Comparions the Effect of Different Treatment Modalities on Chronic Plantar Fasiitis

NCT ID: NCT04323319

Last Updated: 2020-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-27
• Study Completion Date: 2020-03-01

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.

Conditions

Plantar Fasciitis, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ESWT Group

Patients in the ESWT group will be treated with ESWT once a week for 4 weeks. Each patient was treated with epine calcaneus and its surroundings. The treatment dose of 10 Hz, 2.5 bar, 2000 shock wave with BTL L-6000 SWT device will be applied by the same therapist. Patient completed plantar fascia and gastrocnemius streching exercises right after treatment. The patient completed the plantar fascia and gastrocnemius stretching exercises right after treatment and also continue at home for 4 weeks, 2 sets per day. Completed 3 repetation for each exercise and stayed in the same position for 30 seconds.

Group Type: EXPERIMENTAL

ESWT, Graston Technique

Intervention Type: DEVICE

The treatment period for each group was determined as 4 weeks. Stretching program for each group will be given as home exercise program. Stretching exercises will be completed in 3 sets, 2 sets per day, stretching for 30 seconds.

Graston Technique Group will take treatment 2 times per week, ESWT group will take treatment 1 time per week.

Graston Technique® Group

The application was carried out by Graston Technique® (GT®) certified, a therapist with orthopedic rehabilitation and soft tissue treatments for over 12 years. GT® instruments were used to diagnose and treat the damaged soft tissue of gastrocnemius and plantar fascia. The application protocol and the instruments used according to the regions were determined with reference to the GT® manual. GT® treatment can be given to the same region twice a week. A minimum of 2 days break was given between the applications. Gastrocnemius and plantar fascia application completed in 5 minutes in one leg. GT2, GT4 and GT6 instruments used for application.The patient completed the plantar fascia and gastrocnemius stretching exercises right after treatment and also continue at home for 4 weeks, 2 sets per day. Completed 3 repetation for each exercise and stayed in the same position for 30 seconds.

Group Type: EXPERIMENTAL

ESWT, Graston Technique

Intervention Type: DEVICE

The treatment period for each group was determined as 4 weeks. Stretching program for each group will be given as home exercise program. Stretching exercises will be completed in 3 sets, 2 sets per day, stretching for 30 seconds.

Graston Technique Group will take treatment 2 times per week, ESWT group will take treatment 1 time per week.

Control Group

Stretching group was accepted as the control group. the patient monitored once a week at the hospital and continue home stretching program at home. These patients will be given information about plantar fasciitis as well as other groups. Plantar fascia and gastrosoleus self-stretching exercises will be required to be performed twice a day for thirty seconds and three repetitions for 4 weeks. The patients will be followed with an exercise follow-up form.

Group Type: EXPERIMENTAL

ESWT, Graston Technique

Intervention Type: DEVICE

The treatment period for each group was determined as 4 weeks. Stretching program for each group will be given as home exercise program. Stretching exercises will be completed in 3 sets, 2 sets per day, stretching for 30 seconds.

Graston Technique Group will take treatment 2 times per week, ESWT group will take treatment 1 time per week.

Interventions

ESWT, Graston Technique

The treatment period for each group was determined as 4 weeks. Stretching program for each group will be given as home exercise program. Stretching exercises will be completed in 3 sets, 2 sets per day, stretching for 30 seconds.

Graston Technique Group will take treatment 2 times per week, ESWT group will take treatment 1 time per week.

Intervention Type: DEVICE

Other Intervention Names

stretching

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bahçeşehir University

OTHER

Sponsor Role: lead

Responsible Party

Pelin Pişirici

PT, PHD (c), Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pelin Pişirici, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Medipol University Institute of Health Sciences

Dilber Karagozoglu Coskunsu, PT, PhD

Role: STUDY_DIRECTOR

Bahçeşehir University Faculty of Health Sciences

Feryal Subaşı, PT, Prof

Role: STUDY_CHAIR

Yeditepe University Faculty of Health Sciences

Uğur Şaylı, MD. Prof.

Role: STUDY_CHAIR

Yeditepe University Hospital

Elif Tugce Cil, PT, MSc

Role: STUDY_CHAIR

Yeditepe University Faculty of Health Sciences

Locations

Pelin Pişirici

Istanbul, Beşiktaş/İstanbul, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

BAP.2018-03.01

Identifier Type: -

Identifier Source: org_study_id