- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT06890806
Foot Core Stabilization Exercises vs. Shockwave Therapy for Pain, Strength, and Function in Plantar Fasciitis
Comparison of the Effects of Foot Core Stabilization Exercises and Extracorporeal Shock Wave Therapy on Pain, Muscle Strength, and Function in Individuals With Plantar Fasciitis: A Randomized Controlled Trial
This randomized controlled trial was designed to compare the effects of foot core stabilization exercises (FCSE) and extracorporeal shock wave therapy (ESWT) on pain intensity, muscle strength, foot posture, medial longitudinal arch height, lower extremity alignment, and foot function in individuals with plantar fasciitis (PF).
A total of 43 participants were randomized into two intervention groups, and 40 participants completed the study and were included in the final analysis (FCSE: n=20; ESWT: n=20). The FCSE group performed supervised foot core stabilization exercises three times per week for five weeks, while the ESWT group received treatment once per week for five weeks.
The primary outcomes were pain intensity, assessed using the Visual Analog Scale (VAS), and foot function, assessed using the Foot Function Index (FFI). Secondary outcomes included ankle dorsiflexor and plantar flexor muscle strength, navicular drop, quadriceps (Q) angle, and foot posture assessed using the Foot Posture Index (FPI). All outcomes were evaluated before and after the five-week intervention period.
The study aimed to provide evidence regarding the comparative effectiveness of these two conservative treatment approaches in the rehabilitation of individuals with plantar fasciitis.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This prospective, randomized controlled trial compared the effects of foot core stabilization exercises (FCSE) and extracorporeal shock wave therapy (ESWT) on pain intensity, muscle strength, foot posture, and functional outcomes in individuals with plantar fasciitis (PF).
A total of 43 participants aged 25-60 years with plantar fasciitis were randomized into two intervention groups using a computer-generated randomization sequence. Allocation concealment was ensured using sequentially numbered, opaque, sealed envelopes. Three participants discontinued treatment, and 40 participants completed the study and were included in the final analysis (FCSE: n=20; ESWT: n=20).
The primary outcomes were heel pain intensity, assessed using the Visual Analog Scale (VAS), and foot function, assessed using the Foot Function Index (FFI). Secondary outcomes included ankle dorsiflexor and plantar flexor muscle strength measured using a Kinvent K-Force dynamometer, medial longitudinal arch height assessed using the Navicular Drop Test, lower extremity alignment evaluated using the Quadriceps (Q) Angle, and foot posture assessed using the Foot Posture Index (FPI).
The FCSE group performed a supervised exercise program consisting of short foot exercises, towel curls, big toe presses, toe splay exercises, calf raises with big toe presses, leg swings, and backward tandem walking. Exercise sessions lasted 40 minutes and were conducted three times weekly for five weeks.
The ESWT group received treatment using the Gymna ShockMaster 500 device at a frequency of 15 Hz and a pressure of 3 bar, with 1,800 impulses delivered per session. Treatment was administered once weekly for five weeks.
All assessments were performed before and after the intervention period by the same experienced physiotherapist, who was blinded to group allocation.
The study aimed to evaluate the comparative effectiveness of these two conservative rehabilitation approaches in individuals with plantar fasciitis.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Bursa, Tyrkiet (Türkiye)
- Medicalpark Hospital
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Bursa
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Bursa, Bursa, Tyrkiet (Türkiye), 16160
- Mudanya University
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
Adults aged 25-60 years with a diagnosis of plantar fasciitis confirmed by an orthopedic physician.
Heel pain localized to the medial calcaneal tubercle persisting for at least three months.
Exclusion Criteria:
History of foot or ankle surgery.
Chronic or active infection in the treatment area.
Type 1 or Type 2 diabetes mellitus, systemic inflammatory arthritis, cancer, active tuberculosis, or neurological or vascular diseases.
Previous conservative treatments, including nonsteroidal anti-inflammatory drugs, that were ineffective for at least six months.
Provoked or non-provoked numbness or tingling in the lower extremity or undiagnosed pain.
Pregnancy.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Foot Core Stabilization Exercise Group (FCSEG)
Foot Core Stabilization Exercise Group (FCSEG) |
Participants in the Foot Core Stabilization Exercise Group (FCSEG) performed a supervised exercise program consisting of seven exercises: short foot exercise, towel curl exercise, big toe press exercise, toe splay exercise, calf raise to big toe press exercise, leg swing exercise, and backward tandem walking. The exercises were performed for 40 minutes per session, three times per week for five consecutive weeks under the supervision of a physiotherapist. Each exercise was performed according to the standardized protocol, with 15 repetitions for the specified exercises. The exercise intensity and difficulty remained unchanged throughout the intervention period. |
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Eksperimentel: Extracorporeal Shock Wave Therapy Group (ESWTG)
Extracorporeal Shock Wave Therapy Group (ESWTG) |
Participants in the Extracorporeal Shock Wave Therapy Group (ESWTG) received ESWT using the Gymna ShockMaster 500 device with a 12-mm applicator. Treatment was administered in continuous mode at a frequency of 15 Hz and a pressure of 3 bar, delivering a total of 1,800 impulses per session. ESWT was applied to multiple painful points in the heel region, including the central and medial aspects, by a trained physiotherapist. Treatment was administered once weekly for five consecutive weeks. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Heel Pain Intensity Assessed Using the Visual Analog Scale (VAS)
Tidsramme: Baseline and post-intervention (at the end of week 5)
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Heel pain intensity was assessed using the Visual Analog Scale (VAS). Participants indicated their pain intensity on a 10-cm horizontal scale, where 0 represented no pain and 10 represented severe pain. Higher scores indicated greater pain intensity. |
Baseline and post-intervention (at the end of week 5)
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Medial Longitudinal Arch Height Assessed Using the Navicular Drop Test
Tidsramme: Baseline and post-intervention (at the end of week 5)
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The Navicular Drop Test will be used to assess participants' MLA height. Before measurements, the navicular tubercle will be marked while the individual stands barefoot. First, the distance between the navicular tubercle and the ground will be measured in millimeters while seated with the foot unloaded. Then, the individual will stand and bear full weight, and the new distance will be recorded. The difference between these two measurements will be calculated. Results will be classified as increased supination (<5mm), neutral foot (5-9mm), and increased pronation (>9mm). |
Baseline and post-intervention (at the end of week 5)
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Ankle Dorsiflexor and Plantar Flexor Muscle Strength (kg)
Tidsramme: Baseline and post-intervention (at the end of week 5)
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Ankle dorsiflexor and plantar flexor muscle strength was assessed using a Kinvent K-Force digital dynamometer. Participants were positioned supine during testing. For dorsiflexor strength assessment, the dynamometer was placed over the dorsal metatarsal region, while for plantar flexor strength assessment, it was positioned under the plantar metatarsal region. Participants were instructed to exert maximal force against the device. Three maximal voluntary isometric contractions were performed for each muscle group, and the highest recorded force value was used for statistical analysis. Muscle strength was expressed in kilograms (kg). |
Baseline and post-intervention (at the end of week 5)
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Quadriceps (Q) Angle Measurement (Degrees)
Tidsramme: Baseline and post-intervention (at the end of week 5)
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The quadriceps (Q) angle was measured using a plastic goniometer to evaluate lower extremity alignment. Participants were positioned supine with their knees fully extended. The pivot point of the goniometer was placed at the center of the patella, the stationary arm was aligned with the tibial tuberosity, and the moving arm was directed toward the anterior superior iliac spine. The angle formed between the two arms was recorded in degrees (°). |
Baseline and post-intervention (at the end of week 5)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Foot Posture Assessed Using the Foot Posture Index (FPI)
Tidsramme: Baseline and post-intervention (at the end of week 5)
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Foot posture will be assessed using the Foot Posture Index (FPI). Individuals with PF will stand in a relaxed position, looking forward, with arms at their sides, maintaining body alignment. FPI includes six clinical criteria:
Each criterion is scored from -2 to +2, and the total score is recorded. A score of 0 indicates a neutral foot, positive values indicate pronation, and negative values indicate supination. |
Baseline and post-intervention (at the end of week 5)
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Foot Function Assessed Using the Foot Function Index (FFI)
Tidsramme: Baseline and post-intervention (at the end of week 5)
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Foot function was assessed using the Foot Function Index (FFI), a 23-item questionnaire consisting of three subscales: pain, disability, and activity limitation. The pain subscale evaluates foot pain experienced in different situations, the disability subscale assesses difficulties in performing functional activities, and the activity limitation subscale evaluates restrictions in daily activities due to foot problems. Participants rated each item based on their foot condition during the preceding week using a Visual Analog Scale (VAS) scoring system. Higher FFI scores indicate greater foot-related pain, disability, and functional limitation. |
Baseline and post-intervention (at the end of week 5)
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- E-10840098-202.3.02-7450
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