Temporal Differences in Pain, Muscle Stiffness, and Function in Subjects With Plantar Fasciitis After Myofascial Release Therapy (TDPSFPFMR)

March 24, 2025 updated by: Ignacio Gajardo Valenzuela, Universidad Católica del Maule
Plantar fasciitis (PF) is a common condition in the population. One of the interventions used to resolve this condition is myofascial release (MR), which consists of massages that help reduce pain and increase mobility. MR has shown efficacy when applied for 30 minutes, however, it is necessary to compare it with a 15-minute MR intervention, since in clinical practice optimizing time is essential. Accordingly, the present research seeks to evaluate whether there are differences in the application time of myofascial release in people with PF.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Plantar fasciitis (PF) is an acute inflammation of the fascia resulting from degenerative irritation from the median tuberosity of the heel bone to surrounding perifascial structures. Histological findings include granulation tissue, microtears, collagen disorders, and in particular a lack of normal inflammation. It is one of the most common causes of musculoskeletal pain, with a population prevalence in adults aged 50 years or older of 9.6% (95% CI: 8.8 to 10.5) and a population prevalence of disabling pain of 7.9% (95% CI: 7.1 to 8.7), slightly more present in women than in men, with a history of knee, hip, and back pain. It is characterized by pain on the first step and pain during weight-bearing tasks, particularly after periods of rest. Among the possible low-cost and noninvasive treatments that have shown efficacy Manual therapy (MT) is a popular treatment for PF. TM includes treatments such as joint and soft tissue mobilizations, manipulations, myofascial trigger point release, and stretch-contraction-relaxation. In particular, myofascial release is a gradual soft tissue stretching by the clinician that is guided entirely by feedback from the recipient's body to determine the direction, strength, and duration of the stretch to address specific soft tissue restrictions.

TM has been frequently used to treat PF, systematic reviews have reported positive results on pain, function, and pressure pain threshold, but suggest that they should be viewed with caution due to poor methodological quality, intervention heterogeneity in dosing (frequency, intensity, and duration), techniques, and outcome measures, and the frequent use of secondary manual therapy co-interventions. The application of myofascial release is varied in the number of procedures, application time of each technique and total application time of the intervention, without a clear justification regarding the decision of each of these options. A clinical trial applied a protocol for 4 weeks, where each session was performed in 30 minutes, and demonstrated that myofascial release is more effective than the control group, presenting a change in the average pressure pain threshold of 1.3 kg/cm2 at the end of the 4-week treatment. This change is considered clinically important, given that in the literature it has been reported that this difference is > 1.16 kg/cm2. However, the reason for the time used, the number of techniques and the choice of techniques is not justified. In addition, there are no investigations in the literature on the specific effect of myofascial release with a shorter application time in PF. On the other hand, studies with deep massage, a manual therapy technique, combined with flexibility exercise has proven to be effective with an execution time of 10 minutes. Under this context and considering that in clinical practice the optimization of times is essential, it is relevant to carry out a clinical equivalence trial that allows to determine the efficacy of isolated myofascial release in PF, with a 30-minute intervention protocol already carried out and that demonstrated positive effects on the pressure pain threshold, contrasted with a time of less than 15 minutes. Given the context raised, the question arises: In participants with plantar fasciitis, would the application of a myofascial release treatment for 15 minutes have equivalent effects to myofascial release applied for 30 minutes, in the pain and stiffness of the gastrocnemius muscle?

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Chile
    • Septima Región
      • Talca, Septima Región, Chile, 3460000
        • Recruiting
        • Clinical Research Laboratory, Department of Physical Therapy, Faculty of Health Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Study participants must be diagnosed with PF
  • Age between 18 to 60 years a clinical diagnosis of unilateral PF according to the clinical practice guidelines of the orthopedic section of the American Physical Therapy Association (APTA).
  • Pain intensity > 2 on the numerical pain rating scale (NPRS).
  • Pain that is most intense upon awakening and decreases during walking. • Duration of pain greater than 3 months and less than 7 months.
  • Both sexes.

Exclusion Criteria:

  • Who have received ankle or foot interventions within the previous three months, such as physical therapy (manual therapy, exercise, physical agents), injections, long-term history of steroid use.
  • History of surgery on the ankle, foot, or inner leg.
  • Other causes of heel pain: arthritic (fibromyalgia, gout, rheumatoid arthritis, seronegative spondyloarthropathies), infectious (diabetic ulcers, osteomyelitis, plantar warts), neurological (lumbar radiculopathy (L4-S2), nerve entrapment (branches of posterior tibial nerve), neuroma, tarsal tunnel syndrome, (posterior tibial nerve), trauma (calcaneal stress fracture), tumor (Ewing's sarcoma, neuroma), vascular and pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 15 minutes
The group will receive 15 minutes of myofascial release. Each intervention will be performed only on the affected limb. 9 myofascial release techniques will be applied to each group, each procedure will last 1 minute and 40 seconds.
Other: Myofascial release
Nine myofascial release techniques will be applied to each group: Transverse hamstring play; Transverse hamstring and adductor magnus play: posterior to anterior pressure; Transverse gastrocnemius-soleus play; Tibia bone clearing: posterior tibia; Tibia bone clearing: prone grip with half chisel; Lateral fascial distraction of the tibia; Lateral elongation of the peroneal tissue; Cross-friction of the gastrocnemius-soleus musculotendinous junction; Manipulation of the plantar fascia.
Experimental: Gruops 30 minutes
The group will receive 30 minutes of myofascial release. Each intervention will be performed only on the affected limb. Nine myofascial release techniques will be applied to each group, each procedure will last 3 minutes and 20 seconds.
Other: Myofascial release
Nine myofascial release techniques will be applied to each group: Transverse hamstring play; Transverse hamstring and adductor magnus play: posterior to anterior pressure; Transverse gastrocnemius-soleus play; Tibia bone clearing: posterior tibia; Tibia bone clearing: prone grip with half chisel; Lateral fascial distraction of the tibia; Lateral elongation of the peroneal tissue; Cross-friction of the gastrocnemius-soleus musculotendinous junction; Manipulation of the plantar fascia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morning pain intensity measured with the Numeric Pain Rating Scale (NPRS)
Time Frame: It will be measured at Baseline, up to 15 min after the first session, at 4 weeks and at 4 weeks after the end of the treatment
The Numeric Pain Rating Scale (NPRS) measures pain intensity from 0 to 11 points (0, no pain; 10, worst pain imaginable).(18) Numeric pain scales have been shown to be reliable and valid.(25) In addition, the DCMI (minimally clinically important difference) has been reported to be 2 points.(26)
It will be measured at Baseline, up to 15 min after the first session, at 4 weeks and at 4 weeks after the end of the treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pressure pain threshold (PPT)
Time Frame: It will be measured at Baseline, up to 15 min after the first session, at 4 weeks and at 4 weeks after the end of the treatment
The pressure pain threshold (PPT), defined as the minimum pressure to induce a change from a pressure sensation to a pain sensation.(27) The score is obtained from the average of 3 repeated measurements, with a 30 second rest between each one, a method that has demonstrated validity and high reliability with ICC=0.91 (95% CI: 0.82, 0.97).(19, 28) The PPT will be evaluated with an Algometer (Wagner Instruments FPX 50). The pressure (force divided by the surface area) will be applied at a speed of approximately 1kg/cm2/s. It will be measured on the most sensitive point of the lower surface of the calcaneus, posterior surface of the calcaneus, soleus muscle and internal and lateral gastrocnemius muscle.(13, 29) To measure each of these points, the subject must be placed face down on the stretcher, with the extremity to be evaluated uncovered.
It will be measured at Baseline, up to 15 min after the first session, at 4 weeks and at 4 weeks after the end of the treatment
Calf muscle stiffness (Silfverskiöl test)
Time Frame: It will be measured at Baseline, up to 15 min after the first session, at 4 weeks and at 4 weeks after the end of the treatment
Gastrocnemius stiffness or tightness will be assessed with the Silfverskiöld test.(20)The measurement explores the degree of passive dorsiflexion of the ankle in the supine position (with a goniometer), in two positions: with the knee extended and flexed (90°), where the hindfoot is in a neutral or varus position. A moderate force load is applied under the forefoot (it is recommended to apply the goniometric measurement with a force between 1.7 and 2kg),(30) the expected difference for the test to be positive is a minimum of 13 degrees of difference.(20) The reliability at the intra-evaluator level with ICC (95% CI) that fluctuates between 0.845 to 0.924.(31) A digital goniometer will be used (brand: baseline evaluation instruments; model: 12-1027; company: enterprises; Country: USA).
It will be measured at Baseline, up to 15 min after the first session, at 4 weeks and at 4 weeks after the end of the treatment
Functionality (Foot Function Index (FFI))
Time Frame: It will be measured at Baseline, up to 15 min after the first session, at 4 weeks and at 4 weeks after the end of the treatment
Functionality will be assessed through the Foot Function Index (FFI), recommended for subjects who suffer from heel pain,(5) and validated in Spanish.(21) It is a self-administered index consisting of 23 items that measure pain, disability and activity restriction, which has been shown to be reliable, valid and sensitive to foot alterations.(34-36)
It will be measured at Baseline, up to 15 min after the first session, at 4 weeks and at 4 weeks after the end of the treatment
Health-related quality of life (SF-12)
Time Frame: It will be measured at Baseline, at 4 weeks and at 4 weeks after the end of the treatment
Health-related quality of life will be assessed with the SF-12 health questionnaire, which is a shortened version of the SF-36. This scale has 12 items with Likert-style response opinions (3 to 6 points) and a dichotomous scale, it has two summary components, physical (PCS) and mental (MCS), and it summarizes 8 dimensions: physical function, physical role, bodily pain, general health, vitality, social function, emotional role and mental health. The maximum score of the survey indicates good quality of life and is valid in Spanish (correlation with back pain PCS-12 (r= -0.405, P<0.001) and MCS-12 (r=-0.326, P=0.0001)) and reliable (Cronbach's alpha coefficient PCS-12 was 0.77 and MCS-12 was 0.8), in patients with musculoskeletal pain.
It will be measured at Baseline, at 4 weeks and at 4 weeks after the end of the treatment
Perception of change (Patient Global Impression of Change)
Time Frame: It will be measured at at 4 weeks and at 4 weeks after the end of the treatment
Satisfaction after the intervention is measured through the perception of change after the intervention, applying the scale "Patient Global Impression of Change" (PGIC). The results will reflect the patient's belief about the effect of the applied treatment. (22) The scale consists of a 7-point verbal scale, with the options "I have improved a lot", "I have improved quite a bit", "I have improved a little", "I am the same", "I have worsened a little", "I have worsened quite a bit" and "I have worsened a lot". (37, 38) A clinically significant improvement is considered to be achieved when the items "I have improved a lot", "I have improved quite a bit" are scored. The test-retest reliability of the global rating of the change scales is excellent (ICC=0.90). (39)
It will be measured at at 4 weeks and at 4 weeks after the end of the treatment
Foot health (Foot Health Status Questionnaire (FHSQ)
Time Frame: It will be measured at Baseline, at 4 weeks and at 4 weeks after the end of the treatment
Foot health will be measured with the "Foot Health Status Questionnaire (FHSQ)" questionnaire, this scale is validated in Spanish. (24) In addition, it has been shown to have content validity, construct validity, reliability and good responsiveness in patients with plantar fasciitis, who were users of orthopedic physiotherapy.(40)
It will be measured at Baseline, at 4 weeks and at 4 weeks after the end of the treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Católica del Maule

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

November 15, 2024

First Submitted That Met QC Criteria

December 23, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 27, 2025

Last Update Submitted That Met QC Criteria

March 24, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N°116/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The demographic characteristics and the data regarding the main variable and the secondary variables of the participants will be shared.

IPD Sharing Time Frame

Data will be available indefinitely from the moment the results are published.

IPD Sharing Access Criteria

Data will be available upon request to the principal investigator or the corresponding author of related publications

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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