Ultrasound-guided Percutaneous Electrolysis in Chronic Plantar Heel Pain. A randomized clinical trial.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616001430426
• Date of registration: 13/10/2016
• Prospective Registration: No
• Primary sponsor: Camilo Jose Cela University
• Public title: Ultrasound-guided Percutaneous Electrolysis in Chronic Plantar Heel Pain. A randomized clinical trial.
• Scientific title: Effectiveness of US-guided Percutaneous Electrolysis Versus Placebo in Individuals With Plantar Fasciosis
• Date of first enrolment: 03/11/2014
• Target sample size: 68
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12616001430426.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Spain

Contacts

• Name: Dr Tomas Fernandez-Rodriguez

• Name: A/Prof Sebastian Truyols-Dominguez

Key inclusion & exclusion criteria

Inclusion criteria: Insidious onset of sharp pain under the plantar heel surface upon weight bearing after a period of non-weight bearing.

Plantar heel pain which increases in the morning with the first steps after waking up.

Symptoms decreasing with slight levels of activity, such as walking.

Plantar fascia ultrasound thickness greater than 0,4 cm.
Exclusion criteria: Prior surgery in the lower extremity.

Diagnosis of fibromyalgia syndrome.

Previous physical therapy interventions for the foot region in the previous 6 months.

Lidocaine or other injections in the plantar fascia for the management of pain in the previous 6 months.

Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Plantar Fasciosis;
Plantar Fasciosis

Musculoskeletal - Other muscular and skeletal disorders

Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation

Intervention(s)

Experimental: US-guided percutaneous electrolysis
Patients will receive one weekly session for 5 weeks for 5 weeks of US-guided percutaneous electrolysis. This intervention consists of the application of a galvanic electrical current with an acupuncture needle in the soft tissue, in this case the plantar fascia insertion.

Treatment will be applied by Physical Therapist/Medical Doctor with minimum 5 years of experience in ultrasound-guided invasive techniques.

Dosage: 350 microamperes (28 microcoulombs)
Duration: 3 approaches of 80 second each one inside the plantar fascia insertion, on the same visit, once per week
Mode: Percutaneous
Galvanic Device: EPTE device (Registered Trademark). Max 48 Volts, 1000 microamps.
Ultrasound Device: Mindray (Registered Trademark) M7 ultrasound system with linear L12-4s transducer
Adherence monitoring: Not applicable

Primary Outcome(s)

Changes in pain intensity before and after the intervention A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of plantar heel pain. [Baseline, one week after the last session, 3 and 6 months after the last session.]

Secondary Outcome(s)

Changes in thickness of the plantar fascia in centimeters. An ultrasound (US) assessment of the thickness of the plantar fascia (mm) will be conducted to determine changes in fascial tissue thickness.[Baseline, one week after the last session, 3 and 6 months after the last session.]

Changes in disability before and after the intervention The Foot and Ankle Ability Measure (FAAM) Activities of Daily Living Subescale ( 21 items; scores from 4 to 0, being 4 "no difficulty" and 0 "unable to do". Item score totals range from 0 to 84 ) will be used to determine function and disability of the lower extremity induced by plantar heel pain. [Baseline, one week after the last session, 3 and 6 months after the last session.]

Secondary ID(s)

None

Source(s) of Monetary Support

Camilo Jose Cela University

Ethics review

Status: Approved
Approval date:
Contact:

Camilo Jose Cela Clinical Research Ethics Committee