Efficacy of treatment with biofeedback assisted pelvic floor physiotherapy using electromyography (EMG) in patients with chronic anal fissure.
ID
Source
Brief title
Condition
- Anal and rectal conditions NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- The tone at rest during EMG registration of the pelvic floor before and after
therapy
Secondary outcome
- Prevalence of pelvic floor dysfunction in chronic anal fissure measured by
physical examination, balloon expulsion test
- Relation between anal fissure and other pelvic floor dysfunctions
- Proctoprom at the start of the study, after 8 weeks, 20 weeks and one year
follow up
- Difference in EMG signals of the pelvic floor after pelvic floor
physiotherapy for tone at rest, MVC and Endurance at the start of the study,
after weeks, 20 weeks and one year follow up
- Quality of life as measured by scores of the domains of the RAND-36
questionnaire, at the start of the study, after 8 weeks, 20 weeks and one
year follow up
- The efficacy of PFPT with biofeedback and/or electro stimulation
- VAS- pain score at the start of the study, after 8 weeks, 20 weeks and one
year follow up
Background summary
A chronic anal fissure is a painful proctological problem with a persistence
of 6 weeks or more. Patients with an anal fissure usually experience pain
during and immediately after defecation. The etiology of anal fissures and
pain is has not been fully elucidated. Patients with anal fissure often have
raised resting pressures in the anal canal with concomitant anal spasm. In
literature first line treatment for anal fissures consists of conservative
treatment with ointment and laxatives. When conservative treatment fails the
next step can be botox injections or lateral internal sfincterotomy (LIS). A
large percentage of the patients with chronic anal fissures experience also
pelvic floor dysfunctions.
Study objective
Efficacy of treatment with biofeedback assisted pelvic floor physiotherapy
using electromyography (EMG) in patients with chronic anal fissure.
Study design
All patients >18 years old presenting with a chronic anal fissure and pelvic
floor dysfunction are eligible for inclusion after signing informed consent.
Upon inclusion, demographic characteristics will be collected including age,
gender, length and weight and relevant history. Clinical data will be
collected including previous treatment, duration of symptoms and findings on
clinical examination regarding fissure and pelvic floor dysfunction. Quality of
life using validated questionnaires using SF36, VAS pain score, Rome III
classification of obstipation and Altomare are also scored.
EMG-signals of the pelvic floor before, during and after pelvic physiotherapy
are measured with an intra-anal probe (MapleĀ®)
Patients with chronic anal fissure will be included and, by a computer
generated list, randomly assigned to an intervention group(A), which received 8
weeks of PFPT with the MAPLeĀ®, or into a control group whith delayed PFPT wich
will start 8 weeks after inclusion.
After 8 weeks of treatment of group A both groups will be compared.
(flowchart).
Patients in both groups are given an explanation of relevant anatomy and
(patho-) physiology of anal fissure and the relationship with pelvic floor
dysfunction and are given toilet behaviour and lifestyle instructions at the
start of the study. Lifestyle changes will be focused on regulation of the
defecation pattern such as the management of fluid intake and fibres. Patients
will be analysed at inclusion and after 8 weeks follow-up by an experienced
pelvic floor therapist to determine the effect of PFPT on QoL and pain
scores(VAS) with a structured quantitative and qualitative examination.
Besides the SF36, VAS and PROM, a EMG registration of the pelvic floor with the
MAPLe will be used. The MAPLe will be placed intra-anal, with the reference
electrode placed on the spina iliaca anterior superior. Patients are asked to
perform three consecutive tasks: one minute rest, where patients are instructed
to feel the pelvic floor in rest, ten maximum voluntary contractions (MVCs),
where patients are
instructed to perform a controlled contraction and relaxation of the PFM, and
three endurance contractions, where patients are instructed to contract the PFM
at such a level that they could hold for 30 s. From these EMG measurements,
mean EMG amplitudes per electrode are calculated. During these examinations no
instructions are given on how to perform a pelvic floor muscle contraction.
Patients receive seven 30-min sessions in a period of 3 months.
The first visit and control at 8, 20, 52 weeks follow-up will be performed by
the same experienced investigator(pelvic floor therapist). Treatment following
the first visit will be performed by experienced pelvic floor physiotherapist
using a standardised treatment protocol near patient*s residence.
This standardized treatment protocol consists of biofeedback guided exercises
comprising rest, maximal voluntary contraction (MVCs), and endurance, according
to the same principle during intake. Besides this, relaxation and coordination
exercises combined with abdominal breathing are given. Visual feedback of the
EMG signals plus verbal instruction, and reinforcement will be used to teach
patients how to control the pelvic floor muscles, while keeping the abdominal
muscles relaxed. The treatment was individualized to match the patient's
ability and specific needs; in case of hypertonicity of the PFM the focus is
more on relaxation, in case of dyssynergia the focus was more on how to relax
the pelvic floor during squeezing and coordinate the abdominal muscles. If
patients are unable to contract or to relax, electro stimulation will be
applied intra-anally in one or two 30-min sessions to gain awareness of the PFM.
Patients will receive the assignment to exercise the taught techniques at home
in between sessions while in the supine, seated, and upright positions and to
integrate these techniques into their daily activities.
During the study period all data will be collected in a database. Patients will
be identified with a number.
Intervention
Rectal toucher/exam and biofeedback with an anal probe.
Study burden and risks
NA
Professor Bronkhorstlaan 10
Bilthoven 3723MB
NL
Professor Bronkhorstlaan 10
Bilthoven 3723MB
NL
Listed location countries
Age
Inclusion criteria
all patients above 18 years old with a chronic anal fissure with pelvic floor
dysfunction
Exclusion criteria
Patients presenting with perianal abces or fistula
Patients presenting with Chrohns disease or colitis ulcerosa
Patients who received prior anal radiation therapy
Patients with anorectal malignancy
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
Register | ID |
---|---|
CCMO | NL65658.058.18 |