<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/NCT04401566</url>
  </required_header>
  <id_info>
    <org_study_id>:60116787-020/47015</org_study_id>
    <nct_id>NCT04401566</nct_id>
  </id_info>
  <brief_title>Investigation of Acute Effects of Myofascial Trigger Point Release in Women With Chronic Pelvic Pain</brief_title>
  <official_title>Investigation of Acute Effects of Myofascial Trigger Point Release Techniques Using Transperineal Ultrasound in Women With Chronic Pelvic Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Akdeniz University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pamukkale University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Akdeniz 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>
      The patients diagnosed with pelvic pain will be included in the study. Orthopedic tests for&#xD;
      pelvic pain were performed after routine gynecological examinations. After perineometer&#xD;
      measurement, pelvic floor muscle sensitivity grading, ultrasound, and pain score evaluation,&#xD;
      participants will be randomized and divided into 3 groups. According to a randomization plan&#xD;
      the first group will be instructed by a physiotherapist to receive an internal myofascial&#xD;
      trigger point release technique, the second group receive an external myofascial trigger&#xD;
      point release technique, and the third group receive a video of relaxation exercises related&#xD;
      to pelvic pain. After the application, measurement of perineometer and pelvic floor muscle&#xD;
      sensitivity grading, ultrasound, and pain evaluations will be repeated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Turkey has been affected country from a busy and stressful lifestyle in our changing world&#xD;
      and that leads to pelvic floor dysfunction has increased rapidly in Turkey. Pelvic pain that&#xD;
      has in 1 out of every 7 women causes overactivity of pelvic floor muscles with increasing&#xD;
      stress factors. In addition, it becomes chronic due to both the diagnosis process and the&#xD;
      time-out of the right treatment and deteriorates the quality of life of women. There is no&#xD;
      special pelvic floor physiotherapy for the management of pelvic pain in our country, which&#xD;
      also causes psychosocial problems. On the other hand, myofascial trigger point release&#xD;
      technique, which is proposed in addition to medical treatment alone or in pelvic floor&#xD;
      physiotherapy, has been one of the current research areas in the world. However, there is no&#xD;
      study in the national and international literature comparing internal and external myofascial&#xD;
      trigger point relaxation techniques and also evaluating transperineal ultrasound. This study&#xD;
      is unique in terms of comparing two different applications (internal and external trigger&#xD;
      point relaxation technique) with ultrasound measurements in the literature.&#xD;
&#xD;
      33 women diagnosed with pelvic pain between the ages of 18-55 will be included in this study.&#xD;
      Orthopedic tests for pelvic pain will be performed after routine gynecological examinations.&#xD;
      After perineometer measurement, pelvic floor muscle sensitivity grading, ultrasound and pain&#xD;
      score evaluation, participants will be randomized and divided into 3 groups. The first group&#xD;
      will receive internal myofascial trigger point release technique, the second group will&#xD;
      receive external myofascial trigger point release technique, and the third group will be&#xD;
      shown a video of relaxation exercises related to pelvic pain. After the application,&#xD;
      measurement of perineometer and pelvic floor muscle sensitivity grading, ultrasound and pain&#xD;
      evaluations will be repeated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 21, 2018</start_date>
  <completion_date type="Actual">May 2, 2021</completion_date>
  <primary_completion_date type="Actual">August 21, 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>Basic Science</primary_purpose>
    <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>The gynecologist was blind about treatment and the investigator was blind about assesment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Transperineal ultrasound measures</measure>
    <time_frame>6 months</time_frame>
    <description>Transperineal ultrasound (Voluson E8 Expert from GE Healthcare with a convex RM6C probe ranging from 2 to 6 Megahertz) will be used to measure the function of the pelvic floor muscles indirectly through morphometry at rest, valsalva and at maximum contraction. This imaging will measure the position of the bladder neck relative to the pubis, the anorectal angle formed by the anus and rectum, the angle formed by the pelvic floor muscles and a horizontal reference line (parallel to the ground ) in addition to the dimensions of the urogenital hiatus which is delimited by the puborectal muscle and which includes the urethra, the vagina and the anus. This method has been evaluated in several studies and demonstrates good intra- and inter-rater fidelity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Perineometer measurements</measure>
    <time_frame>6 months</time_frame>
    <description>Before starting the assessments as suggested by the International Continence Society, the physiotherapist will check via vaginal palpation the participant's ability to contract and relax the pelvic floor muscles. Afterwords, pelvic examination vaginal manometry (using a Peritron perineometer; Cadio Design, Australia) will be performed to measure resting and maximum contraction of the PFMs</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pelvic floor muscle tenderness scale</measure>
    <time_frame>6 months</time_frame>
    <description>Tenderness of each of the PFMs (pubococcygeus, iliococcygeus, coccygeus, and obturator internus muscles) was assessed using a nonvalidated scale from 0 to 4 (0, no pressure or pain; 1, pressure but no pain; 2, pressure with discomfort; 3, moderate pain intensified with muscle contraction; 4, severe pain or inability to perform muscle contraction because of pain). Manometry and the tenderness assessments will be repeated after 60 minutes from the first assessments</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Pelvic Pain</condition>
  <condition>Pelvic Floor; Relaxation</condition>
  <condition>Myofascial Trigger Point Pain</condition>
  <arm_group>
    <arm_group_label>Internal Myofascial Release Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Internal myofascial trigger point release therapy consists of 30 minutes massage directly to the pelvic floor musculature by vaginally. Patients were instructed in internal myofascial release techniques. Experienced pelvic health physiotherapist (A.B.) to use her fingers with a lubricated glove when the finger could easily reach internal trigger points and follows these steps: (a) finding internal and external trigger points associated with pelvic muscles, especially around sensitive areas of the vagina, anus, and/or pelvic floor; (b) releasing with the fingers the trigger point associated pelvic muscle tension by carefully pressing on the trigger point. Releasing pelvic muscle tension includes applying varying amounts of pressure, sometimes gradually stroking and strumming the muscle region while systematically contracting and relaxing the affected muscles to aid in a trigger point release.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>External Myofascial Release Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eksternal myofascial trigger point release therapy consists of 30 minutes massage to the abdominal wall, gluteal area and abductors, and hamstring muscles. Pain in trigger points may exist at both locations of muscle insertion as well as in the belly and the lower extremity of the muscle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The Control group will have a video about exercises recommended in pelvic pain for 30 minutes. A physiotherapist will teach and show the exercises for pelvic pain. The home exercise for pelvic pain contains diaphragm breathing, pelvic floor muscle stretching, and releasing.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Internal myofascial release</intervention_name>
    <description>Internal myofascial trigger point release therapy consist of 30 minutes massage directly to the pelvic floor musculature by vaginally. Patients were instructed in internal myofascial relase techniques. Experienced pelvic health physiotherapist (A.B.) to use her fingers with a lubricated glove when the finger could easily reach internal trigger points and follows these steps: (a) finding internal and external trigger points associated with pelvic muscles, especially around sensitive areas of the vagina, anus, and/or pelvic floor; (b) releasing with the fingers the trigger point associated pelvic muscle tension by carefully pressing on the trigger point</description>
    <arm_group_label>Internal Myofascial Release Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>External myofascial release</intervention_name>
    <description>Eksternal myofascial trigger point release therapy consist 30 minutes massage to the abdominal wall, gluteal area and adductors and hamstring muscles. Pain in trigger points may exist at both locations of muscle insertion as well as in the belly and lower extremity of the muscle.</description>
    <arm_group_label>External Myofascial Release Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control Group</intervention_name>
    <description>The Control group will have a paper about exercises recommended in pelvic pain for 30 minutes. A physiotherapist will teach and show the exercises for pelvic pain. The home exercise for pelvic pain contains diaphragm breating, pelvic floor muscle stretching and releasing.</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        The inclusion criteria:&#xD;
&#xD;
          -  to have chronic pelvic pain for more than six months,&#xD;
&#xD;
          -  to have 5 pelvic pain orthopedic tests (active straight leg raise (ASLR), flexion&#xD;
             abduction external rotation (FABER), pelvic pain provocation (P4), long dorsal&#xD;
             ligament palpation (LDL), The Gaenslen Test) and at least three of the tests are&#xD;
             positive,&#xD;
&#xD;
          -  to have good communication skills and accept to attend the study.&#xD;
&#xD;
        The exclusion criteria:&#xD;
&#xD;
          -  pregnant women who have had a pregnancy in the last year or who are breastfeeding;&#xD;
&#xD;
          -  other causes of pain (eg pain unrelated to pelvic region relations, dermatological&#xD;
             conditions, herpes, vulvovaginal atrophy);&#xD;
&#xD;
          -  menopause;&#xD;
&#xD;
          -  urogynecological conditions (i.e. pelvic prolapse grade &gt;3 according to the Pelvic&#xD;
             Organ Prolapse - Quantification method (POP-Q) or a urinary or vaginal infection&#xD;
             active or present in the last 3 months);&#xD;
&#xD;
          -  history of pelvic floor surgery (e.g. corrective surgery for organ descent, urinary&#xD;
             incontinence, hysterectomy, mesh surgery,TVT,TOT);&#xD;
&#xD;
          -  previous pelvic floor rehabilitation treatments; 7) expected changes in medication&#xD;
             that may affect the perception of pain (eg pain relievers, antidepressants);&#xD;
&#xD;
          -  any other medical conditions that may interfere with the study procedures (eg&#xD;
             hormonal, psychological, cardiovascular, hematological, neurological, pulmonary or&#xD;
             renal);&#xD;
&#xD;
          -  refusal to abstain from other treatments until the end of their participation in the&#xD;
             study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mehmet Sakıncı, Assos.Prof.</last_name>
    <role>Study Chair</role>
    <affiliation>Akdeniz University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Alime Buyuk</name>
      <address>
        <city>Antalya</city>
        <zip>07070</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <results_reference>
    <citation>Stuge B, Saetre K, Braekken IH. The association between pelvic floor muscle function and pelvic girdle pain--a matched case control 3D ultrasound study. Man Ther. 2012 Apr;17(2):150-6. doi: 10.1016/j.math.2011.12.004. Epub 2012 Jan 15.</citation>
    <PMID>22245422</PMID>
  </results_reference>
  <results_reference>
    <citation>Thibault-Gagnon S, Goldfinger C, Pukall C, Chamberlain S, McLean L. Relationships Between 3-Dimensional Transperineal Ultrasound Imaging and Digital Intravaginal Palpation Assessments of the Pelvic Floor Muscles in Women With and Without Provoked Vestibulodynia. J Sex Med. 2018 Mar;15(3):346-360. doi: 10.1016/j.jsxm.2017.12.017.</citation>
    <PMID>29502982</PMID>
  </results_reference>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>December 30, 2022</last_update_submitted>
  <last_update_submitted_qc>December 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Akdeniz University</investigator_affiliation>
    <investigator_full_name>Alime Buyuk</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>pelvic pain</keyword>
  <keyword>myofascial trigger point release</keyword>
  <keyword>transperineal ultrasound</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myofascial Pain Syndromes</mesh_term>
    <mesh_term>Pelvic Pain</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/NCT04401566
org study id: :60116787-020/47015
nct id: NCT04401566
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The patients diagnosed with pelvic pain will be included in the study. Orthopedic tests for
      pelvic pain were performed after routine gynecological examinations. After perineometer
      measurement, pelvic floor muscle sensitivity grading, ultrasound, and pain score evaluation,
      participants will be randomized and divided into 3 groups. According to a randomization plan
      the first group will be instructed by a physiotherapist to receive an internal myofascial
      trigger point release technique, the second group receive an external myofascial trigger
      point release technique, and the third group receive a video of relaxation exercises related
      to pelvic pain. After the application, measurement of perineometer and pelvic floor muscle
      sensitivity grading, ultrasound, and pain evaluations will be repeated.
Turkey has been affected country from a busy and stressful lifestyle in our changing world
      and that leads to pelvic floor dysfunction has increased rapidly in Turkey. Pelvic pain that
      has in 1 out of every 7 women causes overactivity of pelvic floor muscles with increasing
      stress factors. In addition, it becomes chronic due to both the diagnosis process and the
      time-out of the right treatment and deteriorates the quality of life of women. There is no
      special pelvic floor physiotherapy for the management of pelvic pain in our country, which
      also causes psychosocial problems. On the other hand, myofascial trigger point release
      technique, which is proposed in addition to medical treatment alone or in pelvic floor
      physiotherapy, has been one of the current research areas in the world. However, there is no
      study in the national and international literature comparing internal and external myofascial
      trigger point relaxation techniques and also evaluating transperineal ultrasound. This study
      is unique in terms of comparing two different applications (internal and external trigger
      point relaxation technique) with ultrasound measurements in the literature.

      33 women diagnosed with pelvic pain between the ages of 18-55 will be included in this study.
      Orthopedic tests for pelvic pain will be performed after routine gynecological examinations.
      After perineometer measurement, pelvic floor muscle sensitivity grading, ultrasound and pain
      score evaluation, participants will be randomized and divided into 3 groups. The first group
      will receive internal myofascial trigger point release technique, the second group will
      receive external myofascial trigger point release technique, and the third group will be
      shown a video of relaxation exercises related to pelvic pain. After the application,
      measurement of perineometer and pelvic floor muscle sensitivity grading, ultrasound and pain
      evaluations will be repeated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
masking description: The gynecologist was blind about treatment and the investigator was blind about assesment.
measure: Transperineal ultrasound measures
time frame: 6 months
description: Transperineal ultrasound (Voluson E8 Expert from GE Healthcare with a convex RM6C probe ranging from 2 to 6 Megahertz) will be used to measure the function of the pelvic floor muscles indirectly through morphometry at rest, valsalva and at maximum contraction. This imaging will measure the position of the bladder neck relative to the pubis, the anorectal angle formed by the anus and rectum, the angle formed by the pelvic floor muscles and a horizontal reference line (parallel to the ground ) in addition to the dimensions of the urogenital hiatus which is delimited by the puborectal muscle and which includes the urethra, the vagina and the anus. This method has been evaluated in several studies and demonstrates good intra- and inter-rater fidelity
measure: Perineometer measurements
time frame: 6 months
description: Before starting the assessments as suggested by the International Continence Society, the physiotherapist will check via vaginal palpation the participant's ability to contract and relax the pelvic floor muscles. Afterwords, pelvic examination vaginal manometry (using a Peritron perineometer; Cadio Design, Australia) will be performed to measure resting and maximum contraction of the PFMs
measure: Pelvic floor muscle tenderness scale
time frame: 6 months
description: Tenderness of each of the PFMs (pubococcygeus, iliococcygeus, coccygeus, and obturator internus muscles) was assessed using a nonvalidated scale from 0 to 4 (0, no pressure or pain; 1, pressure but no pain; 2, pressure with discomfort; 3, moderate pain intensified with muscle contraction; 4, severe pain or inability to perform muscle contraction because of pain). Manometry and the tenderness assessments will be repeated after 60 minutes from the first assessments
arm group label: Internal Myofascial Release Group
arm group type: Experimental
description: Internal myofascial trigger point release therapy consists of 30 minutes massage directly to the pelvic floor musculature by vaginally. Patients were instructed in internal myofascial release techniques. Experienced pelvic health physiotherapist (A.B.) to use her fingers with a lubricated glove when the finger could easily reach internal trigger points and follows these steps: (a) finding internal and external trigger points associated with pelvic muscles, especially around sensitive areas of the vagina, anus, and/or pelvic floor; (b) releasing with the fingers the trigger point associated pelvic muscle tension by carefully pressing on the trigger point. Releasing pelvic muscle tension includes applying varying amounts of pressure, sometimes gradually stroking and strumming the muscle region while systematically contracting and relaxing the affected muscles to aid in a trigger point release.
arm group label: External Myofascial Release Group
arm group type: Experimental
description: Eksternal myofascial trigger point release therapy consists of 30 minutes massage to the abdominal wall, gluteal area and abductors, and hamstring muscles. Pain in trigger points may exist at both locations of muscle insertion as well as in the belly and the lower extremity of the muscle.
arm group label: Control Group
arm group type: Other
description: The Control group will have a video about exercises recommended in pelvic pain for 30 minutes. A physiotherapist will teach and show the exercises for pelvic pain. The home exercise for pelvic pain contains diaphragm breathing, pelvic floor muscle stretching, and releasing.
intervention type: Other
intervention name: Internal myofascial release
description: Internal myofascial trigger point release therapy consist of 30 minutes massage directly to the pelvic floor musculature by vaginally. Patients were instructed in internal myofascial relase techniques. Experienced pelvic health physiotherapist (A.B.) to use her fingers with a lubricated glove when the finger could easily reach internal trigger points and follows these steps: (a) finding internal and external trigger points associated with pelvic muscles, especially around sensitive areas of the vagina, anus, and/or pelvic floor; (b) releasing with the fingers the trigger point associated pelvic muscle tension by carefully pressing on the trigger point
arm group label: Internal Myofascial Release Group
intervention type: Other
intervention name: External myofascial release
description: Eksternal myofascial trigger point release therapy consist 30 minutes massage to the abdominal wall, gluteal area and adductors and hamstring muscles. Pain in trigger points may exist at both locations of muscle insertion as well as in the belly and lower extremity of the muscle.
arm group label: External Myofascial Release Group
intervention type: Other
intervention name: Control Group
description: The Control group will have a paper about exercises recommended in pelvic pain for 30 minutes. A physiotherapist will teach and show the exercises for pelvic pain. The home exercise for pelvic pain contains diaphragm breating, pelvic floor muscle stretching and releasing.
arm group label: Control Group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Mehmet Sakıncı, Assos.Prof.
role: Study Chair
affiliation: Akdeniz University
facility: 
country: Turkey
citation: Stuge B, Saetre K, Braekken IH. The association between pelvic floor muscle function and pelvic girdle pain--a matched case control 3D ultrasound study. Man Ther. 2012 Apr;17(2):150-6. doi: 10.1016/j.math.2011.12.004. Epub 2012 Jan 15.
PMID: 22245422
citation: Thibault-Gagnon S, Goldfinger C, Pukall C, Chamberlain S, McLean L. Relationships Between 3-Dimensional Transperineal Ultrasound Imaging and Digital Intravaginal Palpation Assessments of the Pelvic Floor Muscles in Women With and Without Provoked Vestibulodynia. J Sex Med. 2018 Mar;15(3):346-360. doi: 10.1016/j.jsxm.2017.12.017.
PMID: 29502982
responsible party type: Principal Investigator
investigator affiliation: Akdeniz University
investigator full name: Alime Buyuk
investigator title: Principal Investigator
mesh term: Myofascial Pain Syndromes
mesh term: Pelvic Pain