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Plantar FascitisNCT05479526

Effect of The Superficial Back Line on the Development of Plantar Fasciitis

An observational study of Plantar Fascitis, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).

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 The sponsor has not verified this record for over two years, so it may be out of date.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

The primary aim of the study is to determine whether deviations from normal in the myofascial structure have an effect on the development of plantar fasciitis by evaluating the myofascial chain lines as well as the general evaluation parameters in patients diagnosed with plantar fasciitis. Read more about this study

Who is it for?
Ages 30 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Plantar Fascitis
How many people
84 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Sep 2022to 1 Sep 2023
Phase
Observational
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 30 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: In the study, which is planned as a case-control study, the case group will consist of patients diagnosed with Plantar fasciitis, and the control group will consist of healthy people in the similar age group. The control group will consist of relatives of patients who meet the inclusion criteria and agree to participate in the study.

Who may be able to join

  • Volunteers between the ages of 30-60
  • Having experienced pain due to plantar fasciitis for at least 6 months
  • Not having received medical treatment and/or physiotherapy for plantar fasciitis in the last 3 months.
  • The participants' definition of pain over 3 according to the Visual Analogue Scale in the first step of the morning and this pain decreases with movements

Who cannot join

  • Having history of lower extremity surgery and fracture in the last 6 months
  • Having additional orthopedic, neurological and rheumatological diseases that may cause biomechanical malalignment, loss of muscle strength, and deterioration of gait parameters in the lower extremities, vertebral column and pelvis
  • Having static foot deformity
  • Having connective tissue disease that will affect tissue properties
  • Having metabolic syndromes that may affect tissue properties such as diabetes
  • Using sedatives and/or muscle relaxants that may alter muscle tone.
  • Being diagnosed with obesity (BMI>30)
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

Ayça Evkaya Acar, MSc contact

(0216) 280 33 33

ayca.evkaya@gmail.com

Turkey (Türkiye)1 site
  • Istanbul Medeniyet University

    Istanbul, 34862

Other trials in Turkey (Türkiye)

About this study

Official title: Investigation of the Effect of Tissue Properties of The Superficial Back Line on the Development of Plantar Fasciitis-Case Control Study

The primary aim of the study is to determine whether deviations from normal in the myofascial structure have an effect on the development of plantar fasciitis by evaluating the myofascial chain lines as well as the general evaluation parameters in patients diagnosed with plantar fasciitis. The secondary aim of the study is to create a future clinical projection regarding the applications to be made over the myofascial chain in addition to the generally accepted treatment protocols in the light of the findings.

Read the detailed description

The plantar fascia is an important connective structure that extends from the metatarsal heads to the calcaneus and provides the continuity of the longitudinal arch of the foot. With microtraumas and the formation of chronic inflammation on the plantar surface exposed to repetitive stress, the fascia thickens and becomes prone to repetitive injuries and forms plantar fasciitis. The reasons for this repetitive stress are; excessive physical activity, obesity, age, prolonged standing, biomechanical changes, limited dorsiflexion and hamstring tension.

Studies on this subject in the literature have reported that tension in the hind leg muscles is associated with plantar fasciitis, and it has been shown that applications on the Achilles tendon and gastrocnemius relieve plantar fasciitis complaints. Similarly, it has been reported that tension in the hamstring muscle may be associated with the development of plantar fasciitis.

It is known that the Plantar Fascia and Achilles tendon affect each other due to the fascial connection, and therefore these structures are considered together in the solution of their problems. On the other hand, according to the fascial meridian concept developed by Thomas Myers, it was stated that the fascial connection between these two tissues extends to the frontal region in a chain manner, and that a problem at any point in the chain may cause problems in other elements of the chain. For this reason, recently, applications related to the detection and solution of problems have come to the fore by looking at fascial problems more holistically over the fascial chain.

Plantar Fascia; It is located in the Superficial Back Line and as far as we know, there is no plantar fasciitis study in which the myofascial chain is considered as a whole. Based on this, our aim in this study is to examine patients diagnosed with plantar fasciitis in terms of myofascial chain lines as well as general evaluation methods, to determine whether deviations from normal in the myofascial structure have an effect on the development of plantar fasciitis. Our main goal is to create projections for future clinical studies regarding the applications to be made over the myofascial chain in the treatment of plantar fasciitis in the light of the findings we have obtained.

Keywords
Plantar Fascitis, Fascia, Superficial Back Line

What participants receive

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

Study groups in NCT05479526
Study groupRoleWhat they receive
Group 1Control group will consist of 42 healthy individuals, aged between 30-60 years.
Group 2This group will consist of 42 patients with diagnosed Plantar Fasciitis, aged between 30-60 years.

What is being measured

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

  1. Ultrasonography

    It will be used to measure the thickness of the plantar fascia. As a result of these studies, a plantar fascia greater than 4 mm appears to be abnormal and associated with plantar fasciitis. Ultrasonography (USG) evaluation is a routine method for the diagnosis of Plantar Fasciitis.

    Measured: Baseline

  2. Plantar Fasciitis Pain

    Visual Analogue Scale will be used in the assessment of pain severity. It expresses pain severity between a score of 0 (no pain) and 10 (unbearably severe pain)

    Measured: Baseline

  3. Pes planus

    Pes Planus will be evaluated with navicular drop test. The distance between the navicular bone and the ground is measured while the individual sits on the chair with the hip-knee joint in 90º flexion and the subtalar joint in neutral position. Then, the distance between the navicular bone and the ground is measured again while the individual is standing in a position with equal weight on both extremities. The difference between the two measurements is recorded. 10 mm or more difference is considered pes planus.

    Measured: Baseline

  4. Foot Posture

    Foot posture will be evaluated using the Foot posture index, a six item foot posture assessment tool, where each item is scored between -2 and +2 to give a sum total between -12 (highly supinated) and +12 (highly pronated). Items include: talar head palpation, curves above and below the lateral malleoli, calcaneal angle, talonavicular bulge, medial longitudinal arch, and forefoot to rearfoot alignment.

    Measured: Baseline

  5. Ankle Joint Angle

    Active and passive dorsi and plantar flexion angles will be measured with a goniometer.

    Measured: Baseline

  6. Algometer

    It is used to measure the pressure pain threshold. After localization of the painful area by palpation, force is applied with an algometer until patients feel pain and discomfort. The digit displayed on the algometer is recorded. The average of 3 measurements is taken.

    Measured: Baseline

  7. Passive Tone

    Passive Tone will be evaluated with MyotonPro digital palpation device which is a valid and reliable. In the measurements, the Myoton probe will be placed perpendicular to the fibers of the tissue to be measured and when the probe reaches a sufficient depth, 3 repetitive mechanical stimulus (15ms, 0.40N) will be given to the tissue that has pre-compressed (0.18N). Measurements were taken 3 times from each point and the average values will be used in statistical analysis.

    Measured: Baseline

  8. Stiffness

    Stiffness will be evaluated with MyotonPro digital palpation device which is a valid and reliable. In the measurements, the Myoton probe will be placed perpendicular to the fibers of the tissue to be measured and when the probe reaches a sufficient depth, 3 repetitive mechanical stimulus (15ms, 0.40N) will be given to the tissue that has pre-compressed (0.18N). Measurements were taken 3 times from each point and the average values will be used in statistical analysis.

    Measured: Baseline

  9. Decrement

    Decrement will be evaluated with MyotonPro digital palpation device which is a valid and reliable. In the measurements, the Myoton probe will be placed perpendicular to the fibers of the tissue to be measured and when the probe reaches a sufficient depth, 3 repetitive mechanical stimulus (15ms, 0.40N) will be given to the tissue that has pre-compressed (0.18N). Measurements were taken 3 times from each point and the average values will be used in statistical analysis.

    Measured: Baseline

  10. Creep

    Creep will be evaluated with MyotonPro digital palpation device which is a valid and reliable. In the measurements, the Myoton probe will be placed perpendicular to the fibers of the tissue to be measured and when the probe reaches a sufficient depth, 3 repetitive mechanical stimulus (15ms, 0.40N) will be given to the tissue that has pre-compressed (0.18N). Measurements were taken 3 times from each point and the average values will be used in statistical analysis.

    Measured: Baseline

  11. Relaxation time

    Relaxation time will be evaluated with MyotonPro digital palpation device which is a valid and reliable. In the measurements, the Myoton probe will be placed perpendicular to the fibers of the tissue to be measured and when the probe reaches a sufficient depth, 3 repetitive mechanical stimulus (15ms, 0.40N) will be given to the tissue that has pre-compressed (0.18N). Measurements were taken 3 times from each point and the average values will be used in statistical analysis.

    Measured: Baseline

  12. Hamstring Muscle shortness

    Hamstring length will be measured with the straight leg lift test. The patient is asked to keep the opposite leg fixed on the bed with the knee straight in the supine position, wearing suitable clothes, and to raise the leg to be tested upwards with the ankle in dorsiflexion and the knee straight. The patient is instructed to wait where the initial tension occurs, and the last degree of movement is measured.

    Measured: Baseline

  13. Pelvic tilt

    The position of the pelvis will be evaluated with a digital pelvic inclinometer device to determine whether the pelvis has tilted anteriorly or posteriorly. The digital pelvic inclinometer is a valid and reliable method for the evaluation of pelvic tilt. The device consists of two calipers and the calipers are placed on the spina iliaca anterior superior (SIAS) and spina iliaca posterior superior (SIPS) of the pelvis. The score on the digital display is recorded. "-" values indicate posterior pelvic tilt, "+" values indicate anterior pelvic tilt.

    Measured: Baseline

  14. Cervical and Lumbar Lordosis

    It will be determined by photographing. Side photos will be taken while the patient is standing in a free standing position in front of a bare, flat wall with the upper body. Later, the obtained photo shoots will be analyzed with the Tracker 4.11.0 (Physlets, 2017) program and cervical and lumbar lordosis angles will be determined.

    Measured: Baseline

  15. Skin temperature of the Plantar Fascitis area

    In order to see the effectiveness of the applications, the skin temperature will be determined by thermal imaging method. This method is frequently preferred because it is a reliable and non-invasive method. The skin temperature of the plantar fascia will be measured with the P45 thermographic camera (Flir System, ThermaCAM, Sweden) with high thermal sensitivity, while the patient is in the prone position, while the feet are hanging from the bed at the level of the malleolus. The measurement will be made by placing the camera on a tripod placed 1m away from the patient. In the analysis, the area covering 1 cm distance from the point where fasciitis develops will be used. Skin temperature will be determined using the FLIR Quick-Report 1.2 software, one of the temperature indicators obtained from this region. In the calculation of skin temperature, the human skin emissivity value will be accepted as 0.98.

    Measured: Baseline

  16. Headache

    Presence of headache will be questioned and severity assessment will be made with Visual Analogue Scale. It expresses pain severity between a score of 0 (no pain) and 10 (unbearably severe pain).

    Measured: Baseline

  17. Windlass Test

    While the patient is sitting in a chair, the big toe of the foot to be tested is brought into the dorsal flexion of the metatarsal phalangeal joint for a hard time. Pain at the junction of the plantar fascia with the calcaneus during this movement indicates a positive test.

    Measured: Baseline

Timeline

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

  1. First posted29 Jul 2022
  2. Study start1 Sep 2022 (estimated)
  3. Primary completion1 May 2023 (estimated)
  4. Study completion1 Sep 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
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05479526
Sponsor's protocol ID
2022/0345
Status last verified
Jul 2022
First submitted
27 Jul 2022
Last updated
1 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Arshad Z, Aslam A, Razzaq MA, Bhatia M. Gastrocnemius Release in the Management of Chronic Plantar Fasciitis: A Systematic Review. Foot Ankle Int. 2022 Apr;43(4):568-575. doi: 10.1177/10711007211052290. Epub 2021 Nov 12.

    PubMed 34766860
  • Hoefnagels EM, Weerheijm L, Witteveen AG, Louwerens JK, Keijsers N. The effect of lengthening the gastrocnemius muscle in chronic therapy resistant plantar fasciitis. Foot Ankle Surg. 2021 Jul;27(5):543-549. doi: 10.1016/j.fas.2020.07.003. Epub 2020 Jul 12.

    PubMed 32773360
  • Lee JH, Jung HW, Jang WY. A prospective study of the muscle strength and reaction time of the quadriceps, hamstring, and gastrocnemius muscles in patients with plantar fasciitis. BMC Musculoskelet Disord. 2020 Nov 5;21(1):722. doi: 10.1186/s12891-020-03740-1.

    PubMed 33153452

Questions about this trial

What is this clinical trial studying?

An observational study of Plantar Fascitis, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).

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 4 inclusion and 8 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 1 Aug 2022. 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 Turkey (Türkiye). 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 Ayça Evkaya Acar, MSc ((0216) 280 33 33, ayca.evkaya@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ultrasonography (time frame: Baseline). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05479526, which also lists 3 linked publications.

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 1 Aug 2022.

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