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

NCT03554421 | Completed

• 1 other identifier: user
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Key Words: Anal Fissure, tibial nerve stimulation

Outcome Measures

Primary Outcomes (1)

• Rate of wound healing by clinical examination

  Wound healing rate was assessed by visual Clinical examination of the wound taking into consideration the presence or absence of inflammation or epithelialization. The clinical state of the fissure wound was assessed in the scale of : not healed (more than 50% of wound visible), partially healed (more than 50% the healing process was visible but not totally complete) and healed when no sign of the active fissure or inflammation was visible and wound was completely epithilialized.

  3 years

Secondary Outcomes (5)

• Pain Intensity assessed by Visual Analogue Scale (VAS)

  3 years

• Pain Inventory as assessed by Brief Pain Inventory (BPI-SF)

  3 years

• Bleeding of fissure wound as assessed by patient

  3 years

• Bowel control as assessed by St. Marks Incontinence Score

  1 year

• Bowel movements assessed by Constipation Score

  1 year

Study Arms (1)

Posterior tibial nerve stimulation

EXPERIMENTAL

Percutaneous tibial nerve stimulation. Stimulation av posterior tibial nerve via neuromodulator for 30 minutes. 10 sessions

Procedure: Percutaneous tibial nerve stimulation

Interventions

Percutaneous tibial nerve stimulation PROCEDURE

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.

Posterior tibial nerve stimulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Chronic anal fissure for at least 6 months. 2. Above 18 years old. 3. Failed all previous conservative therapy. 4. On high fibre diet.

You may not qualify if:

• Pregnancy 2. Pacemaker device. 3. Blood thinners - Heparin or Warfarin 4. Neurological disease 5. Inflammatory bowel disease 6. Radiation proctitis

Sponsors & Collaborators

• Region Skane: lead

Study Officials

• Bengt Jeppsson, Professor

  Region Skane

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Treatment known to both investigator and patient
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Only patients with chronic anal fissures treated

Study Record Dates

• First Submitted: May 31, 2018
• First Posted: June 13, 2018
• Study Start: September 30, 2013
• Primary Completion: February 11, 2014
• Study Completion: March 29, 2017
• Last Updated: September 13, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share