Clinical trial NCT05479500: Investigation of the Efficacy of Myofascial Chain Release Techniques on Plantar Fasciitis
Official title: Investigation of the Efficacy of Myofascial Chain Release Techniques on Plantar Fasciitis Pain, Lower Extremity Functional Capacity and Quality of Life - Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Plantar Fascitis
Keywords: Plantar Fascitis
Fascia
Myofascial Release Techniques
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2022-07-29
Enrollment: 36
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There will be three groups in this study. Each group will consist of 12 patients aged 30-60 years with plantar fasciitis. A total of 36 participants will take part in the study. Conventional physiotherapy will be applied to the group 1 and, local release technique addition to conventional physiotherapy will be applied to the group 2, while myofascial release techniques will be applied to the experimental group in addition to conventional physiotherapy.
Primary purpose: TREATMENT

Brief summary: The primary aim of the study is to investigate the effectiveness of Myofascial Chain Release Techniques on pain, functional limitation and quality of life in patients 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.

There will be three groups in this study. Each group will consist of 12 patients aged 30-60 years with plantar fasciitis. A total of 36 participants will take part in the study. Conventional physiotherapy will be applied to the group 1 and, local release technique addition to conventional physiotherapy will be applied to the group 2, while myofascial release techniques will be applied to the experimental group in addition to conventional physiotherapy. Treatment programs will be applied to both groups 2 days a week for 6 weeks. Postural problems that can be seen in the superficial back myofascial chain line will be evaluated.

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. Microtraumas and the formation of chronic inflammation on the plantar surface, which is exposed to repetitive stress, thickens the fascia, making it susceptible to repetitive injuries and forming 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 applications on the Achilles tendon and gastrocnemius have been shown to 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. From this point of view, there are many studies reporting the effectiveness of applications performed in any region of the myofascial chain in a different region on this chain.

Plantar Fascia; It is located in the Superficial Back Line, and as far as we know, there is no study of plantar fasciitis treatment in which the myofascial chain is considered as a whole. Based on this, our aim in this study is to investigate the effect of myofascial release techniques applied along the myofascial chain line on pain, lower extremity functionality and quality of life in patients diagnosed with Plantar fasciitis. In the light of the findings, it is to create a projection for future clinical studies regarding the treatment approaches to be applied over the myofascial chain in addition to the generally accepted treatment protocols.

Eligibility criteria: Inclusion Criteria:

* Volunteers between the ages of 30-60
* Diagnosed with plantar fasciitis
* 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: Change from baseline ultrasonography at week 6.
measure: Plantar Fasciitis Pain
timeFrame: Change from baseline plantar fasciitis pain at week 6.
measure: Pes planus
timeFrame: Change from baseline pes planus at week 6.
measure: Foot Posture
timeFrame: Change from baseline foot posture at week 6.
measure: Ankle Joint Angle
timeFrame: Change from baseline ankle joint angles at week 6.
measure: Algometer
timeFrame: Change from baseline pressure pain threshold at week 6.
measure: Passive Tone
timeFrame: Change from baseline passive tone of myofascial tissues at week 6.
measure: Stiffness
timeFrame: Change from baseline Stiffness of myofascial tissues at week 6.
measure: Decrement
timeFrame: Change from baseline Decrement of myofascial tissues at week 6.
measure: Creep
timeFrame: Change from baseline Creep of myofascial tissues at week 6.
measure: Relaxation time
timeFrame: Change from baseline Relaxation time of myofascial tissues at week 6.
measure: Hamstring Muscle shortness
timeFrame: Change from baseline Hamstring muscle shortness at week 6.
measure: Pelvic tilt
timeFrame: Change from baseline pelvic tilt at week 6.
measure: Cervical and Lumbar Lordosis
timeFrame: Change from baseline Cervical and Lumbar Lordosis at week 6.
measure: Skin temperature of the Plantar Fascitis area
timeFrame: Change from baseline Skin temperature of the Plantar Fascitis area at week 6.
measure: Headache
timeFrame: Change from baseline Headache at week 6.
measure: Windlass Test
timeFrame: Change from baseline Windlass Test at week 6.
measure: SF-12 Quality of Life
timeFrame: Change from baseline Quality of Life at week 6.
measure: Lower extremity functionality
timeFrame: Change from baseline lower extremity functionality at week 6.
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: 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.
citation: Williams W, Selkow NM. Self-Myofascial Release of the Superficial Back Line Improves Sit-and-Reach Distance. J Sport Rehabil. 2019 Oct 18;29(4):400-404. doi: 10.1123/jsr.2018-0306. Print 2020 May 1.
citation: Burk C, Perry J, Lis S, Dischiavi S, Bleakley C. Can Myofascial Interventions Have a Remote Effect on ROM? A Systematic Review and Meta-Analysis. J Sport Rehabil. 2019 Oct 18;29(5):650-656. doi: 10.1123/jsr.2019-0074. Print 2020 Jul 1.
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: Martinez-Lema D, Guede-Rojas F, Gonzalez-Fernandez K, Soto-Martinez A, Lagos-Hausheer L, Vergara-Rios C, Marquez-Mayorga H, Mancilla CS. Immediate effects of a direct myofascial release technique on hip and cervical flexibility in inactive females with hamstring shortening: A randomized controlled trial. J Bodyw Mov Ther. 2021 Apr;26:57-63. doi: 10.1016/j.jbmt.2020.12.013. Epub 2020 Dec 11.
citation: Dhiman NR, Das B, Mohanty C, Singh OP, Gyanpuri V, Raj D. Myofascial release versus other soft tissue release techniques along superficial back line structures for improving flexibility in asymptomatic adults: A systematic review with meta-analysis. J Bodyw Mov Ther. 2021 Oct;28:450-457. doi: 10.1016/j.jbmt.2021.06.026. Epub 2021 Jun 16.
citation: Fauris P, Lopez-de-Celis C, Canet-Vintro M, Martin JC, Llurda-Almuzara L, Rodriguez-Sanz J, Labata-Lezaun N, Simon M, Perez-Bellmunt A. Does Self-Myofascial Release Cause a Remote Hamstring Stretching Effect Based on Myofascial Chains? A Randomized Controlled Trial. Int J Environ Res Public Health. 2021 Nov 24;18(23):12356. doi: 10.3390/ijerph182312356.