Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Gastrocnemius Recession vs. Conservative Treatment for Chronic Plantar Fasciitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02116478
Recruitment Status : Active, not recruiting
First Posted : April 17, 2014
Last Update Posted : November 15, 2019
Sponsor:
Information provided by (Responsible Party):
Marius Molund, Oslo University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Plantar Fasciitis Procedure: surgical proximal medial gastrocnemius recession Not Applicable

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Gastrocnemius Recession vs. Conservative Treatment for Chronic Plantar Fasciitis. A Randomized Controlled Trial.
Study Start Date : August 2014
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : June 2022

Arm Intervention/treatment
Experimental: gastrocnemius recession
gastrocnemius recession
Procedure: surgical proximal medial gastrocnemius recession
proximal medial gastrocnemius recession




Primary Outcome Measures :
  1. Change in American Orthopaedic foot and ankle society (AOFAS) ankle-hindfoot score [ Time Frame: 1 year and 6 years postoperative ]
    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.


Secondary Outcome Measures :
  1. 0-10 points Visual analog pain score [ Time Frame: 1 year and 6 years postoperative ]
    Difference in pain between groups will be reported on 0-10 points visual analog scale


Other Outcome Measures:
  1. Short form-36 (SF-36) [ Time Frame: 1 year and 6 years postoperative ]
    Difference in subgroup parameters between baseline and follow-up as well as between group differences will be reported



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02116478


Locations
Layout table for location information
Norway
Oslo University Hospital
Oslo, Norway, 0424
Sponsors and Collaborators
Oslo University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Marius Molund, MD Oslo University Hospital
Layout table for additonal information
Responsible Party: Marius Molund, MD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02116478    
Other Study ID Numbers: 2013/2055
First Posted: April 17, 2014    Key Record Dates
Last Update Posted: November 15, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Marius Molund, Oslo University Hospital:
plantar fasciitis
gastrocnemius recession
Additional relevant MeSH terms:
Layout table for MeSH terms
Fasciitis
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases