NCT04758572

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 17, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

March 22, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2021

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

2 months

First QC Date

February 12, 2021

Last Update Submit

September 9, 2024

Conditions

Keywords

painfunctiontreatment

Outcome Measures

Primary Outcomes (1)

  • 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.

    8 week

Secondary Outcomes (5)

  • Ankle flexion

    8 week

  • Dynamic balance

    8 week

  • Quality of life in relation to foot pain

    8 week

  • Foot health

    8 week

  • Impact and disability from foot pain

    8 week

Study Arms (2)

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.

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.

Other: Massage muscle chain

Interventions

Mobilization, massage and stretching

Manual Therapy

Massage very soft following the directions of the muscle chains, massage and stretching

Massage

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Gemma V Espí López

Valencia, 46010, Spain

Location

Gemma Victoria Espí-López

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Fasciitis, PlantarPain

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal DiseasesFoot DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Gemma V Espí-López

    University of Valencia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 12, 2021

First Posted

February 17, 2021

Study Start

March 22, 2021

Primary Completion

May 30, 2021

Study Completion

September 15, 2021

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations