Shock Wave Therapy: Do the External Appearance of the Device Influence Clinical Outcomes?

Pain Clinical Trial

Official title:

Chronic Plantar Fasciitis Treated With Shock Wave Therapy: Do the External Appearance of the Device Influence Clinical Outcomes? A Randomized Controlled Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02608723
• Other study ID #: 1304
• Status: Completed
• Phase: Phase 4
• First received: November 13, 2015
• Last updated: November 17, 2015
• Start date: June 2014
• Est. completion date: June 2015

Study information

• Verified date: November 2015
• Source: Asociacion Colaboracion Cochrane Iberoamericana
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

To check in patients suffering from chronic plantar fasciitis treated with shock wave therapy, if the outward appearance of the device affects clinical outcomes.

Description:

Study Design: a controlled, randomized, parallel assessor-blinded clinical trial.

Patients suffering from chronic plantar fasciitis (duration more than 6 months) will be assigned to three different groups:

• Group I: Treatment applied by standard shock waves device.

• Group II: Shock wave therapy applied by a modified standard device to offer more attractive, more technical, smarter, better appearance, larger and with an expansion of external information devices more sophisticated.

• Group III: Shock wave therapy applied by a modified standard device to offer a more austere, disfigured, unattractive, modest and smaller external appearance.

The shock waves emitted to the 3 devices will be identical; the only difference will be the external image of the device.

The main outcome will be the function of the foot by the FFI (Foot Function Index) questionnaire.

As secondary variables: pain by VAS (Visual Analogical Scale) in different situations, the plantar fascia thickness measured by ultrasound, and the perception of patient recovery measured with the Likert scale. Adverse effects, painkillers consumption and pain experienced during the treatment of shock waves were also assessed.

The patients will be followed and monitored for a month, two months and four months after treatment finished.

For the statistical analysis of clinical variables, ANOVA (analysis of variance) will be performed to check whether the evolution of patients over time was different depending on the device applied.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age greater than 18 years.

2. Being able to understand the explanations about the potential benefits and risks of study participation.

3. Diagnosis of chronic plantar fasciitis. Proven by clinical examination: Meeting at least 2 of the following criteria:

• Tenderness in the proximal insertion of the plantar fascia (area of the medial calcaneal tuberosity).

• Pain during the first steps to get out of bed in the morning and / or after a period of rest time.

4. With a duration of symptoms = 6 months at the time of study entry.

5. Having received conservative therapy without success, at least two treatments. Treatments may have been made isolated, combined or consecutively.

Exclusion Criteria:

1. Bilateral plantar fasciitis.

2. Hiper/ hypothyroidism.

3. Diabetes mellitus.

4. Treatment with anticoagulants

5. Inflammatory diseases.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Pain
• Plantar Fasciitis

Intervention

Device:
• Standard shock waves device
3 sessions were applied: one per week. Energy flux density 0,18 mJ/mm2. Frequency: 8 Hz. 2500 shockwaves/session. The shock waves emitted to the 3 devices are identical; the only difference is the external image of the device.
• Austere shock waves device
3 sessions were applied: one per week. Energy flux density 0,18 mJ/mm2. Frequency: 8 Hz. 2500 shockwaves/session. The shock waves emitted to the 3 devices are identical; the only difference is the external image of the device.
• Sophisticated shock waves device
3 sessions were applied: one per week. Energy flux density 0,18 mJ/mm2. Frequency: 8 Hz. 2500 shockwaves/session. The shock waves emitted to the 3 devices are identical; the only difference is the external image of the device.

Locations

Country	Name	City	State
Spain	Rehabilitation Center "Salut i Esport"	Santa Perpetua	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Asociacion Colaboracion Cochrane Iberoamericana

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Function of the foot	FFI (Foot Function Index) questionnaire	Four months	No
Secondary	Pain	VAS (Visual Analogical Scale)	Four months	No
Secondary	Plantar fascia thickness	Ultrasounds	Four months	No
Secondary	Perception of patient recovery	Likert scale	Four months	No
Secondary	Painkillers consumption	Painkillers consumption	Four months	No
Secondary	Adverse effects	Adverse effects	Four months	Yes