Cost-effectivenes of minimal interventional procedures for patients with chronic low back pain.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20202

Enrollment

816

Registered

2012-07-18

Start date

2012-09-15

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with mechanical low back pain who are referred by a general practitioner or medical specialist to participating pain clinics.

Interventions

Interventiongroup: 1. Facet join pain: Radiofrequency denervation of the ramus dorsalis at L3, L4, L5, S1 and the multidisciplinary pain programme (consisting of an exercise program and a psychologis

2. Disc pain: Radiofrequency denervation of the involved discus and the multidisciplinary pain programme (consisting of an exercise program and a psychologist visit if necessary)

3. Sacroiliac join pain:Radiofrequency denervation of the ramus dorsalis at L5/S1, S2, S3, S4 and the multidisciplinary pain programme (consisting of an exercise program and a psychologist visit if ne

4. Patients with a combination of the single entities will be randomised after the clinical diagnosis to a group who receives minimal interventional treatments (i.e. a combination of the interventions

Eligibility

Inclusion criteria

Inclusion criteria: 1. Chronic (more than 3 months) mechanical low back pain symptoms; 2. Age between 18 and 70 years; 3. No improvement of symptoms after at least three months of conservative treatment according to the Dutch guidelines for non-specific low back pain in primary care; 4. Patients must answer 'yes' on the question 'is there a 50% or more reduction in pain?', 30 minutes after the test block, or the disc provocation test must be positive.

Exclusion criteria

Exclusion criteria: 1. Patients with severe psychiatric or severe psychological problems; 2. Pregnant women; 3. Patients who are not able to complete the questionnaires; 4. Anticoagulant drug therapy and/or disturbed coagulation; 5. Patients with less than 50% reduction in pain after the test block, or a negative disc provocation test.

Design outcomes

Primary

Measure	Time frame
Pain intensity after 3 months.	—

Secondary

Measure	Time frame
1. Global perceived recovery; 2. Quality of life; 3. Patient satisfaction; 4. Functional status; 5. General health; 6. Chronic pain experience.	—

Contacts

Public ContactEsther Maas

De Boelelaan 1085, Room T-519

esther.maas@vu.nl+31 (0)20 5985351

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)