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Analgesia and nerve function following pulsed radiofrequency for postmastectomy pain

Analgesia and nerve function following pulsed radiofrequency for postmastectomy pain - pulsed radiofrequency for postmastectomy pain

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON33543
Enrollment
80
Registered
2009-07-10
Start date
2009-07-01
Completion date
Unknown
Last updated
2025-03-24

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

Conditions

pijn postmastectomy pain syndrome

Interventions

The C-arm of the fluoroscopy unit is positioned with the beam vertical to the axis of the intervertebral foramen. The entry point is located by projecting a metal ruler over the caudal part of the f

Sponsors

Antoni van Leeuwenhoek Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age 18-65 years Chronic pain (>6 m duration) of the anterior chest wall and / or axilla following breast surgery for cancer Pain intensity > 4 according to NRS At least one other sensory symptom indicating the neuropathic nature of the pain > 50% reduction of pain-intensity following test- block of the ipsilateral spinal nerve TH 1 in subjects with predominant axillary pain or spinal nerve TH 6 with predominant pain of the thoracic wall.

Exclusion criteria

Exclusion criteria: Proven metastases Impaired coagulation Non-surgery related pain of the chest wall Other diseases impairing nerve function Psychiatric disease, dementia Language barriers No written informed consent

Design outcomes

Primary

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

Secondary

MeasureTime frame
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. Socioepidemiological data (age, weight, marital state, number of children, employment, highest academic degree) Clinical parameters (type of surgery, anesthesiologic management, postoperative pain, surgical complications postoperative, additional oncological treatments, precise onset en duration of pain, development of PMPS, additional chronic pain localisations) Fear and depression [HADS] [24] Impact of pain on daily activities [VRS 0=not at all, 1=a little, 2=moderately, 3=quite a lot, 4=a lot] [8] Quality of life [SF-36] [25] Adverse events and symptoms out [VRS 0=not at all, 1=a little, 2=moderately, 3=quite a lot, 4=a lot]

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)