Radial Extracorporeal Shock Wave Treatment for Chronic Plantar Fasciopathy

Fasciitis, Plantar Clinical Trial

— RSWT_CPF  

Official title:

The Effectiveness of Extracorporeal Shock Wave Therapy for Patients With Plantar Fasciitis Who Satisfy a Clinical Prediction Rule

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02679521
• Other study ID #: 070609-02
• Status: Completed
• Phase: N/A
• First received: February 3, 2016
• Last updated: February 7, 2016
• Start date: October 2007
• Est. completion date: December 2010

Study information

• Verified date: February 2016
• Source: Rocky Mountain University of Health Professions
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Radial extracorporeal shock wave therapy (rESWT) has been previously demonstrated as an efficient treatment option for heel pain associated with chronic proximal plantar fasciitis when administered in three sessions. The present study tested the hypothesis that heel pain associated with chronic proximal plantar fasciitis can also be treated successfully with rESWT when only two treatment sessions are performed.

Description:

Plantar fasciitis, the most common cause of heel pain, accounts for approximately 11-15% of foot symptoms presenting to physicians. In the United States, more than two million individuals are treated for PF on an annual basis. The term Plantar Fasciitis implies an inflammatory condition by the suffix 'itis'. However, various lines of evidence indicate that this disorder is better classified as 'fasciosis' or 'fasciopathy'. Details about etiology, pathogenesis, risk factors, diagnosis and general treatment strategies for plantar fasciitis have been provided in a series of comprehensive reviews recently. Briefly, both athletes and the elderly commonly present to physicians with plantar fasciitis, and the diagnosis of plantar fasciitis is usually based on the patient's history and clinical examination. It has been recommended in the literature to start treatment of plantar fasciitis with conservative treatment modalities, including physical therapy, stretching, inserts/orthotics etc. For patients not responding to conservative treatment for 6 months (between 10% and 20% of all patients) extracorporeal shock wave therapy (ESWT) should be considered. In case a patient does not benefit from ESWT either, surgical intervention should be taken into account.

Several randomized, controlled trials of ESWT with focused shock waves for chronic plantar fasciitis were published, demonstrating favourable results in the range of 50% to 70% after a followup period of three months after treatment. Besides this, a recent study demonstrated safety and efficacy of radial extracorporeal shock wave therapy (rESWT) for chronic plantar fasciitis (Gerdesmeyer et al., Am J Sports Med 2008 Nov;36(11):2100-9). These authors administered rESWT or placebo treatment in three sessions, each two weeks (±4 days) apart and evaluated the treatment outcome at twelve weeks and twelve months after the first session. The authors found a statistically significant (p < 0.05) difference in the reduction of the mean Visual Analog Scale composite score between the patients treated with rESWT and the placebo-treated patients both at twelve weeks and twelve months from baseline.

To further evaluate the potential of rESWT to become a routine therapeutic modality in the treatment of chronic plantar fasciitis, the investigators of the present study identified the following questions not addressed in the study by Gerdesmeyer et al. (2008). First, it is unknown whether treatment success can also be reached by two rESWT sessions one week apart, rather than by three rESWT sessions each two weeks apart as applied by Gerdesmeyer et al. (2008). Anecdotal reports by colleagues in Europe indicated that this could indeed be the case. Second, immediate return to normal daily life activities (including sports activities) and normal daily shoe wear indicates that patients suffering from chronic plantar fasciitis and treated with rESWT experience profound pain relief already much earlier than three months after the first rESWT session, applied as first followup in the study by Gerdesmeyer et al. (2008).

Therefore the hypothesis was tested in the present prospective, randomized, double-blinded, placebo-controlled study that treatment of chronic plantar fasciopathy with two rESWT sessions one week apart will result in profound pain relief compared to placebo treatment already four weeks after the first rESWT treatment, lasting for at least six months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults over the age of 18 years

• Diagnosis of painful heel syndrome by clinical examination, with the following positive clinical signs: (i) pain in the morning or after sitting a long time; (ii) local pain where the fascia attaches to the heel; and (iii) increasing pain with extended walking or standing for more than 15 minutes

• History of six months of unsuccessful conservative treatment

• Therapy free period of at least four weeks before referral

• Signed informed consent

Exclusion Criteria:

• Bilateral plantar fasciitis

• Dysfunction of foot or ankle (for example, instability)

• Arthrosis or arthritis of the foot

• Infections or tumors of the lower extremity

• Neurological abnormalities, nerve entrapment (for example, tarsal tunnel syndrome)

• Vascular abnormality (for example, severe varicosities, chronic ischemia)

• Operative treatments of the heel spur

• Hemorrhagic disorders and anticoagulant therapy

• Pregnancy

• Diabetes

Study Design

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

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar

Intervention

Device:
• ESWT
Radial extracorporeal shock wave therapy (rESWT) was performed by the principal investigator with a Swiss DolorClast device (EMS Electro Medical Systems Corporation; Dallas, Texas, USA). The Swiss DolorClast device obtained Pre-Market Approval (PMA) by FDA as Class III orthopedic lithotripsy device to treat heel pain associated with chronic proximal plantar fasciitis on May 8, 2007 (PMA # P050004), and was re-classified as Class III Generator, Shock Wave, For Pain Relief (Product Code NBN) in the Spring 2009. The present study started on October 3, 2007. Each patient received two sessions of rESWT one week apart, with 2,000 impulses per session (air pressure of the device set at 3.5 bar; impulses applied with the 15 mm applicator at frequency of 8 Hz).
• Placebo
Placebo treatment was performed identically as rESWT but with a clasp on the heel that prevented transmission of the impulses from the applicator to the skin at the treatment site.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Dr Mahmoud Ibrahim Ibrahim

References & Publications (1)

Ibrahim MI, Donatelli RA, Schmitz C, Hellman MA, Buxbaum F. Chronic plantar fasciitis treated with two sessions of radial extracorporeal shock wave therapy. Foot Ankle Int. 2010 May;31(5):391-7. doi: 10.3113/FAI.2010.0391. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain (VAS score)		Change from Baseline Pain Score (VAS) at 6 months.	No
Secondary	Quality of life (modified Roles & Maudsley score)		Change from Baseline Quality of Life Score (R&M) at 6 months.	No