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Treatment of functional neurological symptoms.

Treatment of patients with functional neurological symptoms: A randomized controlled trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21971
Enrollment
200
Registered
2009-06-19
Start date
2009-08-01
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

functional neurological symptoms

Interventions

Intervention group: Educational treatment by neurologists: At the (outpatient) department of Neurology the patient is informed that he or she has functional symptoms. For further treatment these pati

Sponsors

Academisch Medisch Centrum Postbus 22660 1100 DD Amsterdam The Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Tension type headache: Headache without alarming symptoms, not consistent with one of the headache syndromes (migraine, cluster headache or analgesic abuse) and at least one other functional symptom; 2. Back and neck pain: Pain not considered to be caused by spinal pathology (fractures, spondylitis, metastases), myelopathy, radiculopathy, plexopathy or neuropathy and at least one other functional symptom; 3. Pseudo movement disorders: Movement disorders not consistent with one of the known movement disorders; 4. Mainly sensory disturbances: These disturbances cannot be explained by central of peripheral nervous system disorders; 5. Mainly motor disturbances other than movement disorders: These disturbances cannot be explained by central of peripheral nervous system disorders; 6. Pseudo-epilepsy ¡V atypical seizures without evidence for epilepsy on electroencephalographic investigations.

Exclusion criteria

Exclusion criteria: 1. Patients under 18 years old; 2. Patients known prior to assessment to have psychiatric disorders other than somatoform, depressive, or anxiety disorders; 3. Patients with a primary diagnosis of a severe mood, anxiety, or psychotic disorders requiring psychiatric treatment; 4. Patient in psychotherapy at the time of the study; 5. Patients who obviously simulate their complaints; 6. Patients who are in dispute about financial or social benefit.

Design outcomes

Primary

MeasureTime frame
The primary outcome is the patient’s health related quality of life 12 months after randomisation. Health related quality of life will be assessed with using the 'Short Form-36' health survey(SF-36).The primary outcome will be assessed 3, 6 and 12 months after randomisation.

Secondary

MeasureTime frame
Secondary outcomes are the level of activities of daily living as measured by the 'AMC linear disability scale' (ALDS), self-reported physical symptoms assessed with the somatization subscale of the symptom checklist-90 (SCL-90), symptoms of anxiety and depression assessed by the ‘hospital anxiety and depression scale’ (HADS), pain catastrophizing thoughts assessed with the 'pain catastrophizing scale' (PCS), severity of pain assessed with the 'visual analogue scale' (VAS), absence of work and medical consumption (number of visits to physicians, medical treatments, additional examinations, alternative care). Secondary outcomes will also be assessed at 3, 6 and 12 months.

Contacts

Public ContactY.B.W.E.M. Roos

Academic Medical Center (AMC), Department of Neurology, H2 P.O. Box 22660.

m.vermeulen@amc.uva.nl+31 (0)20 5663842

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)