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Plantar FascitisNCT05075434

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

A study testing Conventional Treatment and Diacutaneous fibrolysis in people with Plantar Fascitis and Heel Pain Syndrome, run by Universitat Internacional de Catalunya at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Plantar Fascitis, Heel Pain Syndrome
What is being tested?
Conventional Treatment and Diacutaneous fibrolysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteSpain
Study dates
1 Jan 2022to 1 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Jacobo Rodríguez-Sanz, PhD contact

+34636136789

jrodriguezs@uic.es

Spain1 site
  • Universitat Internacional de Catalunya

    Sant Cugat del Vallès, Barcelona, 08195

Other trials in Spain

About this study

Official title: Effects of the Diacutaneous Fibrolysis Approach on Gastrocnemius Length, Plantar Fascia Viscoelasticity and Plantar Arch Diameters in Patients With Plantar Fasciitis.

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.

Read more

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).

Read the detailed description

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.

To overcome these difficulties, Ekman designed hooks that allowed, according to Ekman himself, to treat areas located in depth. The hooks used in the current FD are metallic, curved at both ends, which allow working more specifically in depth and transversally to the tissue without slipping on the skin, focusing the mechanical effect and reducing the stress on the physiotherapist.

Its mechanical effect is described as the elimination of areas of fibrosis, trying to recover physiological sliding between tissue planes, and although there is little scientific evidence on the mechanical effects of FD, several authors have described clinical modifications in passive muscle resistance to stretching or gains in joint movement. These modifications suggest a tendon mechanical adaptation as suggested by Lévenez, Guissard and Duchateau. A cutaneous circulatory effect is also described and is the most visible effect achieved with instrumental soft tissue mobilisation techniques. In addition, Burnotte and Duby, observed that venous return was improved with FD in several pathologies, although the mechanism is unknown. Histamine released after FD application is thought to be responsible for these effects. Neurophysiological effects were observed by Veszely et al. in the application of FD to the triceps suralis, in which neuromodulatory effects were observed 30 minutes after application, with a decrease in tendon reflexes. A neuromuscular effect has now also been described in response to tensomiography and myotonometry with a decrease in tone and stiffness of the triceps suralis muscle in asymptomatic subjects, which was maintained 30 minutes post-intervention.

The relationship of the gastrocnemius with the plantar fascia and this with the maintenance of the plantar arch is well known. The gastrocnemius, with the continuation of the Achilles tendon, modulates the tension of the plantar aponeurosis. As the tension of the triceps suralis increases, so does the tension of the plantar fascia. This is very important for weight-bearing transition during gait. The direction of the tendons of the extrinsic muscles of the foot shows their ability to provide dynamic support and control of the longitudinal and transverse components of the plantar arch. The global movements will provide both absorption and propulsive capacity during dynamic activities.

Plantar fasciitis is one of the most common foot disorders, being the leading cause of heel pain in primary care and accounting for 80% of all heel pain. Plantar fasciitis is a common injury caused by repetitive traction of the origin of the plantar fascia on the distal calcaneus.

In clinical practice, the gastrocnemius approach is commonly used to treat plantar fascia and Achilles problems. FD is one of the techniques used for these treatments; however, no studies have been found on its clinical effects or the effects of this technique on the plantar arch.

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).

Being tested
Conventional Treatment, Diacutaneous fibrolysis
Keywords
plantar fasciitis, diacutaneous fibrolysis, primary care, plantar arch
Medical subject headings
Fasciitis, Plantar

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Conventional TreatmentOther

    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).

  • Diacutaneous fibrolysisOther

    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.

Study groups in NCT05075434
Study groupRoleWhat they receive
Intervention GroupExperimentalThis 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).
Receives: Other: Conventional Treatment; Other: Diacutaneous fibrolysis
Control GroupActive comparatorThis 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).
Receives: Other: Conventional Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

Secondary outcomes (4)
  1. Active Gastrocnemius Flexibility (º)

    The range of motion of active ankle dorsiflexion shall be assessed with the Lunge test. The test shall be performed by placing the foot perpendicular to a wall and throwing the knee towards the wall. The foot is moved away from the wall until the maximum range of dorsiflexion is reached. To ensure that the heel does not lift off the ground, the examiner shall place a band under the heel and apply tension.

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

  2. Pasive Gastrocnemius Flexibility (º)

    To assess passive gastrocnemius flexibility, volunteers will be placed in the supine shirt with the foot relaxed. An inclinometer shall be placed on the plantar surface of the foot in the initial relaxed position of ankle dorsiflexion, placing the inclinometer in the 0-value position. A progressive force shall be applied by passively dorsiflexing the ankle. The angle of dorsiflexion of the ankle at 25 N force shall be recorded and the value obtained noted.

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

  3. Numeric Pain Rating Scale (1-10 scale)

    The numerical pain scale is a unique 11-point numerical scale that has been extensively validated. Pain scores are interpreted as: "0 = no pain"; "1-3 = mild pain"; "4-6 = moderate pain"; "7-10 = severe pain".

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

  4. Global Rating of Change scale (15 items)

    This scale allows us to know the personal evolution experienced by the patient and is considered an efficient way of knowing the score given by the patient to the perceived clinical change. It is a Likert-type scale with 15 items, of which 7 are for improvement, 7 for worsening and 1 for "no change". The patient will be asked to report how he/she felt at the beginning of the treatment; better, worse or no change. If the patient answers better or worse, they will be asked, with the scale in front of them, to indicate whether they are: a little bit almost the same, a little, a little, some, a lot, a lot or very much better or worse.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2021
  2. Study start1 Jan 2022 (estimated)
  3. Primary completion1 May 2023 (estimated)
  4. Study completion1 Jun 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05075434
Sponsor's protocol ID
CER-2021-A1
Status last verified
Sep 2021
First submitted
28 Sep 2021
Last updated
12 Oct 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Conventional Treatment and Diacutaneous fibrolysis in people with Plantar Fascitis and Heel Pain Syndrome, run by Universitat Internacional de Catalunya at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jacobo Rodríguez-Sanz, PhD (+34636136789, jrodriguezs@uic.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Foot Posture Index (score) (time frame: Change between baseline(immediately before intervention) and post intervention (1 month)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2021.

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Clinical Trial NCT05075434 | AzTrials