Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy of Manual Therapy in Plantar Fasciitis (MTPlantarF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04758572
Recruitment Status : Recruiting
First Posted : February 17, 2021
Last Update Posted : March 23, 2021
Sponsor:
Information provided by (Responsible Party):
GEMMA V ESPÍ LÓPEZ, PhD, University of Valencia

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.


Condition or disease Intervention/treatment Phase
Plantar Fasciitis Other: Manual Therapy Other: Placebo massage Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of a Manual Therapy Program in Patients With Plantar Fasciitis
Actual Study Start Date : March 22, 2021
Estimated Primary Completion Date : May 30, 2021
Estimated Study Completion Date : June 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

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




Primary Outcome Measures :
  1. Foot pain [ Time Frame: 8 week ]
    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 :
  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 = __%.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04758572


Contacts
Layout table for location contacts
Contact: Gemma V Espí-López 651948635 gemma.espi@uv.es

Locations
Layout table for location information
Spain
Gemma V Espí López Recruiting
Valencia, Spain, 46010
Contact: Gemma V Espí López, Ph, Dr    +46 39383181    gemma.espi@uv.es   
Gemma Victoria Espí-López Recruiting
Valencia, Spain, 46010
Contact: Gemma V Espí-López    651948635    gemma.espi@uv.es   
Sponsors and Collaborators
University of Valencia
Investigators
Layout table for investigator information
Principal Investigator: Gemma V Espí-López University of Valencia
Layout table for additonal information
Responsible Party: GEMMA V ESPÍ LÓPEZ, PhD, Principal Investigator, University of Valencia
ClinicalTrials.gov Identifier: NCT04758572    
Other Study ID Numbers: ID0033
First Posted: February 17, 2021    Key Record Dates
Last Update Posted: March 23, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GEMMA V ESPÍ LÓPEZ, PhD, University of Valencia:
pain
function
treatment
Additional relevant MeSH terms:
Layout table for MeSH terms
Fasciitis
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases