Plantar Fasciitis, ChronicNCT06846931
Comparison of the Efficacy of Shock Wave Therapy and Laser Therapy for Plantar Fasciitis
A study testing Extracorporeal Shock Wave Therapy, Low Intensity Laser and EXERCİSE in people with Plantar Fasciitis, Chronic, run by Ahi Evran University Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate the effects of extracorporeal shock wave therapy and low-intensity laser therapy on pain, functionality, plantar fascia thickness and balance in patients with plantar fasciitis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Plantar Fasciitis, Chronic
- What is being tested?
- Extracorporeal Shock Wave Therapy, Low Intensity Laser and EXERCİSE
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Mar 2025to 25 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients between 18 and 65 years of age, diagnosed with "plantar fasciitis" by anamnesis and physical examination
- Complaint duration of at least 3 months
- Patients who agree to participate in the study
Who cannot join
- Complaint lasting less than 3 months
- Injection in the heel area in the last 6 months
- Use of physiotherapy modalities for the heel in the last 6 months
- Bilateral complaint
- Pregnancy
- Malignancy
Show all 18Show fewer
- Epilepsy
- History of cardiac pacemaker
- Anticoagulant use
- History of systemic inflammatory disease
- History of lower extremity fracture or surgery
- Existing open wound in the heel area
- Patient hypersensitivity
- Systemic infection in the patient
- Uncontrolled hypertension in the patient
- Patient inability to cooperate
- History of neuromuscular disease affecting balance parameters
- Unwillingness of the patient to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kırşehir Ahi Evran University
Kirşehi̇r, 40100
About this study
Official title: Comparison of the Efficacy of Low Intensity ESWT and Low Intensity LASER Therapy in the Treatment of Chronic Plantar Fasciitis; Randomized Controlled Trial
The aim of this study was to investigate the effects of extracorporeal shock wave therapy and low-intensity laser therapy on pain, functionality, plantar fascia thickness and balance in patients with plantar fasciitis.
Read the detailed description
Plantar fasciitis is a pathology resulting from inflammation and/or degeneration of the plantar fascia of the sole of the foot. It affects about 10% of the population. It is one of the most common causes of chronic heel pain in the community and there is tenderness to palpation on the medial aspect of the heel bone. Patients complain of pain particularly with the first step in the morning and after rest. Mechanical overload and overuse can cause inflammation of the fascia. Diagnosis is usually made by clinical assessment and no further investigations are required.
In this study, 90 patients between the ages of 18 and 65 who meet the inclusion and exclusion criteria will be enrolled and participants will be randomised into 3 groups. The 1st group will be taught ESWT and home exercises for 1 session per week for 3 weeks and will be asked to do it every day. The 2nd group will receive 3 sessions of low intensity LASER per week for 3 weeks and will be asked to do home exercises every day. The 3rd group will only be taught home exercises and asked to do participants every day for 3 weeks. Visual analogue scale, foot function index, plantar fascia thickness measurement with USG and balance parameters will be measured at the beginning of the study, at the end of the treatment and at week 12.
- Conditions
- Plantar Fasciitis, Chronic
- Being tested
- Extracorporeal Shock Wave Therapy, Low Intensity Laser, EXERCİSE
- Keywords
- Rehabilitation, Extracorporeal Shock Wave Therapy, Low Intensity Laser, Plantar Fasciitis
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal Shock Wave TherapyOther
By the same physiotherapist with more than 5 years of clinical experience, radial ESWT treatment with 2500 pulses, 10 Hz frequency, 2.5-3 bar pressure, is applied to the most painful point of the heel and surrounding soft tissues, plantar aponeurosis and Achilles tendon insertion area on the dorsum of the heel, once a week for a total of 3 sessions.
Low Intensity LaserOther
A total of 28j (5.6jx5 points) are applied to the plantar fascia at 5 points on the heel by the same physiotherapist for 3 weeks, a total of 9 sessions (every other day) with the patient lying face down.
EXERCİSEOther
Exercise therapy is carried out by the patient for 3 weeks. Plantar fascia stretching exercises (exercises to stretch the membrane on the sole of the foot), gastrocsoleus stretching exercises (exercises to stretch the calf muscles), foot intrinsic muscle strengthening exercises (exercises to strengthen the muscles on the sole of the foot) are taught to the patients by the doctor and they are asked to perform them 2 times a day 10 times for a total of 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Extracorporeal Shock Wave Therapy Group | Active comparator | By the same physiotherapist with more than 5 years of clinical experience, radial ESWT treatment with 2500 pulses, 10 Hz frequency, 2.5-3 bar pressure, is applied to the most painful point of the heel and surrounding soft tissues, plantar aponeurosis and Achilles tendon insertion area on the dorsum of the heel, once a week for a total of 3 sessions. Plantar fascia stretching exercises (exercises to stretch the membrane on the sole of the foot), gastrocsoleus stretching exercises (exercises to stretch the calf muscles), foot intrinsic muscle strengthening exercises (exercises to strengthen the muscles on the sole of the foot) are taught to the patients by the doctor and they are asked to perform them 2 times a day 10 times for a total of 3 weeks. Receives: Other: Extracorporeal Shock Wave Therapy; Other: EXERCİSE |
| Low Intensity Laser Group | Active comparator | A total of 28j (5.6jx5 points) are applied to the plantar fascia at 5 points on the heel by the same physiotherapist for 3 weeks, a total of 9 sessions (every other day) with the patient lying face down. Plantar fascia stretching exercises (exercises to stretch the membrane on the sole of the foot), gastrocsoleus stretching exercises (exercises to stretch the calf muscles), foot intrinsic muscle strengthening exercises (exercises to strengthen the muscles on the sole of the foot) are taught to the patients by the doctor and they are asked to perform them 2 times a day 10 times for a total of 3 weeks. Receives: Other: Low Intensity Laser; Other: EXERCİSE |
| Exercise Group | Placebo comparator | Exercise therapy is carried out by the patient for 3 weeks. Plantar fascia stretching exercises (exercises to stretch the membrane on the sole of the foot), gastrocsoleus stretching exercises (exercises to stretch the calf muscles), foot intrinsic muscle strengthening exercises (exercises to strengthen the muscles on the sole of the foot) are taught to the patients by the doctor and they are asked to perform them 2 times a day 10 times for a total of 3 weeks. Receives: Other: EXERCİSE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
On the VAS (Visual Analogue Scale), pain intensity is usually rated from 0 for "no pain" to 10 for "the worst pain imaginable" (10 cm scale). Scoring intervals for pain intensity: <3 mild pain, 3-6 moderate pain, >6 severe pain. The VAS is a practical scale that is widely used in chronic pain worldwide. In this study it is evaluated as Visual Analog Scale-rest (VAS-I), Visual Analog Scale-first press (VAS-ib) and Visual Analog Scale-activity (VAS-a).
Measured: Before treatment (Week 0), at the end of treatment (Week 3) and after treatment (Week 12)
Secondary outcomes (3)
Foot Fonction Index
It consists of 23 items with 3 subscales: pain, disability and activity limitation. The pain subscale, with nine items, measures the level of foot pain in different situations. The nine item disability subscale measures the degree of difficulty in performing various functional activities due to foot problems. The five-item Activity limitation subscale assesses activity limitations due to foot problems.
Measured: Before treatment (Week 0), at the end of treatment (Week 3) and after treatment (Week 12)
Plantar Fascia Thickness Measurement with Ultrasound Imaging
Ultrason görüntüleme PF tanısında, ayırıcı tanıda yumuşak doku patolojisinin dışlanmasında ve tedavinin takibinde kullanılabilir. Plantar fasya kalınlığının 4 mm'den fazla olması, Doppler modunda artmış kan akımı ve USG'de plantar fasyada hipoekoik alanlar PF tanısında önemlidir. Bu çalışmada, ayak bileği 90 derece dorsifleksiyonda iken yüzüstü pozisyonda longitudinal eksende kalınlık ölçülür. Fasya kalınlığı plantar fasyanın kalkaneal insersiyosunda ölçülecektir.
Measured: Before treatment (Week 0) and after treatment (Week 12)
Measurement of Balance Parameters in Biodex Balance Device
In a study conducted by Ağırman et al in 2019, plantar fasciitis was found to increase fall risk and negatively affect balance in the population under 65 years of age. In this study, postural stability and fall risk (total score, anteroposterior, mediolateral and overall stability) are assessed using the Bioedex balance device.
Measured: Before treatment (Week 0), at the end of treatment (Week 3) and after treatment (Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start7 Mar 2025
- Primary completion25 Dec 2025
- Study completion25 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar Fasciitis, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three groups with a exercise control group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahi Evran University Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esat POLAT, Ahi Evran University Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06846931
- Sponsor's protocol ID
- AhiEvranUERH-FTR-EP-01
- Status last verified
- Feb 2025
- First submitted
- 21 Feb 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Low Intensity ESWT and Low Intensity LASER Therapy in the Treatment of Chronic Plantar Fasciitis; Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06846931
- Acronym / sponsor ID
- AhiEvranUERH-FTR-EP-01
- Conditions
- Plantar Fasciitis, Chronic
- Keywords
- Rehabilitation, Extracorporeal Shock Wave Therapy, Low Intensity Laser, Plantar Fasciitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ahi Evran University Education and Research HospitalUniversity, hospital or other
- Study start
- 7 Mar 2025 (actual)
- Primary completion
- 25 Dec 2025 (actual)
- Study completion
- 25 Dec 2025 (actual)
- First posted
- 26 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study was to investigate the effects of extracorporeal shock wave therapy and low-intensity laser therapy on pain, functionality, plantar fascia thickness and balance in patients with plantar fasciitis.
Detailed description
Plantar fasciitis is a pathology resulting from inflammation and/or degeneration of the plantar fascia of the sole of the foot. It affects about 10% of the population. It is one of the most common causes of chronic heel pain in the community and there is tenderness to palpation on the medial aspect of the heel bone. Patients complain of pain particularly with the first step in the morning and after rest. Mechanical overload and overuse can cause inflammation of the fascia. Diagnosis is usually made by clinical assessment and no further investigations are required.
In this study, 90 patients between the ages of 18 and 65 who meet the inclusion and exclusion criteria will be enrolled and participants will be randomised into 3 groups. The 1st group will be taught ESWT and home exercises for 1 session per week for 3 weeks and will be asked to do it every day. The 2nd group will receive 3 sessions of low intensity LASER per week for 3 weeks and will be asked to do home exercises every day. The 3rd group will only be taught home exercises and asked to do participants every day for 3 weeks. Visual analogue scale, foot function index, plantar fascia thickness measurement with USG and balance parameters will be measured at the beginning of the study, at the end of the treatment and at week 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Three groups with a exercise control group
| Arm | Type | Receives |
|---|---|---|
| Extracorporeal Shock Wave Therapy Group | Active comparator | Other: Extracorporeal Shock Wave Therapy, Other: EXERCİSEBy the same physiotherapist with more than 5 years of clinical experience, radial ESWT treatment with 2500 pulses, 10 Hz frequency, 2.5-3 bar pressure, is applied to the most painful point of the heel and surrounding soft tissues, plantar aponeurosis and Achilles tendon insertion area on the dorsum of the heel, once a week for a total of 3 sessions. Plantar fascia stretching exercises (exercises to stretch the membrane on the sole of the foot), gastrocsoleus stretching exercises (exercises to stretch the calf muscles), foot intrinsic muscle strengthening exercises (exercises to strengthen the muscles on the sole of the foot) are taught to the patients by the doctor and they are asked to perform them 2 times a day 10 times for a total of 3 weeks. |
| Low Intensity Laser Group | Active comparator | Other: Low Intensity Laser, Other: EXERCİSEA total of 28j (5.6jx5 points) are applied to the plantar fascia at 5 points on the heel by the same physiotherapist for 3 weeks, a total of 9 sessions (every other day) with the patient lying face down. Plantar fascia stretching exercises (exercises to stretch the membrane on the sole of the foot), gastrocsoleus stretching exercises (exercises to stretch the calf muscles), foot intrinsic muscle strengthening exercises (exercises to strengthen the muscles on the sole of the foot) are taught to the patients by the doctor and they are asked to perform them 2 times a day 10 times for a total of 3 weeks. |
| Exercise Group | Placebo comparator | Other: EXERCİSEExercise therapy is carried out by the patient for 3 weeks. Plantar fascia stretching exercises (exercises to stretch the membrane on the sole of the foot), gastrocsoleus stretching exercises (exercises to stretch the calf muscles), foot intrinsic muscle strengthening exercises (exercises to strengthen the muscles on the sole of the foot) are taught to the patients by the doctor and they are asked to perform them 2 times a day 10 times for a total of 3 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female patients between 18 and 65 years of age, diagnosed with "plantar fasciitis" by anamnesis and physical examination
- Complaint duration of at least 3 months
- Patients who agree to participate in the study
Key exclusion criteria (18 listed)
- Complaint lasting less than 3 months
- Injection in the heel area in the last 6 months
- Use of physiotherapy modalities for the heel in the last 6 months
- Bilateral complaint
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracorporeal Shock Wave TherapyBy the same physiotherapist with more than 5 years of clinical experience, radial ESWT treatment with 2500 pulses, 10 Hz frequency, 2.5-3 bar pressure, is applied to the most painful point of the heel and surrounding soft tissues, plantar aponeurosis and Achilles tendon insertion area on the dorsum of the heel, once a week for a total of 3 sessions. | Other | Extracorporeal Shock Wave Therapy Group |
| Low Intensity LaserA total of 28j (5.6jx5 points) are applied to the plantar fascia at 5 points on the heel by the same physiotherapist for 3 weeks, a total of 9 sessions (every other day) with the patient lying face down. | Other | Low Intensity Laser Group |
| EXERCİSEExercise therapy is carried out by the patient for 3 weeks. Plantar fascia stretching exercises (exercises to stretch the membrane on the sole of the foot), gastrocsoleus stretching exercises (exercises to stretch the calf muscles), foot intrinsic muscle strengthening exercises (exercises to strengthen the muscles on the sole of the foot) are taught to the patients by the doctor and they are asked to perform them 2 times a day 10 times for a total of 3 weeks. | Other | Exercise Group, Extracorporeal Shock Wave Therapy Group, Low Intensity Laser Group |
Primary outcome
Visual Analog Scale
Time frame: Before treatment (Week 0), at the end of treatment (Week 3) and after treatment (Week 12)
On the VAS (Visual Analogue Scale), pain intensity is usually rated from 0 for "no pain" to 10 for "the worst pain imaginable" (10 cm scale). Scoring intervals for pain intensity: <3 mild pain, 3-6 moderate pain, >6 severe pain. The VAS is a practical scale that is widely used in chronic pain worldwide. In this study it is evaluated as Visual Analog Scale-rest (VAS-I), Visual Analog Scale-first press (VAS-ib) and Visual Analog Scale-activity (VAS-a).
3 secondary outcomes
Foot Fonction Index
Time frame: Before treatment (Week 0), at the end of treatment (Week 3) and after treatment (Week 12)
Plantar Fascia Thickness Measurement with Ultrasound Imaging
Time frame: Before treatment (Week 0) and after treatment (Week 12)
Measurement of Balance Parameters in Biodex Balance Device
Time frame: Before treatment (Week 0), at the end of treatment (Week 3) and after treatment (Week 12)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Plantar Fasciitis, Chronic
Not yet recruiting
Hip Muscle Strengthening and Calf Myofascial Release in Females With Chronic Plantar Fasciitis
Chronic Planter Fascitis
Recruiting
F-18 Sodium Fluoride PET/CT-Guided Pain Palliation in Chronic Plantar Fasciitis: A Comparative Study of ¹⁷⁷Lutetium-Corticosteroid-Local Anaesthetic Injection vs Corticosteroid-Local Anaesthetic Injection
Plantar Fascitis, Chronic Heel Pain
Not yet recruiting
Radial vs Focused Shockwave Therapy for Plantar Fasciitis
Plantar Fasciitis, Chronic
RecruitingObservational study
Tibial Nerve Size and Clinical Features in Chronic Plantar Fasciitis
Plantar Fasciitis, Chronic, Tibial Nerve
Recruiting
Acupuncture of Different Treatment Frequency in Chronic Plantar Fasciitis
Plantar Fasciitis, Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal Shock Wave Therapy, Low Intensity Laser and EXERCİSE in people with Plantar Fasciitis, Chronic, run by Ahi Evran University Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: Before treatment (Week 0), at the end of treatment (Week 3) and after treatment (Week 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.