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

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

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

Study Overview

• Status: Completed
• Conditions: Pain; Plantar Fasciitis
• Intervention / Treatment: Device: Standard shock waves device; Device: Austere shock waves device; Device: Sophisticated shock waves device

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 135
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Santa Perpetua, Barcelona, Spain, 08130
      • Rehabilitation Center "Salut i Esport"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard shock waves device; 3 sessions were applied: one per week.	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.
Active Comparator: Austere shock waves device; 3 sessions were applied: one per week.	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.
Active Comparator: Sophisticated shock waves device; 3 sessions were applied: one per week.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Function of the foot	FFI (Foot Function Index) questionnaire	Four months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	VAS (Visual Analogical Scale)	Four months
Plantar fascia thickness	Ultrasounds	Four months
Perception of patient recovery	Likert scale	Four months
Painkillers consumption	Painkillers consumption	Four months
Adverse effects	Adverse effects	Four months

Collaborators and Investigators

• Sponsor: Asociacion Colaboracion Cochrane Iberoamericana
• Investigators: Principal Investigator: Antoni Morral, PhDc, Rehabilitation Center "Salut i Esport"

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: November 13, 2015
• First Submitted That Met QC Criteria: November 17, 2015
• First Posted (Estimate): November 20, 2015

Study Record Updates

• Last Update Posted (Estimate): November 20, 2015
• Last Update Submitted That Met QC Criteria: November 17, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: placebo effect; plantar fasciitis; shock wave; nocebo effect
• Additional Relevant MeSH Terms: Foot Diseases; Musculoskeletal Diseases; Fasciitis; Fasciitis, Plantar
• Other Study ID Numbers: 1304