Analgesia and nerve function following pulsed radiofrequency for postmastectomy pain.

Recruiting

Conditions: Postmastectomy painpulsed radiofrequency, breast cancer, post surgical pain

Registration Number: NL-OMON29287

Lead Sponsor: KI-AV

Brief Summary: ukas A, Perez RSGM: Pulsed radiofrequency treatment for postmastectomy pain. Der Schmerz 2009, 23:103.

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 80

Inclusion Criteria

1. Chronic neuropathic pain (>6 m duration) of the anterior chest wall and/or axilla following unilateral breast surgery for cancer. Neuropathic pain being defined as pain arising as direct consequence of a lesion or disease affecting the somatosensory system” of definite or probable certainty;

2. Pain intensity > 4 according to the Numerical Rating Scale (NRS);

Exclusion Criteria

1. Proven metastases;

2. Impaired coagulation;

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the difference in intensity of pain with 90° abduction of the ipsilateral shoulder before and 3 weeks following PRF as measured by the Numerical Rating Scale [NRS] (0=no pain and 10=worst imaginable pain) and the daily dose of analgesics.

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints are changes in sensory disturbances of the thoracic wall and / or axilla as measured by Quantitative Sensory Testing (QST ) according to the protocol of the German Research Network on Neuropathic pain, the globally perceived effect of the treatment [Likert scale 7 P= 75% improvement - Very good, 6P = 50–74% improvement – Good, 5P = 25–49% improvement - Fairly good, 4P = 0–24% improvement or worse - Same as before, 3P = 25–49 % worse - Fairly bad, 2P = 50–74% worse – Bad, 1 P = 75% worse - Very bad] and the duration of the analgesic effect in weeks.