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NCT Number: NCT07060352

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

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.

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Key information

Conditions

Plantar Fasciitis Fasciitis Fasciitis, Plantar Foot Diseases Musculoskeletal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ankle Dorsiflexion Index (ADI) measurement

Diagnostic Test

Ankle Dorsiflexion Index (ADI) measurement at D0 and W8

Primary outcomes

  1. Prevalence of gastrocnemius muscle retraction in patients with plantar fasciitis

    Time frame: At Day 0

    retraction of the gastrocnemius muscles will be defined by an ADI of less than 13° measured by a digital inclinometer

Secondary outcomes

  1. correlation between ADI measurement and Manchester Oxford Foot Questionnaire (MOXFQ)

    Time frame: At Day 0

    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.

  2. correlation between ADI measurement and pain Visual Analog Scale (VAS)

    Time frame: At Day 0

    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

  3. Evolution of Visual Analog Scale (VAS)

    Time frame: between Day 0 and Week 8

    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

  4. Evolution of Visual Analog Scale (VAS)

    Time frame: between Day 0 and Week 16

    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

  5. Evolution of Visual Analog Scale (VAS)

    Time frame: between Day0 and Week 24

    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

  6. Evolution of Manchester Oxford Foot Questionnaire (MOXFQ)

    Time frame: between Day 0 and Week 8

    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.

  7. Evolution of Manchester Oxford Foot Questionnaire (MOXFQ)

    Time frame: between Day 0 and Week 16

    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.

  8. Evolution of Manchester Oxford Foot Questionnaire (MOXFQ)

    Time frame: between Day 0 and Week 24

    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.

  9. Correlation between surgical success and body mass index (BMI)

    Time frame: At Day 0

    Surgical success is based on variation of pain (mesured with Visual Analogic Scale)

  10. Correlation between surgical success and age of patient

    Time frame: At Day 0

    Surgical success is based on variation of pain (mesured with Visual Analogic Scale)

  11. Correlation between surgical success and tobacco consumption

    Time frame: At Day 0

    Surgical success is based on variation of pain (mesured with Visual Analogic Scale)

  12. Correlation between surgical success and location of fasciitis

    Time frame: At Day 0

    Surgical success is based on variation of pain (mesured with Visual Analogic Scale) Location of fasciitis: proximal or central

Study contacts

Contact information is provided by the study sponsor or research team.

Timothée BISSUEL, MD

CONTACT

[email protected]

+334 78 27 07 97

Sponsors and collaborators

Lead sponsor

Clinique Saint Charles

Other

Registry information

Acronym: REGAPOP

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jul 11, 2025
Registry last updated
Jul 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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