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

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ClinicalTrials.gov Identifier: NCT02608723
Recruitment Status : Completed
First Posted : November 20, 2015
Last Update Posted : November 20, 2015
Sponsor:
Information provided by (Responsible Party):
Asociacion Colaboracion Cochrane Iberoamericana

Brief 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.

Condition or disease Intervention/treatment Phase
Plantar Fasciitis Pain Device: Standard shock waves device Device: Austere shock waves device Device: Sophisticated shock waves device Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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.
Study Start Date : June 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

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.




Primary Outcome Measures :
  1. Function of the foot [ Time Frame: Four months ]
    FFI (Foot Function Index) questionnaire


Secondary Outcome Measures :
  1. Pain [ Time Frame: Four months ]
    VAS (Visual Analogical Scale)

  2. Plantar fascia thickness [ Time Frame: Four months ]
    Ultrasounds

  3. Perception of patient recovery [ Time Frame: Four months ]
    Likert scale

  4. Painkillers consumption [ Time Frame: Four months ]
    Painkillers consumption

  5. Adverse effects [ Time Frame: Four months ]
    Adverse effects



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02608723


Locations
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Spain
Rehabilitation Center "Salut i Esport"
Santa Perpetua, Barcelona, Spain, 08130
Sponsors and Collaborators
Asociacion Colaboracion Cochrane Iberoamericana
Investigators
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Principal Investigator: Antoni Morral, PhDc Rehabilitation Center "Salut i Esport"

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Responsible Party: Asociacion Colaboracion Cochrane Iberoamericana
ClinicalTrials.gov Identifier: NCT02608723     History of Changes
Other Study ID Numbers: 1304
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: November 20, 2015
Last Verified: November 2015
Keywords provided by Asociacion Colaboracion Cochrane Iberoamericana:
shock wave
plantar fasciitis
placebo effect
nocebo effect
Additional relevant MeSH terms:
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Fasciitis
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases