Efficacy of Manual Therapy in Plantar Fasciitis (MTPlantarF)

Effects of a Manual Therapy Program in Patients With 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 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.

Study Overview

• Status: Completed
• Conditions: Plantar Fasciitis
• Intervention / Treatment: Other: Manual Therapy; Other: Placebo massage

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46010
    • Gemma V Espí López
  • Valencia, Spain, 46010
    • Gemma Victoria Espí-López

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Manual Therapy; Mobilization. Axial decoaptation, talar mobilization, global and specific articulatory mobilization of the foot, mobilization of the fibular head, femorotibial mobilization, hip mobilization. In addition, lumbar joint mobilization is applied. The articulatory techniques last 15 minutes. Subsequently, Trigger Point Inhibition is applied. in the medial gastrocnemius, soleus, and square plantar muscles. The application of this technique lasted 15 minutes. Plantar fascia massage. A deep friction technique was applied longitudinally and transversely to the plantar fascia and the triceps surae. It lasted 15 minutes. Passive stretching. Stretches were applied to the plantar fascia, the gastrocnemius muscles and the soleus muscles in order to relax these muscles. The duration was 5/10 minutes.	Other: Manual Therapy; Mobilization, massage and stretching
Sham Comparator: Placebo massage; Consist of gentle kneading and rubbing without intention to treat for 15 minutes.	Other: Placebo massage; Kneading and rubbing without intention to treat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Valencia
• Investigators: Principal Investigator: Gemma V Espí-López, University of Valencia

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2021
• Primary Completion (Actual): May 30, 2021
• Study Completion (Actual): September 15, 2021

Study Registration Dates

• First Submitted: February 12, 2021
• First Submitted That Met QC Criteria: February 12, 2021
• First Posted (Actual): February 17, 2021

Study Record Updates

• Last Update Posted (Actual): May 24, 2022
• Last Update Submitted That Met QC Criteria: May 23, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: treatment; pain; function
• Additional Relevant MeSH Terms: Foot Diseases; Musculoskeletal Diseases; Fasciitis; Fasciitis, Plantar
• Other Study ID Numbers: ID0033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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