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NCT Number: NCT04758572

Efficacy of Manual Therapy in Plantar Fasciitis

Plantar fasciitis is characterized by localized pain at the insertion site of the plantar fascia on the calcaneus. The pain worsens in the morning with the first step of the foot, after resting or at the beginning of a workout, it can increase after intense activity and persist even when it stops. The first-line plantar fasciitis treatment is conservative. Although few studies have currently evaluated the effectiveness of physical therapy, it appears that the combination of several techniques is more effective than any technique used in isolation. The objective of this study is to know the results of two manual therapy treatments in terms of pain and functionality with a direct action on the plantar fascia.

Patients diagnosed with plantar fasciitis will be recruited. They will be randomly assigned into two intervention groups: Group 1 will receive a direct treatment on the plantar fascia and posterior aspect of the leg to relax and elongate the tissues. It will consist of manual therapy of the foot and ankle, treatment of the trigger points of the soleus muscle and plantar square, and also massage, and passive stretching and group 2 will receive a treatment with superficial massage based on a muscle chain protocol. It lasts 4 weeks, evaluations will be carried out at the beginning of treatment, at the end of the treatment and a follow-up one month. The evaluations will consist of pain on pressure, ankle goniometry, pain, lower limb functionality dynamic balance, function and daily activities and ankle ability scale.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gemma V Espí López, Valencia, Spain

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About this study

Introduction Plantar fasciitis is characterized by localized pain at the insertion site of the plantar fascia on the calcaneus, which can radiate toward the medial edge of the foot. The pain worsens in the morning with the first step of the foot, after resting or at the beginning of a workout, it can increase after intense activity and persist even when it stops. These symptoms can lead to functional limitation and prolonged disability. It is one of the most common foot pathologies. The first-line plantar fasciitis treatment is conservative. Although few studies have currently evaluated the effectiveness of physical therapy, it appears that the combination of several techniques is more effective than any technique used in isolation.

The objective of this study is to know the results of two manual therapy treatments in terms of pain and functionality with a direct action on the plantar fascia.

Material and methods

Patients diagnosed with plantar fasciitis will be recruited. Patients will sign an explanatory informed consent for the project before starting it. All patients are volunteers. They will be randomly assigned into two intervention groups:

  • Group 1 will receive a direct treatment on the plantar fascia and posterior aspect of the leg to relax and elongate the tissues. It will consist of manual therapy of the foot and ankle, treatment of the trigger points of the soleus muscle and plantar square, and also massage, and passive stretching.
  • Group 2 will receive a treatment with superficial massage based on a muscle chain protocol.

The intervention consists of a 4-week application, evaluations will be carried out at the beginning of treatment, at the end of the treatment and a follow-up one month.

The evaluations will consist of pain on pressure using an algometer, ankle goniometry, pain and lower limb functionality with the validated Foot Function Index scale, dynamic balance using the Star Excursion Balance Test, evaluation of the function and daily activities with the Foot and ankle ability scale.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age between 18 and 65 years old, diagnosed with plantar fasciitis.
  • Evolution of fasciitis greater than 1 month
  • Not being receiving any other type of physiotherapy treatment at the time of the study.

Exclusion criteria

  • Subjects showing tumor, lower limb fractures, rheumatoid arthritis, vascular disease, administration of corticosteroids for long periods of time, pregnancy, previous surgeries in the affected or scheduled surgeries during the study period.
  • Subjects who were not able to understand or respond to the evaluations of the study.

Treatment and study plan

Manual therapy

Other

Mobilization, massage and stretching

Massage muscle chain

Other

Massage very soft following the directions of the muscle chains, massage and stretching

Primary outcomes

  1. Foot pain

    Time frame: 8 week

    Pressure pain threshold is measured by digital algometer to determine overall pressure pain sensitivity at which a sensation of pressure changed to pain. The patient is placed in a prone position with the feet off the table, gradual pressure is applied to the insertion area of the plantar fascia on the calcaneus with the algometer until the sensation of pressure becomes painful. The pressure (cm2/kg) is applied perpendicular to the skin at a speed of 30 kPa/s. Three measurements are applied, with 1 minute between them, and the average is recorded.

Secondary outcomes

  1. Ankle flexion

    Time frame: 8 week

    Evaluation of passive ankle flexion is carried out using a universal goniometer. With the subject in the supine position and with the knees extended, the fulcrum of the goniometer is placed on the lateral malleolus, the mobile arm on the fifth metatarsal, and the fixed arm on the fibula.

  2. Dynamic balance

    Time frame: 8 week

    Evaluation using the Star Excursion Balance Test (SEBT). Its purpose is the prediction of the risk of injury to the lower extremities and the identification of dynamic balance deficits. It is carried out in a standing position and with previous training, the subjects perform the test 4 times before their final evaluation. The subject must remain stable while performing movements of the lower limb in different directions (anterior, lateromedial, lateroposterior) while the other remains fixed and stable at one point.

  3. Quality of life in relation to foot pain

    Time frame: 8 week

    It is evaluated using the SF-12 questionnaire. It is a questionnaire that assesses the quality of life of patients and is composed of 12 questions about the health of the participants and informs us about the physical (PCS) and mental (MCS) health of the subjects. The score ranges from 0 to 100.

  4. Foot health

    Time frame: 8 week

    We will evaluate using the Foot Health Status Questionnaire (FHSQ) (25). It consists of three sections with a total of 23 items in total. Section 1 assesses foot function, foot pain, footwear, and general foot health, making up 13 of the 23 items. Section 2 assesses general health, physical activity, and social ability. Section 3 assesses the socioeconomic level, comorbidity and satisfaction.

  5. Impact and disability from foot pain

    Time frame: 8 week

    Evaluation using the Foot Function Index (FFI), a questionnaire that informs us about the repercussion (pain, disability and restriction) that foot pathology has on the patient. It is made up of 23 items. The result is calculated using the following formula: sum of the questions / 230x100 = __%.

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Official study title

Effects of a Manual Therapy Program in Patients With Plantar Fasciitis

Acronym: MTPlantarF

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 17, 2021
Registry last updated
Sep 19, 2024

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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