Plantar FascitisNCT06446167
Comparative Efficacy of Laser, Extracorporeal Shockwave Therapy and Exercise Therapy on Plantar Fasciitis Outcomes
A study testing Exercises, MLS Laser Treatment and ESWT treatment in people with Plantar Fascitis, run by Istanbul Saglik Bilimleri University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effectiveness of exercise combined with ESWT (Extracorporeal Shockwave Therapy), exercise combined with MLS (Multiwave Locked System) laser therapy, and exercise alone in female patients diagnosed with unilateral plantar fasciitis, using Visual Analog Scale (VAS), Heel Tenderness Index… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Plantar Fascitis
- What is being tested?
- Exercises, MLS Laser Treatment and ESWT treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2021to 29 Apr 2022
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18-65 years
- Female gender
- Symptoms persisting for at least 6 weeks
- Unilateral plantar fasciitis
- Consent to participate in the study
Who cannot join
- Male gender
- Bilateral plantar fasciitis
- Treatment with ESWT, laser or injection therapy for plantar fasciitis in the previous year
- Participation in a physical therapy program for plantar fasciitis in the last six months
- History of systemic inflammatory disease
- History of lower extremity fracture or surgery
Show all 14Show fewer
- Pregnancy
- History of epilepsy
- Malignancy
- Active infection
- Coagulation disorders
- Severe cardiac disease or history of pacemaker
- History of neuromuscular disease affecting balance parameters
- Regular use of nonsteroidal antiinflammatory drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Efficacy of Multiwave Locked System Laser, Extracorporeal Shockwave Therapy and Exercise Therapy on Plantar Fasciitis Outcomes: A Randomized Controlled Trial
This study aims to evaluate the effectiveness of exercise combined with ESWT (Extracorporeal Shockwave Therapy), exercise combined with MLS (Multiwave Locked System) laser therapy, and exercise alone in female patients diagnosed with unilateral plantar fasciitis, using Visual Analog Scale (VAS), Heel Tenderness Index (HTI), Foot and Ankle Outcome Score (FAOS), Foot Function Index (FFI) and fall risk, as clinical parameters to assess any differences in effectiveness levels among these treatments.
Read the detailed description
Plantar fasciitis (PF) is a prevalent condition characterized by the degeneration of the plantar fascia, a band of connective tissue that originates from the calcaneus to the proximal phalanges and the skin of the foot's anterior part. Despite common misconceptions, plantar fasciitis is not primarily an inflammatory process but results from repetitive microtears leading to a secondary inflammatory reaction of the plantar fascia.
Despite the condition's self-limiting nature, with 70% to 80% of patients experiencing symptom relief through conservative treatment alone, a combination of treatments is often necessary for many. Conservative interventions include rest, cold application, stretching and strengthening exercises, orthotic devices, lifestyle modifications, weight loss, and night splints. Additionally, non-invasive physical therapy modalities such as Extracorporeal Shock Wave Therapy (ESWT), laser, and ultrasound have shown to be cost-effective and accessible treatment options. Invasive treatments, including injections and surgery, are considered for resistant cases
Previous studies have examined the effectiveness of ESWT, Low level laser therapy, High intensity laser therapy, and exercise treatments in patients with PF, demonstrating their efficacy. Although there are studies investigating the effectiveness of MLS laser therapy on various musculoskeletal pathologies, to our knowledge, there is no study specifically examining its efficacy on PF
- Conditions
- Plantar Fascitis
- Being tested
- Exercises, MLS Laser Treatment, ESWT treatment
- Keywords
- Plantar Fasciitis, Exercise, Lasers, Extracorporeal Shockwave Therapy
- Medical subject headings
- Fasciitis, Plantar, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExercisesOther
All groups received a regimen of daily exercises, including stretches for the plantar fascia and Achilles tendon, and strengthening exercises for the calf muscles and foot intrinsic muscles. Each type of exercise was demonstrated to the participants by the same physiotherapist at the beginning of the treatment process, to be performed twice a day with 10 repetitions each time.
MLS Laser TreatmentOther
The MLS Laser applied to the treatment group was administered using an ASA brand Mphi model device. Patients in the Laser group were positioned in a prone position. Treatment was applied continuously for 7 minutes along the plantar fascia, sole of the foot, heel area, and Achilles tendon in accordance with the plantar fasciitis treatment program on the device, at a dose of 1.73 J/cm2 and a frequency of 700 Hz. A treatment program was established with 3 sessions per week, totaling 10 sessions
ESWT treatmentOther
The treatment group was administered with the Swiss DolorClast Master ESWT device, which produces radial shock waves. Patients in the ESWT group were positioned in a prone position. The most painful point in the heel area was identified through palpation. Gel was applied to this area, followed by the surrounding soft tissues, towards the plantar fascia and the attachment area of the Achilles tendon at the dorsal aspect of the heel. Radial ESWT treatment was applied at a frequency of 10 Hz, pressure of 2.5 bars, and 2000 impulses per session, once a week for a total of 4 sessions
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Active comparator | All groups received a regimen of daily exercises, including stretches for the plantar fascia and Achilles tendon, and strengthening exercises for the calf muscles and foot intrinsic muscles. Each type of exercise was demonstrated to the participants by the same physiotherapist at the beginning of the treatment process, to be performed twice a day with 10 repetitions each time. Receives: Other: Exercises |
| Laser group | Active comparator | The MLS Laser applied to the treatment group was administered using an ASA brand Mphi model device. Patients in the Laser group were positioned in a prone position. Treatment was applied continuously for 7 minutes along the plantar fascia, sole of the foot, heel area, and Achilles tendon in accordance with the plantar fasciitis treatment program on the device, at a dose of 1.73 J/cm2 and a frequency of 700 Hz. A treatment program was established with 3 sessions per week, totaling 10 sessions. Patients receiving laser therapy also continued with their exercise programs. Receives: Other: Exercises; Other: MLS Laser Treatment |
| ESWT group | Active comparator | The treatment group was administered with the Swiss DolorClast Master ESWT device, which produces radial shock waves. Patients in the ESWT group were positioned in a prone position. The most painful point in the heel area was identified through palpation. Gel was applied to this area, followed by the surrounding soft tissues, towards the plantar fascia and the attachment area of the Achilles tendon at the dorsal aspect of the heel. Radial ESWT treatment was applied at a frequency of 10 Hz, pressure of 2.5 bars, and 2000 impulses per session, once a week for a total of 4 sessions. Patients receiving ESWT therapy also continued with their exercise programs. Receives: Other: Exercises; Other: ESWT treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
VAS is a scale 10 cm in length, starting from "no pain" and ending with "unbearable pain" (0: no pain, 10: unbearable pain). Patients indicate the severity of their pain by marking the appropriate point on this scale. The distance between "no pain" and this marked point is measured and recorded in centimeters
Measured: one month
Secondary outcomes (4)
Foot Function Index (FFI)
The FFI is a self-reported questionnaire designed to assess the impact of foot pathology on three domains: pain (9 items), disability (9 items), and activity limitation (5 items). Each item is rated on a scale from 0 (no issue) to 10 (severe issue). The scores are normalized to a 100-point scale for each domain, offering a detailed metric for functional impairment. To calculate the Total FFI score, the average of the scores from the three subheadings is taken. Higher scores are associated with more severe illness. The Turkish adaptation of the FFI was conducted by Yalıman et al.
Measured: one month
Foot and Ankle Outcome Score (FAOS)
Adapted from the knee injury and osteoarthritis outcome score, the FAOS is a detailed tool that evaluates five domains: symptoms and stiffness (7 items), pain (9 items), daily living activities (17 items), sports and recreational activities (5 items), and quality of life (4 items). Each question has 5 different responses that can be scored from 0 for the best condition to 4 for the worst condition, based on the intensity of the complaint. The result ranges from 0 to 100. A score of 0 indicates the worst possible foot and ankle symptoms, while a score of 100 indicates no foot and ankle symptoms. The Total FAOS score is calculated by taking the percentage of responses given to all 42 questions, regardless of the subheadings. The Turkish adaptation of the FAOS was conducted by Karatepe et al. in 2009.
Measured: one month
Heel Tenderness Index (HTI)
The HTI quantifies pain sensitivity in the heel through clinical palpation. It is scored from 0 (no pain) to 3 (severe pain with withdrawal reflex), enabling objective assessment of localized tenderness.
Measured: one month
Biodex Fall Risk Assessment
The Biodex balance system SD-2014 is a robotic device equipped with computer software that allows tilting up to 20° in all directions, enabling objective assessment of balance and fall risk. High scores indicate impaired balance and increased risk of falling. During measurement, patients are asked to remove their shoes and step onto the platform, maintaining a comfortable position while visually monitoring themselves on the screen to stay centered. Patients are instructed to maintain this position throughout the measurements. Subsequently, according to the fall risk measurement protocol of the device, fall risk calculations are performed at levels 12-8, with 20-second test durations repeated 3 times. The fall risk resulting from these 3 measurements is provided as the overall stability index (OSI) score.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start1 May 2021
- Primary completion29 Apr 2022
- Study completion29 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FascitisStudies 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
- 60 patients met the eligibility criteria and were enrolled in the study. The eligible participants were randomized into three distinct groups each comprising 20 individuals: an exercise alone group (Exercise group), an exercise combined with MLS laser therapy group (Laser group), and an exercise combined with ESWT group (ESWT group). Randomization was conducted using a computer-assisted program
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Saglik Bilimleri University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Ethem Kirez, Istanbul Saglik Bilimleri University
- Investigators
- İbrahim Ethem Kirez, Principal investigator, İstanbulSBÜ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06446167
- Sponsor's protocol ID
- İstanbulSBÜ-FTR-IEK-01
- Status last verified
- Jun 2024
- First submitted
- 1 Jun 2024
- Last updated
- 6 Jun 2024
- 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 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Multiwave Locked System Laser, Extracorporeal Shockwave Therapy and Exercise Therapy on Plantar Fasciitis Outcomes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06446167
- Acronym / sponsor ID
- İstanbulSBÜ-FTR-IEK-01
- Conditions
- Plantar Fascitis
- Keywords
- Plantar Fasciitis, Exercise, Lasers, Extracorporeal Shockwave Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul Saglik Bilimleri UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 29 Apr 2022 (actual)
- Study completion
- 29 Apr 2022 (actual)
- First posted
- 6 Jun 2024 (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.
This study aims to evaluate the effectiveness of exercise combined with ESWT (Extracorporeal Shockwave Therapy), exercise combined with MLS (Multiwave Locked System) laser therapy, and exercise alone in female patients diagnosed with unilateral plantar fasciitis, using Visual Analog Scale (VAS), Heel Tenderness Index (HTI), Foot and Ankle Outcome Score (FAOS), Foot Function Index (FFI) and fall risk, as clinical parameters to assess any differences in effectiveness levels among these treatments.
Detailed description
Plantar fasciitis (PF) is a prevalent condition characterized by the degeneration of the plantar fascia, a band of connective tissue that originates from the calcaneus to the proximal phalanges and the skin of the foot's anterior part. Despite common misconceptions, plantar fasciitis is not primarily an inflammatory process but results from repetitive microtears leading to a secondary inflammatory reaction of the plantar fascia.
Despite the condition's self-limiting nature, with 70% to 80% of patients experiencing symptom relief through conservative treatment alone, a combination of treatments is often necessary for many. Conservative interventions include rest, cold application, stretching and strengthening exercises, orthotic devices, lifestyle modifications, weight loss, and night splints. Additionally, non-invasive physical therapy modalities such as Extracorporeal Shock Wave Therapy (ESWT), laser, and ultrasound have shown to be cost-effective and accessible treatment options. Invasive treatments, including injections and surgery, are considered for resistant cases
Previous studies have examined the effectiveness of ESWT, Low level laser therapy, High intensity laser therapy, and exercise treatments in patients with PF, demonstrating their efficacy. Although there are studies investigating the effectiveness of MLS laser therapy on various musculoskeletal pathologies, to our knowledge, there is no study specifically examining its efficacy on PF
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 60 patients met the eligibility criteria and were enrolled in the study. The eligible participants were randomized into three distinct groups each comprising 20 individuals: an exercise alone group (Exercise group), an exercise combined with MLS laser therapy group (Laser group), and an exercise combined with ESWT group (ESWT group). Randomization was conducted using a computer-assisted program
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Active comparator | Other: ExercisesAll groups received a regimen of daily exercises, including stretches for the plantar fascia and Achilles tendon, and strengthening exercises for the calf muscles and foot intrinsic muscles. Each type of exercise was demonstrated to the participants by the same physiotherapist at the beginning of the treatment process, to be performed twice a day with 10 repetitions each time. |
| Laser group | Active comparator | Other: Exercises, Other: MLS Laser TreatmentThe MLS Laser applied to the treatment group was administered using an ASA brand Mphi model device. Patients in the Laser group were positioned in a prone position. Treatment was applied continuously for 7 minutes along the plantar fascia, sole of the foot, heel area, and Achilles tendon in accordance with the plantar fasciitis treatment program on the device, at a dose of 1.73 J/cm2 and a frequency of 700 Hz. A treatment program was established with 3 sessions per week, totaling 10 sessions. Patients receiving laser therapy also continued with their exercise programs. |
| ESWT group | Active comparator | Other: Exercises, Other: ESWT treatmentThe treatment group was administered with the Swiss DolorClast Master ESWT device, which produces radial shock waves. Patients in the ESWT group were positioned in a prone position. The most painful point in the heel area was identified through palpation. Gel was applied to this area, followed by the surrounding soft tissues, towards the plantar fascia and the attachment area of the Achilles tendon at the dorsal aspect of the heel. Radial ESWT treatment was applied at a frequency of 10 Hz, pressure of 2.5 bars, and 2000 impulses per session, once a week for a total of 4 sessions. Patients receiving ESWT therapy also continued with their exercise programs. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18-65 years
- Female gender
- Symptoms persisting for at least 6 weeks
- Unilateral plantar fasciitis
- Consent to participate in the study
Key exclusion criteria (14 listed)
- Male gender
- Bilateral plantar fasciitis
- Treatment with ESWT, laser or injection therapy for plantar fasciitis in the previous year
- Participation in a physical therapy program for plantar fasciitis in the last six months
- History of systemic inflammatory disease
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 |
|---|---|---|
| ExercisesAll groups received a regimen of daily exercises, including stretches for the plantar fascia and Achilles tendon, and strengthening exercises for the calf muscles and foot intrinsic muscles. Each type of exercise was demonstrated to the participants by the same physiotherapist at the beginning of the treatment process, to be performed twice a day with 10 repetitions each time. | Other | ESWT group, Exercise group, Laser group |
| MLS Laser TreatmentThe MLS Laser applied to the treatment group was administered using an ASA brand Mphi model device. Patients in the Laser group were positioned in a prone position. Treatment was applied continuously for 7 minutes along the plantar fascia, sole of the foot, heel area, and Achilles tendon in accordance with the plantar fasciitis treatment program on the device, at a dose of 1.73 J/cm2 and a frequency of 700 Hz. A treatment program was established with 3 sessions per week, totaling 10 sessions | Other | Laser group |
| ESWT treatmentThe treatment group was administered with the Swiss DolorClast Master ESWT device, which produces radial shock waves. Patients in the ESWT group were positioned in a prone position. The most painful point in the heel area was identified through palpation. Gel was applied to this area, followed by the surrounding soft tissues, towards the plantar fascia and the attachment area of the Achilles tendon at the dorsal aspect of the heel. Radial ESWT treatment was applied at a frequency of 10 Hz, pressure of 2.5 bars, and 2000 impulses per session, once a week for a total of 4 sessions | Other | ESWT group |
Primary outcome
Visual Analog Scale (VAS)
Time frame: one month
VAS is a scale 10 cm in length, starting from "no pain" and ending with "unbearable pain" (0: no pain, 10: unbearable pain). Patients indicate the severity of their pain by marking the appropriate point on this scale. The distance between "no pain" and this marked point is measured and recorded in centimeters
4 secondary outcomes
Foot Function Index (FFI)
Time frame: one month
Foot and Ankle Outcome Score (FAOS)
Time frame: one month
Heel Tenderness Index (HTI)
Time frame: one month
Biodex Fall Risk Assessment
Time frame: one month
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 6 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Plantar Fascitis
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Active Release Technique vs. Dynamic Soft Tissue Mobilization for Plantar Pain
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Hip Muscle Strengthening and Calf Myofascial Release in Females With Chronic Plantar Fasciitis
Chronic Planter Fascitis
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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
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Radial vs Focused Shockwave Therapy for Plantar Fasciitis
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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.
İbrahim Ethem Kirez principal investigator
İstanbulSBÜ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercises, MLS Laser Treatment and ESWT treatment in people with Plantar Fascitis, run by Istanbul Saglik Bilimleri University 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 5 inclusion and 14 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 6 Jun 2024. 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. 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 (VAS) (time frame: one month). 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 6 Jun 2024.