Ketamine, hallucinogens such as LSD and/or sympathomimetics such as Cocaine.
- Patients with asthma, cardiac arrhythmias such as Wolff-Parkinson-White syndrome, coronary artery disease, congestive heart failure, renal failure or dialysis, liver insufficiency, diabetes mellitus, hyperthyroidism.
- Heart rate less than 60 bpm or systolic/diastolic blood pressure less than 105/60 mmHg during the initial visit.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre for Innovative Medicine - McGill University Health Centre
Montreal, Quebec, H4A 3J1
About this study
Official title: Genetic Variants Associated With the Occurrence of Localized Low Back Pain or Low Back Pain With Widespread Pain Symptoms, and Their Response to Treatment With Duloxetine or Propranolol
This study is a randomized, double-blind, placebo controlled, three period crossover clinical trial. The main purpose of this study is to determine if Chronic Low Back Pain patients presenting with either localized or widespread painful symptoms respond differently to treatment with Duloxetine or Propranolol, and if the effectiveness of treatment with these drugs can determined by the presence or absence of SNPs associated with the Serotonin receptor or Cathecol-O-MethylTransferase activity. Each treatment period will be of two weeks duration with a 1 week washout phase between treatment periods. Following a Latin square design, patients will be randomly assigned to one of six different treatment groups, starting their first treatment cycle with either Duloxetine, Propranolol or Placebo and rotating through the other treatments in the subsequent cycles. Effectiveness of treatment will be measured by means of Pain Index as the primary outcome measure, and secondary outcome measures will include Pressure Pain Threshold and the Pain Disability Index, Perceived Stress Scale, Symptom Checklist -90R and the Patient's Global Impression of Change questionnaires.
Read the detailed description
Low back pain disorders are reported in 19-21% of the North American population, with the majority of them associating pain and physical impairment. Patients with this illness have an increased utilization of medical services, higher incidence of lost work days and long-term disability, representing a significant burden to the healthcare system and the economy.
Within the population of CLBP patients, two broad subgroups can easily be identified in the clinical setting: the patients who present with CLBP as their only pain symptom, and patients that present with CLBP and also associate widespread painful symptoms. The presence of widespread painful symptoms in the setting of low back pain has been recognized as a strong predictor of chronicity, apart from this, patients in this subgroup are more commonly middle aged females, report higher intensity of pain, more emotional problems and sleep disorders amongst others.
A recent publication by Slate et al has described genetic differences in patients with Temporal Mandibular Disorder (TMD) that present with either localized or widespread painful symptoms. This study established a link between Single Nucleotide Polymorphisms (SNPs) associated to the Serotonin Receptor and patients with localized TDM, and the presence of SNPs associated to the T cell receptor with patients with TMD and widespread symptoms. CLBP and TMD are two chronic pain conditions that are commonly present together. Given the connection between these two chronic pain disorders, it is highly likely that the genetic association findings from Slate et al could also be present in the CLPB population.
The main purpose of this study is to determine if CLBP patients presenting with either localized or widespread painful symptoms respond differently to treatment with Duloxetine, a Serotonin and Norepinephrine Reuptake Inhibitor (SNRI), and if the effectiveness of treatment with this drug can determined by the presence or absence of SNPs associated with the Serotonin receptor.
Another novel treatment alternative for patients with CLBP is Propranolol. This drug is a non-selective beta blocker that has also been shown to have analgesic effects on TMD. These effects though, are only present in patients carrying haplotypes associated with low activity of catechol-O-methyltransferase (COMT). The effect of beta blockers as analgesics has not yet been fully characterized, in animal models, catecholamine stimulation of beta 2 and beta 3 adrenoreceptors has shown to produce hyperalgesia and allodynia, on the other hand, in the clinical setting, the beta 1 selective blocker Esmolol has also been shown to have an analgesic effect in postoperative acute pain management. The inclusion of Propranolol as one of the treatment arms of this study will help elucidate Propranolol's possible role in chronic pain management; the expectation being that a more prominent analgesic effect will be found in patients displaying low activity COMT haplotypes.
Patients will be recruited from the Montreal General Hospital (MGH) Pain Centre and from the Quebec Pain Registry.
This study is a randomized, double-blind, placebo controlled, three period crossover clinical study. Each treatment period will be of two weeks duration with a 1 week washout phase between treatment periods. Following a Latin square design, patients will be randomly assigned to one of six different treatment groups, starting their first treatment cycle with either Duloxetine, Propranolol or Placebo and rotating through the other treatments in the subsequent cycles. The trial has a duration of 56 days total, and involves 6 clinic visits per participant, one at the beginning and at the end of each treatment cycle.
Randomization will be performed by a member of our research group that is not involved in the study using the online software (http//:www.randomization.com). The software's first generator will be used which randomizes each subject to a single treatment group by using the method of randomly permuted blocks. The randomization log will be provided to the pharmacy which will be in charge of dispensing the treatment.
All clinicians and researchers involved in the study data collection and experimental procedures will remain blinded to study group allocation for the duration of the study. Blinding will be maintained until the end for statistical analysis.
In case of serious adverse effects interfering with the patient safety, the blind responsible (pharmacy) will disclose the treatment to the MD of the MGH Pain Centre and that subject will be dropped out of the study.
- Conditions
- Low Back Pain
- Being tested
- Duloxetine, Propranolol, Genotype for SNPs associated to Serotonin and COMT, Placebo Treatment
- 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.
DuloxetineDrug
Also called Cymbalta
30 mg for seven days, then increased to 60 mg for seven days
PropranololDrug
Also called TevaPropranolol
40 mg for seven days, then increase to 60 mg for seven days
Genotype for SNPs associated to Serotonin and COMTGenetic
DNA and RNA extraction from blood samples to identify genetic variants associated to pain pathways
Placebo TreatmentDrug
1 capsule BID for two weeks
| Study group | Role | What they receive |
|---|---|---|
| Duloxetine Treatment | Active comparator | patients treated with Duloxetine Receives: Drug: Duloxetine; Genetic: Genotype for SNPs associated to Serotonin and COMT; Drug: Placebo Treatment |
| Propranolol Treatment | Active comparator | patients treated with Propranolol Receives: Drug: Propranolol; Genetic: Genotype for SNPs associated to Serotonin and COMT; Drug: Placebo Treatment |
| Placebo Treatment | Placebo comparator | patients treated with placebo Receives: Drug: Duloxetine; Drug: Propranolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain index
Average pain intensity multiplied by percentage of time in pain in the waking day.
Measured: Difference between the average pain index on the first three days of treatment compared to the last three days of the 14 day treatment cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study start1 Sep 2017
- Primary completion31 May 2018
- Study completion31 May 2018
Why it stopped: Recruitment issue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mark Ware
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mark Ware, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Mark Ware, MBBS MRCP, Principal investigator, Director of Clinical Research Alan Edwards Pain Management Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03364075
- Sponsor's protocol ID
- MUHC15046
- Status last verified
- Aug 2018
- First submitted
- 22 Mar 2016
- Last updated
- 28 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lim KL, Jacobs P, Klarenbach S. A population-based analysis of healthcare utilization of persons with back disorders: results from the Canadian Community Health Survey 2000-2001. Spine (Phila Pa 1976). 2006 Jan 15;31(2):212-8. doi: 10.1097/01.brs.0000194773.10461.9f.
PubMed 16418643Von Korff M, Crane P, Lane M, Miglioretti DL, Simon G, Saunders K, Stang P, Brandenburg N, Kessler R. Chronic spinal pain and physical-mental comorbidity in the United States: results from the national comorbidity survey replication. Pain. 2005 Feb;113(3):331-339. doi: 10.1016/j.pain.2004.11.010.
PubMed 15661441Coyte PC, Asche CV, Croxford R, Chan B. The economic cost of musculoskeletal disorders in Canada. Arthritis Care Res. 1998 Oct;11(5):315-25. doi: 10.1002/art.1790110503.
PubMed 9830876Koes BW, van Tulder M, Lin CW, Macedo LG, McAuley J, Maher C. An updated overview of clinical guidelines for the management of non-specific low back pain in primary care. Eur Spine J. 2010 Dec;19(12):2075-94. doi: 10.1007/s00586-010-1502-y. Epub 2010 Jul 3.
PubMed 20602122Fairbank J, Gwilym SE, France JC, Daffner SD, Dettori J, Hermsmeyer J, Andersson G. The role of classification of chronic low back pain. Spine (Phila Pa 1976). 2011 Oct 1;36(21 Suppl):S19-42. doi: 10.1097/BRS.0b013e31822ef72c.
PubMed 21952188Thomas E, Silman AJ, Croft PR, Papageorgiou AC, Jayson MI, Macfarlane GJ. Predicting who develops chronic low back pain in primary care: a prospective study. BMJ. 1999 Jun 19;318(7199):1662-7. doi: 10.1136/bmj.318.7199.1662.
PubMed 10373170Natvig B, Bruusgaard D, Eriksen W. Localized low back pain and low back pain as part of widespread musculoskeletal pain: two different disorders? A cross-sectional population study. J Rehabil Med. 2001 Jan;33(1):21-5. doi: 10.1080/165019701300006498.
PubMed 11480465Slade GD, Smith SB, Zaykin DV, Tchivileva IE, Gibson DG, Yuryev A, Mazo I, Bair E, Fillingim R, Ohrbach R, Greenspan J, Maixner W, Diatchenko L. Facial pain with localized and widespread manifestations: separate pathways of vulnerability. Pain. 2013 Nov;154(11):2335-2343. doi: 10.1016/j.pain.2013.07.009. Epub 2013 Jul 16.
PubMed 23867732Wiesinger B, Malker H, Englund E, Wanman A. Back pain in relation to musculoskeletal disorders in the jaw-face: a matched case-control study. Pain. 2007 Oct;131(3):311-319. doi: 10.1016/j.pain.2007.03.018. Epub 2007 Apr 24.
PubMed 17459585Millan MJ. Descending control of pain. Prog Neurobiol. 2002 Apr;66(6):355-474. doi: 10.1016/s0301-0082(02)00009-6.
PubMed 12034378Tchivileva IE, Lim PF, Smith SB, Slade GD, Diatchenko L, McLean SA, Maixner W. Effect of catechol-O-methyltransferase polymorphism on response to propranolol therapy in chronic musculoskeletal pain: a randomized, double-blind, placebo-controlled, crossover pilot study. Pharmacogenet Genomics. 2010 Apr;20(4):239-48. doi: 10.1097/FPC.0b013e328337f9ab.
PubMed 20216107
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Variants Associated With the Occurrence of Localized Low Back Pain or Low Back Pain With Widespread Pain Symptoms, and Their Response to Treatment With Duloxetine or Propranolol
- ClinicalTrials.gov ID
- NCT03364075
- Acronym / sponsor ID
- MUHC15046
- Conditions
- Low Back Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment issue
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mark WareUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 6 Dec 2017 (actual)
- 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.
This study is a randomized, double-blind, placebo controlled, three period crossover clinical trial. The main purpose of this study is to determine if Chronic Low Back Pain patients presenting with either localized or widespread painful symptoms respond differently to treatment with Duloxetine or Propranolol, and if the effectiveness of treatment with these drugs can determined by the presence or absence of SNPs associated with the Serotonin receptor or Cathecol-O-MethylTransferase activity. Each treatment period will be of two weeks duration with a 1 week washout phase between treatment periods. Following a Latin square design, patients will be randomly assigned to one of six different treatment groups, starting their first treatment cycle with either Duloxetine, Propranolol or Placebo and rotating through the other treatments in the subsequent cycles. Effectiveness of treatment will be measured by means of Pain Index as the primary outcome measure, and secondary outcome measures will include Pressure Pain Threshold and the Pain Disability Index, Perceived Stress Scale, Symptom Checklist -90R and the Patient's Global Impression of Change questionnaires.
Detailed description
Low back pain disorders are reported in 19-21% of the North American population, with the majority of them associating pain and physical impairment. Patients with this illness have an increased utilization of medical services, higher incidence of lost work days and long-term disability, representing a significant burden to the healthcare system and the economy.
Within the population of CLBP patients, two broad subgroups can easily be identified in the clinical setting: the patients who present with CLBP as their only pain symptom, and patients that present with CLBP and also associate widespread painful symptoms. The presence of widespread painful symptoms in the setting of low back pain has been recognized as a strong predictor of chronicity, apart from this, patients in this subgroup are more commonly middle aged females, report higher intensity of pain, more emotional problems and sleep disorders amongst others.
A recent publication by Slate et al has described genetic differences in patients with Temporal Mandibular Disorder (TMD) that present with either localized or widespread painful symptoms. This study established a link between Single Nucleotide Polymorphisms (SNPs) associated to the Serotonin Receptor and patients with localized TDM, and the presence of SNPs associated to the T cell receptor with patients with TMD and widespread symptoms. CLBP and TMD are two chronic pain conditions that are commonly present together. Given the connection between these two chronic pain disorders, it is highly likely that the genetic association findings from Slate et al could also be present in the CLPB population.
The main purpose of this study is to determine if CLBP patients presenting with either localized or widespread painful symptoms respond differently to treatment with Duloxetine, a Serotonin and Norepinephrine Reuptake Inhibitor (SNRI), and if the effectiveness of treatment with this drug can determined by the presence or absence of SNPs associated with the Serotonin receptor.
Another novel treatment alternative for patients with CLBP is Propranolol. This drug is a non-selective beta blocker that has also been shown to have analgesic effects on TMD. These effects though, are only present in patients carrying haplotypes associated with low activity of catechol-O-methyltransferase (COMT). The effect of beta blockers as analgesics has not yet been fully characterized, in animal models, catecholamine stimulation of beta 2 and beta 3 adrenoreceptors has shown to produce hyperalgesia and allodynia, on the other hand, in the clinical setting, the beta 1 selective blocker Esmolol has also been shown to have an analgesic effect in postoperative acute pain management. The inclusion of Propranolol as one of the treatment arms of this study will help elucidate Propranolol's possible role in chronic pain management; the expectation being that a more prominent analgesic effect will be found in patients displaying low activity COMT haplotypes.
Patients will be recruited from the Montreal General Hospital (MGH) Pain Centre and from the Quebec Pain Registry.
This study is a randomized, double-blind, placebo controlled, three period crossover clinical study. Each treatment period will be of two weeks duration with a 1 week washout phase between treatment periods. Following a Latin square design, patients will be randomly assigned to one of six different treatment groups, starting their first treatment cycle with either Duloxetine, Propranolol or Placebo and rotating through the other treatments in the subsequent cycles. The trial has a duration of 56 days total, and involves 6 clinic visits per participant, one at the beginning and at the end of each treatment cycle.
Randomization will be performed by a member of our research group that is not involved in the study using the online software (http//:www.randomization.com). The software's first generator will be used which randomizes each subject to a single treatment group by using the method of randomly permuted blocks. The randomization log will be provided to the pharmacy which will be in charge of dispensing the treatment.
All clinicians and researchers involved in the study data collection and experimental procedures will remain blinded to study group allocation for the duration of the study. Blinding will be maintained until the end for statistical analysis.
In case of serious adverse effects interfering with the patient safety, the blind responsible (pharmacy) will disclose the treatment to the MD of the MGH Pain Centre and that subject will be dropped out of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Duloxetine Treatment | Active comparator | Drug: Duloxetine, Genetic: Genotype for SNPs associated to Serotonin and COMT, Drug: Placebo Treatmentpatients treated with Duloxetine |
| Propranolol Treatment | Active comparator | Drug: Propranolol, Genetic: Genotype for SNPs associated to Serotonin and COMT, Drug: Placebo Treatmentpatients treated with Propranolol |
| Placebo Treatment | Placebo comparator | Drug: Duloxetine, Drug: Propranololpatients treated with placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (18 listed)
- Uncontrolled medical or psychiatric conditions.
- History of major depressive disorder, psychotic disorder or schizophrenia, and/or manic episodes within the past year.
- Pregnancy and/or breast-feeding. Patients who are unsure of their status will also be excluded from participating
- Pain due to cancer.
- Disability compensation or litigation.
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 |
|---|---|---|
| DuloxetineAlso: Cymbalta30 mg for seven days, then increased to 60 mg for seven days | Drug | Duloxetine Treatment, Placebo Treatment |
| PropranololAlso: TevaPropranolol40 mg for seven days, then increase to 60 mg for seven days | Drug | Placebo Treatment, Propranolol Treatment |
| Genotype for SNPs associated to Serotonin and COMTDNA and RNA extraction from blood samples to identify genetic variants associated to pain pathways | Genetic | Duloxetine Treatment, Propranolol Treatment |
| Placebo Treatment1 capsule BID for two weeks | Drug | Duloxetine Treatment, Propranolol Treatment |
Primary outcome
pain index
Time frame: Difference between the average pain index on the first three days of treatment compared to the last three days of the 14 day treatment cycle
Average pain intensity multiplied by percentage of time in pain in the waking day.
Results and safety
The study was stopped early (reason given: Recruitment issue). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
- Background: PubMed 16418643Lim KL, Jacobs P, Klarenbach S. A population-based analysis of healthcare utilization of persons with back disorders: results from the Canadian Community Health Survey 2000-2001. Spine (Phila Pa 1976). 2006 Jan 15;31(2):212-8. doi: 10.1097/01.brs.0000194773.10461.9f.
- Background: PubMed 15661441Von Korff M, Crane P, Lane M, Miglioretti DL, Simon G, Saunders K, Stang P, Brandenburg N, Kessler R. Chronic spinal pain and physical-mental comorbidity in the United States: results from the national comorbidity survey replication. Pain. 2005 Feb;113(3):331-339. doi: 10.1016/j.pain.2004.11.010.
- Background: PubMed 9830876Coyte PC, Asche CV, Croxford R, Chan B. The economic cost of musculoskeletal disorders in Canada. Arthritis Care Res. 1998 Oct;11(5):315-25. doi: 10.1002/art.1790110503.
- Background: PubMed 20602122Koes BW, van Tulder M, Lin CW, Macedo LG, McAuley J, Maher C. An updated overview of clinical guidelines for the management of non-specific low back pain in primary care. Eur Spine J. 2010 Dec;19(12):2075-94. doi: 10.1007/s00586-010-1502-y. Epub 2010 Jul 3.
- Background: PubMed 21952188Fairbank J, Gwilym SE, France JC, Daffner SD, Dettori J, Hermsmeyer J, Andersson G. The role of classification of chronic low back pain. Spine (Phila Pa 1976). 2011 Oct 1;36(21 Suppl):S19-42. doi: 10.1097/BRS.0b013e31822ef72c.
- Background: PubMed 10373170Thomas E, Silman AJ, Croft PR, Papageorgiou AC, Jayson MI, Macfarlane GJ. Predicting who develops chronic low back pain in primary care: a prospective study. BMJ. 1999 Jun 19;318(7199):1662-7. doi: 10.1136/bmj.318.7199.1662.
- Background: PubMed 11480465Natvig B, Bruusgaard D, Eriksen W. Localized low back pain and low back pain as part of widespread musculoskeletal pain: two different disorders? A cross-sectional population study. J Rehabil Med. 2001 Jan;33(1):21-5. doi: 10.1080/165019701300006498.
- Background: PubMed 23867732Slade GD, Smith SB, Zaykin DV, Tchivileva IE, Gibson DG, Yuryev A, Mazo I, Bair E, Fillingim R, Ohrbach R, Greenspan J, Maixner W, Diatchenko L. Facial pain with localized and widespread manifestations: separate pathways of vulnerability. Pain. 2013 Nov;154(11):2335-2343. doi: 10.1016/j.pain.2013.07.009. Epub 2013 Jul 16.
- Background: PubMed 17459585Wiesinger B, Malker H, Englund E, Wanman A. Back pain in relation to musculoskeletal disorders in the jaw-face: a matched case-control study. Pain. 2007 Oct;131(3):311-319. doi: 10.1016/j.pain.2007.03.018. Epub 2007 Apr 24.
- Background: PubMed 12034378Millan MJ. Descending control of pain. Prog Neurobiol. 2002 Apr;66(6):355-474. doi: 10.1016/s0301-0082(02)00009-6.
- Background: PubMed 20216107Tchivileva IE, Lim PF, Smith SB, Slade GD, Diatchenko L, McLean SA, Maixner W. Effect of catechol-O-methyltransferase polymorphism on response to propranolol therapy in chronic musculoskeletal pain: a randomized, double-blind, placebo-controlled, crossover pilot study. Pharmacogenet Genomics. 2010 Apr;20(4):239-48. doi: 10.1097/FPC.0b013e328337f9ab.
- Individual participant dataSharing planned: No
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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.
Mark Ware, MBBS MRCP principal investigator
Director of Clinical Research Alan Edwards Pain Management Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Duloxetine, Propranolol and Genotype for SNPs associated to Serotonin and COMT in people with Low Back Pain, run by Mark Ware at 1 site in Canada.
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 0 inclusion and 18 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 Aug 2018. 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 Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Recruitment issue). 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?
pain index (time frame: Difference between the average pain index on the first three days of treatment compared to the last three days of the 14 day treatment cycle). 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 NCT03364075, which also lists 11 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 Aug 2018.