No registrations found.
ID
Source
Brief title
Health condition
Sciatica, Pain medication, Cost-effectiveness
Sponsors and support
Intervention
Outcome measures
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.
Background 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.
Objective:
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?
Study design:
A randomized controlled trial with alongside an economic evaluation.
Study population:
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.
Intervention:
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.
Study objective
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?
Study design
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.
Intervention
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).
Department of General Practice<br>
Room NA1905<br>
PO Box 2040<br>
P.A.J. Luijsterburg
Rotterdam 3000 CA
The Netherlands
+31 10 7037513
p.luijsterburg@erasmusmc.nl
Department of General Practice<br>
Room NA1905<br>
PO Box 2040<br>
P.A.J. Luijsterburg
Rotterdam 3000 CA
The Netherlands
+31 10 7037513
p.luijsterburg@erasmusmc.nl
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
4. Pregnancy
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4883 |
| NTR-old | NTR5120 |
| CCMO | NL49507.078.14 |
| OMON | NL-OMON44314 |