Estimating the Prevalence of GAstrocnemius Muscle REtraction in a Population Suffering From Plantar aPOneurositis and Describing the Effects of Lengthening (REGAPOP)

The gastrocnemius muscles, which form the upper part of the calf, can suffer from retraction, a common but often under-diagnosed condition, which can be a risk factor for plantar fasciitis. Retraction can be treated medically, by stretching, or surgically, by lengthening the muscles. Gastrocnemius retraction is difficult to measure, but tests such as the Ankle Dorsiflexion Index (ADI) provide a more accurate assessment.

Knowing the prevalence of this retraction in patients suffering from plantar fasciitis would enable us to improve diagnostic criteria and better target treatments. Surgical lengthening of the gastrocnemius, particularly by tenotomy, is effective in cases of chronic plantar fasciitis, even without apparent muscle retraction.

Study Overview

• Status: Not yet recruiting
• Conditions: Plantar Fasciitis
• Intervention / Treatment: Diagnostic test: Ankle Dorsiflexion Index (ADI) measurement

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Timothée BISSUEL, MD; Phone Number: +334 78 27 07 97; Email: drtimothee.bissuel@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient aged 70 or under
• Patient suffering from unilateral plantar fasciitis that has progressed for more than 6 months and is recalcitrant to medical treatment
• Collection of express, oral consent
• Available for follow-up visits

Exclusion Criteria:

• Patients with neuropathic pain
• History of fracture of the lower limb, surgery on the lower limb, inflammatory rheumatism of the lower limb, injury to the Achilles tendon
• Patient with another painful orthopedic lesion of the legs/feet
• Patient with surgically treated plantar fasciitis in the year prior to inclusion
• Persons unable to give consent
• Not affiliated to a social security scheme
• Persons under court protection
• Participant in another study with an ongoing exclusion period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• 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: Ankle Dorsiflexion Index (ADI) measurement; Ankle Dorsiflexion Index (ADI) measurement at D0 and W8	Diagnostic test: Ankle Dorsiflexion Index (ADI) measurement; Ankle Dorsiflexion Index (ADI) measurement at D0 and W8

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of gastrocnemius muscle retraction in patients with plantar fasciitis	retraction of the gastrocnemius muscles will be defined by an ADI of less than 13° measured by a digital inclinometer	At Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
correlation between ADI measurement and Manchester Oxford Foot Questionnaire (MOXFQ)	The Manchester Oxford Foot Questionnaire (MOXFQ) is used to measure the impact of foot pain on patients' quality of life. It consists of 16 questions. The raw scores of the scales are converted into a metric scale ranging from 0 to 100, where 100 indicates the maximum intensity of suffering or limitation.	At Day 0
correlation between ADI measurement and pain Visual Analog Scale (VAS)	The VAS consists of a straight line where one extreme represents the total absence of pain and the other extreme, the most intense pain possible. Patients are asked to mark on this line the level of pain they feel at any given moment. Pain intensity is then measured according to the distance between the start of the scale (0) and the point where the patient placed his mark: 0 cm (or the start of the scale): No pain; 10 cm (or the end of the scale): Maximum imaginable pain	At Day 0
Evolution of Visual Analog Scale (VAS)	The VAS consists of a straight line where one extreme represents the total absence of pain and the other extreme, the most intense pain possible. Patients are asked to mark on this line the level of pain they feel at any given moment. Pain intensity is then measured according to the distance between the start of the scale (0) and the point where the patient placed his mark: - 0 cm (or the start of the scale): No pain - 10 cm (or the end of the scale): Maximum imaginable pain	between Day 0 and Week 8
Evolution of Visual Analog Scale (VAS)	The VAS consists of a straight line where one extreme represents the total absence of pain and the other extreme, the most intense pain possible. Patients are asked to mark on this line the level of pain they feel at any given moment. Pain intensity is then measured according to the distance between the start of the scale (0) and the point where the patient placed his mark: - 0 cm (or the start of the scale): No pain - 10 cm (or the end of the scale): Maximum imaginable pain	between Day 0 and Week 16
Evolution of Visual Analog Scale (VAS)	The VAS consists of a straight line where one extreme represents the total absence of pain and the other extreme, the most intense pain possible. Patients are asked to mark on this line the level of pain they feel at any given moment. Pain intensity is then measured according to the distance between the start of the scale (0) and the point where the patient placed his mark: - 0 cm (or the start of the scale): No pain - 10 cm (or the end of the scale): Maximum imaginable pain	between Day0 and Week 24
Evolution of Manchester Oxford Foot Questionnaire (MOXFQ)	The Manchester Oxford Foot Questionnaire (MOXFQ) is used to measure the impact of foot pain on patients' quality of life. It consists of 16 questions. The raw scores of the scales are converted into a metric scale ranging from 0 to 100, where 100 indicates the maximum intensity of suffering or limitation.	between Day 0 and Week 8
Evolution of Manchester Oxford Foot Questionnaire (MOXFQ)	The Manchester Oxford Foot Questionnaire (MOXFQ) is used to measure the impact of foot pain on patients' quality of life. It consists of 16 questions. The raw scores of the scales are converted into a metric scale ranging from 0 to 100, where 100 indicates the maximum intensity of suffering or limitation.	between Day 0 and Week 16
Evolution of Manchester Oxford Foot Questionnaire (MOXFQ)	The Manchester Oxford Foot Questionnaire (MOXFQ) is used to measure the impact of foot pain on patients' quality of life. It consists of 16 questions. The raw scores of the scales are converted into a metric scale ranging from 0 to 100, where 100 indicates the maximum intensity of suffering or limitation.	between Day 0 and Week 24
Correlation between surgical success and body mass index (BMI)	Surgical success is based on variation of pain (mesured with Visual Analogic Scale)	At Day 0
Correlation between surgical success and age of patient	Surgical success is based on variation of pain (mesured with Visual Analogic Scale)	At Day 0
Correlation between surgical success and tobacco consumption	Surgical success is based on variation of pain (mesured with Visual Analogic Scale)	At Day 0
Correlation between surgical success and location of fasciitis	Surgical success is based on variation of pain (mesured with Visual Analogic Scale) Location of fasciitis: proximal or central	At Day 0

Collaborators and Investigators

• Sponsor: Clinique Saint Charles

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2025
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: June 23, 2025
• First Submitted That Met QC Criteria: July 1, 2025
• First Posted (Actual): July 11, 2025

Study Record Updates

• Last Update Posted (Actual): July 11, 2025
• Last Update Submitted That Met QC Criteria: July 1, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Foot Diseases; Fasciitis; Fasciitis, Plantar
• Other Study ID Numbers: REGAPOP; 2025-A00798-41 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No