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

NCT06754982 | Recruiting DMC

• 1 other identifier: N°116/2023
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Plantar Fasciitis of Both Feet

Keywords

Plantar fasciitis; Myofascial release; manual therapy

Outcome Measures

Primary Outcomes (1)

• Morning pain intensity measured with the Numeric Pain Rating Scale (NPRS)

  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 Outcomes (6)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Group 15 minutes

EXPERIMENTAL

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

Gruops 30 minutes

EXPERIMENTAL

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

Interventions

Myofascial release OTHER

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.

Group 15 minutes; Gruops 30 minutes

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Católica del Maule: lead

Study Sites (1)

Clinical Research Laboratory, Department of Physical Therapy, Faculty of Health Sciences

Talca, Maule Region, 3460000, Chile

RECRUITING

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MeSH Terms

Conditions

Fasciitis, Plantar

Interventions

Myofascial Release Therapy

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Central Study Contacts

Ignacio Andrés Gajardo Valenzuela, Magíster

CONTACT

+56993263470; igajardovalen@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: January 1, 2025
• Study Start: January 31, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available indefinitely from the moment the results are published.
• Access Criteria: Data will be available upon request to the principal investigator or the corresponding author of related publications

Locations

CL (1)