Clinical trial NCT05479526: Effect of The Superficial Back Line on the Development of Plantar Fasciitis
Official title: Investigation of the Effect of Tissue Properties of The Superficial Back Line on the Development of Plantar Fasciitis-Case Control Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Plantar Fascitis
Keywords: Plantar Fascitis
Fascia
Superficial Back Line
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2022-07-29
Enrollment: 84
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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. 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Ultrasonography
timeFrame: Baseline
measure: Plantar Fasciitis Pain
timeFrame: Baseline
measure: Pes planus
timeFrame: Baseline
measure: Foot Posture
timeFrame: Baseline
measure: Ankle Joint Angle
timeFrame: Baseline
measure: Algometer
timeFrame: Baseline
measure: Passive Tone
timeFrame: Baseline
measure: Stiffness
timeFrame: Baseline
measure: Decrement
timeFrame: Baseline
measure: Creep
timeFrame: Baseline
measure: Relaxation time
timeFrame: Baseline
measure: Hamstring Muscle shortness
timeFrame: Baseline
measure: Pelvic tilt
timeFrame: Baseline
measure: Cervical and Lumbar Lordosis
timeFrame: Baseline
measure: Skin temperature of the Plantar Fascitis area
timeFrame: Baseline
measure: Headache
timeFrame: Baseline
measure: Windlass Test
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medeniyet University
Study officials:
affiliation: Istanbul Medeniyet University
name: Nilüfer Kablan, Asst. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.