Efficacy of Manual Therapy in Plantar Fasciitis

Plantar Fasciitis Clinical Trial

— MTPlantarF  

Official title:

Effects of a Manual Therapy Program in Patients With Plantar Fasciitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04758572
• Other study ID #: ID0033
• Status: Completed
• Phase: N/A
• Start date: March 22, 2021
• Est. completion date: September 15, 2021

Study information

• Verified date: May 2022
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 placebo treatment with superficial massage. The intervention consists of a weekly session for 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 ankle goniometry, pain, lower limb functionality dynamic balance, function and daily activities and ankle ability scale and pain on pressure.

Description:

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 placebo treatment with superficial massage. The intervention consists of a weekly session for 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 ankle goniometry, pain measurement using the visual analog scale (VAS), pain and lower limb functionality with the validated Foot Function Index (FFI) scale, dynamic balance using the Star Excursion Balance Test, evaluation of the function and daily activities with the Foot and ankle ability measure (FAAM) scale and pain on pressure using an algometer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 15, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Plantar Fasciitis

Intervention

Other:
• Manual Therapy
Mobilization, massage and stretching
• Placebo massage
Kneading and rubbing without intention to treat

Locations

Country	Name	City	State
Spain	Gemma V Espí López	Valencia
Spain	Gemma Victoria Espí-López	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Foot pain	It is evaluated using the pain scale, the pain is recorded at the first foot support in the morning. This scale values from 0-10 in which 0 = no pain and 10 = excruciating pain.	8 week
Secondary	Ankle flexion	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.	8 week
Secondary	Dynamic balance	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.	8 week
Secondary	Quality of life in relation to foot pain	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.	8 week
Secondary	Foot health	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.	8 week
Secondary	Impact and disability from foot pain	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 = __%.	8 week