Effects of the Diacutaneous Fibrolysis Approach in Patients With Plantar Fasciitis.

NCT05075434 | Unknown DMC

• 1 other identifier: CER-2021-A1
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Diacutaneous Fibrolysis (FD) is a physiotherapy technique based on Cyricax's transverse massage. Kurt Ekman, its creator, observed that Cyriax's deep transverse massage was intended to achieve a mechanical effect on the tissues, but this had a series of disadvantages such as the difficulty in penetrating between tissue septa due to the large surface area of the finger tips, as well as its soft consistency in the face of adhesions or fibrosis. Hypothesis: Adding FD to the gastrocnemius and plantar fascia to a primary care treatment protocol will produce a decrease in the stiffness (viscoelastic property) of the plantar fascia, an increase in length, width, height and a decrease in the plantar arch, as well as an increase in the length of the gastrocnemius greater than not adding it in subjects with plantar fasciitis. Data collection. Once the participant has passed the selection criteria and signed the informed consent form, the measurements of the anthropometric variables and classification of the foot with the Foot Posture Index will be carried out. Subsequently, the dependent variables will be collected, starting with active and passive gastrocnemius flexibility, followed by measurements with the anthropometric foot measurement platform (foot length, arch height in loading and unloading, arch height index, foot width in loading and unloading, windlass force at 20º, 40º and maximum, myotonometry measurements (tone, stiffness, elasticity, relaxation and creep) and pain. Once the initial variables have been recorded, the first patient intervention will be carried out according to the assigned group. A total of 8 sessions will be carried out over 4 weeks (2 sessions per week). The variables of this study will be collected at the beginning of the study and at the end of the 8 intervention sessions (1 month). Intervention "Protocol The usual protocol that the health service guidelines for this pathology will be carried out. The protocol consists of calf stretching exercises, plantar fascia, proprioception exercises, ultrasound, magnet therapy and gait re-education and proprioceptive exercises. The average intervention lasts between 30-45 minutes. "Protocol "+FD Participants in this group will additionally receive 15 minutes of the treatment technique. The FD intervention will be carried out with the same duration and protocol for all participants. The intervention protocol will be: Start with the point of maximum tension between the two muscle bellies of the calf and hamstring (Reverse hook). Then work on the peroneus longus lateralis and soleus. Then the external calf muscle belly and soleus and the internal calf muscle belly and soleus. Then work on the tendon of the flexor hallucis proprio of the big toe and the inner edge of the Achilles tendon and peroneus longus. Then treatment of the peroneus longus with the peroneus brevis. Scraping of the insertion of the Achilles tendon, hooking of the internal and external part of the plantar fascia. Finally, longitudinal friction of the plantar fascia. The participant will be in prone position with a support on the front of the leg with the foot off the stretcher. The physiotherapist will be in a standing position next to the participant. The procedure will be to palpate the different intermuscular septa and grooves and then perform the FD phases with the hook (supplementary transverse traction).

Conditions

Plantar Fascitis; Heel Pain Syndrome

Keywords

plantar fasciitis; diacutaneous fibrolysis; primary care; plantar arch

Outcome Measures

Primary Outcomes (5)

• Foot Posture Index (score)

  Is a clinical diagnostic tool that uses observation and palpation of clinical criteria to classify the posture of the loaded foot. It consists of 6 items, each of which is scored from -2 to +2, with 0 being the neutral value of the foot and the total score ranging from -12 to +12. The assessment is carried out with the patient standing upright in a relaxed position.

  Change between baseline(immediately before intervention) and post intervention (1 month)

• Anthropometric foot measurement platform (p-MAC) (milimeters)

  Is a platform for measuring three variables: total foot length, truncated length (length to the head of the first metatarsal) and the height of the dorsal arch.

  Change between baseline(immediately before intervention) and post intervention (1 month)

• Myotonometry (Hz)

  Myotonometry is a non-invasive tool that assesses the viscoelastic properties of muscle, fascia and connective tissue. Muscle tone (Hz): is defined as the intrinsic tension of the muscle at the cellular level in the resting state.

  Change between baseline(immediately before intervention) and post intervention (1 month)

• Myotonometry (N/m)

  Myotonometry is a non-invasive tool that assesses the viscoelastic properties of muscle, fascia and connective tissue. Stiffness (N/m): The biomechanical property of the muscle that characterises the resistance to an external force that deforms its initial shape.

  Change between baseline(immediately before intervention) and post intervention (1 month)

• Myotonometry (m/s)

  Myotonometry is a non-invasive tool that assesses the viscoelastic properties of muscle, fascia and connective tissue. Relaxation (m/s): The time it takes for a muscle to regain its shape after the removal of an external force.

  Change between baseline(immediately before intervention) and post intervention (1 month)

Secondary Outcomes (4)

• Active Gastrocnemius Flexibility (º)

  Change between baseline(immediately before intervention) and post intervention (1 month)

• Pasive Gastrocnemius Flexibility (º)

  Change between baseline(immediately before intervention) and post intervention (1 month)

• Numeric Pain Rating Scale (1-10 scale)

  Change between baseline(immediately before intervention) and post intervention (1 month)

• Global Rating of Change scale (15 items)

  Change between baseline(immediately before intervention) and post intervention (1 month)

Study Arms (2)

Intervention Group

EXPERIMENTAL

This group will receive the protocol prescribed by the health centre (calf stretching exercises, plantar fascia, proprioception exercises, ultrasound, magnet therapy and gait re-education and proprioceptive exercises for 40-45 minutes). In addition, you will receive 15 minutes of the instrumental technique of diacutaneous fibrolysis. Participants will receive 8 treatment sessions spread over 4 weeks (2 sessions per week).

Other: Conventional Treatment; Other: Diacutaneous fibrolysis

Control Group

ACTIVE COMPARATOR

This protocol will be the one prescribed by the health centre. It consists of calf stretching exercises, plantar fascia, proprioceptive exercises, ultrasound, magnetic therapy and gait re-education and proprioceptive exercises for 40-45 minutes. Participants will receive 8 treatment sessions spread over 4 weeks (2 sessions per week).

Other: Conventional Treatment

Interventions

Conventional Treatment OTHER

This protocol will be the one prescribed by the health centre. It consists of calf stretching exercises, plantar fascia, proprioceptive exercises, ultrasound, magnetic therapy and gait re-education and proprioceptive exercises for 40-45 minutes. Participants will receive 8 treatment sessions spread over 4 weeks (2 sessions per week).

Control Group; Intervention Group

Diacutaneous fibrolysis OTHER

15 minutes of the treatment technique. The FD intervention will be carried out with the same duration and protocol for all participants. The intervention protocol will be: Start with the point of maximum tension between the two muscle bellies of the calf and hamstring (reverse hook). Then work on the peroneus longus lateralis and soleus. Then the external calf muscle belly and soleus and the internal calf muscle belly and soleus. Then work on the tendon of the flexor hallucis proprio of the big toe and the inner edge of the Achilles tendon and peroneus longus. Then treatment of the peroneus longus with the peroneus brevis. Scraping of the insertion of the Achilles tendon, hooking of the internal and external part of the plantar fascia. Finally, longitudinal friction of the plantar fascia.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 18 years
• Medical diagnosis of plantar fasciitis.
• Sign the informed consent for participation in the study.

You may not qualify if:

• Present pathology in the lower limbs other than plantar fasciitis, which may alter the assessments.
• History of orthopaedic injuries in the last 6 months that may influence correct standing.
• Use of corrective insoles due to plantar arch problems.
• Skin lesions in the region of application that prevent the application of the technique.

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

Study Sites (1)

Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, 08195, Spain

Location

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Central Study Contacts

Jacobo Rodríguez-Sanz, PhD

CONTACT

+34636136789; jrodriguezs@uic.es

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

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: October 12, 2021
• Study Start: January 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: June 1, 2023
• Last Updated: October 12, 2021

Record last verified: 2021-09

Locations

ES (1)