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/NCT05974761</url>
    </required_header>
    <id_info>
      <org_study_id>jigubchao202307</org_study_id>
      <secondary_id>Z-2022046</secondary_id>
      <nct_id>NCT05974761</nct_id>
    </id_info>
    <brief_title>Clinical Observation on the Treatment of Massage Based on Fascia Chain</brief_title>
    <official_title>Clinical Observation on the Treatment of Chronic Low Back Pain With Side-lying Massage Based on Fascia Chain</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>muxing zhu</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Shandong University of Traditional Chinese Medicine</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>
        The goal of thisclinical trial is to observe and quantify the impact of our massage methods&#xD;
        on the human body based on B-mode ultrasound, Vas score, and ODI score, and to compare our&#xD;
        massage methods with traditional Chinese massage treatment. The main questions it aims to&#xD;
        answer are:&#xD;
  &#xD;
          -  To set up our standard operating procedure of massage therapy to adjust the stress line&#xD;
             of psoas myofascial chain, and provide a more simple and effective therapy for Chronic&#xD;
             low back pain.&#xD;
  &#xD;
          -  try to establish a kind of ultrasonic standard to evaluate the curative effect of&#xD;
             treating chronic low back pain.&#xD;
  &#xD;
        The subjects were randomly divided into two groups, the experimental group and the control&#xD;
        group, the experimental group was given our characteristic massage treatment, the control&#xD;
        group was given traditional Chinese massage treatment.Both groups were treated once every&#xD;
        other day, 3 times a week, 2 weeks as a course of treatment, 2 courses of treatment.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        1. the patients in the observation group were treated with the manipulation of side-lying&#xD;
             and tendons poking. The specific manipulation methods were as follows: (1) the&#xD;
             relaxation method: the patients were in prone position, in order to relieve the&#xD;
             superficial muscle and fascia, the doctor applied the method of massage, palm massage&#xD;
             and arm movement up and down the vertical spine muscle for 3-5 minutes, move your body&#xD;
             as close to the bedside as possible. Straighten your lower legs, bend your hips and&#xD;
             knees, rest your ankles on your lower legs, and lift your arms to the side of your head.&#xD;
             The surgeon stands on the ventral side of the patient, with the crotch resting on the&#xD;
             anterior edge of the superior iliac crest, with the elbow rising from the medial top of&#xD;
             the superior iliac crest, and slowly following the palpation along the vertical edge of&#xD;
             the skeleton toward the spine (avoiding the L 3 transverse process) , and focus on the&#xD;
             pain point or the rope to repeatedly apply elbow pressure, elbow plucking method 1-2&#xD;
             minutes to ease the spasm and analgesia, ease adhesion, promote the absorption of&#xD;
             inflammatory edema, manipulation is appropriate to ease the gentle; Then the elbow moved&#xD;
             down to the buttocks, with the elbow tip touch to find the sinew knot and along the&#xD;
             vertical direction of the vertical plucking 3-5 times, the force should be deep&#xD;
             penetration. (3) the method of adjusting the extensor muscles and bones: keeping the&#xD;
             upper posture, doing the lumbar oblique pulling, one time each side, further stretching&#xD;
             the deep muscles of the waist, adjusting the disorder of the lumbar facet joints caused&#xD;
             by the twinning contraction of the muscles and fascia. 4 ending type: with double palm&#xD;
             up and down alternately percussion waist muscle ten times to end.&#xD;
  &#xD;
          2. control group: according to the Tuina treatment scheme of low back pain in the textbook&#xD;
             of the 13th five-year plan for higher education of Chinese medicine published by China&#xD;
             Traditional Chinese Medicine Press in July 2016 and edited by Fan Binghua. The specific&#xD;
             methods of operation are as follows: 1 relaxation method: the patient lies prone, the&#xD;
             operator stands on the affected side, and applies the massage to the affected side&#xD;
             waist, arm and thigh back and forth for 5 minutes, the strength should be deep and&#xD;
             gentle, in order to relax the tendons and activate the blood circulation, promote the&#xD;
             absorption of peripheral inflammation and edema. 2 point method: the Doctor uses one&#xD;
             finger to push the middle acupoints in Ashi, Shenshu, Baihuanshu, Huantiao, zhibian,&#xD;
             Chengfu, and massages each point for about half a minute to relax the muscles and&#xD;
             activate the blood, 3 method of relieving spasm and pain: the Doctor applied the thumb&#xD;
             plucking method at the tendon of the cord-like muscle 2-3cm below the medial side of the&#xD;
             highest point of the skeletal crest. The manipulation was from light to heavy, and could&#xD;
             be alternately operated with the thumb pressing and kneading method for about 2 minutes,&#xD;
             in order to release adhesion, Pain Relief 4 end: the operator to small thenar vertical&#xD;
             rub both sides of the erector muscles, transverse rub lumbosacral department, diaphanous&#xD;
             heat for the degree. To double palm up and down alternately tap the lumbosacral end of a&#xD;
             dozen times. The Observation Group and the control group were treated once every other&#xD;
             day, 3 times a week, 2 weeks as a course of treatment, 2 courses of treatment.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">July 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">July 1, 2025</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>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The changes of fascia of erector spine muscle before and after 4 weeks treatment were compared.</measure>
      <time_frame>24months</time_frame>
      <description>The position of the lower edge of the transverse process of T12, the lower edge of the transverse process of L 3 and the upper edge of the sacral pathway were determined, take these three points as the placement point of probe center position. After placing the probe, move the probe up and down to get a clear echo of the center point. The musculus erectus erectus muscle appeared between l 3 transverse process, T 12 transverse process lower edge, sacral camel upper edge and fascia layer lower edge, and the thickness of musculus erectus erectus muscle was measured in turn. 3 measurements are required at the same location, and the mean value is taken as the corrected thickness value.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The changes of Vas score were compared before and after 4 weeks treatment</measure>
      <time_frame>24months</time_frame>
      <description>Before and after the treatment, the changes of the thickness membrane of the erector spine muscle were observed by b-mode ultrasonography, and the therapeutic effect of lateral supine massage on Psoas myofascitis was quantitatively expressed,A straight line with a ruler is divided into 10 segments, with 0 and 10 marks at both ends. The larger the scale, the higher the pain level. 0 was painless, 1-3 was mild pain that could be tolerated, 4-6 was pain that affected sleep but could be tolerated, 7-9 was pain that was gradually intense and affected appetite and sleep, and 10 was severe pain.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The changes of ODI score were compared before and after 4 weeks treatment</measure>
      <time_frame>24months</time_frame>
      <description>Before and after the treatment, the changes of the thickness membrane of the erector spine muscle were observed by b-mode ultrasonography, and the therapeutic effect of lateral supine massage on Psoas myofascitis was quantitatively expressed,It was divided into 10 related questions, such as pain intensity, self-care ability, lifting ability, walking ability, sitting ability, walking ability, ability, standing time and sleep quality. There are 6 options for each question, with scores ranging from 0 to 5. The maximum cumulative score for 10 questions is 50. The formula is: Total Score = (score/5 × number of questions answered) × 100% . The higher the score, the more severe the dysfunction</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">76</enrollment>
    <condition>Low Back Pain</condition>
    <arm_group>
      <arm_group_label>Side lying muscle massage</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The patient was placed in a lateral decubitus position with the physician standing on the ventral side of the patient, with the crotch resting on the anterior edge of the superior iliac crest, and the elbow rising from the medial side of the highest point of the superior iliac crest, follow the palpation (avoiding the L3 transverse process) along the steep edge of the skeleton slowly toward the spine, and focus on the painful points or cords by repeatedly applying the elbow press method and the elbow flick method for 1-2 minutes, after that, the tendon was found to be induration with elbow tip probing, and the tendon was plucked 3-5 times vertically along the vertical direction.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Traditional Chinese massage</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Through the point, massage, bone-setting treatment</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>massage</intervention_name>
      <description>The patient was placed in a lateral decubitus position with the physician standing on the ventral side of the patient, with the crotch resting on the anterior edge of the superior iliac crest, and the elbow rising from the medial side of the highest point of the superior iliac crest, follow the palpation (avoiding the L3 transverse process) along the steep edge of the skeleton slowly toward the spine, and focus on the painful points or cords by repeatedly applying the elbow press method and the elbow flick method for 1-2 minutes, and then the elbow tip contact to find the sinew knot and along the vertical direction of 3-5 times, the force should be deep penetration.</description>
      <arm_group_label>Side lying muscle massage</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Traditional Chinese massage</intervention_name>
      <description>Through the point, massage, bone-setting treatment</description>
      <arm_group_label>Traditional Chinese massage</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Those who met the diagnostic criteria of chronic low back pain, aged 18-65 years,&#xD;
               volunteered to join the trial and signed the informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  In the course of treatment, the skin of waist and buttocks was obviously damaged,&#xD;
               infected and ulcerated, and the women were in the period of menstruation, pregnancy or&#xD;
               lactation Patients with cardiac cerebrovascular disease, hepatic and renal&#xD;
               insufficiency, bleeding disorders and mental disorders, and participants in other&#xD;
               clinical trials within one month.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>shuwen mao</last_name>
      <role>Principal Investigator</role>
      <affiliation>Shandong University of Traditional Chinese Medicine</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>muxing zhu</last_name>
      <phone>15966649706</phone>
      <email>807132313@qq.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>jiageng zhao</last_name>
      <phone>18769546572</phone>
      <email>2388022175@qq.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Affiliated Hospital of Shandong University of traditional Chinese medicine</name>
        <address>
          <city>Jinan</city>
          <state>Shandong</state>
          <zip>250013</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>muxing zhu</last_name>
        <phone>15966649706</phone>
        <email>807132313@qq.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 7, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Shandong University of Traditional Chinese Medicine</investigator_affiliation>
      <investigator_full_name>muxing zhu</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Back Pain</mesh_term>
      <mesh_term>Low Back Pain</mesh_term>
    </condition_browse>
    <!-- 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/NCT05974761
  org study id: jigubchao202307
  secondary id: Z-2022046
  nct id: NCT05974761
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of thisclinical trial is to observe and quantify the impact of our massage methods
        on the human body based on B-mode ultrasound, Vas score, and ODI score, and to compare our
        massage methods with traditional Chinese massage treatment. The main questions it aims to
        answer are:
  
          -  To set up our standard operating procedure of massage therapy to adjust the stress line
             of psoas myofascial chain, and provide a more simple and effective therapy for Chronic
             low back pain.
  
          -  try to establish a kind of ultrasonic standard to evaluate the curative effect of
             treating chronic low back pain.
  
        The subjects were randomly divided into two groups, the experimental group and the control
        group, the experimental group was given our characteristic massage treatment, the control
        group was given traditional Chinese massage treatment.Both groups were treated once every
        other day, 3 times a week, 2 weeks as a course of treatment, 2 courses of treatment.
  1. the patients in the observation group were treated with the manipulation of side-lying
             and tendons poking. The specific manipulation methods were as follows: (1) the
             relaxation method: the patients were in prone position, in order to relieve the
             superficial muscle and fascia, the doctor applied the method of massage, palm massage
             and arm movement up and down the vertical spine muscle for 3-5 minutes, move your body
             as close to the bedside as possible. Straighten your lower legs, bend your hips and
             knees, rest your ankles on your lower legs, and lift your arms to the side of your head.
             The surgeon stands on the ventral side of the patient, with the crotch resting on the
             anterior edge of the superior iliac crest, with the elbow rising from the medial top of
             the superior iliac crest, and slowly following the palpation along the vertical edge of
             the skeleton toward the spine (avoiding the L 3 transverse process) , and focus on the
             pain point or the rope to repeatedly apply elbow pressure, elbow plucking method 1-2
             minutes to ease the spasm and analgesia, ease adhesion, promote the absorption of
             inflammatory edema, manipulation is appropriate to ease the gentle; Then the elbow moved
             down to the buttocks, with the elbow tip touch to find the sinew knot and along the
             vertical direction of the vertical plucking 3-5 times, the force should be deep
             penetration. (3) the method of adjusting the extensor muscles and bones: keeping the
             upper posture, doing the lumbar oblique pulling, one time each side, further stretching
             the deep muscles of the waist, adjusting the disorder of the lumbar facet joints caused
             by the twinning contraction of the muscles and fascia. 4 ending type: with double palm
             up and down alternately percussion waist muscle ten times to end.
  
          2. control group: according to the Tuina treatment scheme of low back pain in the textbook
             of the 13th five-year plan for higher education of Chinese medicine published by China
             Traditional Chinese Medicine Press in July 2016 and edited by Fan Binghua. The specific
             methods of operation are as follows: 1 relaxation method: the patient lies prone, the
             operator stands on the affected side, and applies the massage to the affected side
             waist, arm and thigh back and forth for 5 minutes, the strength should be deep and
             gentle, in order to relax the tendons and activate the blood circulation, promote the
             absorption of peripheral inflammation and edema. 2 point method: the Doctor uses one
             finger to push the middle acupoints in Ashi, Shenshu, Baihuanshu, Huantiao, zhibian,
             Chengfu, and massages each point for about half a minute to relax the muscles and
             activate the blood, 3 method of relieving spasm and pain: the Doctor applied the thumb
             plucking method at the tendon of the cord-like muscle 2-3cm below the medial side of the
             highest point of the skeletal crest. The manipulation was from light to heavy, and could
             be alternately operated with the thumb pressing and kneading method for about 2 minutes,
             in order to release adhesion, Pain Relief 4 end: the operator to small thenar vertical
             rub both sides of the erector muscles, transverse rub lumbosacral department, diaphanous
             heat for the degree. To double palm up and down alternately tap the lumbosacral end of a
             dozen times. The Observation Group and the control group were treated once every other
             day, 3 times a week, 2 weeks as a course of treatment, 2 courses of treatment.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Care Provider, Outcomes Assessor)
  measure: The changes of fascia of erector spine muscle before and after 4 weeks treatment were compared.
  time frame: 24months
  description: The position of the lower edge of the transverse process of T12, the lower edge of the transverse process of L 3 and the upper edge of the sacral pathway were determined, take these three points as the placement point of probe center position. After placing the probe, move the probe up and down to get a clear echo of the center point. The musculus erectus erectus muscle appeared between l 3 transverse process, T 12 transverse process lower edge, sacral camel upper edge and fascia layer lower edge, and the thickness of musculus erectus erectus muscle was measured in turn. 3 measurements are required at the same location, and the mean value is taken as the corrected thickness value.
  measure: The changes of Vas score were compared before and after 4 weeks treatment
  time frame: 24months
  description: Before and after the treatment, the changes of the thickness membrane of the erector spine muscle were observed by b-mode ultrasonography, and the therapeutic effect of lateral supine massage on Psoas myofascitis was quantitatively expressed,A straight line with a ruler is divided into 10 segments, with 0 and 10 marks at both ends. The larger the scale, the higher the pain level. 0 was painless, 1-3 was mild pain that could be tolerated, 4-6 was pain that affected sleep but could be tolerated, 7-9 was pain that was gradually intense and affected appetite and sleep, and 10 was severe pain.
  measure: The changes of ODI score were compared before and after 4 weeks treatment
  time frame: 24months
  description: Before and after the treatment, the changes of the thickness membrane of the erector spine muscle were observed by b-mode ultrasonography, and the therapeutic effect of lateral supine massage on Psoas myofascitis was quantitatively expressed,It was divided into 10 related questions, such as pain intensity, self-care ability, lifting ability, walking ability, sitting ability, walking ability, ability, standing time and sleep quality. There are 6 options for each question, with scores ranging from 0 to 5. The maximum cumulative score for 10 questions is 50. The formula is: Total Score = (score/5 × number of questions answered) × 100% . The higher the score, the more severe the dysfunction
  arm group label: Side lying muscle massage
  arm group type: Experimental
  description: The patient was placed in a lateral decubitus position with the physician standing on the ventral side of the patient, with the crotch resting on the anterior edge of the superior iliac crest, and the elbow rising from the medial side of the highest point of the superior iliac crest, follow the palpation (avoiding the L3 transverse process) along the steep edge of the skeleton slowly toward the spine, and focus on the painful points or cords by repeatedly applying the elbow press method and the elbow flick method for 1-2 minutes, after that, the tendon was found to be induration with elbow tip probing, and the tendon was plucked 3-5 times vertically along the vertical direction.
  arm group label: Traditional Chinese massage
  arm group type: Other
  description: Through the point, massage, bone-setting treatment
  intervention type: Other
  intervention name: massage
  description: The patient was placed in a lateral decubitus position with the physician standing on the ventral side of the patient, with the crotch resting on the anterior edge of the superior iliac crest, and the elbow rising from the medial side of the highest point of the superior iliac crest, follow the palpation (avoiding the L3 transverse process) along the steep edge of the skeleton slowly toward the spine, and focus on the painful points or cords by repeatedly applying the elbow press method and the elbow flick method for 1-2 minutes, and then the elbow tip contact to find the sinew knot and along the vertical direction of 3-5 times, the force should be deep penetration.
  arm group label: Side lying muscle massage
  intervention type: Other
  intervention name: Traditional Chinese massage
  description: Through the point, massage, bone-setting treatment
  arm group label: Traditional Chinese massage
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: shuwen mao
  role: Principal Investigator
  affiliation: Shandong University of Traditional Chinese Medicine
  last name: muxing zhu
  phone: 15966649706
  email: 807132313@qq.com
  last name: jiageng zhao
  phone: 18769546572
  email: 2388022175@qq.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor-Investigator
  investigator affiliation: Shandong University of Traditional Chinese Medicine
  investigator full name: muxing zhu
  investigator title: Professor
  mesh term: Back Pain
  mesh term: Low Back Pain