Plantar FasciitisMTPlantarFNCT04758572
Efficacy of Manual Therapy in Plantar Fasciitis
A study testing Manual Therapy and Massage muscle chain in people with Plantar Fasciitis, run by University of Valencia at 2 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Plantar Fasciitis
- What is being tested?
- Manual Therapy and Massage muscle chain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesSpain
- Study dates
- 22 Mar 2021to 15 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Gemma V Espí López
Valencia, 46010
Gemma Victoria Espí-López
Valencia, 46010
About this study
Official title: 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 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.
Read the 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.
- Conditions
- Plantar Fasciitis
- Being tested
- Manual Therapy, Massage muscle chain
- Keywords
- pain, function, treatment
- Medical subject headings
- Fasciitis, Plantar, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual TherapyOther
Mobilization, massage and stretching
Massage muscle chainOther
Massage very soft following the directions of the muscle chains, massage and stretching
| Study group | Role | What they receive |
|---|---|---|
| Manual Therapy | Experimental | 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. It lasted 20 minutes. Subsequently, Trigger Point Inhibition is applied. in the medial gastrocnemius, soleus, and square plantar muscles.
Plantar fascia massage. A deep friction technique was applied longitudinally and transversely to the plantar fascia and the triceps surae. The duration was 5/10 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. Receives: Other: Manual Therapy |
| Massage | Active comparator | Consist of gentle kneading and rubbing based on a muscle chain protocol (20 minutes), and the same trigger point Inhibition, plantar fascia massage, and passive stretching. Receives: Other: Massage muscle chain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot pain
Pressure pain threshold is measured by digital algometer to determine overall pressure pain sensitivity at which a sensation of pressure changed to pain. The patient is placed in a prone position with the feet off the table, gradual pressure is applied to the insertion area of the plantar fascia on the calcaneus with the algometer until the sensation of pressure becomes painful. The pressure (cm2/kg) is applied perpendicular to the skin at a speed of 30 kPa/s. Three measurements are applied, with 1 minute between them, and the average is recorded.
Measured: 8 week
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 = __%.
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start22 Mar 2021
- Primary completion30 May 2021
- Study completion15 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FasciitisStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GEMMA V ESPÍ LÓPEZ, PhD, University of Valencia
- Investigators
- Gemma V Espí-López, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04758572
- Sponsor's protocol ID
- ID0033
- Acronym
- MTPlantarF
- Status last verified
- Sep 2024
- First submitted
- 12 Feb 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Manual Therapy Program in Patients With Plantar Fasciitis
- ClinicalTrials.gov ID
- NCT04758572
- Acronym / sponsor ID
- MTPlantarF / ID0033
- Conditions
- Plantar Fasciitis
- Keywords
- pain, function, treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 17 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual Therapy | Experimental | Other: Manual TherapyMobilization. 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. It lasted 20 minutes. Subsequently, Trigger Point Inhibition is applied. in the medial gastrocnemius, soleus, and square plantar muscles. Plantar fascia massage. A deep friction technique was applied longitudinally and transversely to the plantar fascia and the triceps surae. The duration was 5/10 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. |
| Massage | Active comparator | Other: Massage muscle chainConsist of gentle kneading and rubbing based on a muscle chain protocol (20 minutes), and the same trigger point Inhibition, plantar fascia massage, and passive stretching. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual TherapyMobilization, massage and stretching | Other | Manual Therapy |
| Massage muscle chainMassage very soft following the directions of the muscle chains, massage and stretching | Other | Massage |
Primary outcome
Foot pain
Time frame: 8 week
Pressure pain threshold is measured by digital algometer to determine overall pressure pain sensitivity at which a sensation of pressure changed to pain. The patient is placed in a prone position with the feet off the table, gradual pressure is applied to the insertion area of the plantar fascia on the calcaneus with the algometer until the sensation of pressure becomes painful. The pressure (cm2/kg) is applied perpendicular to the skin at a speed of 30 kPa/s. Three measurements are applied, with 1 minute between them, and the average is recorded.
5 secondary outcomes
Ankle flexion
Time frame: 8 week
Dynamic balance
Time frame: 8 week
Quality of life in relation to foot pain
Time frame: 8 week
Foot health
Time frame: 8 week
Impact and disability from foot pain
Time frame: 8 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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F-18 Sodium Fluoride PET/CT-Guided Pain Palliation in Chronic Plantar Fasciitis: A Comparative Study of ¹⁷⁷Lutetium-Corticosteroid-Local Anaesthetic Injection vs Corticosteroid-Local Anaesthetic Injection
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gemma V Espí-López principal investigator
University of Valencia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Therapy and Massage muscle chain in people with Plantar Fasciitis, run by University of Valencia at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Foot pain (time frame: 8 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.