Gastrocnemius Recession vs. Conservative Treatment for Chronic Plantar Fasciitis

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Plantar Fasciitis
• Intervention / Treatment: Procedure: surgical proximal medial gastrocnemius recession

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0424
    • Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: gastrocnemius recession	Procedure: surgical proximal medial gastrocnemius recession; proximal medial gastrocnemius recession

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Oslo University Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: April 8, 2014
• First Submitted That Met QC Criteria: April 14, 2014
• First Posted (Estimate): April 17, 2014

Study Record Updates

• Last Update Posted (Actual): March 15, 2021
• Last Update Submitted That Met QC Criteria: March 12, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: plantar fasciitis; gastrocnemius recession
• Additional Relevant MeSH Terms: Foot Diseases; Musculoskeletal Diseases; Fasciitis; Fasciitis, Plantar
• Other Study ID Numbers: 2013/2055

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No