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Efficacy of Manual Therapy in Plantar Fasciitis (MTPlantarF)

Primary Purpose

Plantar Fasciitis

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Manual Therapy
Placebo massage
Sponsored by
University of Valencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plantar Fasciitis focused on measuring pain, function, treatment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Gemma V Espí López
  • Gemma Victoria Espí-López

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Manual Therapy

Placebo massage

Arm Description

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.

Consist of gentle kneading and rubbing without intention to treat for 15 minutes.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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 = __%.

Full Information

First Posted
February 12, 2021
Last Updated
May 23, 2022
Sponsor
University of Valencia
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1. Study Identification

Unique Protocol Identification Number
NCT04758572
Brief Title
Efficacy of Manual Therapy in Plantar Fasciitis
Acronym
MTPlantarF
Official Title
Effects of a Manual Therapy Program in Patients With Plantar Fasciitis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
March 22, 2021 (Actual)
Primary Completion Date
May 30, 2021 (Actual)
Study Completion Date
September 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Valencia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Fasciitis
Keywords
pain, function, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Manual Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo massage
Arm Type
Sham Comparator
Arm Description
Consist of gentle kneading and rubbing without intention to treat for 15 minutes.
Intervention Type
Other
Intervention Name(s)
Manual Therapy
Intervention Description
Mobilization, massage and stretching
Intervention Type
Other
Intervention Name(s)
Placebo massage
Intervention Description
Kneading and rubbing without intention to treat
Primary Outcome Measure Information:
Title
Foot pain
Description
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.
Time Frame
8 week
Secondary Outcome Measure Information:
Title
Ankle flexion
Description
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.
Time Frame
8 week
Title
Dynamic balance
Description
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.
Time Frame
8 week
Title
Quality of life in relation to foot pain
Description
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.
Time Frame
8 week
Title
Foot health
Description
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.
Time Frame
8 week
Title
Impact and disability from foot pain
Description
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 = __%.
Time Frame
8 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gemma V Espí-López
Organizational Affiliation
University of Valencia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gemma V Espí López
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Gemma Victoria Espí-López
City
Valencia
ZIP/Postal Code
46010
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy of Manual Therapy in Plantar Fasciitis

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