Gastrocnemius Recession vs. Conservative Treatment for Chronic Plantar Fasciitis

Plantar Fasciitis Clinical Trial

Official title:

Gastrocnemius Recession vs. Conservative Treatment for Chronic Plantar Fasciitis. A Randomized Controlled Trial.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02116478
• Other study ID #: 2013/2055
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2014
• Est. completion date: June 2022

Study information

• Verified date: March 2021
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to compare the clinical results for patients suffering from plantar fasciitis treated with gastrocnemius recession vs. conservative treatment.

Description:

All patients will be instructed in stretching exercises. Half of the patients will be randomized to proximal medial gastrocnemius recession. All patients will be followed for 1 year. Additional long term follow-up will be 6 years after inclusion

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: June 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Symptoms of plantar fasciitis lasting more than 12 months.

• Isolated gastrocnemius contracture

Exclusion Criteria:

• No previous surgery to foot or ankle

• No active arthritis

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Plantar Fasciitis

Intervention

Procedure:
• surgical proximal medial gastrocnemius recession
proximal medial gastrocnemius recession

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Short form-36 (SF-36)	Difference in subgroup parameters between baseline and follow-up as well as between group differences will be reported	1 year and 6 years postoperative
Primary	Change in American Orthopaedic foot and ankle society (AOFAS) ankle-hindfoot score	The change in AOFAS from baseline to follow-up, as well as the difference between the groups treated non-operatively and operatively will be reported on a 0-100 scale.	1 year and 6 years postoperative
Secondary	0-10 points Visual analog pain score	Difference in pain between groups will be reported on 0-10 points visual analog scale	1 year and 6 years postoperative