Clinical trial NCT04323319: Comparions the Effect of Different Treatment Modalities on Chronic Plantar Fasiitis
Official title: The Comparison of the Effects of ESWT and Instrument Assisted Soft Tissue Mobilization Techniques in the Treatment of Chronic Plantar Fasiitis- Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plantar Fasciitis, Chronic
Keywords: Plantar Fasciitis
Extracorporeal shock wave therapy
Graston Technique
Instrument assisted soft tissue mobilization
Stretching
Plantar pressure analysis
Lead sponsor: Bahçeşehir University
Sponsor class: OTHER
First posted: 2020-03-26
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Plantar fasciitis is a common cause of heel pain affecting about 20% of the general population. The basic treatment of plantar fasciitis is conservative. Approximately 85-90% of plantar fasciitis patients can be successfully treated without surgery. Methods include resting, nonsteroidal anti-inflammatory drugs, stretching, shoe orthotics, corticosteroid injections, physical therapy, night splints, and extracorporeal shock wave therapy (ESWT) and ultrasound therapy. Plantar fasciitis treatment is a chronic treatment that has been clearly described in the literature despite the use of treatment modalities. In the literature, treatment modalities which should be used respectively in the treatment of plantar fasciitis are expressed. Nevertheless, it is a chronic disease caused by skipping the treatment steps for various reasons or applying the treatments in the wrong hierarchy. The aim of this project is to compare the effects of stretching exercises, ESWT and instrument-assisted myofascial relaxation technique (Graston Technique®) in the treatment of chronic plantar fasciitis in terms of pain, disability level, quality of life and static and dynamic plantar pressure analysis.

Detailed description: Traditionally, the fascia tissue was described as a single connective tissue surrounding each muscle, muscle fiber and myofibril. In the International Fascia Research Congress held in Vancover, Canada in 2012, the definition of fascia was redefined, including aponeurosis, ligament, tendon, joint capsule, central nervous system, epinerium, bronchial connective tissue and abdominal mesentery. With the emphasis on the importance of fascia in the literature, soft tissue techniques, including fascia, have gained popularity.

Plantar fasciitis is a common cause of heel pain affecting about 20% of the general population. It is usually caused by biomechanical imbalance resulting from tension occurring along the plantar fascia.Plantar fascia is thought to be effective in the pathogenesis of micro-ruptures and inflammation caused by recurrent tension in the insersio. A variety of predisposing factors have also been proposed, including minor trauma, foot pronation, inappropriate shoes, obesity, and prolonged standing. Diagnosis is usually based on clinical history and local sensitivity. The pain is typically felt in the morning and / or after long sitting, in the origin of the plantar aponeurosis, and a centimeter distal to this area, and typically occurs in the first steps after getting out of bed in the morning, resulting in difficulty in daily activities. Basic treatment of plantar fasciitis is conservative. Approximately 85-90% of plantar fasciitis patients can be successfully treated without surgery. Methods include resting, nonsteroidal anti-inflammatory drugs, stretching, shoe additions, orthoses, corticosteroid injections, physical therapy, night splints, and extracorporeal shock wave therapy (ESWT) and ultrasound therapy. Plantar fasciitis treatment is a chronic treatment that has been clearly described in the literature despite the use of treatment modalities.In 2000, the Food and Drug Administration (FDA) approved the use of Extracorporeal Shock Wave Therapy (ESWT), an electrohydraulic device for use in the treatment of chronic plantar fasciitis. Pain, redness, edema and ecchymosis are rarely reported during ESWT treatment, but these effects are not permanent.The exact mechanism of action of the ESWT has not been clearly established. However it is believed that the body responds by increasing the healing ability in that area, by stimulating a repair process. For the patients who treated with ESWT, there was a decrease in pain and an increase in walking ability compared to a control group. ESWT is recommended in chronic plantar fasciitis patients who do not respond to conservative treatment.

Tight bands in the gastrocnemius muscles, myofascial / intramuscular trigger points, may interfere with the development of plantar heel pain. Intramuscular trigger points are defined as hyperirritable areas that are painful on the compression, contraction, or stretching of the muscles in a skeletal muscle stretched and produce pain that is reflected at a distant point away from the intramuscular trigger point, and may affect their stiffness, myofascial constraints and the extensibility of the muscles or fascia.

Instrument-assisted soft tissue mobilization is a treatment approach developed by James Cyriax. Although there are many different name instruments used for myofascial release, the most popular is Graston Technique® (GT®). GT® is a therapeutic technique based on soft tissue mobilization logic, which is used with specially designed instruments and by applying longitudinal pressure along the muscle fibers. This technique differs from conventional cross friction or transverse friction massage. Longitudinal pressure is applied along the fibers of the muscles associated with specially designed instruments. By changing the tissue properties with the instruments, it enables the patient to realize the changing feeling in the treated areas. Damaged tissues are determined by changing the tissue vibration under the instrument. In addition, the clinician's hands with the depth can be much more than the depth that can be brought down and the clinician's fatigue level is reduced. Treatment typically involves greater application at the points of pain than at other tissues.The clinical use of this technique aims to increase the effectiveness of treatment, especially in patients. It is believed that by creating microtrauma in tissue, it will produce a local inflammatory response that promotes the disintegration of scar tissue, opening of adhesions, new collagen synthesis and connective tissue remodeling. The treatment efficacy of the instruments increases the local inflammation response, especially with microtrauma created in the damaged areas, increases the scar tissue destruction, loosens the adhesions, increases collagen synthesis and stimulates the remodeling of the connective tissue.

In the literature, treatment modalities which should be used respectively in the treatment of plantar fasciitis are expressed. Nevertheless, it is a chronic disease caused by skipping the treatment steps for various reasons or applying the treatments in the wrong hierarchy.

The comparison of stress, GT® and the effectiveness of ESWT applications will contribute both to the deficiency of the literature and to decide on effective treatment.

Eligibility criteria: Inclusion Criteria:

* diagnosis with plantar fasciitis, between age o 18-60 and have pain for more than 3 months,
* patients with at least 3 conservative treatments were unsuccessful (include usage of anti-inflammatory drugs, cortisone injection and surgical),
* according to Visual Analogue Scale (VAS), patients with (VAS)≥5

Exclusion Criteria:

* calcaneal fracture and implants,
* tarsal tunnel syndrome,
* infection,
* neurological problems,
* tumor,
* coagulated impairments,
* pregnancy

Primary outcomes:
measure: First step pain: Visuel Analog Scale (VAS)
timeFrame: Changes in the VAS scores of the three groups before the treatment.
measure: First step pain: Visuel Analog Scale (VAS)
timeFrame: Changes in the VAS scores of the three groups 4 weeks after treatment.
measure: First step pain: Visuel Analog Scale (VAS)
timeFrame: Changes in the VAS scores of the three groups 8 weeks after treatment.
Secondary outcomes:
measure: Pressure Pain Threshold
timeFrame: Changes in the pressure pain threshold (mean value of three measurement) of the three groups before and 4 weeks after treatment and at 8 weeks will be compared.
measure: Kinesiophobia
timeFrame: Changes in the Tampa scores of the three groups before and 4 weeks after treatment and at 8 weeks will be compared.
measure: Foot Function Index
timeFrame: Changes in the Foot function Index scores of the three groups before and 4 weeks after treatment and at 8 weeks will be compared.
measure: SF-12
timeFrame: Pre-intervention, 5th weeks (post-intervention) and 8th weeks.
measure: Plantar Pressure Analysis
timeFrame: Changes in the VAChanges in the Plantar Pressure Analysis of the three groups before and 4 weeks after treatment and at 8 weeks will be compared.
measure: Global Rating of Change
timeFrame: Global Rating of Change scores will be evaluated at 4 weeks (at the end of treatment) and at 8 weeks.
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Pelin Pişirici
state: Beşiktaş/İstanbul
Study officials:
affiliation: Medipol University Institute of Health Sciences
name: Pelin Pişirici, PT, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bahçeşehir University Faculty of Health Sciences
name: Dilber Karagozoglu Coskunsu, PT, PhD
role: STUDY_DIRECTOR
affiliation: Yeditepe University Faculty of Health Sciences
name: Feryal Subaşı, PT, Prof
role: STUDY_CHAIR
affiliation: Yeditepe University Hospital
name: Uğur Şaylı, MD. Prof.
role: STUDY_CHAIR
affiliation: Yeditepe University Faculty of Health Sciences
name: Elif Tugce Cil, PT, MSc
role: STUDY_CHAIR
References: