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Percutaneous Tibial Nerve Stimulation - an Alternative Treatment Option for Chronic Therapy Resistant Anal Fissure

NCT03554421 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2018-09-13

No results posted yet for this study

Summary

At a tertiary referral centre, 10 patients (4 male and 6 female; mean age 49.8 years) were given neuromodulation via the posterior tibial nerve to the sacral nerve for 30 min on 10 consecutive days. All patients had failed conventional medical treatment. The visual analogue scale (VAS), St. Marks score, Wexner's constipation score, Brief Pain Inventory (BPI - SF), bleeding and mucosal healing were evaluated before treatment, at termination, after 3 months and then yearly during three years.

Conditions

  • Chronic Anal Fissure

Interventions

PROCEDURE

Percutaneous tibial nerve stimulation

A 20Hz electrical current is given via an electrode inserted through the skin over the posterior tibial nerve above the medial malleolus of the foot and the nerve is stimulated until a motor reflex of the big toe is acheived. Treatment is then continued for 30 minutes at this level. The treatment is then repeated for a total of 10 sessions within a 2 week period.

Sponsors & Collaborators

  • Region Skane

    lead OTHER

Principal Investigators

  • Bengt Jeppsson, Professor · Region Skane

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2014-02-11
Completion
2017-03-29

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03554421 on ClinicalTrials.gov