<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/NCT03840473</url>
  </required_header>
  <id_info>
    <org_study_id>RRC-2017-007</org_study_id>
    <nct_id>NCT03840473</nct_id>
  </id_info>
  <brief_title>Efficacy of Combination Therapies on Neck Pain &amp; Muscle Tenderness in Patients With Upper Trapezius MTrPs</brief_title>
  <official_title>Efficacy of Combination Therapies on Neck Pain and Muscle Tenderness in Patients With Upper Trapezius Myofascial Trigger Points</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King Saud University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shah Physiotherapy Center, Delhi, India</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>King Saud University</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>
      Myofascial pain syndrome thought to be the main cause of neck pain and shoulder muscle&#xD;
      tenderness in the working population is characterized by myofascial trigger points (MTrPs).&#xD;
      This study aimed to examine the immediate and short-term effect of the combination of two&#xD;
      therapeutic techniques for improving neck pain and muscle tenderness in patients with upper&#xD;
      trapezius Myofascial Trigger points.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Purpose: Myofascial pain syndrome, thought to be the main cause of neck pain and shoulder&#xD;
      muscle tenderness in the working population, is characterized by myofascial trigger points&#xD;
      (MTrPs). This study aimed to examine the immediate and short-term effect of the combination&#xD;
      of two therapeutic techniques for improving neck pain and muscle tenderness in male patients&#xD;
      with upper trapezius active MTrPs.&#xD;
&#xD;
      Methods: This was a pretest-posttest single-blinded randomized controlled trial. Sixty male&#xD;
      subjects with mechanical neck pain due to upper trapezius active MTrPs were recruited and&#xD;
      randomly allocated into group A, which received muscle energy technique (MET) and ischemic&#xD;
      compression technique (ICT)along with conventional intervention; group B, which received all&#xD;
      the interventions of group A except ICT; and group C, which received conventional treatment&#xD;
      only. Baseline (Pr), immediate post-intervention (Po), and 2-week follow-up (Fo) measurements&#xD;
      were made for all variables. Pain intensity and pressure pain threshold (PPT)were assessed by&#xD;
      a visual analog scale (VAS) and pressure threshold meter, respectively. All three groups&#xD;
      received their defined intervention plans only. Repeated-measures analysis of variance was&#xD;
      used to perform intra- inter-group analyses. Cohen's d test was used to assess the effect&#xD;
      size of the applied interventions within the groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 11, 2017</start_date>
  <completion_date type="Actual">February 15, 2018</completion_date>
  <primary_completion_date type="Actual">December 19, 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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Muscle tenderness</measure>
    <time_frame>Change from baseline PPT scores at day 1 post intervention and after 2-weeks follow-up</time_frame>
    <description>A pressure algometer used to assess the muscle tenderness by measuring Pressure Pain Threshold (PPT) level of MTrPs as suggested by Fischer. The trigger point with the lowest PPT value was chosen as a primary trigger point. The subjects were instructed to indicate the sensation of pressure they felt from changing from one of pressure to one of pain by saying &quot;there&quot;/ &quot;yes.&quot; Three repeated measurements were obtained by the same assistant, and the mean was used in the analysis. At least a 1-minute gap was added between the two repeated measurements as recommended by Fischer.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neck pain intensity</measure>
    <time_frame>Change from baseline VAS scores at day 1 post intervention and after 2-weeks follow-up</time_frame>
    <description>Visual analogue scale (VAS) used to measure neck pain intensity. VAS is a subjective rating scale marked with 0 (No pain) and 10 (extremely unbearable pain) on its either end. An application of 2.5 kg/cm-square of pressure was applied at the rate of 1 kg/cm-square by the physiotherapist while the subjects were stated to rate their pain on the visual analog scale (VAS) to evaluate local pain evoked by the application of that amount of pressure.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Myofascial Trigger Point Pain</condition>
  <arm_group>
    <arm_group_label>MET+ICT+Conventional intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hot packs (75°C) for 20 minutes and supervised active stretching exercises for upper trapezius muscle (slow, 5 repetitions per session, 10-second hold and 10-second relaxation between two repetitions) followed by ICT (90-second hold-time) and MET (5-second hold-time, 3-second relaxation by exhalation while reaching the new barrier).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MET+Conventional Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hot packs (75°C) for 20 minutes and supervised active stretching exercises for upper trapezius muscle (slow, 5 repetitions per session, 10-second hold and 10-second relaxation between two repetitions) followed by MET (5-second hold-time, 3-second relaxation by exhalation while reaching the new barrier).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Received hot packs (75°C) for 20 minutes and supervised active stretching exercises for upper trapezius muscle (slow, 5 repetitions per session, 10-second hold and 10-second relaxation between two repetitions) only.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>MET</intervention_name>
    <description>The patient was in a supine position with the cervical spine in the opposite lateral flexion to the treating part so that the upper trapezius muscle fibers were in a lengthened position.19 The moderate isometric contraction (approximately 75% of maximal) of the upper trapezius muscles was elicited for a period of 5 seconds followed by 3 seconds of relaxation while reaching the new barrier. The technique was repeated four times in each session.</description>
    <arm_group_label>MET+Conventional Intervention</arm_group_label>
    <arm_group_label>MET+ICT+Conventional intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>ICT</intervention_name>
    <description>The patient lying in the supine position with the cervical spine in opposite lateral flexion to the treating part so that the upper trapezius muscle fibers were kept in a lengthened position.18,22 The physiotherapist applied gradually increasing pressure to the MTrPs until the subject perceived the first noticeable pain. At that moment, the pressure was maintained until the discomfort and/or pain eased by around 50% as perceived by the patient, at which time the pressure was increased until the discomfort appeared again. This process was maintained for 90 seconds.</description>
    <arm_group_label>MET+ICT+Conventional intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Conventional Intervention</intervention_name>
    <description>Hot packs (75°C) for 20 minutes and active stretching exercises for the upper trapezius muscle (slow, 5 repetitions per session, 10-second hold and 10-second relaxation between two repetitions). Active stretching exercises were done by all the participants under the supervision of the physical therapist. This approach was standardized for all participants.</description>
    <arm_group_label>Conventional Intervention</arm_group_label>
    <arm_group_label>MET+Conventional Intervention</arm_group_label>
    <arm_group_label>MET+ICT+Conventional intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male subject diagnosed with non-specific neck pain and muscle tenderness over the&#xD;
             upper trapezius muscle due to an active MTrP&#xD;
&#xD;
          -  Age19-38 years&#xD;
&#xD;
          -  Presence of a maximum of 1-2active MTrPs in a unilateral upper trapezius muscle The&#xD;
             number of TrPs in upper trapezius is not limited to two; it may be one or may be more&#xD;
             than two (satellite TrPs) also. However, due to time constraints of the study sessions&#xD;
             allowed for treatment of up to 2 active MTrPs only.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with fibromyalgia syndrome according to the American College of Rheumatology&#xD;
             criteria;&#xD;
&#xD;
          -  Had active MTrPs in the bilateral upper trapezius muscles&#xD;
&#xD;
          -  Had a history of whiplash injury or cervical spine surgery&#xD;
&#xD;
          -  Were diagnosed with cervical radiculopathy or myelopathy determined by their primary&#xD;
             health care physician&#xD;
&#xD;
          -  Had accepted myofascial pain therapy within the 1 month before the study&#xD;
&#xD;
          -  Showed poor cooperation.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Male only</gender_description>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>38 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amir Iqbal, MPT</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rehabilitation Research Chair</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rehabilitation Research Chair</name>
      <address>
        <city>Riyadh</city>
        <zip>11433</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 11, 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>February 12, 2019</last_update_submitted>
  <last_update_submitted_qc>February 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>King Saud University</investigator_affiliation>
    <investigator_full_name>AMIR IQBAL</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <keyword>Neck pain</keyword>
  <keyword>Upper trapezius muscle</keyword>
  <keyword>Myofascial trigger points</keyword>
  <keyword>Muscle tenderness</keyword>
  <keyword>Pain pressure threshold</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myofascial Pain Syndromes</mesh_term>
    <mesh_term>Myalgia</mesh_term>
    <mesh_term>Neck Pain</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/NCT03840473
org study id: RRC-2017-007
nct id: NCT03840473
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Myofascial pain syndrome thought to be the main cause of neck pain and shoulder muscle
      tenderness in the working population is characterized by myofascial trigger points (MTrPs).
      This study aimed to examine the immediate and short-term effect of the combination of two
      therapeutic techniques for improving neck pain and muscle tenderness in patients with upper
      trapezius Myofascial Trigger points.
Purpose: Myofascial pain syndrome, thought to be the main cause of neck pain and shoulder
      muscle tenderness in the working population, is characterized by myofascial trigger points
      (MTrPs). This study aimed to examine the immediate and short-term effect of the combination
      of two therapeutic techniques for improving neck pain and muscle tenderness in male patients
      with upper trapezius active MTrPs.

      Methods: This was a pretest-posttest single-blinded randomized controlled trial. Sixty male
      subjects with mechanical neck pain due to upper trapezius active MTrPs were recruited and
      randomly allocated into group A, which received muscle energy technique (MET) and ischemic
      compression technique (ICT)along with conventional intervention; group B, which received all
      the interventions of group A except ICT; and group C, which received conventional treatment
      only. Baseline (Pr), immediate post-intervention (Po), and 2-week follow-up (Fo) measurements
      were made for all variables. Pain intensity and pressure pain threshold (PPT)were assessed by
      a visual analog scale (VAS) and pressure threshold meter, respectively. All three groups
      received their defined intervention plans only. Repeated-measures analysis of variance was
      used to perform intra- inter-group analyses. Cohen's d test was used to assess the effect
      size of the applied interventions within the groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Muscle tenderness
time frame: Change from baseline PPT scores at day 1 post intervention and after 2-weeks follow-up
description: A pressure algometer used to assess the muscle tenderness by measuring Pressure Pain Threshold (PPT) level of MTrPs as suggested by Fischer. The trigger point with the lowest PPT value was chosen as a primary trigger point. The subjects were instructed to indicate the sensation of pressure they felt from changing from one of pressure to one of pain by saying "there"/ "yes." Three repeated measurements were obtained by the same assistant, and the mean was used in the analysis. At least a 1-minute gap was added between the two repeated measurements as recommended by Fischer.
measure: Neck pain intensity
time frame: Change from baseline VAS scores at day 1 post intervention and after 2-weeks follow-up
description: Visual analogue scale (VAS) used to measure neck pain intensity. VAS is a subjective rating scale marked with 0 (No pain) and 10 (extremely unbearable pain) on its either end. An application of 2.5 kg/cm-square of pressure was applied at the rate of 1 kg/cm-square by the physiotherapist while the subjects were stated to rate their pain on the visual analog scale (VAS) to evaluate local pain evoked by the application of that amount of pressure.
arm group label: MET+ICT+Conventional intervention
arm group type: Experimental
description: Hot packs (75°C) for 20 minutes and supervised active stretching exercises for upper trapezius muscle (slow, 5 repetitions per session, 10-second hold and 10-second relaxation between two repetitions) followed by ICT (90-second hold-time) and MET (5-second hold-time, 3-second relaxation by exhalation while reaching the new barrier).
arm group label: MET+Conventional Intervention
arm group type: Experimental
description: Hot packs (75°C) for 20 minutes and supervised active stretching exercises for upper trapezius muscle (slow, 5 repetitions per session, 10-second hold and 10-second relaxation between two repetitions) followed by MET (5-second hold-time, 3-second relaxation by exhalation while reaching the new barrier).
arm group label: Conventional Intervention
arm group type: Active Comparator
description: Received hot packs (75°C) for 20 minutes and supervised active stretching exercises for upper trapezius muscle (slow, 5 repetitions per session, 10-second hold and 10-second relaxation between two repetitions) only.
intervention type: Behavioral
intervention name: MET
description: The patient was in a supine position with the cervical spine in the opposite lateral flexion to the treating part so that the upper trapezius muscle fibers were in a lengthened position.19 The moderate isometric contraction (approximately 75% of maximal) of the upper trapezius muscles was elicited for a period of 5 seconds followed by 3 seconds of relaxation while reaching the new barrier. The technique was repeated four times in each session.
arm group label: MET+Conventional Intervention
arm group label: MET+ICT+Conventional intervention
intervention type: Behavioral
intervention name: ICT
description: The patient lying in the supine position with the cervical spine in opposite lateral flexion to the treating part so that the upper trapezius muscle fibers were kept in a lengthened position.18,22 The physiotherapist applied gradually increasing pressure to the MTrPs until the subject perceived the first noticeable pain. At that moment, the pressure was maintained until the discomfort and/or pain eased by around 50% as perceived by the patient, at which time the pressure was increased until the discomfort appeared again. This process was maintained for 90 seconds.
arm group label: MET+ICT+Conventional intervention
intervention type: Behavioral
intervention name: Conventional Intervention
description: Hot packs (75°C) for 20 minutes and active stretching exercises for the upper trapezius muscle (slow, 5 repetitions per session, 10-second hold and 10-second relaxation between two repetitions). Active stretching exercises were done by all the participants under the supervision of the physical therapist. This approach was standardized for all participants.
arm group label: Conventional Intervention
arm group label: MET+Conventional Intervention
arm group label: MET+ICT+Conventional intervention
criteria: 
gender: Male
gender based: Yes
gender description: Male only
minimum age: 19 Years
maximum age: 38 Years
healthy volunteers: No
last name: Amir Iqbal, MPT
role: Principal Investigator
affiliation: Rehabilitation Research Chair
facility: 
country: Saudi Arabia
responsible party type: Principal Investigator
investigator affiliation: King Saud University
investigator full name: AMIR IQBAL
investigator title: Principle Investigator
mesh term: Myofascial Pain Syndromes
mesh term: Myalgia
mesh term: Neck Pain
sharing ipd: Undecided