xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05984121</url>
    </required_header>
    <id_info>
      <org_study_id>AEU-FTR-DG-01</org_study_id>
      <nct_id>NCT05984121</nct_id>
    </id_info>
    <brief_title>Comparison of the Effectiveness of Local Ozone Injection and Dextrose Prolotherapy Injection in Chronic Plantar Fasciitis</brief_title>
    <official_title>Which is Outstanding, Local Ozone Injection or Dextrose Prolotherapy Injection in Chronic Plantar Fasciitis?: A Randomised Controlled Study&quot;</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ahi Evran University Education and Research Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ahi Evran University Education and Research Hospital</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of our study was to investigate the effect of local ozone injection and dextrose&#xD;
        prolotherapy applications on pain and foot functions to compare the efficacy and to evaluate&#xD;
        the thickness of the plantar fascia.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In this study, 60 plantar fasciitis patients aged between 18 and 75 years admitted to&#xD;
        Kırşehir Ahi Evran University Training and Research Hospital were examined. Plantar fasciitis&#xD;
        (PF) is a common cause of heel pain associated with gait disorders.&#xD;
  &#xD;
        is one of the causes and has a significant negative impact on quality of life. The diagnosis&#xD;
        is usually made by clinical assessment and no additional investigations are required.&#xD;
        Treatment with non-steroidal anti-inflammatory drugs, night splints and therapeutic exercises&#xD;
        are the first choice extracorporeal shock wave therapy and plasma-rich Minimally invasive&#xD;
        treatments such as platelet (prp) can also be applied.Plantar dextrose prolotherapy, which is&#xD;
        another treatment method in fasciitis, improves the ligament structure strengthens and&#xD;
        reduces pain.In 2022, Chutumstid T et al. conducted a meta-analysis and found that dextrose&#xD;
        prolotherapy reduces pain, increases functionality and increases plantar fascia thickness in&#xD;
        chronic plantar fasciitis.&#xD;
  &#xD;
        decreased the risk of complications. Seyam Omar et al. concluded that ozone therapy can be&#xD;
        applied subcutaneously, periarticularly and intraarticularly. It can be preferred due to its&#xD;
        low risk and high chance of success. is a treatment method.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 17, 2023</start_date>
    <completion_date type="Anticipated">April 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Three groups with a conventional therapy control group</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>Patients will be randomly divided into 3 groups. (They will be selected by simple random sampling using the closed envelope method). They will be divided into Group 1 (local ozon injections and exercise) and group 2 (local dextroz prolotherapy and exercise) and group 3 (exercise) Outcome evalutions in the stduy will be carried out by a researcher who is blind to group allocation</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Visual analogue scale (VAS)</measure>
      <time_frame>0. week</time_frame>
      <description>A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.Pain intensity was measured with visual analogue scale for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Visual analogue scale (VAS)</measure>
      <time_frame>2. week</time_frame>
      <description>A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.Pain intensity was measured with visual analogue scale for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Visual analogue scale (VAS)</measure>
      <time_frame>4. week</time_frame>
      <description>A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.Pain intensity was measured with visual analogue scale for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Visual analogue scale (VAS)</measure>
      <time_frame>12.week</time_frame>
      <description>A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.Pain intensity was measured with visual analogue scale for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Foot Function Index (FFI)</measure>
      <time_frame>0. week</time_frame>
      <description>Foot function index; 3 subgroups as pain, disability and activity limitation consists of 23 items. The pain subscale, which contains nine items, includes the foot measures the level of pain in various situations. The inadequacy sub-scale, which contains nine items scale, on the other hand, is a scale of various functional activities depending on foot problems. determines the degree of difficulty in performing the activity. The five-item activity limitation subscale The scale assesses activity limitations due to foot problems</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Foot Function Index (FFI)</measure>
      <time_frame>2. week</time_frame>
      <description>Foot function index; 3 subgroups as pain, disability and activity limitation consists of 23 items. The pain subscale, which contains nine items, includes the foot measures the level of pain in various situations. The inadequacy sub-scale, which contains nine items scale, on the other hand, is a scale of various functional activities depending on foot problems. determines the degree of difficulty in performing the activity. The five-item activity limitation subscale The scale assesses activity limitations due to foot problems</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Foot Function Index (FFI)</measure>
      <time_frame>4. week</time_frame>
      <description>Foot function index; 3 subgroups as pain, disability and activity limitation consists of 23 items. The pain subscale, which contains nine items, includes the foot measures the level of pain in various situations. The inadequacy sub-scale, which contains nine items scale, on the other hand, is a scale of various functional activities depending on foot problems. determines the degree of difficulty in performing the activity. The five-item activity limitation subscale The scale assesses activity limitations due to foot problems</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Foot Function Index (FFI)</measure>
      <time_frame>12.week</time_frame>
      <description>Foot function index; 3 subgroups as pain, disability and activity limitation consists of 23 items. The pain subscale, which contains nine items, includes the foot measures the level of pain in various situations. The inadequacy sub-scale, which contains nine items scale, on the other hand, is a scale of various functional activities depending on foot problems. determines the degree of difficulty in performing the activity. The five-item activity limitation subscale The scale assesses activity limitations due to foot problems</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>plantar fascia thickness measurement</measure>
      <time_frame>0. week</time_frame>
      <description>plantar fascia thickness measurement will be performed by ultrasonography</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>plantar fascia thickness measurement</measure>
      <time_frame>12. week</time_frame>
      <description>plantar fascia thickness measurement will be performed by ultrasonography</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Plantar Fascitis</condition>
    <arm_group>
      <arm_group_label>Local ozon injections</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Local ozone therapy consists of 95-99% oxygen, 1-5% medical ozone mixture and is obtained from medical ozone generators. Medical ozone therapy contains at least 95% oxygen and at most 5% ozone. (Bocci, Velio Alvaro. 2006)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Local dextroz prolotherapy injections</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Hypertonic dextrose prolotherapy stimulates the cells at the injection site dehydrates, causing local tissue trauma, and increases macrophage and attracts granulocytes to that area and provides tissue healing. (Hauser, Ross and et al, 2016). Kesikburun Serdar et al. in 2022 with plantar fasciitis prolotherapy injection 3 times at 2 weeks intervals in their study &quot;They used a 15% dextrose prolotherapy solution.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Exercise Group (Control Group)</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Patients in the exercise group were treated as in the other groups during the treatment period.&#xD;
  plantar fascia stretching exercises, gastrocsoleus stretching exercises, foot intrinsic muscle strengthening exercises will be taught 2 times a day 10 times each will be asked to do so. In a systematic review by Siriphorn et al. fascia stretching exercises and gastrocsoleus stretching exercises in plantar fasciitis There is evidence that it is effective. The control group was given exercise therapy We aimed to ensure that the control group was not left untreated. in case of cold application and NSAIDs other than paracetamol will be asked not to take medication.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Local ozon injections</intervention_name>
      <description>Local ozone therapy is approximately 2-3 cc of medical ozone, ozone-resistant is realised by injecting subcutaneously or intramuscularly with injectors. Local ozone injection group at 0., 2. and 4. weeks with ultrasound guided medial Firstly 1.5 cc with a 25 gauge needle into the plantar fascia insertion in the plantar region &quot;02 lidocaine injection in a sterile way and then (according to the weeks 3 cc ozone injection of 10, 15 and 20 pyg/ml will be made respectively.</description>
      <arm_group_label>Exercise Group (Control Group)</arm_group_label>
      <arm_group_label>Local ozon injections</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Local dextroz prolotherapy injections</intervention_name>
      <description>Dextrose prolotherapy injection group under ultrasound guidance at weeks 0, 2 and 4 1.5 cc 30% dextrose solution and 1.5 cc 2 lidocaine mixture with a 25 gauge needle into the medial plantar region cc 2 lidocaine mixture will be made sterile with 3 cc 15% dextrose.</description>
      <arm_group_label>Exercise Group (Control Group)</arm_group_label>
      <arm_group_label>Local dextroz prolotherapy injections</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Exercise Group</intervention_name>
      <description>Patients will receive a conventional therapy program consisting of exercises</description>
      <arm_group_label>Exercise Group (Control Group)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18-75 years old, both sexes&#xD;
  &#xD;
            -  Pain in the plantar medial calcaneal tubercle on palpation for more than 3 months&#xD;
  &#xD;
            -  Accepting to participate in the study&#xD;
  &#xD;
            -  Heel pain, especially in the first few steps in the morning, increasing with loading&#xD;
               during the day&#xD;
  &#xD;
            -  Patients with an initial VAS assessment of 4 or more on a 10 cm scale&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Hyperthyroidism&#xD;
  &#xD;
            -  Glucose6 phosphate dehydrogenase deficiency&#xD;
  &#xD;
            -  Ozone allergy&#xD;
  &#xD;
            -  Acute metabolic disease comorbidity (acute MI, acute hyperglycaemia, diabetic&#xD;
               ketoacidosis, acute cerebrovascular disease etc.)&#xD;
  &#xD;
            -  Pregnancy and breastfeeding&#xD;
  &#xD;
            -  Malignite&#xD;
  &#xD;
            -  Epilepsy&#xD;
  &#xD;
            -  Tipl, having a history of type 2 diabetes&#xD;
  &#xD;
            -  History of inflammatory rheumatic disease&#xD;
  &#xD;
            -  History of bleeding disorders&#xD;
  &#xD;
            -  Use of anticoagulants other than aspirin&#xD;
  &#xD;
            -  Local corticosteroid injection into the plantar fascia within the last 3 months to&#xD;
               have a story&#xD;
  &#xD;
            -  ESWT treatment of the plantar fascia in the last 3 months&#xD;
  &#xD;
            -  To have received physiotherapy to the foot, ankle area within the last 3 months&#xD;
  &#xD;
            -  History of foot and ankle surgery&#xD;
  &#xD;
            -  Active infection at the application site (cellulitis, erysipelas, etc.)&#xD;
  &#xD;
            -  Allergy to dextrose&#xD;
  &#xD;
            -  History of peripheral neuropathy&#xD;
  &#xD;
            -  SI radiculopathy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Figen TUNCAY, Prof.Dr.</last_name>
      <phone>5353046401</phone>
      <phone_ext>+90</phone_ext>
      <email>figentuncay3206@hotmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Dogus Gümüsay, Ass.Dr.</last_name>
      <phone>5556502708</phone>
      <phone_ext>+90</phone_ext>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Kırşehir Ahi Evran Üniversitesi</name>
        <address>
          <city>Kırşehir</city>
          <zip>40100</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Figen Tuncay, Prof.Dr.</last_name>
        <phone>5353046401</phone>
        <phone_ext>+90</phone_ext>
        <email>figentuncay3206@hotmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ahi Evran University Education and Research Hospital</investigator_affiliation>
      <investigator_full_name>Figen Tuncay</investigator_full_name>
      <investigator_title>Physical Medicine and Rehabilitation</investigator_title>
    </responsible_party>
    <keyword>Local Ozon therapy</keyword>
    <keyword>Rehabilitation</keyword>
    <keyword>Dextroz prolotherapy</keyword>
    <keyword>Ultrasonography</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fasciitis</mesh_term>
      <mesh_term>Fasciitis, Plantar</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05984121
  org study id: AEU-FTR-DG-01
  nct id: NCT05984121
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of our study was to investigate the effect of local ozone injection and dextrose
        prolotherapy applications on pain and foot functions to compare the efficacy and to evaluate
        the thickness of the plantar fascia.
  In this study, 60 plantar fasciitis patients aged between 18 and 75 years admitted to
        Kırşehir Ahi Evran University Training and Research Hospital were examined. Plantar fasciitis
        (PF) is a common cause of heel pain associated with gait disorders.
  
        is one of the causes and has a significant negative impact on quality of life. The diagnosis
        is usually made by clinical assessment and no additional investigations are required.
        Treatment with non-steroidal anti-inflammatory drugs, night splints and therapeutic exercises
        are the first choice extracorporeal shock wave therapy and plasma-rich Minimally invasive
        treatments such as platelet (prp) can also be applied.Plantar dextrose prolotherapy, which is
        another treatment method in fasciitis, improves the ligament structure strengthens and
        reduces pain.In 2022, Chutumstid T et al. conducted a meta-analysis and found that dextrose
        prolotherapy reduces pain, increases functionality and increases plantar fascia thickness in
        chronic plantar fasciitis.
  
        decreased the risk of complications. Seyam Omar et al. concluded that ozone therapy can be
        applied subcutaneously, periarticularly and intraarticularly. It can be preferred due to its
        low risk and high chance of success. is a treatment method.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Three groups with a conventional therapy control group
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  masking description: Patients will be randomly divided into 3 groups. (They will be selected by simple random sampling using the closed envelope method). They will be divided into Group 1 (local ozon injections and exercise) and group 2 (local dextroz prolotherapy and exercise) and group 3 (exercise) Outcome evalutions in the stduy will be carried out by a researcher who is blind to group allocation
  measure: Visual analogue scale (VAS)
  time frame: 0. week
  description: A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.Pain intensity was measured with visual analogue scale for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity
  measure: Visual analogue scale (VAS)
  time frame: 2. week
  description: A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.Pain intensity was measured with visual analogue scale for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity
  measure: Visual analogue scale (VAS)
  time frame: 4. week
  description: A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.Pain intensity was measured with visual analogue scale for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity
  measure: Visual analogue scale (VAS)
  time frame: 12.week
  description: A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.Pain intensity was measured with visual analogue scale for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity
  measure: Foot Function Index (FFI)
  time frame: 0. week
  description: Foot function index; 3 subgroups as pain, disability and activity limitation consists of 23 items. The pain subscale, which contains nine items, includes the foot measures the level of pain in various situations. The inadequacy sub-scale, which contains nine items scale, on the other hand, is a scale of various functional activities depending on foot problems. determines the degree of difficulty in performing the activity. The five-item activity limitation subscale The scale assesses activity limitations due to foot problems
  measure: Foot Function Index (FFI)
  time frame: 2. week
  description: Foot function index; 3 subgroups as pain, disability and activity limitation consists of 23 items. The pain subscale, which contains nine items, includes the foot measures the level of pain in various situations. The inadequacy sub-scale, which contains nine items scale, on the other hand, is a scale of various functional activities depending on foot problems. determines the degree of difficulty in performing the activity. The five-item activity limitation subscale The scale assesses activity limitations due to foot problems
  measure: Foot Function Index (FFI)
  time frame: 4. week
  description: Foot function index; 3 subgroups as pain, disability and activity limitation consists of 23 items. The pain subscale, which contains nine items, includes the foot measures the level of pain in various situations. The inadequacy sub-scale, which contains nine items scale, on the other hand, is a scale of various functional activities depending on foot problems. determines the degree of difficulty in performing the activity. The five-item activity limitation subscale The scale assesses activity limitations due to foot problems
  measure: Foot Function Index (FFI)
  time frame: 12.week
  description: Foot function index; 3 subgroups as pain, disability and activity limitation consists of 23 items. The pain subscale, which contains nine items, includes the foot measures the level of pain in various situations. The inadequacy sub-scale, which contains nine items scale, on the other hand, is a scale of various functional activities depending on foot problems. determines the degree of difficulty in performing the activity. The five-item activity limitation subscale The scale assesses activity limitations due to foot problems
  measure: plantar fascia thickness measurement
  time frame: 0. week
  description: plantar fascia thickness measurement will be performed by ultrasonography
  measure: plantar fascia thickness measurement
  time frame: 12. week
  description: plantar fascia thickness measurement will be performed by ultrasonography
  arm group label: Local ozon injections
  arm group type: Active Comparator
  description: Local ozone therapy consists of 95-99% oxygen, 1-5% medical ozone mixture and is obtained from medical ozone generators. Medical ozone therapy contains at least 95% oxygen and at most 5% ozone. (Bocci, Velio Alvaro. 2006)
  arm group label: Local dextroz prolotherapy injections
  arm group type: Active Comparator
  description: Hypertonic dextrose prolotherapy stimulates the cells at the injection site dehydrates, causing local tissue trauma, and increases macrophage and attracts granulocytes to that area and provides tissue healing. (Hauser, Ross and et al, 2016). Kesikburun Serdar et al. in 2022 with plantar fasciitis prolotherapy injection 3 times at 2 weeks intervals in their study "They used a 15% dextrose prolotherapy solution.
  arm group label: Exercise Group (Control Group)
  arm group type: Other
  description: Patients in the exercise group were treated as in the other groups during the treatment period.
  plantar fascia stretching exercises, gastrocsoleus stretching exercises, foot intrinsic muscle strengthening exercises will be taught 2 times a day 10 times each will be asked to do so. In a systematic review by Siriphorn et al. fascia stretching exercises and gastrocsoleus stretching exercises in plantar fasciitis There is evidence that it is effective. The control group was given exercise therapy We aimed to ensure that the control group was not left untreated. in case of cold application and NSAIDs other than paracetamol will be asked not to take medication.
  intervention type: Drug
  intervention name: Local ozon injections
  description: Local ozone therapy is approximately 2-3 cc of medical ozone, ozone-resistant is realised by injecting subcutaneously or intramuscularly with injectors. Local ozone injection group at 0., 2. and 4. weeks with ultrasound guided medial Firstly 1.5 cc with a 25 gauge needle into the plantar fascia insertion in the plantar region "02 lidocaine injection in a sterile way and then (according to the weeks 3 cc ozone injection of 10, 15 and 20 pyg/ml will be made respectively.
  arm group label: Exercise Group (Control Group)
  arm group label: Local ozon injections
  intervention type: Drug
  intervention name: Local dextroz prolotherapy injections
  description: Dextrose prolotherapy injection group under ultrasound guidance at weeks 0, 2 and 4 1.5 cc 30% dextrose solution and 1.5 cc 2 lidocaine mixture with a 25 gauge needle into the medial plantar region cc 2 lidocaine mixture will be made sterile with 3 cc 15% dextrose.
  arm group label: Exercise Group (Control Group)
  arm group label: Local dextroz prolotherapy injections
  intervention type: Other
  intervention name: Exercise Group
  description: Patients will receive a conventional therapy program consisting of exercises
  arm group label: Exercise Group (Control Group)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Figen TUNCAY, Prof.Dr.
  phone: 5353046401
  phone ext: +90
  email: figentuncay3206@hotmail.com
  last name: Dogus Gümüsay, Ass.Dr.
  phone: 5556502708
  phone ext: +90
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Ahi Evran University Education and Research Hospital
  investigator full name: Figen Tuncay
  investigator title: Physical Medicine and Rehabilitation
  mesh term: Fasciitis
  mesh term: Fasciitis, Plantar
  sharing ipd: No