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

Not Applicable

Recruiting

• Conditions: Plantar Fasciitis of Both Feet

• Registration Number: NCT06754982
• Lead Sponsor: Universidad Católica del Maule

Brief Summary

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.

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 Timeline

• Study First Submitted: 2024-11-15
• Study First Submitted QC: 2024-12-23
• Study Start: 2025-01-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-27
• Primary Completion: 2026-12-01
• Study Completion: 2027-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Morning pain intensity measured with the Numeric Pain Rating Scale (NPRS)	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)

Secondary Outcome Measures

Name	Time	Method
Pressure pain threshold (PPT)	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.
Calf muscle stiffness (Silfverskiöl test)	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).
Functionality (Foot Function Index (FFI))	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)
Health-related quality of life (SF-12)	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.
Perception of change (Patient Global Impression of Change)	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)
Foot health (Foot Health Status Questionnaire (FHSQ)	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)

Trial Locations

Locations (1)

Clinical Research Laboratory, Department of Physical Therapy, Faculty of Health Sciences; 🇨🇱 Talca, Septima Región, Chile