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/NCT05970003</url>
    </required_header>
    <id_info>
      <org_study_id>REC/RCR &amp; AHS/23/0412</org_study_id>
      <nct_id>NCT05970003</nct_id>
    </id_info>
    <brief_title>Comparative Effects of Copenhagen and Holmich Exercises in Hip Adductor</brief_title>
    <official_title>Comparative Effects of Copenhagen and Holmich Exercises in Hip Adductor Related Groin Pain, Strength and Lower Extremity Function in Soccer Players</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Riphah International University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Riphah International University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Groin pain that relates to the adductor muscle usually represents in the groin region&#xD;
        specifically in superior internal thigh. Tears or strains may happen within the muscles&#xD;
        itself, tears or strains mainly occurs at musculotendinous junctions or within the tendons.&#xD;
        Adductor strain is a familiar but mostly ignored cause of groin injury and pain among&#xD;
        athletes. Risk factors include past hip or groin injury, age, weak adductors, muscle fatigue,&#xD;
        lessen range of motion, and deficient stretching of the adductor muscle complex.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study will be a randomized clinical trial and will be conducted in Pakistan sports board&#xD;
        and coaching center. Non-probability consecutive sampling will be used to collect the data.&#xD;
        Sample size of this research is 46 subjects with age group between 18-30 years will be taken.&#xD;
        Data will be collected from the patients of adductor strain that causes groin pain by using&#xD;
        tools Numeric Pain Rating Scale for pain, Adductor Muscle Strength Test by Hand Held&#xD;
        Dynamometer, The Copenhagen Hip and Groin Outcome Score (HAGO's) questionnaire and Lower&#xD;
        Extremity Functional Scale (LEFS). An informed consent will be taken. Squeeze test will be&#xD;
        performed to evaluate the adductor related groin pain. The subjects will be divided into two&#xD;
        groups i.e. Group A and Group B. Group A will receive the Copenhagen exercise, also known as&#xD;
        the adductor strengthening protocol, is a dynamic and high-intensity exercise. It doesn't&#xD;
        require any special equipment and can be done in any training center. Group B will receive&#xD;
        Holmich continues to provide the strongest evidence for the efficacy of exercise as an ARGP&#xD;
        treatment. Both groups will perform their routine warm ups and cool downs the total duration&#xD;
        of the protocol is 6 weeks, 3 times a week the duration of each session 3 sets of 10&#xD;
        repetitions with 15 sec recovery period Keywords groin pain, Holmich protocol, Copenhagen&#xD;
        exercise, adductor strain.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 5, 2023</start_date>
    <completion_date type="Anticipated">September 7, 2023</completion_date>
    <primary_completion_date type="Anticipated">August 27, 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>
      <primary_purpose>Other</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Numerical pain rating scale (NPRS)</measure>
      <time_frame>upto 4th weeks</time_frame>
      <description>Numeric Pain Rating Scale for Pain In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10, 0 and 20 or 0 and 100 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Lower Extremity Functional Scale (LEFS)</measure>
      <time_frame>upto 4th weeks</time_frame>
      <description>Lower Extremity Functional Scale (LEFS) The Lower Extremity Functional Scale (LEFS) is a questionnaire containing 20 questions about a person's ability to perform everyday tasks. The LEFS can be used by clinicians as a measure of patients' initial function, ongoing progress and outcome, as well as to set functional goals. The LEFS can be used to evaluate the functional impairment of a patient with a disorder of one or both lower extremities. It can be used to monitor the patient over time and to evaluate the effectiveness of an intervention.&#xD;
  The final version of the LEFS consists 20 items, each with a maximum score of 4. The total possible score of 80 indicates a high functional level (Appendix). The scale is one page, can be filled out by most patients in less than 2 minutes, and is scored by tallying the responses for all of the items. Scoring is performed without the use of a calculator or computer and requires approximately 20 seconds</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Manual Muscle Testing</measure>
      <time_frame>upto 4th weeks</time_frame>
      <description>MMT grades are usually labelled with the following terms: &quot;zero,&quot; &quot;trace,&quot; &quot;poor,&quot; &quot;fair,&quot; &quot;good,&quot; and &quot;normal.&quot; In addition, manual muscle testing grades can be further described using a numerical scale from 0 through 5.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">46</enrollment>
    <condition>Groin Strain</condition>
    <arm_group>
      <arm_group_label>Group A: Copenhagen exercise</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Group A will receive the Copenhagen exercise, also known as the adductor strengthening protocol, is a dynamic and high-intensity exercise. It doesn't require any special equipment and can be done in any training center.&#xD;
  There are 3 different levels of exercise were performed by players.&#xD;
  Level 1: Side-lying hip adduction exercise.&#xD;
  Level 2: Copenhagen adduction exercises while both arms support at the knee.&#xD;
  Level 3: Copenhagen adduction exercise - primary support at the ankle and minor support at the knee.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group B : Holmich Exercises</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Group B will receive Holmich continues to provide the strongest evidence for the efficacy of exercise as an ARGP treatment.&#xD;
  The Holmich treatment protocol exercise includes static and dynamic and/or isometric and isotonic strengthening exercises for hip adductors and abductors and also for abdominal muscles.&#xD;
  There are 6 Different types of exercises were performed by players who were a participant with 3 sets of 10 repetitions with 15 sec recovery period.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Copenhagen exercises</intervention_name>
      <description>Group A performs copenhagen exercises&#xD;
  Both groups will perform their routine warm ups and cool downs the total duration of the protocol is 6 weeks, 3 times a week the duration of each session 3 sets of 10 repetitions with 15 sec recovery period. Hip extensor and flexor stretching and strengthening.</description>
      <arm_group_label>Group A: Copenhagen exercise</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Holmich exercises</intervention_name>
      <description>The Holmich treatment protocol exercise includes static and dynamic and/or isometric and isotonic strengthening exercises for hip adductors and abductors and also for abdominal muscles.&#xD;
  There are 6 Different types of exercises were performed by players who were a participant with 3 sets of 10 repetitions with 15 sec recovery period.&#xD;
  Both groups will perform their routine warm ups and cool downs the total duration of the protocol is 6 weeks, 3 times a week the duration of each session 3 sets of 10 repetitions with 15 sec recovery period. Hip extensor and flexor stretching and strengthening.</description>
      <arm_group_label>Group B : Holmich Exercises</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  • Male soccer player age group 18-30 years&#xD;
  &#xD;
                 -  Groin pain during or after game&#xD;
  &#xD;
                 -  Persistent groin pain over 2-3 weeks&#xD;
  &#xD;
                 -  Pain at palpation of groin&#xD;
  &#xD;
                 -  Positive pain with Adductor squeeze test&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  • Low back pain&#xD;
  &#xD;
                 -  Infection (UTI)&#xD;
  &#xD;
                 -  Malignancy&#xD;
  &#xD;
                 -  Recent fractures or injuries&#xD;
  &#xD;
                 -  Hip osteoarthritis&#xD;
  &#xD;
                 -  Inguinal hernia&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>30 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Samrood Akram, Mphil</last_name>
      <role>Principal Investigator</role>
      <affiliation>Riphah International University,Lahore</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Samrood Akram, MPhil</last_name>
      <phone>923324806143</phone>
      <email>samrood.akram@riphah.edu.pk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Samrood Akram, Mphil</last_name>
      <phone>923324806143</phone>
      <email>samrood.akram@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Pakistan Sports Board</name>
        <address>
          <city>Lahore</city>
          <state>Punjab</state>
          <zip>54000</zip>
          <country>Pakistan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Samrood Akram, Mphil</last_name>
        <phone>923324806143</phone>
        <email>samrood.akram@riphah.edu.pk</email>
      </contact>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <reference>
      <citation>Mercurio M, Corona K, Galasso O, Cerciello S, Morris BJ, Guerra G, Gasparini G. Soccer players show the highest seasonal groin pain prevalence and the longest time loss from sport among 500 athletes from major team sports. Knee Surg Sports Traumatol Arthrosc. 2022 Jun;30(6):2149-2157. doi: 10.1007/s00167-022-06924-5. Epub 2022 Mar 8.</citation>
      <PMID>35258646</PMID>
    </reference>
    <reference>
      <citation>Haroy J, Clarsen B, Wiger EG, Oyen MG, Serner A, Thorborg K, Holmich P, Andersen TE, Bahr R. The Adductor Strengthening Programme prevents groin problems among male football players: a cluster-randomised controlled trial. Br J Sports Med. 2019 Feb;53(3):150-157. doi: 10.1136/bjsports-2017-098937. Epub 2018 Jun 10.</citation>
      <PMID>29891614</PMID>
    </reference>
    <reference>
      <citation>Schaber M, Guiser Z, Brauer L, Jackson R, Banyasz J, Miletti R, Hassen-Miller A. The Neuromuscular Effects of the Copenhagen Adductor Exercise: A Systematic Review. Int J Sports Phys Ther. 2021 Oct 1;16(5):1210-1221. doi: 10.26603/001c.27975. eCollection 2021.</citation>
      <PMID>34631242</PMID>
    </reference>
    <reference>
      <citation>Almeida MO, Silva BN, Andriolo RB, Atallah AN, Peccin MS. Conservative interventions for treating exercise-related musculotendinous, ligamentous and osseous groin pain. Cochrane Database Syst Rev. 2013 Jun 6;2013(6):CD009565. doi: 10.1002/14651858.CD009565.pub2.</citation>
      <PMID>23740671</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 27, 2023</study_first_submitted>
    <study_first_submitted_qc>July 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 23, 2023</last_update_submitted>
    <last_update_submitted_qc>July 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Holmich protocol</keyword>
    <keyword>Copenhagen exercises</keyword>
    <keyword>groin pain</keyword>
    <keyword>adductor strain</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sprains and Strains</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/NCT05970003
  org study id: REC/RCR & AHS/23/0412
  nct id: NCT05970003
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Groin pain that relates to the adductor muscle usually represents in the groin region
        specifically in superior internal thigh. Tears or strains may happen within the muscles
        itself, tears or strains mainly occurs at musculotendinous junctions or within the tendons.
        Adductor strain is a familiar but mostly ignored cause of groin injury and pain among
        athletes. Risk factors include past hip or groin injury, age, weak adductors, muscle fatigue,
        lessen range of motion, and deficient stretching of the adductor muscle complex.
  This study will be a randomized clinical trial and will be conducted in Pakistan sports board
        and coaching center. Non-probability consecutive sampling will be used to collect the data.
        Sample size of this research is 46 subjects with age group between 18-30 years will be taken.
        Data will be collected from the patients of adductor strain that causes groin pain by using
        tools Numeric Pain Rating Scale for pain, Adductor Muscle Strength Test by Hand Held
        Dynamometer, The Copenhagen Hip and Groin Outcome Score (HAGO's) questionnaire and Lower
        Extremity Functional Scale (LEFS). An informed consent will be taken. Squeeze test will be
        performed to evaluate the adductor related groin pain. The subjects will be divided into two
        groups i.e. Group A and Group B. Group A will receive the Copenhagen exercise, also known as
        the adductor strengthening protocol, is a dynamic and high-intensity exercise. It doesn't
        require any special equipment and can be done in any training center. Group B will receive
        Holmich continues to provide the strongest evidence for the efficacy of exercise as an ARGP
        treatment. Both groups will perform their routine warm ups and cool downs the total duration
        of the protocol is 6 weeks, 3 times a week the duration of each session 3 sets of 10
        repetitions with 15 sec recovery period Keywords groin pain, Holmich protocol, Copenhagen
        exercise, adductor strain.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: Single (Outcomes Assessor)
  measure: Numerical pain rating scale (NPRS)
  time frame: upto 4th weeks
  description: Numeric Pain Rating Scale for Pain In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10, 0 and 20 or 0 and 100 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible.
  measure: Lower Extremity Functional Scale (LEFS)
  time frame: upto 4th weeks
  description: Lower Extremity Functional Scale (LEFS) The Lower Extremity Functional Scale (LEFS) is a questionnaire containing 20 questions about a person's ability to perform everyday tasks. The LEFS can be used by clinicians as a measure of patients' initial function, ongoing progress and outcome, as well as to set functional goals. The LEFS can be used to evaluate the functional impairment of a patient with a disorder of one or both lower extremities. It can be used to monitor the patient over time and to evaluate the effectiveness of an intervention.
  The final version of the LEFS consists 20 items, each with a maximum score of 4. The total possible score of 80 indicates a high functional level (Appendix). The scale is one page, can be filled out by most patients in less than 2 minutes, and is scored by tallying the responses for all of the items. Scoring is performed without the use of a calculator or computer and requires approximately 20 seconds
  measure: Manual Muscle Testing
  time frame: upto 4th weeks
  description: MMT grades are usually labelled with the following terms: "zero," "trace," "poor," "fair," "good," and "normal." In addition, manual muscle testing grades can be further described using a numerical scale from 0 through 5.
  arm group label: Group A: Copenhagen exercise
  arm group type: Active Comparator
  description: Group A will receive the Copenhagen exercise, also known as the adductor strengthening protocol, is a dynamic and high-intensity exercise. It doesn't require any special equipment and can be done in any training center.
  There are 3 different levels of exercise were performed by players.
  Level 1: Side-lying hip adduction exercise.
  Level 2: Copenhagen adduction exercises while both arms support at the knee.
  Level 3: Copenhagen adduction exercise - primary support at the ankle and minor support at the knee.
  arm group label: Group B : Holmich Exercises
  arm group type: Active Comparator
  description: Group B will receive Holmich continues to provide the strongest evidence for the efficacy of exercise as an ARGP treatment.
  The Holmich treatment protocol exercise includes static and dynamic and/or isometric and isotonic strengthening exercises for hip adductors and abductors and also for abdominal muscles.
  There are 6 Different types of exercises were performed by players who were a participant with 3 sets of 10 repetitions with 15 sec recovery period.
  intervention type: Other
  intervention name: Copenhagen exercises
  description: Group A performs copenhagen exercises
  Both groups will perform their routine warm ups and cool downs the total duration of the protocol is 6 weeks, 3 times a week the duration of each session 3 sets of 10 repetitions with 15 sec recovery period. Hip extensor and flexor stretching and strengthening.
  arm group label: Group A: Copenhagen exercise
  intervention type: Other
  intervention name: Holmich exercises
  description: The Holmich treatment protocol exercise includes static and dynamic and/or isometric and isotonic strengthening exercises for hip adductors and abductors and also for abdominal muscles.
  There are 6 Different types of exercises were performed by players who were a participant with 3 sets of 10 repetitions with 15 sec recovery period.
  Both groups will perform their routine warm ups and cool downs the total duration of the protocol is 6 weeks, 3 times a week the duration of each session 3 sets of 10 repetitions with 15 sec recovery period. Hip extensor and flexor stretching and strengthening.
  arm group label: Group B : Holmich Exercises
  criteria: 
  gender: Male
  gender based: Yes
  minimum age: 18 Years
  maximum age: 30 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Samrood Akram, Mphil
  role: Principal Investigator
  affiliation: Riphah International University,Lahore
  last name: Samrood Akram, MPhil
  phone: 923324806143
  email: samrood.akram@riphah.edu.pk
  last name: Samrood Akram, Mphil
  phone: 923324806143
  email: samrood.akram@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Pakistan
  citation: Mercurio M, Corona K, Galasso O, Cerciello S, Morris BJ, Guerra G, Gasparini G. Soccer players show the highest seasonal groin pain prevalence and the longest time loss from sport among 500 athletes from major team sports. Knee Surg Sports Traumatol Arthrosc. 2022 Jun;30(6):2149-2157. doi: 10.1007/s00167-022-06924-5. Epub 2022 Mar 8.
  PMID: 35258646
  citation: Haroy J, Clarsen B, Wiger EG, Oyen MG, Serner A, Thorborg K, Holmich P, Andersen TE, Bahr R. The Adductor Strengthening Programme prevents groin problems among male football players: a cluster-randomised controlled trial. Br J Sports Med. 2019 Feb;53(3):150-157. doi: 10.1136/bjsports-2017-098937. Epub 2018 Jun 10.
  PMID: 29891614
  citation: Schaber M, Guiser Z, Brauer L, Jackson R, Banyasz J, Miletti R, Hassen-Miller A. The Neuromuscular Effects of the Copenhagen Adductor Exercise: A Systematic Review. Int J Sports Phys Ther. 2021 Oct 1;16(5):1210-1221. doi: 10.26603/001c.27975. eCollection 2021.
  PMID: 34631242
  citation: Almeida MO, Silva BN, Andriolo RB, Atallah AN, Peccin MS. Conservative interventions for treating exercise-related musculotendinous, ligamentous and osseous groin pain. Cochrane Database Syst Rev. 2013 Jun 6;2013(6):CD009565. doi: 10.1002/14651858.CD009565.pub2.
  PMID: 23740671
  responsible party type: Sponsor
  mesh term: Sprains and Strains
  sharing ipd: No