<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/NCT04504409</url>
  </required_header>
  <id_info>
    <org_study_id>127</org_study_id>
    <nct_id>NCT04504409</nct_id>
  </id_info>
  <brief_title>Comparison of Efficacy of Dry Needling and Kinesio-taping</brief_title>
  <official_title>Comparison of Efficacy of Dry Needling and Kinesio-taping on Myofascial Trigger Points in Patients With Common Shoulder Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul University - Cerrahpasa (IUC)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istanbul University - Cerrahpasa (IUC)</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>
      The aim of the current study was to investigate the effects of KT and DN combined with&#xD;
      exercise on pain, range of motion (ROM), and upper extremity function in patients with common&#xD;
      shoulder disorders.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Shoulder pain is a common musculoskeletal problem seen in working population. The main&#xD;
      contributor to nontraumatic upper-limb pain, in which chronicity and recurrence of symptoms&#xD;
      are common. A common cause of muscle pain is myofascial pain caused by myofascial trigger&#xD;
      points (MTrPs). Travel and Simons have described trigger points as 'a tender point on&#xD;
      palpation characterized by referring pain, motor dysfunction and autonomic symptoms and&#xD;
      usually located in the taut band or the fascia of the muscle. MTrPs in the shoulder muscles&#xD;
      produce symptoms similar to those of other shoulder pain syndromes, including pain at rest&#xD;
      and with movement, sleep disturbances and pain provocation during impingement tests. MTrPs&#xD;
      are classified into active and latent trigger points. An active MTrP causes a clinical pain&#xD;
      complaint. It is always tender, prevents full lengthening of the muscle, weakens the muscle,&#xD;
      refers a patient-recognized pain on compression, mediates a local twitch response of muscle&#xD;
      fibers when adequately stimulated and, when compressed within the patient's pain tolerance,&#xD;
      produces referred motor phenomena and often autonomic phenomena, generally in its pain&#xD;
      reference zone, and causes tenderness in the pain reference zone. A latent MTrP is clinically&#xD;
      quiescent with respect to spontaneous pain; it is painful only when palpated. A latent MTrP&#xD;
      may have all the other clinical characteristics of an active MTrP and always has a taut band&#xD;
      that increases muscle tension and restricts range of motion. An alternative approach to the&#xD;
      management of persons with shoulder problems consists of a treatment aimed at inactivating&#xD;
      MTrPs and eliminating factors that perpetuate them. Manual techniques (such as compression on&#xD;
      the trigger point or other massage techniques), cooling the skin with ethyl chloride spray&#xD;
      and stretch and trigger point needling can inactivate MTrPs. MTrP inactivation may be&#xD;
      combined with active exercises, postural correction, extracorporeal shock wave therapy,&#xD;
      kinesio taping and relaxation if and when appropriate. Kinesio taping (KT) and dry needling&#xD;
      (DN) are two common applications being used in treatment of acute and chronic musculoskeletal&#xD;
      problems in recent years. Several therapies have been proposed for MTrPs, including KT, a&#xD;
      relatively new method that has become widely used as a therapeutic tool in a variety of&#xD;
      prevention and rehabilitation protocols. KT is an elastic cotton adhesive tape which is&#xD;
      latex-free and can be used on any joint or muscle. Te exact mechanism by which KT functions&#xD;
      remain unknown, though it is thought that its effectiveness may be mediated by cutaneous&#xD;
      mechanoreceptors which would provide sensorimotor and proprioceptive feedback, and/or by&#xD;
      mechanical restraint and inhibitory and excitatory nociceptive stimuli [16]. Various groups&#xD;
      have shown that the use of KT can be beneficial, for example, by decreasing pain or by&#xD;
      increasing range of motion (ROM) in shoulder pathologies. Among the non-pharmacological&#xD;
      options, DN, despite the controversy, is currently considered one of the most effective&#xD;
      interventions for the direct inactivation of MTrPs and is gaining attention for the treatment&#xD;
      of MTrPs in musculoskeletal pain by targeting trigger points and non- trigger point&#xD;
      structures. It is a skilled intervention that uses a thin filiform needle to penetrate the&#xD;
      skin and stimulate underlying trigger points, muscular and connective tissues without the use&#xD;
      of injectate. A systematic review with meta-analysis reported that DN, compared with&#xD;
      sham/placebo, can decrease pain immediately after treatment and in four weeks among patients&#xD;
      with upper quarter myofascial pain syndrome. Another systematic review with metaanalysis&#xD;
      reported that DN can be recommended to relieve MTrP pain of neck and shoulders in short and&#xD;
      medium terms, but wet needling is more effective than DN in reducing MTrP pain in neck and&#xD;
      shoulders in medium term.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 10, 2020</start_date>
  <completion_date type="Actual">February 10, 2021</completion_date>
  <primary_completion_date type="Actual">December 25, 2020</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain intensity</measure>
    <time_frame>3-weeks</time_frame>
    <description>Pain intensity was assessed using the Visual Analog Scale (VAS), in which the patient is asked to indicate his/her perceived pain during rest, activity and at night (0-10 VAS, with 0 as no pain and 10 as worst imaginable pain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Range of Motion</measure>
    <time_frame>3-weeks</time_frame>
    <description>Limited and painful ROM is often observed in patients with shoulder disorders. Shoulder active ROM was measured in a supine position using a universal goniometer. The goniometer is a reliable instrument for measuring shoulder ROM . All measurements will be taken with patients standing. In this study, three repetitions were performed in each direction, and the average of three trials will determine the mean ROM values for each condition.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Upper extremity functions</measure>
    <time_frame>3-weeks</time_frame>
    <description>The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item scale of disability symptoms used to assess a patient's health status. The scores obtained from all items are then used to calculate a score ranging from 0 (no disability) to 100 (most severe disability).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">59</enrollment>
  <condition>Myofascial Pain Syndromes</condition>
  <arm_group>
    <arm_group_label>Exercise group (ExG)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The exercise program consisted of; Codman , wand, stretching and strengthening exercises [25] applied twice a day, 5 times a week and duration of 3 weeks in all groups. All exercises were performed for 10 repetitions and 3 sets. Patients performed exercises with under supervision of physiotherapist in the clinic settings. In ExG, patients received only this exercise protocol for 3-weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>KT application combined with exercise (KTG)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Before KT application, their skin was shaved, cleaned with alcohol, and dried. Prior to application, the patient was seated and asked to flex their neck laterally to the contralateral side and to rotate their head to the same side. KTs (Ares®) tape was used. The first strip was a Y-strip representative of the supraspinatus, which was applied from its insertion to origin with paper off tension. A Y-strip refers to a section of tape that has a portion cut down the middle to produce 2 tails. In KTG, patients wore the KT for a 3-week duration (renewed twice a week periodically in this time).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DN combined with exercise (DNG)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The MTrP dry needling procedure employed was similar to the MTrP injection described by Hong. The MTrP was located by palpating the taut band and identifying the point of maximal tenderness. This was then firmly compressed by the index finger or middle finger of the nondominant hand to direct the placement of the needle tip while inserting the needle. The needle was inserted into the skin at a point above the taut band, approximately 1 cm from the MTrP region. After penetration of the needle into the subcutaneous layer, it was kept there and obliquely (about 45 degrees) directed to the MTrP region under the fingertip of the non-dominant hand. Then, the needle was inserted rapidly into the MTrP region and withdrawn rapidly. In DNG, patients received DN for a 3-week duration (twice a week periodically in this time).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Rehabilitation</intervention_name>
    <description>Training</description>
    <arm_group_label>DN combined with exercise (DNG)</arm_group_label>
    <arm_group_label>Exercise group (ExG)</arm_group_label>
    <arm_group_label>KT application combined with exercise (KTG)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients were eligible if they had unilateral non-traumatic shoulder pain (described&#xD;
             as pain felt in the shoulder or upper arm) for at least six months, were between ages&#xD;
             18-60 years, and diagnosed with at least one active MTrP in shoulder region.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have been diagnosed with shoulder instability, shoulder fractures,&#xD;
             neurological diseases, or other severe medical or psychiatric disorders will be&#xD;
             excluded from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rüstem Mustafaoğlu</last_name>
    <role>Principal Investigator</role>
    <affiliation>İstanbul Üniversitesi, Sağlık Bilimleri Fakültesi</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rüstem Mustafaoğlu</name>
      <address>
        <city>İstanbul</city>
        <zip>34147</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <results_reference>
    <citation>Roquelaure Y, Ha C, Leclerc A, Touranchet A, Sauteron M, Melchior M, Imbernon E, Goldberg M. Epidemiologic surveillance of upper-extremity musculoskeletal disorders in the working population. Arthritis Rheum. 2006 Oct 15;55(5):765-78. doi: 10.1002/art.22222.</citation>
    <PMID>17013824</PMID>
  </results_reference>
  <results_reference>
    <citation>Mitchell C, Adebajo A, Hay E, Carr A. Shoulder pain: diagnosis and management in primary care. BMJ. 2005 Nov 12;331(7525):1124-8. doi: 10.1136/bmj.331.7525.1124. No abstract available.</citation>
    <PMID>16282408</PMID>
  </results_reference>
  <results_reference>
    <citation>Hidalgo-Lozano A, Fernandez-de-las-Penas C, Alonso-Blanco C, Ge HY, Arendt-Nielsen L, Arroyo-Morales M. Muscle trigger points and pressure pain hyperalgesia in the shoulder muscles in patients with unilateral shoulder impingement: a blinded, controlled study. Exp Brain Res. 2010 May;202(4):915-25. doi: 10.1007/s00221-010-2196-4. Epub 2010 Feb 26.</citation>
    <PMID>20186400</PMID>
  </results_reference>
  <results_reference>
    <citation>Bron C, Dommerholt J, Stegenga B, Wensing M, Oostendorp RA. High prevalence of shoulder girdle muscles with myofascial trigger points in patients with shoulder pain. BMC Musculoskelet Disord. 2011 Jun 28;12:139. doi: 10.1186/1471-2474-12-139.</citation>
    <PMID>21711512</PMID>
  </results_reference>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>August 5, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>August 4, 2021</last_update_submitted>
  <last_update_submitted_qc>August 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul University - Cerrahpasa (IUC)</investigator_affiliation>
    <investigator_full_name>Rüstem Mustafaoğlu</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>shoulder pain</keyword>
  <keyword>myofascial trigger point</keyword>
  <keyword>dry needling</keyword>
  <keyword>kinesio tape</keyword>
  <keyword>exercise</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myofascial Pain Syndromes</mesh_term>
    <mesh_term>Fibromyalgia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04504409
org study id: 127
nct id: NCT04504409
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the current study was to investigate the effects of KT and DN combined with
      exercise on pain, range of motion (ROM), and upper extremity function in patients with common
      shoulder disorders.
Shoulder pain is a common musculoskeletal problem seen in working population. The main
      contributor to nontraumatic upper-limb pain, in which chronicity and recurrence of symptoms
      are common. A common cause of muscle pain is myofascial pain caused by myofascial trigger
      points (MTrPs). Travel and Simons have described trigger points as 'a tender point on
      palpation characterized by referring pain, motor dysfunction and autonomic symptoms and
      usually located in the taut band or the fascia of the muscle. MTrPs in the shoulder muscles
      produce symptoms similar to those of other shoulder pain syndromes, including pain at rest
      and with movement, sleep disturbances and pain provocation during impingement tests. MTrPs
      are classified into active and latent trigger points. An active MTrP causes a clinical pain
      complaint. It is always tender, prevents full lengthening of the muscle, weakens the muscle,
      refers a patient-recognized pain on compression, mediates a local twitch response of muscle
      fibers when adequately stimulated and, when compressed within the patient's pain tolerance,
      produces referred motor phenomena and often autonomic phenomena, generally in its pain
      reference zone, and causes tenderness in the pain reference zone. A latent MTrP is clinically
      quiescent with respect to spontaneous pain; it is painful only when palpated. A latent MTrP
      may have all the other clinical characteristics of an active MTrP and always has a taut band
      that increases muscle tension and restricts range of motion. An alternative approach to the
      management of persons with shoulder problems consists of a treatment aimed at inactivating
      MTrPs and eliminating factors that perpetuate them. Manual techniques (such as compression on
      the trigger point or other massage techniques), cooling the skin with ethyl chloride spray
      and stretch and trigger point needling can inactivate MTrPs. MTrP inactivation may be
      combined with active exercises, postural correction, extracorporeal shock wave therapy,
      kinesio taping and relaxation if and when appropriate. Kinesio taping (KT) and dry needling
      (DN) are two common applications being used in treatment of acute and chronic musculoskeletal
      problems in recent years. Several therapies have been proposed for MTrPs, including KT, a
      relatively new method that has become widely used as a therapeutic tool in a variety of
      prevention and rehabilitation protocols. KT is an elastic cotton adhesive tape which is
      latex-free and can be used on any joint or muscle. Te exact mechanism by which KT functions
      remain unknown, though it is thought that its effectiveness may be mediated by cutaneous
      mechanoreceptors which would provide sensorimotor and proprioceptive feedback, and/or by
      mechanical restraint and inhibitory and excitatory nociceptive stimuli [16]. Various groups
      have shown that the use of KT can be beneficial, for example, by decreasing pain or by
      increasing range of motion (ROM) in shoulder pathologies. Among the non-pharmacological
      options, DN, despite the controversy, is currently considered one of the most effective
      interventions for the direct inactivation of MTrPs and is gaining attention for the treatment
      of MTrPs in musculoskeletal pain by targeting trigger points and non- trigger point
      structures. It is a skilled intervention that uses a thin filiform needle to penetrate the
      skin and stimulate underlying trigger points, muscular and connective tissues without the use
      of injectate. A systematic review with meta-analysis reported that DN, compared with
      sham/placebo, can decrease pain immediately after treatment and in four weeks among patients
      with upper quarter myofascial pain syndrome. Another systematic review with metaanalysis
      reported that DN can be recommended to relieve MTrP pain of neck and shoulders in short and
      medium terms, but wet needling is more effective than DN in reducing MTrP pain in neck and
      shoulders in medium term.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pain intensity
time frame: 3-weeks
description: Pain intensity was assessed using the Visual Analog Scale (VAS), in which the patient is asked to indicate his/her perceived pain during rest, activity and at night (0-10 VAS, with 0 as no pain and 10 as worst imaginable pain.
measure: Range of Motion
time frame: 3-weeks
description: Limited and painful ROM is often observed in patients with shoulder disorders. Shoulder active ROM was measured in a supine position using a universal goniometer. The goniometer is a reliable instrument for measuring shoulder ROM . All measurements will be taken with patients standing. In this study, three repetitions were performed in each direction, and the average of three trials will determine the mean ROM values for each condition.
measure: Upper extremity functions
time frame: 3-weeks
description: The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item scale of disability symptoms used to assess a patient's health status. The scores obtained from all items are then used to calculate a score ranging from 0 (no disability) to 100 (most severe disability).
arm group label: Exercise group (ExG)
arm group type: Active Comparator
description: The exercise program consisted of; Codman , wand, stretching and strengthening exercises [25] applied twice a day, 5 times a week and duration of 3 weeks in all groups. All exercises were performed for 10 repetitions and 3 sets. Patients performed exercises with under supervision of physiotherapist in the clinic settings. In ExG, patients received only this exercise protocol for 3-weeks.
arm group label: KT application combined with exercise (KTG)
arm group type: Experimental
description: Before KT application, their skin was shaved, cleaned with alcohol, and dried. Prior to application, the patient was seated and asked to flex their neck laterally to the contralateral side and to rotate their head to the same side. KTs (Ares®) tape was used. The first strip was a Y-strip representative of the supraspinatus, which was applied from its insertion to origin with paper off tension. A Y-strip refers to a section of tape that has a portion cut down the middle to produce 2 tails. In KTG, patients wore the KT for a 3-week duration (renewed twice a week periodically in this time).
arm group label: DN combined with exercise (DNG)
arm group type: Active Comparator
description: The MTrP dry needling procedure employed was similar to the MTrP injection described by Hong. The MTrP was located by palpating the taut band and identifying the point of maximal tenderness. This was then firmly compressed by the index finger or middle finger of the nondominant hand to direct the placement of the needle tip while inserting the needle. The needle was inserted into the skin at a point above the taut band, approximately 1 cm from the MTrP region. After penetration of the needle into the subcutaneous layer, it was kept there and obliquely (about 45 degrees) directed to the MTrP region under the fingertip of the non-dominant hand. Then, the needle was inserted rapidly into the MTrP region and withdrawn rapidly. In DNG, patients received DN for a 3-week duration (twice a week periodically in this time).
intervention type: Other
intervention name: Rehabilitation
description: Training
arm group label: DN combined with exercise (DNG)
arm group label: Exercise group (ExG)
arm group label: KT application combined with exercise (KTG)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Rüstem Mustafaoğlu
role: Principal Investigator
affiliation: İstanbul Üniversitesi, Sağlık Bilimleri Fakültesi
facility: 
country: Turkey
citation: Roquelaure Y, Ha C, Leclerc A, Touranchet A, Sauteron M, Melchior M, Imbernon E, Goldberg M. Epidemiologic surveillance of upper-extremity musculoskeletal disorders in the working population. Arthritis Rheum. 2006 Oct 15;55(5):765-78. doi: 10.1002/art.22222.
PMID: 17013824
citation: Mitchell C, Adebajo A, Hay E, Carr A. Shoulder pain: diagnosis and management in primary care. BMJ. 2005 Nov 12;331(7525):1124-8. doi: 10.1136/bmj.331.7525.1124. No abstract available.
PMID: 16282408
citation: Hidalgo-Lozano A, Fernandez-de-las-Penas C, Alonso-Blanco C, Ge HY, Arendt-Nielsen L, Arroyo-Morales M. Muscle trigger points and pressure pain hyperalgesia in the shoulder muscles in patients with unilateral shoulder impingement: a blinded, controlled study. Exp Brain Res. 2010 May;202(4):915-25. doi: 10.1007/s00221-010-2196-4. Epub 2010 Feb 26.
PMID: 20186400
citation: Bron C, Dommerholt J, Stegenga B, Wensing M, Oostendorp RA. High prevalence of shoulder girdle muscles with myofascial trigger points in patients with shoulder pain. BMC Musculoskelet Disord. 2011 Jun 28;12:139. doi: 10.1186/1471-2474-12-139.
PMID: 21711512
responsible party type: Principal Investigator
investigator affiliation: Istanbul University - Cerrahpasa (IUC)
investigator full name: Rüstem Mustafaoğlu
investigator title: Principal Investigator
mesh term: Myofascial Pain Syndromes
mesh term: Fibromyalgia
sharing ipd: No