<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/NCT03243227</url>
  </required_header>
  <id_info>
    <org_study_id>47/2016/2256</org_study_id>
    <nct_id>NCT03243227</nct_id>
  </id_info>
  <brief_title>Effectiveness of Neurodynamic Techniques for the Treatment of Carpal Tunnel Syndrome</brief_title>
  <official_title>Effectiveness of Neurodynamic Techniques for the Treatment of Carpal Tunnel Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Jordan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Jordan</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Carpal tunnel syndrome CTS is the most common peripheral neuropathy seen in clinic. It&#xD;
      results in marked functional limitations of patients. Most patients undergo surgical release&#xD;
      which places a heavy burden on health system. Neurodynamic exercise is claimed to be an&#xD;
      effective physiotherapy treatment for these patients. It is a practical and&#xD;
      complications-free treatment which can be used as a home exercise program. This study aims to&#xD;
      investigate the effect of median nerve gliding exercise on symptoms severity and functional&#xD;
      limitation in CTS patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  Design: Two groups randomized controlled trial&#xD;
&#xD;
        -  Participants: 50 subjects diagnosed with CTS will be recruited from JUH physical&#xD;
           medicine and rehabilitation department, diagnosis will be confirmed by a physician&#xD;
           clinically and using nerve conduction test. Subjects will be randomized into treatment&#xD;
           and control groups.&#xD;
&#xD;
        -  Procedures: Participants will be recruited from the physical medicine department at JUH&#xD;
           and the diagnosis and initial assessment will be performed by a physician. Baseline&#xD;
           outcomes will be measured by an experienced physiotherapist.&#xD;
&#xD;
      Treatment Group: Neurodynamics evaluation and treatment will be provided by an experienced&#xD;
      physiotherapist. Each treatment session involves both manual therapy and median nerve&#xD;
      mobilization exercise following the neurodynamics concept. Four 60 minutes sessions over a&#xD;
      period of four weeks will be performed for each patient. Median nerve mobilization exercise&#xD;
      will be continued as home exercise program and will be monitored by the treating&#xD;
      physiotherapist using exercise diary.&#xD;
&#xD;
      Control group: four sessions of exercise will be given to participants. CTS standard exercise&#xD;
      brochure will be given for the patients to follow over 4 weeks. The brochure will include&#xD;
      wrist joint strengthening, stretching and AROM exercise.&#xD;
&#xD;
      Outcomes will be measured at the end of the 4 weeks treatment, 6 weeks and 6 months post&#xD;
      treatment.&#xD;
&#xD;
      • Data analysis: Microsoft Excel and SPSS will be used for data entry and analysis.&#xD;
&#xD;
      Descriptive analysis: All obtained data will be tabulated, means, standard deviations and&#xD;
      differences will be measured.&#xD;
&#xD;
      Inferential analysis: Two way repeated measure ANOVA will be used to measure differences&#xD;
      between the groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Actual">September 1, 2019</completion_date>
  <primary_completion_date type="Actual">July 1, 2019</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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Boston Carpal Tunnel Questionnaire score</measure>
    <time_frame>Baseline, 1 month, 6 months</time_frame>
    <description>BCTS is a patient-based outcome measure used for patients with CTS. It includes two distinct scales, the Symptom Severity Scale (SSS) which has 11 questions and uses a five-point rating scale and the Functional Status Scale (FSS) containing 8 items which have to be rated for degree of difficulty on a five-point scale. Each scale generates a final score (sum of individual scores divided by number of items) which ranges from 1 to 5, with a higher score indicating greater disability.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Disabilities of the Arm, Shoulder and Hand (DASH) Score</measure>
    <time_frame>Baseline, 1 month, 6 months</time_frame>
    <description>DASH is a patient-based outcome measure used to assess function in patients with arm or hand pain. it includes two components: the disability/symptom</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain severity scale</measure>
    <time_frame>Baseline,1 month , 6 months</time_frame>
    <description>subjective rating of pain severity is specified by patient as a number from 0-10. the higher the number the greater level of pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wrist ROM</measure>
    <time_frame>Baseline, 1 month , 6 months</time_frame>
    <description>Range of movement of the wrist joint is measured using universal goniometer. All wrist joint movements will be measured actively and passively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Grip strength</measure>
    <time_frame>Baseline, 1 month, 6 months</time_frame>
    <description>Hand grip strength is measured using a hand held dynamometer device. Reading is taken in pounds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgery</measure>
    <time_frame>6 months</time_frame>
    <description>whether or not the patient decided to undergo median nerve decompression surgery</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">53</enrollment>
  <condition>Carpal Tunnel Syndrome</condition>
  <arm_group>
    <arm_group_label>Neurodynamic techniques</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>4 sessions of Neurodynamics treatment will be provided by an experienced physiotherapist. It will include manual therapy, median nerve gliding exercise, median nerve tension exercise. patients will continue the exercises as home exercise program during and after the treatment period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Exercise</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Exercise therapy 4 sessions of exercise treatment will be provided by an experienced physiotherapist. It will include active range of motion, stretching, and strengthening exercise. patients will be given a brochure to continue the exercises as home exercise program during and after the treatment period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Neurodynamic techniques</intervention_name>
    <description>4 sessions of Neurodynamics treatment will be provided by and experienced physiotherapist. It will include manual therapy, median nerve gliding exercise, median nerve tension exercise. patients will continue the exercises as home exercise program during and after the treatment period.</description>
    <arm_group_label>Neurodynamic techniques</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise therapy</intervention_name>
    <description>AROM exercise stretching exercise strengthening exercise 4 sessions</description>
    <arm_group_label>Exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Confirmed CTS diagnosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Previous trauma or surgery involving the upper extremities known neurological condition&#xD;
        pregnancy history of radiating neck or back pain in the previous 3 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hayat Hamzeh, MSC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lecturer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The University of Jordan</name>
      <address>
        <city>Amman</city>
        <zip>11942</zip>
        <country>Jordan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Jordan</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>September 19, 2019</last_update_submitted>
  <last_update_submitted_qc>September 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Jordan</investigator_affiliation>
    <investigator_full_name>Hayat Hamzeh</investigator_full_name>
    <investigator_title>Lecturer</investigator_title>
  </responsible_party>
  <keyword>carpal tunnel syndrome</keyword>
  <keyword>neurodynamics</keyword>
  <keyword>median nerve gliding exercise</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carpal Tunnel Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <!-- 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/NCT03243227
org study id: 47/2016/2256
nct id: NCT03243227
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Carpal tunnel syndrome CTS is the most common peripheral neuropathy seen in clinic. It
      results in marked functional limitations of patients. Most patients undergo surgical release
      which places a heavy burden on health system. Neurodynamic exercise is claimed to be an
      effective physiotherapy treatment for these patients. It is a practical and
      complications-free treatment which can be used as a home exercise program. This study aims to
      investigate the effect of median nerve gliding exercise on symptoms severity and functional
      limitation in CTS patients.
-  Design: Two groups randomized controlled trial

        -  Participants: 50 subjects diagnosed with CTS will be recruited from JUH physical
           medicine and rehabilitation department, diagnosis will be confirmed by a physician
           clinically and using nerve conduction test. Subjects will be randomized into treatment
           and control groups.

        -  Procedures: Participants will be recruited from the physical medicine department at JUH
           and the diagnosis and initial assessment will be performed by a physician. Baseline
           outcomes will be measured by an experienced physiotherapist.

      Treatment Group: Neurodynamics evaluation and treatment will be provided by an experienced
      physiotherapist. Each treatment session involves both manual therapy and median nerve
      mobilization exercise following the neurodynamics concept. Four 60 minutes sessions over a
      period of four weeks will be performed for each patient. Median nerve mobilization exercise
      will be continued as home exercise program and will be monitored by the treating
      physiotherapist using exercise diary.

      Control group: four sessions of exercise will be given to participants. CTS standard exercise
      brochure will be given for the patients to follow over 4 weeks. The brochure will include
      wrist joint strengthening, stretching and AROM exercise.

      Outcomes will be measured at the end of the 4 weeks treatment, 6 weeks and 6 months post
      treatment.

      • Data analysis: Microsoft Excel and SPSS will be used for data entry and analysis.

      Descriptive analysis: All obtained data will be tabulated, means, standard deviations and
      differences will be measured.

      Inferential analysis: Two way repeated measure ANOVA will be used to measure differences
      between the groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Change in Boston Carpal Tunnel Questionnaire score
time frame: Baseline, 1 month, 6 months
description: BCTS is a patient-based outcome measure used for patients with CTS. It includes two distinct scales, the Symptom Severity Scale (SSS) which has 11 questions and uses a five-point rating scale and the Functional Status Scale (FSS) containing 8 items which have to be rated for degree of difficulty on a five-point scale. Each scale generates a final score (sum of individual scores divided by number of items) which ranges from 1 to 5, with a higher score indicating greater disability.
measure: The Disabilities of the Arm, Shoulder and Hand (DASH) Score
time frame: Baseline, 1 month, 6 months
description: DASH is a patient-based outcome measure used to assess function in patients with arm or hand pain. it includes two components: the disability/symptom
measure: Pain severity scale
time frame: Baseline,1 month , 6 months
description: subjective rating of pain severity is specified by patient as a number from 0-10. the higher the number the greater level of pain
measure: Wrist ROM
time frame: Baseline, 1 month , 6 months
description: Range of movement of the wrist joint is measured using universal goniometer. All wrist joint movements will be measured actively and passively.
measure: Grip strength
time frame: Baseline, 1 month, 6 months
description: Hand grip strength is measured using a hand held dynamometer device. Reading is taken in pounds.
measure: Surgery
time frame: 6 months
description: whether or not the patient decided to undergo median nerve decompression surgery
arm group label: Neurodynamic techniques
arm group type: Experimental
description: 4 sessions of Neurodynamics treatment will be provided by an experienced physiotherapist. It will include manual therapy, median nerve gliding exercise, median nerve tension exercise. patients will continue the exercises as home exercise program during and after the treatment period.
arm group label: Exercise
arm group type: Active Comparator
description: Exercise therapy 4 sessions of exercise treatment will be provided by an experienced physiotherapist. It will include active range of motion, stretching, and strengthening exercise. patients will be given a brochure to continue the exercises as home exercise program during and after the treatment period.
intervention type: Other
intervention name: Neurodynamic techniques
description: 4 sessions of Neurodynamics treatment will be provided by and experienced physiotherapist. It will include manual therapy, median nerve gliding exercise, median nerve tension exercise. patients will continue the exercises as home exercise program during and after the treatment period.
arm group label: Neurodynamic techniques
intervention type: Other
intervention name: Exercise therapy
description: AROM exercise stretching exercise strengthening exercise 4 sessions
arm group label: Exercise
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hayat Hamzeh, MSC
role: Principal Investigator
affiliation: Lecturer
facility: 
country: Jordan
responsible party type: Principal Investigator
investigator affiliation: University of Jordan
investigator full name: Hayat Hamzeh
investigator title: Lecturer
mesh term: Carpal Tunnel Syndrome
mesh term: Syndrome