<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/NCT03839108</url>
  </required_header>
  <id_info>
    <org_study_id>2018/419</org_study_id>
    <nct_id>NCT03839108</nct_id>
  </id_info>
  <brief_title>Comparison of Effect of Prolotherapy and Paraffin Waxes for Hand Osteoarthritis</brief_title>
  <official_title>Which is More Effective: Prolotherapy or Paraffin Waxes for Hand Ostearthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bakirkoy Dr. Sadi Konuk Research and Training Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bakirkoy Dr. Sadi Konuk Research and Training 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>
      Patients with hand osteoarthritis will be randomized into two groups, paraffin wax and&#xD;
      prolotherapy group. Patients will be evaluated before and after treatment , after 2 weeks 4&#xD;
      weeks and 3 months after treatment. Evaluation parameters are visual analog scale, Duruoz&#xD;
      hand index scales, grip strength, lateral pinch, two point pinch and three point pinch&#xD;
      strengths.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a randomized clinical trial. 40 Patients with hand osteoarthritis will be&#xD;
      randomized into 2 groups, paraffin wax and prolotherapy group.Paraffin group patients will be&#xD;
      told to take of jewellery and dip their hands into the bath of melted wax (52 ºC) with hands&#xD;
      open and hand wrist in neutral position for 10 times .In paraffin wax group, patients will be&#xD;
      treated 5 days a week for 2 weeks period. Paraffin wax bath will be applied for 20 minutes in&#xD;
      every physical therapy session. Prolotherapy is a nonsurgical regenerative injection&#xD;
      technique that introduces small amounts of an irritant solution to the site of painful and&#xD;
      degenerated tendon insertions (entheses), joints, ligaments, and in adjacent joint spaces&#xD;
      during several treatment sessions to promote growth of normal cells and tissues.Hypertonic&#xD;
      dextrose solution is most common used agent. In prolotherapy group, %15 dextrose solution&#xD;
      will be applied to medial and lateral aspect of proximal interphalangeal joints (PIJ), distal&#xD;
      interphalangeal joints and carpometacarpal joint of thumb for 3 sessions once a week period.&#xD;
      Grip strength, lateral pinch, two point pinch, three point pinch strengths, Visual analog&#xD;
      scale (VAS), Duruoz Hand Index scales will be assessed before the intervention and after two&#xD;
      weeks, 4 weeks and 3 months after intervention .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 14, 2018</start_date>
  <completion_date type="Actual">March 15, 2020</completion_date>
  <primary_completion_date type="Actual">December 15, 2018</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
    <masking_description>randomised single blind study</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Changed pain score &gt;%20 in hand osteoarthritis in paraffin wax group measured by Visual Analog Scale at 3 months</measure>
    <time_frame>3 months</time_frame>
    <description>Pain is measured by visual analog scale (VAS). The score is determined by measuring the distance (mm) on the 10-cm line between the &quot;no pain&quot; anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm). The patients' pain in paraffin wax group are assessed by VAS in 3 months. Changed pain score &gt;%20 VAS is one of the primary outcomes</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changed pain score &gt;%20 in hand osteoarthritis in prolotherapy group measured by Visual Analogue Scale</measure>
    <time_frame>3 months</time_frame>
    <description>pain change is measured by Visual analogue scales (VAS). The score is determined by measuring the distance (mm) on the 10-cm line between the &quot;no pain&quot; anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm). Changed pain score &gt;%20 VAS in prolotherapy group are assessed in 3 months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Comparison of effect of prolotherapy and paraffin wax on pain score change</measure>
    <time_frame>3 months</time_frame>
    <description>VAS score changes of two groups will be compared</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duruoz Hand Index Scale</measure>
    <time_frame>3 months</time_frame>
    <description>The DHI is a self-report questionnaire which was developed about 15 years ago to evaluate the capacity to carry out manual functional activities with no assistance or aids in patients with rheumatoid arthritis .&#xD;
It consists of 18 questions regarding manual tasks which are frequently carried out while cooking, washing, dressing, etc. The patient is asked to evaluate the difficulty which he/she has in carrying out these tasks (from 0: no difficulty, to 4: nearly impossible)&#xD;
The psychometric properties of this scale have been evaluated in patients with rheumatoid arthritis, scleroderma, hand osteoarthritis, stroke, trauma , diabetes and patients on haemodialysis. Duruoz Hand Index Scales of both groups before the treatment, 3 months after treatment will be compared</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Grip strength, lateral pinch strength, three point strength, two point pinch strength</measure>
    <time_frame>3 months</time_frame>
    <description>Grip strength, lateral pinch strength, three point strength, two point pinch strength is measured by dynamometer in both groups before and after treatment. Effect of therapy on strength of hands will be compared</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Hand Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Paraffin wax group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Paraffin group patients will be told to take of jewellery and dip their hands into the bath of melted wax (52 ºC) with hands open and hand wrist in neutral position for 10 times .In paraffin wax group, patients will be treated 5 days a week for 2 weeks period. Paraffin wax bath will be applied for 20 minutes in every physical therapy session.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Prolotherapy group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug = prolotherapy (%15 dextrose solution) into hand joints&#xD;
%15 dextrose solution will be injected into medial and lateral aspect of proximal interphalangeal joints (PIJ), distal interphalangeal joints and carpometacarpal joint of thumb for 3 sessions once a week period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Paraffin wax</intervention_name>
    <description>Paraffin group patients will be told to take of jewellery and dip their hands into the bath of melted wax (52 ºC) with hands open and hand wrist in neutral position for 10 times .In paraffin wax group, patients will be treated 5 days a week for 2 weeks period. Paraffin wax bath will be applied for 20 minutes in every physical therapy session.</description>
    <arm_group_label>Paraffin wax group</arm_group_label>
    <other_name>paraffin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prolotherapy</intervention_name>
    <description>. Prolotherapy is a nonsurgical regenerative injection technique that introduces small amounts of an irritant solution to the site of painful and degenerated tendon insertions (entheses), joints, ligaments, and in adjacent joint spaces during several treatment sessions to promote growth of normal cells and tissues.Hypertonic dextrose solution is most common used agent. In prolotheraphy group, %15 dextrose solution will be applied to medial and lateral aspect of proximal interphalangeal joints (PIJ), distal interphalangeal joints and carpometacarpal joint of thumb for 3 sessions once a week period</description>
    <arm_group_label>Prolotherapy group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hand osteoarthritis defined according to American College of Rheumatology criteria&#xD;
&#xD;
          -  Older than 40 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Carpal tunnel syndrome&#xD;
&#xD;
          -  De quervain tenosynovitis&#xD;
&#xD;
          -  Dupuytren's contracture&#xD;
&#xD;
          -  Secondary osteoarthritis due to Rheumatoid arthritis, chondrocalcinosis, Psoriatic&#xD;
             arthritis, hemachromatosis&#xD;
&#xD;
          -  Trigger finger&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Işıl Üstün</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bakırköy Dr. Sadi Konuk Training and Research Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sibel Çağlar Okur</last_name>
    <role>Study Director</role>
    <affiliation>Dr Sadi Konuk Training and Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Health Sciences Bakirkoy Dr Sadi Konuk Training and Research Hospital</name>
      <address>
        <city>İstanbul</city>
        <zip>34147</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Dilek B, Gozum M, Sahin E, Baydar M, Ergor G, El O, Bircan C, Gulbahar S. Efficacy of paraffin bath therapy in hand osteoarthritis: a single-blinded randomized controlled trial. Arch Phys Med Rehabil. 2013 Apr;94(4):642-9. doi: 10.1016/j.apmr.2012.11.024. Epub 2012 Nov 24.</citation>
    <PMID>23187044</PMID>
  </reference>
  <reference>
    <citation>Jahangiri A, Moghaddam FR, Najafi S. Hypertonic dextrose versus corticosteroid local injection for the treatment of osteoarthritis in the first carpometacarpal joint: a double-blind randomized clinical trial. J Orthop Sci. 2014 Sep;19(5):737-43. doi: 10.1007/s00776-014-0587-2. Epub 2014 Aug 27.</citation>
    <PMID>25158896</PMID>
  </reference>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>February 5, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>August 31, 2023</last_update_submitted>
  <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bakirkoy Dr. Sadi Konuk Research and Training Hospital</investigator_affiliation>
    <investigator_full_name>Işıl Üstün</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>paraffin</keyword>
  <keyword>prolotherapy</keyword>
  <keyword>hand osteoarthritis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Results of the study will be written as a manuscript. In Turkey, we do not have a system sharing data to other researchers</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03839108
org study id: 2018/419
nct id: NCT03839108
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients with hand osteoarthritis will be randomized into two groups, paraffin wax and
      prolotherapy group. Patients will be evaluated before and after treatment , after 2 weeks 4
      weeks and 3 months after treatment. Evaluation parameters are visual analog scale, Duruoz
      hand index scales, grip strength, lateral pinch, two point pinch and three point pinch
      strengths.
This study is a randomized clinical trial. 40 Patients with hand osteoarthritis will be
      randomized into 2 groups, paraffin wax and prolotherapy group.Paraffin group patients will be
      told to take of jewellery and dip their hands into the bath of melted wax (52 ºC) with hands
      open and hand wrist in neutral position for 10 times .In paraffin wax group, patients will be
      treated 5 days a week for 2 weeks period. Paraffin wax bath will be applied for 20 minutes in
      every physical therapy session. Prolotherapy is a nonsurgical regenerative injection
      technique that introduces small amounts of an irritant solution to the site of painful and
      degenerated tendon insertions (entheses), joints, ligaments, and in adjacent joint spaces
      during several treatment sessions to promote growth of normal cells and tissues.Hypertonic
      dextrose solution is most common used agent. In prolotherapy group, %15 dextrose solution
      will be applied to medial and lateral aspect of proximal interphalangeal joints (PIJ), distal
      interphalangeal joints and carpometacarpal joint of thumb for 3 sessions once a week period.
      Grip strength, lateral pinch, two point pinch, three point pinch strengths, Visual analog
      scale (VAS), Duruoz Hand Index scales will be assessed before the intervention and after two
      weeks, 4 weeks and 3 months after intervention .
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Investigator)
masking description: randomised single blind study
measure: Changed pain score >%20 in hand osteoarthritis in paraffin wax group measured by Visual Analog Scale at 3 months
time frame: 3 months
description: Pain is measured by visual analog scale (VAS). The score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm). The patients' pain in paraffin wax group are assessed by VAS in 3 months. Changed pain score >%20 VAS is one of the primary outcomes
measure: Changed pain score >%20 in hand osteoarthritis in prolotherapy group measured by Visual Analogue Scale
time frame: 3 months
description: pain change is measured by Visual analogue scales (VAS). The score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm). Changed pain score >%20 VAS in prolotherapy group are assessed in 3 months.
measure: Comparison of effect of prolotherapy and paraffin wax on pain score change
time frame: 3 months
description: VAS score changes of two groups will be compared
measure: Duruoz Hand Index Scale
time frame: 3 months
description: The DHI is a self-report questionnaire which was developed about 15 years ago to evaluate the capacity to carry out manual functional activities with no assistance or aids in patients with rheumatoid arthritis .
It consists of 18 questions regarding manual tasks which are frequently carried out while cooking, washing, dressing, etc. The patient is asked to evaluate the difficulty which he/she has in carrying out these tasks (from 0: no difficulty, to 4: nearly impossible)
The psychometric properties of this scale have been evaluated in patients with rheumatoid arthritis, scleroderma, hand osteoarthritis, stroke, trauma , diabetes and patients on haemodialysis. Duruoz Hand Index Scales of both groups before the treatment, 3 months after treatment will be compared
measure: Grip strength, lateral pinch strength, three point strength, two point pinch strength
time frame: 3 months
description: Grip strength, lateral pinch strength, three point strength, two point pinch strength is measured by dynamometer in both groups before and after treatment. Effect of therapy on strength of hands will be compared
arm group label: Paraffin wax group
arm group type: Active Comparator
description: Paraffin group patients will be told to take of jewellery and dip their hands into the bath of melted wax (52 ºC) with hands open and hand wrist in neutral position for 10 times .In paraffin wax group, patients will be treated 5 days a week for 2 weeks period. Paraffin wax bath will be applied for 20 minutes in every physical therapy session.
arm group label: Prolotherapy group
arm group type: Experimental
description: Drug = prolotherapy (%15 dextrose solution) into hand joints
%15 dextrose solution will be injected into medial and lateral aspect of proximal interphalangeal joints (PIJ), distal interphalangeal joints and carpometacarpal joint of thumb for 3 sessions once a week period.
intervention type: Other
intervention name: Paraffin wax
description: Paraffin group patients will be told to take of jewellery and dip their hands into the bath of melted wax (52 ºC) with hands open and hand wrist in neutral position for 10 times .In paraffin wax group, patients will be treated 5 days a week for 2 weeks period. Paraffin wax bath will be applied for 20 minutes in every physical therapy session.
arm group label: Paraffin wax group
other name: paraffin
intervention type: Drug
intervention name: Prolotherapy
description: . Prolotherapy is a nonsurgical regenerative injection technique that introduces small amounts of an irritant solution to the site of painful and degenerated tendon insertions (entheses), joints, ligaments, and in adjacent joint spaces during several treatment sessions to promote growth of normal cells and tissues.Hypertonic dextrose solution is most common used agent. In prolotheraphy group, %15 dextrose solution will be applied to medial and lateral aspect of proximal interphalangeal joints (PIJ), distal interphalangeal joints and carpometacarpal joint of thumb for 3 sessions once a week period
arm group label: Prolotherapy group
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: No
last name: Işıl Üstün
role: Principal Investigator
affiliation: Bakırköy Dr. Sadi Konuk Training and Research Hospital
last name: Sibel Çağlar Okur
role: Study Director
affiliation: Dr Sadi Konuk Training and Research Hospital
facility: 
country: Turkey
citation: Dilek B, Gozum M, Sahin E, Baydar M, Ergor G, El O, Bircan C, Gulbahar S. Efficacy of paraffin bath therapy in hand osteoarthritis: a single-blinded randomized controlled trial. Arch Phys Med Rehabil. 2013 Apr;94(4):642-9. doi: 10.1016/j.apmr.2012.11.024. Epub 2012 Nov 24.
PMID: 23187044
citation: Jahangiri A, Moghaddam FR, Najafi S. Hypertonic dextrose versus corticosteroid local injection for the treatment of osteoarthritis in the first carpometacarpal joint: a double-blind randomized clinical trial. J Orthop Sci. 2014 Sep;19(5):737-43. doi: 10.1007/s00776-014-0587-2. Epub 2014 Aug 27.
PMID: 25158896
responsible party type: Principal Investigator
investigator affiliation: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
investigator full name: Işıl Üstün
investigator title: Principal investigator
mesh term: Osteoarthritis
sharing ipd: No
ipd description: Results of the study will be written as a manuscript. In Turkey, we do not have a system sharing data to other researchers