The aim of this study is the evaluation of efficacy of PRF on the intensity of pain in patients with PMPS for more than six months after surgery with the hypothesis that PRF reduces the intensity of pain more than 50%. In addition, the precise…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
pijn
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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]
Background summary
About one third of the women undergoing breast surgery for cancer develop
chronic postmastectomy pain (PMPS) in their axilla and chest wall. PMPS is a
neuropathic pain syndrome that is predominantly caused by a lesion of the
intercostobrachial nerve during surgery. As the pain is typically exacerbated
by arm movements and lying on the painful side and is accompanied by
allodynia, PMPS has considerable impact on daily functioning, quality of sleep
and sexual life.
The standard treatment of PMPS with antidepressants, capsaicine-crème and TENS
often gives poor painrelief or has unacceptable side effects. Alternatively,
the isothermal radiofrequency treatment known as pulsed radiofrequency (PRF)
may be used to relieve neuropathic pain. PRF is widely used as a treatment
option for neuropathic pain in the Netherlands. However the effect of PRF on
PMPS has not been shown yet. In addition the effect of PRF on nerve function
has not been evaluated yet.
Study objective
The aim of this study is the evaluation of efficacy of PRF on the intensity of
pain in patients with PMPS for more than six months after surgery with the
hypothesis that PRF reduces the intensity of pain more than 50%. In addition,
the precise evaluation of afferent nerve function via Quantitative Sensory
Testing (QST) before and after treatment will be performed in order to obtain
information on prognosis possible mode of action of PRF related to subgroups
based on neuropathic pain phenotype.
Study design
In a prospective double-blind randomized placebo-controlled trial patients are
assigned to receive PRF of the thoracic dorsal root ganglia Th 6 or Th 1
respectively or a sham-intervention.
See attatchment for flow scheme of the study
Intervention
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 foramen. The 22 G cannula (SMK Pole
needle 100 mm with 4 mm active tip, Cosman International) is introduced
parallel to the beam and, if necessary, the position is corrected
in the superficial subcutaneous layers. The fluoroscope is then adjusted to the
lateral view and the cannula is inserted further until the tip projected over
the middle or lower dorsal third of the intervertebral foramen. The stylet of
the cannula is then replaced by the RF probe (SMK-TC 10, Radionics, Burlington,
MA). After checking the impedance, indicating a normal, closed electrical
circuit, stimulation is performed at a frequency of 50 Hz to obtain a sensory
stimulation threshold in all patients. If paresthesias are elicited along the
tested thoracic nerve root with less than 0.3 V an adequate proximity of the
DRG (Ford et al., 1984) is achieved. PRF current of 45 V/ 140 mA with pulses of
2 Hz and 20 ms duration is then applied for 6 min generator (Cosman RFG-1B
Lesion Generator)
Study burden and risks
The intervention studied is frequently performed for the treatment of
neuropathic pain without any complications that can be attributed to pulsed
radiofrequency. The only risks of the treatment is adherent to the placement of
the electrode and the applicated lidocaine, ie pain at the puncture site,
pneumothorax due to accidental puncture of the pleura and allergic reaction to
lidicaine. Pneumothorax is the most serious hypothetic complication. It has
not occured in the personal experience of the study ccordinator (AL) and is not
described in the literature. To keep this risc as low as possible the electrode
is placed onder fluroscopy and patients are controled for dyspnoe 30 min
following PRF treatment.
Plesmanlaan 121
1066CX, Amsterdam
NL
Plesmanlaan 121
1066CX, Amsterdam
NL
Listed location countries
Age
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
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL26023.031.09 |
OMON | NL-OMON29287 |