Pituitary Gland Stimulation for pain relief

Completed

Conditions: Oncogene pijn, centrale neuropathische pijn
intractable pain
severe pain
10027655
10007951

Registration Number: NL-OMON52130

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

two patient categories are studied, with each their own set of inclusion
criteria

set one:
- Adult patient
- In palliative phase of metastatic disease
- Inadequately controlled pain with standard care
- Karnofsky Performance Score >=50

set two:
- Adult patient
- Diagnosed with central neuropathic pain
- Inadequately controlled pain with standard care

Exclusion Criteria

• Not fit for general anesthesia
• Pregnancy
• Unfavorable local anatomy for PGS, due to a disease process, or anatomical
configuration
• Clinical signs of posterior pituitary gland disfunction
• Recent history of alcohol or drug abuse
• Immunodeficiency
• Need for anticoagulation therapy that cannot be abrogated for surgery
• Cognitive impairments prohibiting full understanding of study and ability to
provide informed consent
• Not able to adequately communicate in Dutch or English

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pain, defined as continuous or background pain, measured via a Numeric Rating<br /><br>Scale and on the Brief Pain Inventory, corrected for medication use<br /><br>Patient satisfaction with treatment<br /><br>Treatment safety in terms of side effects</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Use of analgetic medication<br /><br>Hormone levels<br /><br>Patient-reported outcome measures: pain interference, social role functioning,<br /><br>cognitive functioning</p><br>