Patients with (sub)acute sciatica in primary care.
Conditions
Interventions
Trade Name: Paracetamol
Product Name: Paracetamol
Product Code: RVG 12253
Pharmaceutical Form: Tablet
Trade Name: Diclofenac
Product Name: Diclofenac
Product Code: RVG 26014
Pharmaceutical Form: Tabl
Sponsors
ZonMW GGG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Women and men aged 18 to 65 years, 2) No use of analgesics besides paracetamol, 3) Radiating (pain) complaints in one leg below the knee, 4) Severity of pain scored 7 or more on an 11-point numerical rating scale (0= no pain; 10= maximum pain), 5) Duration of the (pain) complaints less than 12 weeks, and 4) Presence of at least one of the following symptoms: a) More pain on coughing, sneezing or straining, b) Decreased muscle strength in the leg, c) Sensory deficits in the leg, d) Decreased reflex activity in the leg, e) Positive straight leg raising test. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 234 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) An episode of radiating (pain) complaints 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 osteoporostic 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 outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): 1) Pain severity of the leg (11-point numerical rating scale; higher score means more pain). 2) Number of days with a severity of leg pain score of 7 or more (via diary). 3) Costs; all direct medical and patient costs and productivity costs.;Timepoint(s) of evaluation of this end point: 1): At 3, 6, 9 and 12 weeks after baseline measurement. 2): Every day (diary) during the 12 weeks follow-up. 3): At 6 and 12 weeks after baseline measurement.;Main Objective: 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?;Secondary 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 12 weeks? 2) What are effectmodifiers for effectiveness in the two prescription strategies for pain relieve? | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Adverse reactions, systematically recorded in the questionnaires at follow-up measurements. 2) Quality of life (EQ-5D). 3) Patients’ perceived recovery (7-point Likert scale; dichotomized in recovered [score 1 ‘complete recovery’ and 2 ‘much improved] and not-recovered [score 3 ‘improvement’ to score 7 ‘worse than ever’]). 4) Patients’ perceived comfort during tapering of the medication (11-point numerical rating scale; higher score means more comfort). 5) Disability measured with the Roland Disability Questionnaire for sciatica (score range 0- 24; higher score means more disability). 6) Pain severity of the low back (11-point numerical rating scale; higher score means more pain). 7) Compliance to treatment (Brief Medication Questionnaire). 8) Use of ‘rescue medication’ (via diary). 9) Patients’ satisfaction (11-point numerical rating scale; higher score means more satisfaction). 10) Co-interventions will systematically be recorded in the questionnaires at follow-up measurements.;Timepoint(s) of evaluation of this end point: 1,2,3, 5, 6, 10): At 3, 6, 9 and 12 weeks follow-up. 4,7): At 3 and 6 weeks follow-up. 8): Every day (diary) during the first 6 weeks follow-up. 9): At 6 and 12 weeks follow-up. | — |
Countries
Netherlands
Contacts
Public ContactProjectleader
ZonMW GGG
Outcome results
None listed