To evaluate the effect of surgical decompression of the nerves in the lower extremities in patients with painful diabetic neuropathy.
ID
Source
Brief title
Condition
- Diabetic complications
- Peripheral neuropathies
- Nervous system, skull and spine therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To study the influence of decompression on pain.
Evaluation of pain with the Visual Analogue Scale.
The VAS will be used for both legs separately.
The VAS is a straight line, the ends of which are the extreme limits of the
sensation being assessed. The line is 10 cm in length using a 10-point scale
ranging from 1 to 10, with 1 being barely perceptible and 10 being intolerably
painful. Primary endpoint will be VAS<2 or a significant greater change in VAS
in the surgery group compared with the control group after 6 months.
Secondary outcome
To study the effect of decompression on vibration perceprion threshold and
tactile sensation
Evaluation of the Vibration Perception Threshold (VPT) with the biothesiometer:
The VPT will be determined using a hand-held biothesiometer (Biomedical
Instruments, Newbury, OH). VPT will be tested on the tip of the hallux. The
biothesiometer is a device with a rubber probe that vibrates at 100 Hz. The
unit contains a linear scale that displays the applied voltage, ranging from 0
to 50 V. The voltage of vibration will be increased until the patient can
perceive a vibration. The mean of three readings will be used to determine the
VPT. A VPT value of >25V in at least one foot has been associated with a high
cumulative risk of neuropathic ulceration. Values between 16 and 24V indicate
intermediate risk and values <15, low risk. Secondary endpoints will be:
significantly higher proportion of patients with VPT<25V in the surgery group
or a significant lower mean VPT in the surgery group compared with the control
group.
Evaluation of the tactile sensibility with the Semmes-Weinstein (monofilament),
and two-point discriminator (TPD). With monofilament Semmes Weinstein, 10
plantar sites on the forefoot will be tested. The patient has to say Yes or No
when asked if he/she believes the Semmes Weinstein monofilament is being
applied. Inability to perceive the 10 g of force a 5.07 monofilament applies is
associated with clinically large-fiber polyneuropathy.
Evaluation of the tactile sensibility with two-point discriminator (TPD). With
TPD the minimum distance between two stimulus points on the skin perceived as
disctinct points is measured. The foot is divided into ten standard significant
areas. Secondary endpoints will be a significant difference in number of
perceived applications after 6 months between the two groups.
To study the effect of decompression on prevention of foot ulcers and
amputations.
To study the effect of decompression on functional status of patients with
painful neuropathy.
Evaluation of the quality of life with the SF-36. Secondary endpoints will be a
significant difference in score between the two groups after six months.
To study if the posterior tibial nerve can anatomically recover after
decompression of the tarsal tunnel. To study the reduction of edema in the
tarsal tunnel and the thickness of the ligament covering the tarsal tunnel with
ultrasound.
A secondary endpoint of the study is a significant difference between the two
groups after six months.
To study the effect of decompression on postural stability with the SWAY,
center of gravity.
To study the effect of decompression on foot temperature as an autonomic nerve
function.
To study the cost-effectiveness of surgical decompression of pedal nerves
compared with medical therapy.
To study the effect of surgical decompression on nerve conduction.
To study the effect on heat and cold perception thresholds
(stimulus-response-function).
Background summary
Diabetic symmetrical peripheral neuropathy is a well known complication in
patients with diabetes. The symptoms vary from a burning or itching sensation
to pain or numbness. Because of diminished protective sensation, the risk of
ulcers and amputations is increased. Medication is helpful in treatment of pain
in a limited number of patients with diabetic neuropathy, but does not prevent
progression of neuropathy. There is some evidence that surgical decompression
of lower limb nerves is an effective intervention that relieves pain, restores
sensation and prevents foot ulcers and amputations in diabetic neuropathy.
Study objective
To evaluate the effect of surgical decompression of the nerves in the lower
extremities in patients with painful diabetic neuropathy.
Study design
A randomized controlled clinical trial.
Intervention
Decompression of the lower limb nerves includes: the posterior tibial nerve and
its calcaneal, medial and lateral plantar branches at the ankle, the deep
peroneal nerve over the dorsum of the foot, the common peroneal nerve near the
head of the fibula and the superficial peroneal nerve at the calf .
Study burden and risks
Since all patients will be examined for vascular/arterial insufficiency, high
risk patients can be excluded from this research project. Nevertheless patients
who will undergo surgery will have 4 small incision. To minimize the risk for
infection of the wound, the patient will receive antibiotics pre operatively.
To optimize the woundhealing, patients are only allowed to mobilize with
crutches after operation.
Heidelberglaan 100
Utrecht 3508 GA
NL
Heidelberglaan 100
Utrecht 3508 GA
NL
Listed location countries
Age
Inclusion criteria
Painful Diabetic Neuropathy
positive Tinel sign
age 18-90;first control group: the same inclusion criteria but without diabetic neuropathy
second control group: people without diabetes mellitus and without neuropathy
Exclusion criteria
need for vascular surgical intervention of the extremity
ulcers on the foot
Sufficiënt treatment of pain with medication( VAS 0-1)
neuropathy caused by other factors than diabetes mellitus
patients with physical problems leading to instability;control group: anamnestic signs of periheral neuropathy
control group ultrasound: anamnastic signs of peripheral neuropathy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL29338.041.09 |