Clinical trial NCT04758572: Efficacy of Manual Therapy in Plantar Fasciitis
Official title: Effects of a Manual Therapy Program in Patients With Plantar Fasciitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plantar Fasciitis
Keywords: pain
function
treatment
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2021-02-17
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Foot pain
timeFrame: 8 week
Secondary outcomes:
measure: Ankle flexion
timeFrame: 8 week
measure: Dynamic balance
timeFrame: 8 week
measure: Quality of life in relation to foot pain
timeFrame: 8 week
measure: Foot health
timeFrame: 8 week
measure: Impact and disability from foot pain
timeFrame: 8 week
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Gemma V Espí López
city: Valencia
country: Spain
facility: Gemma Victoria Espí-López
Study officials:
affiliation: University of Valencia
name: Gemma V Espí-López
role: PRINCIPAL_INVESTIGATOR
References: