Comparions the Effect of Different Treatment Modalities on Chronic Plantar Fasiitis

Plantar Fasciitis, Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04323319
• Other study ID #: BAP.2018-03.01
• Status: Completed
• Phase: N/A
• Start date: December 27, 2018
• Est. completion date: March 1, 2020

Study information

• Verified date: March 2020
• Source: Bahçesehir University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: March 1, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Plantar Fasciitis, Chronic

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Turkey	Pelin Pisirici	Istanbul	Besiktas/Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bahçesehir University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First step pain: Visuel Analog Scale (VAS)	Visuel Analog Scale by using 10 cm likert scale.	Changes in the VAS scores of the three groups before the treatment.
Primary	First step pain: Visuel Analog Scale (VAS)	Visuel Analog Scale by using 10 cm likert scale.	Changes in the VAS scores of the three groups 4 weeks after treatment.
Primary	First step pain: Visuel Analog Scale (VAS)	Visuel Analog Scale by using 10 cm likert scale.	Changes in the VAS scores of the three groups 8 weeks after treatment.
Secondary	Pressure Pain Threshold	Pressure algometers measure pressure pain thresholds of muscles.Pressure threshold to investigate the effects of both attempts on pain, by a blind assessor evaluated at three points on the affected leg, gastrocnemii (midpoint of the muscle belly), soleus (midpoint of the muscle at 10 cm above the Achilles tendon) on the muscles and on the posterior face of the calcaneus. FDX Force Ten algometer (FDX-Wagner Instruments) is used for evaluation.	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.
Secondary	Kinesiophobia	The Tampa Scale for Kinesiophobia (TSK) is a 17 item questionnaire used to assess the subjective rating of kinesiophobia or fear of movement. The range of scores are from 17 to 68 where the higher scores indicate an increasing degree of kinesiophobia.	Changes in the Tampa scores of the three groups before and 4 weeks after treatment and at 8 weeks will be compared.
Secondary	Foot Function Index	A Foot Function Index (FFI) measures the impact of foot pathology on function in terms of pain, disability and activity restriction.The FFI consists of 23 self-reported items divided into 3 subcategories on the basis of patient values: pain, disability and activity limitation.; The pain subcategory consists of 9 items and measures foot pain in different situations, such as walking barefoot versus walking with shoes.; Recorded on a visual analogue scale (VAS), scores range from 0 to 100 mm, with higher scores indicating worse pain. Both total and subcategory scores are calculated.	Changes in the Foot function Index scores of the three groups before and 4 weeks after treatment and at 8 weeks will be compared.
Secondary	SF-12	SF-12 is composed of 12 subheadings of SF-36. The SF-12 summary scores (PCS-12 and MCS-12) also range from 0 to 100, with higher scores representing better self-reported health.	Pre-intervention, 5th weeks (post-intervention) and 8th weeks.
Secondary	Plantar Pressure Analysis	The platform systems are made of a series of flat, solid pressure sensing elements arranged in a matrix configuration and embedded in the ground to allow normal walking. Platform systems can be used for both static and dynamic applications. With the analyzer sensor medika fm4040 the load distribution of the soles will be evaluated both statically and dynamically.	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.
Secondary	Global Rating of Change	General proportion scales provide a flexible, fast and simple method for self-evaluation of improvement in research and clinical settings. provides a way to obtain information on treatment efficacy quickly, flexibly and efficiently. The instrument has advantages such as clinical significance, appropriate reproducibility and sensitivity to change, and is easy to understand by the patient and the practitioner. Scale 11 has a retestability rate of 90% and a minimal clinical significance of 2. In the investigator's study, it was used to evaluate the rate of satisfaction with treatment.	Global Rating of Change scores will be evaluated at 4 weeks (at the end of treatment) and at 8 weeks.