|- candidate number||21870|
|- NTR Number||NTR5120|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||26-mrt-2015|
|- Secondary IDs||NL49507.078.14 |
|- Public Title||Step-down versus step-up analgesics in patients with (sub)acute sciatica in primary care.|
|- Scientific Title||Step-down versus step-up analgesics in patients with (sub)acute sciatica in primary care.|
|- ACRONYM||STEP-UP trial|
|- hypothesis||1. What is the effectiveness of immediate opioid pain medication (followed by step-down) versus step-up pain medication within the treatment according general practitioners’ clinical guideline in patients with (sub)acute sciatica, over a period of 6 weeks?
2. What is the cost-effectiveness of immediate opioid pain medication (followed by step-down) versus step-up pain medication within the treatment according general practitioners’ clinical guideline in patients with (sub)acute sciatica, over a period of 12 weeks?|
|- Healt Condition(s) or Problem(s) studied||Sciatica, Pain relief, Cost-effectiveness |
|- Inclusion criteria||Patients will be eligible for inclusion if they:|
1. Are aged 18 to 65 years
2. Don’t use opioids
3. Have radiating (pain) complaints in one leg below the knee
4. Have a severity of pain scored 7 or more on an 11-point numerical rating scale (0= no pain; 10= maximum pain)
5. Have less than 12 weeks (pain) complaints
6. Have at least one of the following symptoms:
- More pain on coughing, sneezing or straining
- Decreased muscle strength in the leg
- Sensory deficits in the leg
- Decreased reflex activity in the leg
- Positive straight leg raising test.
|- Exclusion criteria||A patient who meets any of the following criteria will be excluded from participation in this study:|
1. An episode of radiating (pain) complaints occurred in the preceding 6 months
2. Back surgery in the past 3 years
3. Treated with epidural injections
5. Co-morbidity that primary determines overall wellbeing such as an osteoporotic fracture, malignity, herpes zoster and Lymes’disease
6. Hypersensitivity to paracetamol, NSAID or opioids
7. Previous or active peptic ulcer
8. Direct indication for surgery (fast progression of paresis or cauda equina syndrome
9. History of substance addiction or abuse.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||13-apr-2015|
|- planned closingdate||13-apr-2017|
|- Target number of participants||234|
|- Interventions||Group 1: Step-down: Immediate Morphine, with tapering period.|
Group 2: Step-up: First Paracetamol, Second NSAID, Thrith Tramadol, Fourth Morphine. (according general practitioners’ clinical guideline).
|- Primary outcome||Pain severity of the leg (11 point numerical rating scale; higher score means more pain) measured daily over a period of 6 weeks follow-up.|
|- Secondary outcome||1. Adverse reactions, systematically recorded in the questionnaires at follow-up measurements.|
2. Costs; all direct medical and patient costs and productivity costs.
3. Quality of life.
4. Patients’ perceived recovery.
5. Patients’ perceived comfort during tapering of the medication.
6. Disability measured with the Roland Disability Questionnaire for sciatica.
7. Pain severity of the low back.
8. Number of days with a severity of leg pain score of 7 or more.
9. Compliance to treatment.
10. Use of ‘rescue medication’.
11. Patients’ satisfaction.
12. Co-interventions will systematically be recorded in the questionnaires at follow-up measurements.
|- Timepoints||All participating patients will fill in the questionnaires at baseline and at 3,6, 9, 12 weeks. During the first 6 weeks the patients will be fill in an online diary.|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||Dr. P.A.J. Luijsterburg|
|- CONTACT for SCIENTIFIC QUERIES||Dr. P.A.J. Luijsterburg|
|- Sponsor/Initiator ||Erasmus Medical Center, Department of General Practice|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Rationale:|
A systematic review and meta-analysis (2012) reported that the efficacy and tolerability of pain medication commonly prescribed for the management of sciatica in primary care is unclear. There are no data available about the (cost)-effectiveness regarding the recommended stepped medication care in patients with sciatica.
What is the effectiveness and cost-effectiveness of immediate opioid pain medication (followed by step-down) versus step-up pain medication within the treatment according general practitioners’ clinical guideline in patients with (sub) acute sciatica, over a period of 6 and 12 weeks respectively?
A randomized controlled trial with alongside an economic evaluation.
Patients aged 18 to 65 years (n=234) who are consulting their general practitioner with (sub)acute sciatica with a pain severity of 7 or more on an 11-point numeric rating scale.
Patients will be randomized in two groups: 1) receiving immediate morphine; followed by a taper period (step-down), and 2) receiving stepped-up medication (step1: paracetamol, step2: NSAID, step3: tramadol, step4: morphine).
Main study parameters/endpoints:
The primary outcome is severity of leg pain. Secondary outcomes are adverse reactions, costs, quality of life, patients’ perceived recovery, patients’ perceived comfort during tapering of the medication, disability, pain severity of the low back, number of days with a severity of leg pain score of 7 or more, compliance to treatment, use of ‘rescue medication’, patients’ satisfaction, and co-interventions.
Outcomes will be measured at baseline and at 3,6,9,12 weeks follow-up.
|- Main changes (audit trail)||After one year of insufficient patient recruitment, the trial was prematurely terminated. To analyze the underperforming recruitment, patient information systems of 20 general practices were screened twice a month to search for eligible patients and identify reasons for non-eligibility. Secondly, after study termination, an open question was distributed among participating GPs to retrieve their views on the trial recruitment.|
116 GPs from 37 general practices collaborated in the trial. In 12 months recruiting, only 8 out of 234 patients could be included. 21 GPs shared their views on the recruitment process. According to them the low incidence rate due to strict eligibility criteria, and strong patient and/or GP preference were main reasons for the unsuccessful recruitment.
Multiple factors played a role in the recruitment problems of our trial. It remains unknown which of the determinants prevailed. The research question remains relevant, but unanswered. Future recommendations: 1) take GPs daily practice into account when designing a randomized study; 2) perform a pilot study for feasibility of recruitment; 3) involve GP assistants in an early stage.
|- RECORD||26-mrt-2015 - 23-aug-2016|