Decompressive surgery for treating nerve damage in leprosy. A Cochrane review.
ABSTRACT Decompressive surgery is used for treating nerve damage in leprosy. We assessed the effectiveness of decompressive surgery for patients with nerve damage due to leprosy.
A broad search strategy was performed to find eligible studies, selecting randomised controlled trials (RCTs) comparing decompressive surgery alone or plus corticosteroids with corticosteroids alone, placebo or no treatment. Two authors independently assessed quality and extracted data. Where it was not possible to perform a meta-analysis, the data for each trial was summarised.
We included two randomised controlled trials involving 88 people. The trials examined the added benefit of surgery over prednisolone for treatment of nerve damage of less than 6 months duration. After 2 years follow-up there was no significant difference in nerve function improvement between people treated with surgery plus prednisolone or with prednisolone alone. Adverse effects of decompression surgery were not adequately described.
Evidence from randomised controlled trials does not show a significant added benefit of surgery over steroid treatment alone. Well-designed randomised controlled trials are needed to establish the effectiveness of the combination of surgery and medical treatment compared to medical treatment alone.
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ABSTRACT: Leprosy has nearly disappeared in France but continues to affect two million patients in the world. Involvement of the peripheral nerve must be identified and requires surgical treatment, which can provide good results for pain and function. The author reviews the most frequently affected peripheral nerves and reports her personal series, with surgery performed concomitantly with the medical treatment of the disease.Neurochirurgie 10/2009; 55(4):421-426. · 0.47 Impact Factor
- Dermatology practical & conceptual. 01/2013; 3(1):17-20.
Decompressive surgery for treating nerve damage
in leprosy. A Cochrane review
NATASJA H.J. VAN VEEN*, TON A.R. SCHREUDERS**,
WILLEM J. THEUVENET***, AMIT AGRAWAL****
& JAN HENDRIK RICHARDUS*
*Department of Public Health, Erasmus MC, University Medical
Center Rotterdam, The Netherlands
**Rehabilitation Medicine, Erasmus MC, University Medical Center
Rotterdam, The Netherlands
***Plastic Surgery, Regional Hospitals of Apeldoorn, Deventer and
Zutphen, Apeldoorn, The Netherlands
****Division of Neurosurgery, Datta Meghe Institute of Medical
Sciences, Wardha, India
Accepted for publication 02 January 2009
assessed the effectiveness of decompressive surgery for patients with nerve damage
due to leprosy.
MethodsA broad search strategy was performed to find eligible studies, selecting
randomised controlled trials (RCTs) comparing decompressive surgery alone or plus
corticosteroids with corticosteroids alone, placebo or no treatment. Two authors
independently assessed quality and extracted data. Where it was not possible to
perform a meta-analysis, the data for each trial was summarised.
ResultsWe included two randomised controlled trials involving 88 people. The
trials examined the added benefit of surgery over prednisolone for treatment of nerve
damage of less than 6 months duration. After 2 years follow-up there was no
significant difference in nerve function improvement between people treated with
surgery plus prednisolone or with prednisolone alone. Adverse effects of
decompression surgery were not adequately described.
ConclusionsEvidence from randomised controlled trials does not show a
significant added benefit of surgery over steroid treatment alone. Well-designed
randomised controlled trials are needed to establish the effectiveness of the
combination of surgery and medical treatment compared to medical treatment alone.
Decompressive surgery is used for treating nerve damage in leprosy. We
Correspondence to: Natasja H. J. van Veen, Department of Public Health, Erasmus MC, University Medical
Center Rotterdam, PO Box 2040, 3000 CA, The Netherlands (e-mail: firstname.lastname@example.org)
Lepr Rev (2009) 80, 3–12
This paper is based on a Cochrane review first published in The Cochrane Library 2009,
Issue 1 (see http://www.thecochranelibrary.com/ for information). Cochrane reviews are
regularly updated as new evidence emerges and in response to feedback, and The Cochrane
Library should be consulted for the most recent version of the review.
Decompressive surgery or neurolysis as treatment for nerve damage has been done for
several decennia. The objective of this surgery is to relieve mechanical compression, due to
oedema caused by neuritis, of the affected nerve. Decompression is done by incision of the
thickened nerve sheath (epineurium) where the nerve is enlarged and often tender on
palpation. This incision is often of a considerable length at the place before entering the fibro-
osseous tunnel which, during surgery, needs to be opened as well. Results of surgery from
non-randomised studies have been widely published.1–7Decompressive surgery is not
recommended without medical treatment. Indications for surgery are mainly based on
common practice but not well defined. These may include the presence of nerve abscess,
nerve pain or nerve function impairment that does not respond to medical treatment.8–12
Decompressive surgery isfrequently used for treating nerve damage in leprosy. The effect
of surgery, especially in the long term, is uncertain and it is unclear whether surgery is more
beneficial than medical treatment alone. While this review focused on evidence from
randomised controlled trials (RCTs), it was expected that only a few RCTs had been
conducted in this area. Therefore, the results were also considered in the light of non-
randomised evidence in the Discussion section.
We searched the Cochrane Neuromuscular Disease Group Trials Register (November 2007)
using the following terms: leprosy or Hansen disease and decompression or neurolysis or
epicondylectomy or epineurotomy or neuritis or nerve damage or nerve loss or nerve function
impairment or neuropath* or nerve problem or nerve involvement or nerve pain. This search
strategy, combined with a search strategy for identifying randomised trials, was adapted to
include additional search terms where necessary and was modified to search the Cochrane
Central Register of Controlled Trials in The Cochrane Library (Issue 4, 2007); MEDLINE
(from January 1950 to November 2007) and EMBASE (from January 1980 to November
2007); AMED (Allied and Complementary Medicine, from January 1985 to November
2007), CINAHL (from January 1982 to November 2007), and LILACS (Latin American and
Caribbean Health Science Information database, from January 1982 to November 2007).
We checked reference lists of the studies identified, the Current Controlled Trials Register
(www.controlled-trials.com), conference proceedings and contacted trial authors. There were
no languagerestrictions. Two authors independently screened the titles and abstracts ofall the
publications identified to examine whether studies were eligible.
Studies were eligible if they were (quasi-) randomised controlled trials (RCTs) assessing
decompressive surgery versus corticosteroids, placebo or no treatment for patients with
N. H. J. van Veen et al.4
leprosy and related nerve damage. Nerve damage or nerve function impairment (NFI) was
defined as clinically detectable impairment of motor or sensory nerve function. It did not
include impairment of nerve conduction that was only detectable by electrophysiological
means.13Outcome measures of interest were: improvement in sensory nerve function as
measured with graded nylon filaments14or a ball-point pen after 1 or 2 years, improvement in
motor nerve function, assessed with the modified MRC grading scale15after 1 or 2 years,
change in nerve pain and tenderness after 1 year, changes in quality of life, and adverse
The methodological quality of the included studies was based on the following criteria:
concealment of allocation; blinding of participants and outcome assessors; loss to follow-up;
baseline differences and explicit outcome measures mentioned. Each criterion was assessed
as A: adequate, B: unclear or C: inadequate. If one of the criteria was not described in the
study, it was labelled ‘inadequate’. Two authors independently assessed the included studies
for methodological quality.
DATA EXTRACTION AND ANALYSIS
Two authors extracted data regarding methodology and outcome measures from the included
studies onto a data extraction form. If there were missing data, the trial authors were
contacted. Authors were not blinded to trial author, journal or institution. We used the
Cochrane statistical package, Review Manager, for statistical data analysis. Results were
expressed as mean differences with 95% confidence intervals (CI) for continuous outcome
measures and relative risks (RR) with 95% CI for dichotomous outcomes. In case of clinical
heterogeneity, or if data were lacking, the results for each trial were summarised.
We identified 10 potentially relevant studies and excluded seven, because they were not
randomised. Two RCTs (one RCT was described in two papers) were included.
Characteristics of the studies included are shown in Table 1.
Both studies tested decompression surgery plus oral corticosteroids versus oral
corticosteroids alone. One tested treatment of ulnar neuritis of less than 6 months
duration16,17and one tested treatment of neuritis of several types of less than 6 months
The primary outcomes ‘improvement in sensory nerve function 1 year after registration’ and
‘improvement in motor nerve function 1 year after registration’ were evaluated in one trial.16
Review of surgery for nerve damage5
Table 1. Characteristics of included studies. From Van Veen, et al. Cochrane Database Sys Review 2009; CD006983; with permission
Study Methods ParticipantsInterventionsOutcomesResultsNotes
parallel group trial
31 leprosy patients with
nerve deficit ,6 months
Unit of randomisation: ulnar,
median, common peroneal,
or posterior tibial nerve
Unit of analysis: nerve
Nerves randomised: unclear
Nerves analysed: 93
(a: 47, b: 46)
57 leprosy patients with ulnar
neuritis ,6 months duration
Unit of randomisation:
Unit of analysis: ulnar nerve
Persons randomised: 57 with
75 ulnar nerves (18 bilateral
Nerves analysed: 62 of 44
persons (a: 31, b: 31) after
one year, 57 of 39 persons
(a: 28, b: 29) after two years
(a) prednisone start at
40mg/day for 15 days and
thereafter gradually tapered
with 5mg/15 or 30 days until
6 months completed (total
(b) same intervention plus
decompression and a simple,
(a) prednisolone 30mg/day
for one week, reducing the
daily dose by 5mg every
week for 6 weeks (total
(b) same intervention plus
decompression and a simple,
Sensory improvement (SI)
after 2 years, motor
improvement (MI) after
2 years, nerve pain
after 2 years
No data Single
parallel group trial
Sensory improvement (SI)
after 1 and 2 years, motor
improvement (MI) after 1
and 2 years
After one year: Change
in SI: MD ¼ 0·08
(95% CI 22·45; 2·61)
% with SI: RR ¼ 1·30
(95% CI 0·48; 3·54)
Change in MI:
MD ¼ 0·82 (95% CI
% with MI: RR ¼ 0·74
(95% CI 0·26; 2·17)
Change in SI:
MD ¼ 0·08 (95% CI
After two years:
Change in SI:
MD ¼ 20·02 (95% CI
Change in MI:
MD ¼ 0·22 (95% CI
N. H. J. van Veen et al.
The secondary outcome ‘improvement in nerve function 2 years after registration’ was
evaluated in two trials.17,18‘Change in nerve pain and in nerve tenderness’ was assessed in
one trial161 year after registration and in two trials17,182 years after registration. None of the
trials evaluated ‘changes in quality of life.’ Adverse events were not well-reported in any of
Randomisation was considered adequate in one trial,18while the other trial used alternation as
randomisation procedure which was considered inadequate.16,17Participant and outcome
assessor blinding was not possible in any of the trials. One trial18had 6% loss to follow-up of
participants, but did not report how many nerves were involved. The other trial16,17had 17%
loss to follow-up of nerves after 1 year and 24% loss to follow-up of nerves after 2 years.
None of the trials reported how many participants or nerves were lost to follow up in each
arm. Boucher et al. described the reasons for losses. Baseline characteristics in both treatment
arms were similar in the trials.
MEDIAL EPICONDYLECTOMY PLUS ORAL CORTICOSTEROIDS VERSUS ORAL
CORTICOSTEROIDS ALONE FOR PARTICIPANTS WITH ULNAR NEURITIS OF LESS
THAN SIX MONTHS DURATION16,17
Results were available for 77% (44/57) of the participants. After 1year the mean difference in
sensory score was 2·08 (95% CI 0·28 to 3·88) in the surgery group and 2·00 (95% CI 0·06 to
3·94) in the medical group indicating a mean sensory improvement in both. The improvement
was slightly greater in the surgery group but the mean difference 0·08 (95% CI 22·45 to 2·61)
between the two groups was not significant. In the surgery group 18 out of 31 nerves (58%)
had sensory improvement after 1 year compared with 16 out of 31 nerves (52%) in the
medical group. The difference was not significant (relative risk 1·30, 95% CI 0·48 to 3·54).
Results of changes in motor nerve function were provided. After 1 year the mean
difference in motor score was 3·08 (95% CI 2·12 to 4·04) in the surgery group and 2·26 (95%
CI 0·21 to 4·31) in the medical group indicating a mean improvement in both. The
improvement was greater in the surgery group but the mean difference 0·82 (95% CI 21·34
to 2·98) between the two groups was not significant. In the surgery group 20 out of 31 nerves
(65%) had motor improvement after 1 year compared with 22 out of 31 nerves (71%) in the
medical group. The difference was not significant (relative risk 0·74, 95% CI 0·26 to 2·17).
Results after 2 years were available for 68% (39/57) of the participants. After 2 years the
mean difference in sensory score was 2·89 (95% CI 0·94 to4·84) in the surgery group and 2·91
(95% CI 0·73 to 5·09) in the medical group indicating a mean improvement in both. The
improvement was slightly greater in the medical group but the mean difference 20·02 (95%
CI 22·82 to 2·78) between the two groups was not significant. The mean difference in motor
score after 2 years was 2·79 (95% CI 1·03 to 4·55) in the surgery group and 2·57 (95% CI 0·49
to 4·65) in the medical group indicating a mean improvement in both. The improvement was
greater in the surgery group but the mean difference 0·22 (95% CI 22·39 to 2·83) between the
two groups was not significant. Nerve pain and tenderness had disappeared in both groups
after 1 year and no new nerve pain or tenderness between the first and second year was
reported. The trial did not report any adverse events or reasons of loss to follow-up.
Contacting the authors did not yield additional information.
Review of surgery for nerve damage7
Longitudinal epineurotomy plus oral corticosteroids versus oral corticosteroids alone for
participants with neuritis of less than six months duration18
Results were available for 97% (30/31) of the participants. Outcomes were given after 2 years
of follow-up and were expressed as median improvement, meaning that 50% of the data had
greater improvement than this value and 50% of the data had less improvement than this
median. In the surgery group median sensory improvement was 25% compared to 20%
median improvement in the medical group. The difference was not significant at a 5% level
(Tukey box plot test). Median motor improvement was 30% in the surgery group and 20% in
the medical group. The difference was not significant at a 5% level (Tukey box plot test). No
numbers, test values or 95% confidence interval values were given. In the surgery group
median nerve pain relief was 11% compared to 0% in the medical group. The difference was
significant at a 5% level (Tukey box plot test). One participant was excluded from the study
due to haemorrhage, but it was unclear if it was caused by the intervention. The study did not
provide any numbers, test values or 95% confidence interval values. Contacting the author
revealed that original data were not available anymore.
Two randomised controlled trials were available for this review. One trial compared the
added benefit of medial epicondylectomy over corticosteroids for participants with ulnar
neuritis of less than 6 months duration.16,17The other trial compared the added benefit of
longitudinal epineurotomy over corticosteroids for participants with ulnar, median, common
peroneal or posterior tibial nerve involvement of less than 6 months duration.18The
interventions and outcomes were too heterogeneous to be combined in a meta-analysis. The
numbers of participants included in the trials were small and did not allow for subgroup
analysis. The variability between studies and the limitations in study design and sample size
made it difficult to draw any robust conclusions.
and medical group after a follow-up of 1 or 2 years. This result may have been biased by the
selection criteria used for inclusion of patients and nerves. Only a small proportion may benefit
from decompressive surgery. Results from a study indicate that only 5–10% of nerves may
improve after surgery (Naafs, personal communication). The other nerves need no
The two trials had some drawbacks. One major drawback of both trials was that they used
sometimes more than one nerve from individual patients in the analyses thereby considering
the outcomes from each nerve independent. The trial of Pannikar and Ebenezer included
18 patients with ulnar nerve damage at both sides (bilateral involvement). The right side was
allocated to the group drawn by random selection and the left side was allocated to the other
group. The final results reflect the outcomes of all nerves. No separate analysis was done
using only one independent outcome from each patient. Original data were not available. The
trial of Boucher included 31 patients with 93 nerves in total. It is unclear how many nerves
each patient contributed. The final results reflect the outcomes of all nerves. No separate
analysis was done using only one independent outcome from each patient. Original data were
not available. The results from these studies should be treated with considerable caution,
N. H. J. van Veen et al.8
because results from a patient contributing outcomes from more than one nerve will be
treated, in the analysis, as having more weight as a patient contributing only one nerve.
Other limitations of the study of Pannikar were that randomisation was done by
alternation, which is considered an inadequate randomisation procedure. With regard to loss
to follow-up, 23% of the participants were lost to follow-up after 1 year and 32% after
2 years. No reasons for these losses were reported and no intention-to-treat analysis was
The randomisation procedure and loss to follow-up (6%) were considered adequate in the
study of Boucher. Outcomes were expressed as median improvement. No numbers or original
data were available to calculate mean differences or relative risks making comparison and
interpretation of the results difficult. Subgroup analyses showed no difference in median
improvement between operated or non-operated nerves with respect to type of leprosy
(lepromatous or non-lepromatous), type of antibacillary drug therapy (mono or multi), type of
nerve function impairment (motor or sensory), and duration of neuritis (0- to 3 months or 3- to
6 months). There were significant differences for pain relief and severity of the neuritis before
surgery. Operated nerves had higher median pain relief compared to non-operated nerves. In
the group with considerable loss of nerve function the operated nerves had higher median
improvement compared to non-operated nerves.
The occurrence of adverse effects was not adequately reported in the trials. One study18
excluded a participant with haemorrhage during the course of the trial, but it was unclear
whether this was due to the intervention. The literature reviewing decompressive surgery in
leprosy often does not take adverse effects into account, but stresses the importance of having
adequate techniques and instruments and competent surgeons to prevent unfavourable
outcomes.10,19,20Complications of decompressive surgery in general may be painful scars,
wound problems, haematoma, infection and damage to nerves, arteries or tendons.21–23
None of the trials included quality of life measures or cost-effectiveness calculations
which could be useful indicators of the effectiveness of interventions.
Many published and unpublished non-randomised studies have examined the effect of
decompressive surgery for treating nerve damage in leprosy. While the two RCTs give
insufficient evidence in favour of decompressive surgery in addition to steroid treatment,
most non-randomised studies report beneficial effects of decompressive surgery. Relief of
nerve pain and tenderness is the most frequently and consistently reported benefit. Nerve
function improvement is frequently reported, but the response to surgery seems to depend on
several factors, such as severity and duration of neuritis before surgery, the type of leprosy,
the nerve involved and the surgical technique used. Nerves which are partially damaged, have
neuritis of less than 6 months duration and are associated with multibacillary (MB) leprosy
show better results.8,9,11,12,24Studies examining the effects of surgery reported sensory
improvement varying from about 38% to 97% and motor improvement varying from about
26% to 63%.2,4,7,19,25–33Comparison of these studies is difficult due to differences in surgical
techniques used, duration and severity of neuritis, type of leprosy, follow-up time, and
Several non-randomised studies compared operated versus non-operated nerves. One
study evaluated nerve function in nine individuals with neuritis of less than 6 months
duration. Three patients underwent ulnar nerve decompression, three patients received
corticosteroid therapy for ulnar neuritis and three patients underwent median nerve
decompression. The study found an average nerve function improvement of 35% for ulnar
Review of surgery for nerve damage9
nerve decompression (n ¼ 3), 32% for steroid treatment of 8 weeks (n ¼ 3) and 18% median
nerve decompression (n ¼ 3) 6 months after surgery or start of treatment.34
Three studies examined surgery alone versus surgery plus steroids. One study compared
medial epicondylectomy alone (n ¼ 7) with medial epicondylectomy plus steroids (n ¼ 7)
follow-up motor improvement was not better in the group receiving additional steroids.35
Another study compared neurolysis (n ¼ 21) with neurolysis in combination with perineural
corticosteroid injections (n ¼ 18) for ulnar neuritis of less than 6 months duration. The
One year after surgery the mean difference between final and initial nerve function score was
14 for the surgery only group and 21 for the surgery plus steroids group.6The third study
compareddecompressivesurgeryalone(n ¼ 59)withsurgery plussteroids(n ¼ 25)givenfor
3 to 4 months for sensory impairment of the posterior tibial nerve of varying duration.
Satisfactory recovery of nerves with duration of anaesthesia of less than 6 months was 60% in
the surgery group and 83% in the surgery plus steroids group 4 weeks after surgery.5
One study compared operated nerves with contralateral non-operated nerves. Prior to
surgery all participants had received 3 months of steroid treatment. The most affected nerves
underwent surgical decompression and were compared with the contralateral non-operated
nerves 1 year or more after surgery. Of the more than 100 nerve decompressions four
operated nerves had decreased nerve function after 1 year of follow-up. The other operated
nerves had unchanged or improved nerve function 1 year after surgery. It is unclear how
many of the contralateral non-operated nerves improved or deteriorated.36
Afterlossestofollow-up,anotherstudycomparedoperatednerves(n ¼ 195)of95patients
with non-operated nerves of 96 patients, matched for type of leprosy, age and duration of
sensory loss but not randomised, on changes in sensation. Participants, in whom no
improvement of sensory nerve function was found after a standard steroid treatment (40mg
prednisolone daily for 3 weeks after which the dosage was reduced by 5mg per week), were
included in the study. Between 27% and 66% of the nerves had definite improvement 2 years
more likely if the sensory loss had been present for a shorter time. Studies from Carayon et al.
favour surgery plus medical treatment above medical treatment alone.1,38,39
Corticosteroids are the cornerstone of management in acute nerve damage in leprosy, are
recommended by the WHO and are widely available. But corticosteroids have some
shortcomings. The effects of corticosteroids in the long-term remain uncertain and a
considerable proportion of people treated for nerve damage do not benefit from corticosteroid
treatment. Long-term therapy may cause serious adverse effects, such as peptic ulcer,
cataract, or psychosis. Spontaneous improvement or recovery of nerve function in untreated
or placebo treated individuals has been reported and needs more investigation. The
limitations of corticosteroids urge the need to find alternative therapeutic approaches.40
Surgery alone as therapy for treating neuritis is not recommended, but there is discussion
about whether the combination of surgery and medical treatment (e.g. steroids) will give
better results than medical treatment alone and there is a call for appropriate trials examining
N. H. J. van Veen et al.10
IMPLICATIONS FOR PRACTICE
Evidence from the two randomised controlled trials is insufficient to draw robust conclusions
about the effect of decompressive surgery for treating nerve damage in leprosy. Two trials
examining the added benefit of surgery over steroids for neuritis of less than 6 months
duration did not show significantly better outcomes with steroids plus surgery than steroids
alone in the long-term. Adverse effects of decompressive surgery for treating nerve damage
in leprosy are not well-documented.
IMPLICATIONS FOR RESEARCH
There is a need to identify factors which will predict a favourable response to decompressive
surgery or groups of patients or nerves that will be likely to benefit from surgery. Future
randomised controlled trials should be well-designed to establish the usefulness and
effectiveness of the combination of decompressive surgery and medical treatment compared
to medical treatment alone. New trials should pay more attention to non-clinical aspects, such
as costs and impact on quality of life, because these are highly relevant indicators for both
policy makers and participants.
We would like to thank the Netherlands Leprosy Relief for financial support, Dr P Bourrel,
Dr M Ebenezer, Dr J Millan and Dr B Naafs for providing additional information and the
Cochrane Neuromuscular Disease Group for advice and help.
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