Clinical trial NCT06754982: Temporal Differences in Pain, Muscle Stiffness, and Function in Subjects With Plantar Fasciitis After Myofascial Release Therapy
Official title: Temporal Differences in Pain, Muscle Stiffness, and Function in Subjects With Plantar Fasciitis After Myofascial Release Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Plantar Fasciitis of Both Feet
Keywords: Plantar fasciitis
Myofascial release
manual therapy
Lead sponsor: Universidad Católica del Maule
Sponsor class: OTHER
First posted: 2025-01-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, two-group parallel equivalence clinical trial will be conducted. Participants will be randomly assigned to one of two groups, 15 minutes of myofascial release, 30 minutes of myofascial release. In order to establish equivalence between groups, the equivalence limit or tolerance range will be adopted so that the groups do not present more than half of the value of the main variable that can be used in a superiority test (12). Therefore, for this research the adopted value will be 0.65 kg/cm2 in the pressure pain threshold, because an average change of 1.3 kg/cm2 has been observed.(10) Randomization and evaluations will be carried out by external assistants.
Primary purpose: TREATMENT

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?

Eligibility criteria: 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.

Primary outcomes:
measure: Morning pain intensity measured with the Numeric Pain Rating Scale (NPRS)
timeFrame: 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 outcomes:
measure: Pressure pain threshold (PPT)
timeFrame: 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
measure: Calf muscle stiffness (Silfverskiöl test)
timeFrame: 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
measure: Functionality (Foot Function Index (FFI))
timeFrame: 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
measure: Health-related quality of life (SF-12)
timeFrame: It will be measured at Baseline, at 4 weeks and at 4 weeks after the end of the treatment
measure: Perception of change (Patient Global Impression of Change)
timeFrame: It will be measured at at 4 weeks and at 4 weeks after the end of the treatment
measure: Foot health (Foot Health Status Questionnaire (FHSQ)
timeFrame: It will be measured at Baseline, at 4 weeks and at 4 weeks after the end of the treatment
Other outcomes:
Locations:
city: Talca
country: Chile
facility: Clinical Research Laboratory, Department of Physical Therapy, Faculty of Health Sciences
state: Septima Región
Study officials:
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