Plantar FascitisNCT06023836
Myofascial Pain Syndrome and Plantar Fasciitis Treatment
A study testing ESWT and Dry needling in people with Plantar Fascitis and Myofascial Pain Syndrome, run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Patients with plantar fasciitis between the ages of 25-65 years who presented to the Physical Medicine and Rehabilitation clinic with the complaint of heel pain and met the inclusion and exclusion criteria will be included in the study. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Plantar Fascitis, Myofascial Pain Syndrome
- What is being tested?
- ESWT and Dry needling
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2023to 8 Sep 2023
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 25-65 years with heel pain for more than 6 weeks
- tenderness on palpation in the medial calcaneal region
- aggravation of symptoms while standing and in the first hours of the morning
- who agreed not to receive anti-inflammatory treatment during the study period
- fascia thickness >4mm measured by ultrasound.
Who cannot join
- Patients diagnosed with rheumatologic diseases
- Those diagnosed with Diabetes Mellitus (DM), those with chronic liver and kidney failure
- Anti-inflammatory-analgesic treatment within the last 1 month
- Diagnosed with inflammatory rheumatic disease
- Those with a history of foot surgery
- Those with mid or hindfoot deformity
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- Previous history of central or peripheral nerve damage, lower extremity neuropathy
- Those diagnosed with Diabetes Mellitus
- Those with cognitive impairment
- Unassisted mobilization
- Those with bleeding disorders
- Pregnant women
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Training and Resarch Hospital
Istanbul
About this study
Official title: Myofascial Pain Syndrome in Plantar Fasciitis; Comparison of Dry Needling and Extracorporeal Shockwave Therapy (ESWT) Effects on Pain and Function
Patients with plantar fasciitis between the ages of 25-65 years who presented to the Physical Medicine and Rehabilitation clinic with the complaint of heel pain and met the inclusion and exclusion criteria will be included in the study. Demographic data (age, gender, body mass index, symptom duration) will be recorded at the beginning of the study. Then, Foot Functional Index (FFI) and Visual Analog Scale (VAS) scales will be recorded. Participants will be randomly divided into two groups. Group 1 will receive dry needling and Group 2 will receive extracorporeal shock wave therapy (ESWT). Patients in the 1st group will undergo 3 sessions of dry needling with Seirin branded 0.6*50 mm acupuncture needles at one week intervals for the trigger point detected by manual palpation in the medial gastrocnemius, lateral gastrocnemius, soleus, flexor digitorum brevis, quadratus plantae, abductor hallucis brevis muscles. Patients in the 2nd group, Patients in this group received three sessions of ESWT (MASTERPLUS MP 200 ENERGY 2 trademarked ESWT device) at an energy density of 2 bars and a frequency of 2,000 shocks/min at 12 Hz for three weeks, each session once a week. Each of the five most sensitive and painful points was given 400 pulses in the supine position
- Conditions
- Plantar Fascitis, Myofascial Pain Syndrome
- Being tested
- ESWT, Dry needling
- Keywords
- plantar fasciitis, ESWT, dry needling
- Medical subject headings
- Myofascial Pain Syndromes, Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESWTDevice
Patients in this group received three sessions of ESWT (MASTERPLUS MP 200 ENERGY 2 trademarked ESWT device) at an energy density of 2 bars and a frequency of 2,000 shocks/min at 12 Hz for three weeks, each session once a week. Each of the five most sensitive and painful points was given 400 pulses in the supine position
Dry needlingProcedure or surgery
Dry needling with Seirin branded 0.6*50 mm acupuncture needles will be performed for 3 sessions with one week intervals for the trigger point detected by manual palpation in the medial gastrocnemius, lateral gastrocnemius, soleus, flexor digitorum brevis, quadratus plantae, abductor hallucis brevis muscles of the patients in the group.
| Study group | Role | What they receive |
|---|---|---|
| group 1: ESWT treatment | Active comparator | Participants in this group will only receive ESWT treatment Receives: Device: ESWT |
| Dry needling | Active comparator | Participants in this group will only receive Dry needling treatment Receives: Procedure: Dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain was evaluated with a Visual analog scale (VAS) score.
VAS score ranges from 0 to 10.
Comparison of the effects of ESWT and dry needling on pain in the management of plantar fasciitis
Measured: 5 months
Function was evaluated with (Foot Functional Index) FFI score.
Comparison of the effects of ESWT and dry needling on function in the management of plantar fasciitis
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start1 May 2023
- Primary completion28 Aug 2023
- Study completion8 Sep 2023
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
- Participants will be randomly divided into 2 groups and will be treated with ESWT or Dry needling.
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Burak Tayyip Dede, Istanbul Training and Research Hospital
- Investigators
- Burak Tayyip Dede, Principal investigator, İstanbul Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06023836
- Sponsor's protocol ID
- 07/04/2023; 2011-KAEK-50;89
- Status last verified
- Sep 2023
- First submitted
- 26 Aug 2023
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myofascial Pain Syndrome in Plantar Fasciitis; Comparison of Dry Needling and Extracorporeal Shockwave Therapy (ESWT) Effects on Pain and Function
- ClinicalTrials.gov ID
- NCT06023836
- Acronym / sponsor ID
- 07/04/2023; 2011-KAEK-50;89
- Conditions
- Plantar Fascitis, Myofascial Pain Syndrome
- Keywords
- plantar fasciitis, ESWT, dry needling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Istanbul Training and Research HospitalOther government
- Study start
- 1 May 2023 (actual)
- Primary completion
- 28 Aug 2023 (actual)
- Study completion
- 8 Sep 2023 (actual)
- First posted
- 5 Sep 2023 (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.
Patients with plantar fasciitis between the ages of 25-65 years who presented to the Physical Medicine and Rehabilitation clinic with the complaint of heel pain and met the inclusion and exclusion criteria will be included in the study. Demographic data (age, gender, body mass index, symptom duration) will be recorded at the beginning of the study. Then, Foot Functional Index (FFI) and Visual Analog Scale (VAS) scales will be recorded. Participants will be randomly divided into two groups. Group 1 will receive dry needling and Group 2 will receive extracorporeal shock wave therapy (ESWT). Patients in the 1st group will undergo 3 sessions of dry needling with Seirin branded 0.6*50 mm acupuncture needles at one week intervals for the trigger point detected by manual palpation in the medial gastrocnemius, lateral gastrocnemius, soleus, flexor digitorum brevis, quadratus plantae, abductor hallucis brevis muscles. Patients in the 2nd group, Patients in this group received three sessions of ESWT (MASTERPLUS MP 200 ENERGY 2 trademarked ESWT device) at an energy density of 2 bars and a frequency of 2,000 shocks/min at 12 Hz for three weeks, each session once a week. Each of the five most sensitive and painful points was given 400 pulses in the supine position
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly divided into 2 groups and will be treated with ESWT or Dry needling.
| Arm | Type | Receives |
|---|---|---|
| group 1: ESWT treatment | Active comparator | Device: ESWTParticipants in this group will only receive ESWT treatment |
| Dry needling | Active comparator | Procedure: Dry needlingParticipants in this group will only receive Dry needling treatment |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 25-65 years with heel pain for more than 6 weeks
- tenderness on palpation in the medial calcaneal region
- aggravation of symptoms while standing and in the first hours of the morning
- who agreed not to receive anti-inflammatory treatment during the study period
- fascia thickness >4mm measured by ultrasound.
Key exclusion criteria (12 listed)
- Patients diagnosed with rheumatologic diseases
- Those diagnosed with Diabetes Mellitus (DM), those with chronic liver and kidney failure
- Anti-inflammatory-analgesic treatment within the last 1 month
- Diagnosed with inflammatory rheumatic disease
- Those with a history of foot surgery
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 |
|---|---|---|
| ESWTPatients in this group received three sessions of ESWT (MASTERPLUS MP 200 ENERGY 2 trademarked ESWT device) at an energy density of 2 bars and a frequency of 2,000 shocks/min at 12 Hz for three weeks, each session once a week. Each of the five most sensitive and painful points was given 400 pulses in the supine position | Device | group 1: ESWT treatment |
| Dry needlingDry needling with Seirin branded 0.6*50 mm acupuncture needles will be performed for 3 sessions with one week intervals for the trigger point detected by manual palpation in the medial gastrocnemius, lateral gastrocnemius, soleus, flexor digitorum brevis, quadratus plantae, abductor hallucis brevis muscles of the patients in the group. | Procedure or surgery | Dry needling |
Primary outcome
Pain was evaluated with a Visual analog scale (VAS) score.
Time frame: 5 months
VAS score ranges from 0 to 10. Comparison of the effects of ESWT and dry needling on pain in the management of plantar fasciitis
Function was evaluated with (Foot Functional Index) FFI score.
Time frame: 5 months
Comparison of the effects of ESWT and dry needling on function in the management of plantar fasciitis
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 3 Oct 2023.
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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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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.
Burak Tayyip Dede principal investigator
İstanbul Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESWT and Dry needling in people with Plantar Fascitis and Myofascial Pain Syndrome, run by Istanbul Training 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 5 inclusion and 12 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 3 Oct 2023. 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?
Pain was evaluated with a Visual analog scale (VAS) score. (time frame: 5 months). The study lists 2 primary outcomes in all. 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 3 Oct 2023.