<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/NCT03270488</url>
  </required_header>
  <id_info>
    <org_study_id>UMalaga2</org_study_id>
    <nct_id>NCT03270488</nct_id>
  </id_info>
  <brief_title>Laser Therapy, Pain and Carpometacarpal Joint Osteoarthritis Treatment</brief_title>
  <acronym>Laser</acronym>
  <official_title>Effects of Laser Therapy on Pain Intensity for Carpometacarpal Joint Osteoarthritis as a Isolated Treatment. A Randomized (Double-blind) Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Malaga</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Malaga</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>
      Osteoarthritis (OA) is a chronic and prevalent joint disorder with great impact on quality of&#xD;
      life and high economic burden. Although a number of conservative therapies have proven to be&#xD;
      effective for the management of hand OA, only modest treatment effects were reported for most&#xD;
      individual interventions. The aim of the proposed study is to assess the effect of laser&#xD;
      therapy on pain, function and force in patients with carpometacarpal osteoarthritis (CMC OA).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized, controlled, single-center, double-blind, clinical trial, with 1:1 allocation&#xD;
      ratio, were carried out involving patients diagnosis of CMC joint OA grade 1-2 (aged 18 years&#xD;
      and above). Both assessor and statistician remained blinded. The research diagnostic criteria&#xD;
      for carpometacarpal joint osteoarthritis was used to assess all individuals who agree to&#xD;
      participate. All participants were submitted to a clinical examination and X-ray assessment&#xD;
      of thumb base to determine carpometacarpal osteoarthritis grade. Based on the clinical and&#xD;
      radiological findings, the participants were classified by a rheumatology. Those with CMC OA&#xD;
      grade 2-3 were included in the study. The experimental group received laser therapy and&#xD;
      control group received a placebo treatment.&#xD;
&#xD;
      The primary outcome measures was pain scores during daily living activities (DLA)- at the&#xD;
      base of the thumb measured with VAS (Unidimensional measure of pain: 0-10 (0, no pain and 10,&#xD;
      worst pain), and changes in hand function measured using the Quick-Dash questionnaire.&#xD;
      Secondary outcome measures included changes in pinch strength. All outcome measures were&#xD;
      collected at baseline, immediately following the intervention at 4 weeks and at 12 weeks&#xD;
      following the end of the intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 24, 2017</start_date>
  <completion_date type="Actual">September 25, 2017</completion_date>
  <primary_completion_date type="Actual">June 15, 2017</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analogue Scale (VAS)</measure>
    <time_frame>3 months</time_frame>
    <description>VAS has been shown to be a reliable and valid instrument for pain assessment which is used frequently for clinical and research purposes. It consists of a 10-cm line anchored at each end. The left-hand anchor reads 'no pain' and the right-hand anchor reads 'worst possible pain'; the patients marked a line to represent their pain level. EVA scale was development by Huskisson in 1974. Ensen MP, Karoly P. Self-report scales and procedures for assessing pain in adults. In: Turk DC, Melzack R (eds). Handbook of Pain Assessment. 2nd ed. New York, NY: The Guilford Press, 2001. pp. 15-34.&#xD;
Seymour RA. The use of pain scales in assessing the efficacy ofanalgesics in post-operative dental pain. Eur J Clin Pharmacol. 1982;23:441-4 Gatson-Johansson F. Measurement of pain: the psychometric properties of the Pain-O-Meter, a simple, inexpensive pain assessment tool that could change health care practices. J Pain Symptom Manage. 1996;12:172-81.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Key pinch strength</measure>
    <time_frame>3 months</time_frame>
    <description>For measure pinch key we used Key pinch dynamometer. Pinch strength was less in patients with early thumb CMC OA. Key pinch had the most robust association with OA diagnosis. Tomas J et al. Weaker Functional Pinch Strength Is Associated With Early Thumb Carpometacarpal Osteoarthritis. Clin Orthop Relat Res (2016) 474:557-561 MacDermid JC, Wessel J, MacIntyre N, Galea V. The relationship between impairment, dexterity and self-reported disability of persons with osteoarthritis of the hand. J Hand Ther. 2008;21:427-8</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>Thumb Osteoarthritis</condition>
  <condition>Pain</condition>
  <condition>Physical Disorder</condition>
  <arm_group>
    <arm_group_label>Laser Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Laser application three times a week for 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The same equipment was used with a pen that emits a red guide light and a warning sound, but without the emission of a laser beam.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Laser</intervention_name>
    <description>Laser (power of 3.0w).</description>
    <arm_group_label>Laser Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Laser (power 0,0w)</description>
    <arm_group_label>Placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women over 18 diagnosis of CMC joint OA in their dominan hand.&#xD;
&#xD;
          -  State 1-2 according to the American College of Rheumatology.&#xD;
&#xD;
          -  Pain intensity during activities of daily living (ADLs) of up to 4 of 10 on the visual&#xD;
             analog scale (VAS)&#xD;
&#xD;
          -  Ability to read or understand the patient information sheets.&#xD;
&#xD;
          -  Ability to sign a consent form will be included in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Neurologic disorder affecting the upper limb&#xD;
&#xD;
          -  Previous treatment for their hand problem in the last 6 months including an&#xD;
             intra-articular joint injection to wrist, fingers, or thumb&#xD;
&#xD;
          -  Had fractures or a significant hand injury or previous surgery to the wrist, thumb or&#xD;
             hand&#xD;
&#xD;
          -  Finger tenosynovitis.&#xD;
&#xD;
          -  Dupuytren disease.&#xD;
&#xD;
          -  Psychological treatment.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Raquel Cantero</name>
      <address>
        <city>Málaga</city>
        <state>Malaga</state>
        <zip>29012</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>December 13, 2018</last_update_submitted>
  <last_update_submitted_qc>December 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Malaga</investigator_affiliation>
    <investigator_full_name>Raquel Cantero-Téllez</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>Thumb</keyword>
  <keyword>Osteoarthritis</keyword>
  <keyword>Physical Therapy</keyword>
  <keyword>Pain</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>Undecided</sharing_ipd>
  </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/NCT03270488
org study id: UMalaga2
nct id: NCT03270488
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Osteoarthritis (OA) is a chronic and prevalent joint disorder with great impact on quality of
      life and high economic burden. Although a number of conservative therapies have proven to be
      effective for the management of hand OA, only modest treatment effects were reported for most
      individual interventions. The aim of the proposed study is to assess the effect of laser
      therapy on pain, function and force in patients with carpometacarpal osteoarthritis (CMC OA).
A randomized, controlled, single-center, double-blind, clinical trial, with 1:1 allocation
      ratio, were carried out involving patients diagnosis of CMC joint OA grade 1-2 (aged 18 years
      and above). Both assessor and statistician remained blinded. The research diagnostic criteria
      for carpometacarpal joint osteoarthritis was used to assess all individuals who agree to
      participate. All participants were submitted to a clinical examination and X-ray assessment
      of thumb base to determine carpometacarpal osteoarthritis grade. Based on the clinical and
      radiological findings, the participants were classified by a rheumatology. Those with CMC OA
      grade 2-3 were included in the study. The experimental group received laser therapy and
      control group received a placebo treatment.

      The primary outcome measures was pain scores during daily living activities (DLA)- at the
      base of the thumb measured with VAS (Unidimensional measure of pain: 0-10 (0, no pain and 10,
      worst pain), and changes in hand function measured using the Quick-Dash questionnaire.
      Secondary outcome measures included changes in pinch strength. All outcome measures were
      collected at baseline, immediately following the intervention at 4 weeks and at 12 weeks
      following the end of the intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Visual Analogue Scale (VAS)
time frame: 3 months
description: VAS has been shown to be a reliable and valid instrument for pain assessment which is used frequently for clinical and research purposes. It consists of a 10-cm line anchored at each end. The left-hand anchor reads 'no pain' and the right-hand anchor reads 'worst possible pain'; the patients marked a line to represent their pain level. EVA scale was development by Huskisson in 1974. Ensen MP, Karoly P. Self-report scales and procedures for assessing pain in adults. In: Turk DC, Melzack R (eds). Handbook of Pain Assessment. 2nd ed. New York, NY: The Guilford Press, 2001. pp. 15-34.
Seymour RA. The use of pain scales in assessing the efficacy ofanalgesics in post-operative dental pain. Eur J Clin Pharmacol. 1982;23:441-4 Gatson-Johansson F. Measurement of pain: the psychometric properties of the Pain-O-Meter, a simple, inexpensive pain assessment tool that could change health care practices. J Pain Symptom Manage. 1996;12:172-81.
measure: Key pinch strength
time frame: 3 months
description: For measure pinch key we used Key pinch dynamometer. Pinch strength was less in patients with early thumb CMC OA. Key pinch had the most robust association with OA diagnosis. Tomas J et al. Weaker Functional Pinch Strength Is Associated With Early Thumb Carpometacarpal Osteoarthritis. Clin Orthop Relat Res (2016) 474:557-561 MacDermid JC, Wessel J, MacIntyre N, Galea V. The relationship between impairment, dexterity and self-reported disability of persons with osteoarthritis of the hand. J Hand Ther. 2008;21:427-8
arm group label: Laser Group
arm group type: Experimental
description: Laser application three times a week for 4 weeks.
arm group label: Placebo group
arm group type: Placebo Comparator
description: The same equipment was used with a pen that emits a red guide light and a warning sound, but without the emission of a laser beam.
intervention type: Other
intervention name: Laser
description: Laser (power of 3.0w).
arm group label: Laser Group
intervention type: Other
intervention name: Placebo
description: Laser (power 0,0w)
arm group label: Placebo group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: University of Malaga
investigator full name: Raquel Cantero-Téllez
investigator title: PhD
mesh term: Osteoarthritis
sharing ipd: Undecided