<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/NCT04485182</url>
  </required_header>
  <id_info>
    <org_study_id>PolyclinicHBSJG</org_study_id>
    <nct_id>NCT04485182</nct_id>
  </id_info>
  <brief_title>Underwater Jet Massage Therapy for Chronic Low Back Pain</brief_title>
  <official_title>Underwater Jet Massage Therapy for Chronic Low Back Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Polyclinic of the Hospitaller Brothers of St. John of God, Budapest</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Polyclinic of the Hospitaller Brothers of St. John of God, Budapest</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>
      Underwater massage is the more modern variety of massages otherwise known as tangentor, where&#xD;
      the temperature of the water of the treatment tub and the mechanical effect of the water jet&#xD;
      is utilised. It is typical of chronic low back pain that, after the first painful episode, is&#xD;
      repeated at 44-78% of patients.&#xD;
&#xD;
      Our goals are the followings:&#xD;
&#xD;
        1. Is the beneficial effect of a Underwater massage therapy addition to a complex&#xD;
           physiotherapy comparable to a control group with respect to clinical parameters?&#xD;
&#xD;
        2. How much does the quality of life change in an initial state and how much is it in&#xD;
           comparison with the control group?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Informed consent was obtained from all participants. We use two groups to investigate the&#xD;
      effects of the tangentor on the low back pain.&#xD;
&#xD;
      The patients presenting at the rheumatology inpatient clinics were enrolled without into the&#xD;
      treatment and control groups.&#xD;
&#xD;
      Patients receiving Transcutaneous Electrical Nerve Stimulation + underwater massage + spine&#xD;
      gymnastics&#xD;
&#xD;
      In the controll group the Patients receiving Transcutaneous Electrical Nerve Stimulation +&#xD;
      spine gymnastics&#xD;
&#xD;
      Underwater jet massage (Tangentor) would be performed in a tub developed for this purpose,&#xD;
      where the water temperature: 33-35 ° C. The treatments lasting from 15 atm and 15 cm for 15&#xD;
      minutes.&#xD;
&#xD;
      The water temperature is precisely measured by a built-in thermometer. Pressure is controlled&#xD;
      by a manometer.&#xD;
&#xD;
      They take a minimum of 10 treatments for approx. under 2 weeks.&#xD;
&#xD;
      The back massage position is, that the patient lying on their side, hip and knees are&#xD;
      slightly bent and the head and neck rest on a support.&#xD;
&#xD;
      After the massage the client should rest for about 30minutes.&#xD;
&#xD;
      Patients participated in two visits, for the first time before the study, right after the&#xD;
      therapy treatments.&#xD;
&#xD;
      During the study, all participants received the usual or necessary medications. On a Visual&#xD;
      Analogue Scale (VAS) patients indicated degree of pain on a scale from 0 to 100 mm for the&#xD;
      past week. VAS scores were expressed in millimetres (zero point-no pain; endpoint-intolerable&#xD;
      pain). Patients recorded on the VAS scale the level of low back pain at rest as well as&#xD;
      during activity. Functional disability was assessed by using the Oswestry Disability Index&#xD;
      (ODI).&#xD;
&#xD;
      Furthermore, there was a questionnaire on the quality of life, known as the EuroQol Five&#xD;
      Dimensions Questionnaire (EQ-5D-5L).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Due to the COVID pandemia the tubes of the treatments baths went wrong.&#xD;
  </why_stopped>
  <start_date type="Actual">June 1, 2019</start_date>
  <completion_date type="Actual">March 28, 2023</completion_date>
  <primary_completion_date type="Actual">March 28, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Tangentor</measure>
    <time_frame>2 years</time_frame>
    <description>Investigate the beneficial effect of a Underwater massage therapy addition to a complex physiotherapy comparable to a control group with respect to clinical parameters on a Visual Analogue Scale (VAS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tangentor</measure>
    <time_frame>2 years</time_frame>
    <description>How much does the quality of life change in an initial state and how much is it in comparison with the control group on the EuroQol Five Dimensions Questionnaire (EQ-5D-5L).</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Low Back Pain</condition>
  <arm_group>
    <arm_group_label>First</arm_group_label>
    <description>Patients receiving Transcutaneous Electrical Nerve Stimulation + underwater massage + spine gymnastics +</description>
  </arm_group>
  <arm_group>
    <arm_group_label>controll group</arm_group_label>
    <description>Patients receiving Transcutaneous Electrical Nerve Stimulation + spine gymnastics</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Underwater jet massage (Tangentor)</intervention_name>
    <description>Underwater jet massage (Tangentor) would be performed in a tub developed for this purpose, where the water temperature: 33-35 ° C. The treatments lasting from 15 atm and 15 cm for 15 minutes.&#xD;
They take a minimum of 10 treatments for approx. under 2 weeks.</description>
    <arm_group_label>First</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Enrollment criteria were as follows: outpatients aged 18-85 with non-specific low back pain&#xD;
        that persists for at least 12 weeks, showing degenerative symptoms and suffering from&#xD;
        moderately reduced mobility. Patient's pain intensity during activity should have been&#xD;
        minimum 30mm on Visual Analogue Scale (0-100 mm VAS).&#xD;
&#xD;
        Written information on the methodology and process they would be undergoing was provided to&#xD;
        each participant, and an informed consent form was subsequently signed before the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  at least 12 weeks of non-specific lymphatic pain,the pain sensitivity of the&#xD;
             paravertebral muscle and the painful movement of the lumbar spine can be observed,&#xD;
             which can be characterized by segmental motion, segmental instability or other&#xD;
             reasons.&#xD;
&#xD;
          -  radiographically confirmed spondylosis, discopathy, and spondylarthrosis within one&#xD;
             year.&#xD;
&#xD;
          -  back pain at least 30mm (100mm visualis analogue scale).&#xD;
&#xD;
          -  patient consent form signed before the start of test&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients could not received systemic or locally administered steroid therapy,&#xD;
             physiotherapy or they get balneotherapy in the last 2 months&#xD;
&#xD;
          -  The exclusion criteria included:&#xD;
&#xD;
          -  previous lumbar spine surgery,&#xD;
&#xD;
          -  progressive neurologic loss,&#xD;
&#xD;
          -  pregnancy,&#xD;
&#xD;
          -  umbilical- , inguinal hernia,&#xD;
&#xD;
          -  malignities,&#xD;
&#xD;
          -  infectious diseases,&#xD;
&#xD;
          -  inflammatory pathologies,&#xD;
&#xD;
          -  severe pulmonary and cardiovascular diseases,&#xD;
&#xD;
          -  uncontrolled hypertension,&#xD;
&#xD;
          -  mental disorders,&#xD;
&#xD;
          -  incontinence,&#xD;
&#xD;
          -  Acute lower back pain; Organic neurological symptoms associated with the lower back;&#xD;
&#xD;
          -  pain in the background of osteoporosis or other causes of vertebral compression is&#xD;
             likely; malignity in the background;&#xD;
&#xD;
          -  Lack of complience,&#xD;
&#xD;
          -  Pain due to inflammatory spinal disease;&#xD;
&#xD;
          -  spondylolisthesis (which is not greater than 25% of vertebral skeleton compared to&#xD;
             adjacent vertebrae)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Polyclinic of the Hospitaller Brothers of St. John of God,</name>
      <address>
        <city>Budapest</city>
        <state>Árpád Fejedelem Útja 7</state>
        <zip>1027</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hungary</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>April 12, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>March 28, 2023</last_update_submitted>
  <last_update_submitted_qc>March 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Polyclinic of the Hospitaller Brothers of St. John of God, Budapest</investigator_affiliation>
    <investigator_full_name>Tamas Gati</investigator_full_name>
    <investigator_title>1027 Budapest Árpád fejedelem út 7.</investigator_title>
  </responsible_party>
  <keyword>hydrotherapy, massage</keyword>
  <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>


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/NCT04485182
org study id: PolyclinicHBSJG
nct id: NCT04485182
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Underwater massage is the more modern variety of massages otherwise known as tangentor, where
      the temperature of the water of the treatment tub and the mechanical effect of the water jet
      is utilised. It is typical of chronic low back pain that, after the first painful episode, is
      repeated at 44-78% of patients.

      Our goals are the followings:

        1. Is the beneficial effect of a Underwater massage therapy addition to a complex
           physiotherapy comparable to a control group with respect to clinical parameters?

        2. How much does the quality of life change in an initial state and how much is it in
           comparison with the control group?
Informed consent was obtained from all participants. We use two groups to investigate the
      effects of the tangentor on the low back pain.

      The patients presenting at the rheumatology inpatient clinics were enrolled without into the
      treatment and control groups.

      Patients receiving Transcutaneous Electrical Nerve Stimulation + underwater massage + spine
      gymnastics

      In the controll group the Patients receiving Transcutaneous Electrical Nerve Stimulation +
      spine gymnastics

      Underwater jet massage (Tangentor) would be performed in a tub developed for this purpose,
      where the water temperature: 33-35 ° C. The treatments lasting from 15 atm and 15 cm for 15
      minutes.

      The water temperature is precisely measured by a built-in thermometer. Pressure is controlled
      by a manometer.

      They take a minimum of 10 treatments for approx. under 2 weeks.

      The back massage position is, that the patient lying on their side, hip and knees are
      slightly bent and the head and neck rest on a support.

      After the massage the client should rest for about 30minutes.

      Patients participated in two visits, for the first time before the study, right after the
      therapy treatments.

      During the study, all participants received the usual or necessary medications. On a Visual
      Analogue Scale (VAS) patients indicated degree of pain on a scale from 0 to 100 mm for the
      past week. VAS scores were expressed in millimetres (zero point-no pain; endpoint-intolerable
      pain). Patients recorded on the VAS scale the level of low back pain at rest as well as
      during activity. Functional disability was assessed by using the Oswestry Disability Index
      (ODI).

      Furthermore, there was a questionnaire on the quality of life, known as the EuroQol Five
      Dimensions Questionnaire (EQ-5D-5L).
observational model: Cohort
time perspective: Prospective
measure: Tangentor
time frame: 2 years
description: Investigate the beneficial effect of a Underwater massage therapy addition to a complex physiotherapy comparable to a control group with respect to clinical parameters on a Visual Analogue Scale (VAS)
measure: Tangentor
time frame: 2 years
description: How much does the quality of life change in an initial state and how much is it in comparison with the control group on the EuroQol Five Dimensions Questionnaire (EQ-5D-5L).
arm group label: First
description: Patients receiving Transcutaneous Electrical Nerve Stimulation + underwater massage + spine gymnastics +
arm group label: controll group
description: Patients receiving Transcutaneous Electrical Nerve Stimulation + spine gymnastics
intervention type: Other
intervention name: Underwater jet massage (Tangentor)
description: Underwater jet massage (Tangentor) would be performed in a tub developed for this purpose, where the water temperature: 33-35 ° C. The treatments lasting from 15 atm and 15 cm for 15 minutes.
They take a minimum of 10 treatments for approx. under 2 weeks.
arm group label: First
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
facility: 
country: Hungary
responsible party type: Principal Investigator
investigator affiliation: Polyclinic of the Hospitaller Brothers of St. John of God, Budapest
investigator full name: Tamas Gati
investigator title: 1027 Budapest Árpád fejedelem út 7.
mesh term: Back Pain
mesh term: Low Back Pain