Radial Extracorporeal Shock Wave Treatment for Chronic Plantar Fasciopathy

NCT02679521 | Completed

• 1 other identifier: 070609-02
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Fasciitis, Plantar

Keywords

Extracorporeal Shock Wave Therapy; Painful Heel; Plantar fasciitis

Outcome Measures

Primary Outcomes (1)

• Pain (VAS score)

  Change from Baseline Pain Score (VAS) at 6 months.

Secondary Outcomes (1)

• Quality of life (modified Roles & Maudsley score)

  Change from Baseline Quality of Life Score (R&M) at 6 months.

Study Arms (2)

rESWT

ACTIVE COMPARATOR

Radial extracorporeal shock wave therapy (rESWT).

Device: ESWT

Placebo

PLACEBO COMPARATOR

Placebo treatment.

Device: Placebo

Interventions

ESWT DEVICE

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).

Also known as: Swiss DolorClast

rESWT

Placebo DEVICE

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prof. Dr Mahmoud Ibrahim Ibrahim: lead

Related 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.

  PMID: 20460065 RESULT

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Study Officials

• Mahmoud I Ibrahim, PhD, PT

  Rocky Mountain University of Health Professions, Provo, UT 84601, USA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Scientist

Study Record Dates

• First Submitted: February 3, 2016
• First Posted: February 10, 2016
• Study Start: October 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: February 10, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share