<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/NCT04440293</url>
  </required_header>
  <id_info>
    <org_study_id>KaratayUKY</org_study_id>
    <nct_id>NCT04440293</nct_id>
  </id_info>
  <brief_title>Effects of Basic Body Awareness Therapy on Patients With Chronic Neck Pain</brief_title>
  <official_title>Effects of Basic Body Awareness Therapy on Pain, Balance and Proprioceptive Sense in Patients With Chronic Neck Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>KTO Karatay University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>KTO Karatay 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 aim of this study was to compare the effects of Basic Body Awareness Therapy (BBAT) and&#xD;
      conventional therapies (CT) on pain, balance and proprioceptive sensation of cervical region&#xD;
      in patients with chronic neck pain. As a cross-over study, patients were divided into BBAT /&#xD;
      CT (n=17) and CT / BBAT (n=18) groups. BBAT program has been implemented to patients within&#xD;
      group BBAT / CT two days a week for 6 weeks while group CT / BBAT received the CT program&#xD;
      during the same period. After the interval of 5-week, group BBAT / CT was treated with CT and&#xD;
      group CT / BBAT was treated with BBAT. Pain severity with; Visual Analogue Scale (VAS),&#xD;
      disability level with; Neck Disability Index (NDI), cervical proprioception with; Cervical&#xD;
      Range of Motion Deluxe (CROM) device, balance with; Computerized Dynamic Posturography were&#xD;
      evaluated. The evaluations were conducted before and after the first and second treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic neck pain is a common musculoskeletal disease that affects many people at some point&#xD;
      in life.Its prevalence in the general population varies between 30-50% and is more common in&#xD;
      women over 50 years old.The cervical area is an important body part due to the sensorial&#xD;
      receptors of the muscles and joints as well as central and reflexes connections with visual,&#xD;
      vestibular, and postural control systems.Numerous sensorimotor disorders have been detected&#xD;
      in patients with chronic neck pain.Some patients with neck pain have impaired proprioceptive&#xD;
      sensation and postural control.Pain can affect presynaptic inhibition of muscle afferents and&#xD;
      modulation of proprioceptive muscle spindles, causing prolonged delays.These changes may&#xD;
      result in decreased muscle control and increased postural release.Different updated and&#xD;
      conventional therapy (CT) methods are used for the treatment of neck pain. Mobilization of&#xD;
      soft tissue and joint, stabilization techniques, cervical collars, relaxation training,&#xD;
      strengthening exercises, and posture arrangement by body awareness are common therapeutic&#xD;
      modalities. Basic Body Awareness Therapy (BBAT) is a method used by physiotherapists to&#xD;
      increase patient awareness and control posture.The method is increasingly used in the&#xD;
      treatment of painful conditions related to the chronic musculoskeletal system.However, there&#xD;
      are not enough studies in the literature examining the effects of proprioceptive senses and&#xD;
      postural control in patients with chronic neck pain. The aim of this study is to compare the&#xD;
      effects of BBAT and conventional treatments (CT) on pain, balance and proprioceptive&#xD;
      sensation of the cervical region in patients with chronic neck pain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2017</start_date>
  <completion_date type="Actual">May 16, 2018</completion_date>
  <primary_completion_date type="Actual">April 2, 2018</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Balance</measure>
    <time_frame>at the beginning of treatments</time_frame>
    <description>The balance assessed by the Sensorial Organization Test (SOT) in the Computerized Dynamic Posturography device.The results of the SOT are calculated according to anterior-posterior sways. A balance score ranging from 0 to 100 is achieved, where 0 indicates loss of balance and 100 indicates excellent stability.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Balance</measure>
    <time_frame>6 weeks later</time_frame>
    <description>The balance assessed by the Sensorial Organization Test (SOT) in the Computerized Dynamic Posturography device.The results of the SOT are calculated according to anterior-posterior sways. A balance score ranging from 0 to 100 is achieved, where 0 indicates loss of balance and 100 indicates excellent stability.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Balance</measure>
    <time_frame>11 weeks later</time_frame>
    <description>The balance assessed by the Sensorial Organization Test (SOT) in the Computerized Dynamic Posturography device.The results of the SOT are calculated according to anterior-posterior sways. A balance score ranging from 0 to 100 is achieved, where 0 indicates loss of balance and 100 indicates excellent stability.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Balance</measure>
    <time_frame>17 weeks later</time_frame>
    <description>The balance assessed by the Sensorial Organization Test (SOT) in the Computerized Dynamic Posturography device.The results of the SOT are calculated according to anterior-posterior sways. A balance score ranging from 0 to 100 is achieved, where 0 indicates loss of balance and 100 indicates excellent stability.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neck proprioception</measure>
    <time_frame>at the beginning of treatments</time_frame>
    <description>Proprioceptive sensation was evaluated using the Cervical Range of Motion Deluxe (CROM, Deluxe Performance Attainment Associates, Lindstrom, Minnesota, USA) device.Joint position error and deflection angles of the head in all 3 planes were measured with CROM device.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neck proprioception</measure>
    <time_frame>6 weeks later</time_frame>
    <description>Proprioceptive sensation was evaluated using the Cervical Range of Motion Deluxe (CROM, Deluxe Performance Attainment Associates, Lindstrom, Minnesota, USA) device.Joint position error and deflection angles of the head in all 3 planes were measured with CROM device.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neck proprioception</measure>
    <time_frame>11 weeks later</time_frame>
    <description>Proprioceptive sensation was evaluated using the Cervical Range of Motion Deluxe (CROM, Deluxe Performance Attainment Associates, Lindstrom, Minnesota, USA) device.Joint position error and deflection angles of the head in all 3 planes were measured with CROM device.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neck proprioception</measure>
    <time_frame>17 weeks later</time_frame>
    <description>Proprioceptive sensation was evaluated using the Cervical Range of Motion Deluxe (CROM, Deluxe Performance Attainment Associates, Lindstrom, Minnesota, USA) device.Joint position error and deflection angles of the head in all 3 planes were measured with CROM device.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain severity</measure>
    <time_frame>at the beginning of treatments</time_frame>
    <description>Visual Analogue Scale (VAS) was used to determine the severity of pain in the patients with neck pain. Patients were asked to indicate their pain levels on a scale of 0-10 cm. The value &quot;0&quot; indicates no pain while the value &quot;10&quot; indicates unbearable pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain severity</measure>
    <time_frame>6 weeks later</time_frame>
    <description>Visual Analogue Scale (VAS) was used to determine the severity of pain in the patients with neck pain. Patients were asked to indicate their pain levels on a scale of 0-10 cm. The value &quot;0&quot; indicates no pain while the value &quot;10&quot; indicates unbearable pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain severity</measure>
    <time_frame>11 weeks later</time_frame>
    <description>Visual Analogue Scale (VAS) was used to determine the severity of pain in the patients with neck pain. Patients were asked to indicate their pain levels on a scale of 0-10 cm. The value &quot;0&quot; indicates no pain while the value &quot;10&quot; indicates unbearable pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain severity</measure>
    <time_frame>17 weeks later</time_frame>
    <description>Visual Analogue Scale (VAS) was used to determine the severity of pain in the patients with neck pain. Patients were asked to indicate their pain levels on a scale of 0-10 cm. The value &quot;0&quot; indicates no pain while the value &quot;10&quot; indicates unbearable pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neck disability level</measure>
    <time_frame>at the beginning of treatments</time_frame>
    <description>The Neck Disability Index was used to determine the patients' neck disability levels. There are ten sections of the scale that question the severity of pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation, consisting of 6 questions. Item scores range from 0 (no disability) to 5 (total disability).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neck disability level</measure>
    <time_frame>6 weeks later</time_frame>
    <description>The Neck Disability Index was used to determine the patients' neck disability levels. There are ten sections of the scale that question the severity of pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation, consisting of 6 questions. Item scores range from 0 (no disability) to 5 (total disability).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neck disability level</measure>
    <time_frame>11 weeks later</time_frame>
    <description>The Neck Disability Index was used to determine the patients' neck disability levels. There are ten sections of the scale that question the severity of pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation, consisting of 6 questions. Item scores range from 0 (no disability) to 5 (total disability).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neck disability level</measure>
    <time_frame>17 weeks later</time_frame>
    <description>The Neck Disability Index was used to determine the patients' neck disability levels. There are ten sections of the scale that question the severity of pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation, consisting of 6 questions. Item scores range from 0 (no disability) to 5 (total disability).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Neck Pain</condition>
  <condition>Proprioceptive Disorders</condition>
  <condition>Balance; Distorted</condition>
  <arm_group>
    <arm_group_label>Group BBAT / CT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group BBAT / CT started treatment with BBAT and received 2 days a week for 6 weeks. After the interval of 5-week, group BBAT / CT was treated with CT twice a week for 6 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group CT / BBAT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group CT / BBAT started treatment with CT and received 2 days a week for 6 weeks. After the interval of 5-week, group CT / BBAT was treated with BBAT twice a week for 6 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>BBAT</intervention_name>
    <description>The BBAT was applied by a trained and certified physiotherapist in this area for about an hour, two days a week, as a group therapy. The BBAT program includes movements related to daily activities such as lying, sitting, standing and walking. BBAT focuses on basic movement principles such as postural stability, energy adjustment in movements, comfortable breathing and coordination.</description>
    <arm_group_label>Group BBAT / CT</arm_group_label>
    <arm_group_label>Group CT / BBAT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CT</intervention_name>
    <description>The CT program was applied two days a week for about an hour. The CT program includes active range of motion (ROM) exercises, stretching, isometric and resistant strengthening, posture exercises and relaxation training.</description>
    <arm_group_label>Group BBAT / CT</arm_group_label>
    <arm_group_label>Group CT / BBAT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Being 18 or over,&#xD;
&#xD;
          -  Having neck pain for more than 3 months,&#xD;
&#xD;
          -  Having neck problems that do not cause neurological deficits&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of cervical vertebra fracture or spinal tumor,&#xD;
&#xD;
          -  Those diagnosed with cervical dystonia,&#xD;
&#xD;
          -  Whiplash-related disorders,&#xD;
&#xD;
          -  Those diagnosed with vertigo, fibromyalgia, or rheumatoid arthritis,&#xD;
&#xD;
          -  The presence of inflammatory disease or infection.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kamil Yılmaz, 1</last_name>
    <role>Principal Investigator</role>
    <affiliation>KTO Karatay University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>KTO Karatay University</name>
      <address>
        <city>Konya</city>
        <zip>42020</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>June 18, 2020</last_update_submitted>
  <last_update_submitted_qc>June 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>neck pain</keyword>
  <keyword>proprioception</keyword>
  <keyword>balance</keyword>
  <keyword>body awareness</keyword>
  <keyword>exercise</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Somatosensory Disorders</mesh_term>
    <mesh_term>Neck 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/NCT04440293
org study id: KaratayUKY
nct id: NCT04440293
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study was to compare the effects of Basic Body Awareness Therapy (BBAT) and
      conventional therapies (CT) on pain, balance and proprioceptive sensation of cervical region
      in patients with chronic neck pain. As a cross-over study, patients were divided into BBAT /
      CT (n=17) and CT / BBAT (n=18) groups. BBAT program has been implemented to patients within
      group BBAT / CT two days a week for 6 weeks while group CT / BBAT received the CT program
      during the same period. After the interval of 5-week, group BBAT / CT was treated with CT and
      group CT / BBAT was treated with BBAT. Pain severity with; Visual Analogue Scale (VAS),
      disability level with; Neck Disability Index (NDI), cervical proprioception with; Cervical
      Range of Motion Deluxe (CROM) device, balance with; Computerized Dynamic Posturography were
      evaluated. The evaluations were conducted before and after the first and second treatment.
Chronic neck pain is a common musculoskeletal disease that affects many people at some point
      in life.Its prevalence in the general population varies between 30-50% and is more common in
      women over 50 years old.The cervical area is an important body part due to the sensorial
      receptors of the muscles and joints as well as central and reflexes connections with visual,
      vestibular, and postural control systems.Numerous sensorimotor disorders have been detected
      in patients with chronic neck pain.Some patients with neck pain have impaired proprioceptive
      sensation and postural control.Pain can affect presynaptic inhibition of muscle afferents and
      modulation of proprioceptive muscle spindles, causing prolonged delays.These changes may
      result in decreased muscle control and increased postural release.Different updated and
      conventional therapy (CT) methods are used for the treatment of neck pain. Mobilization of
      soft tissue and joint, stabilization techniques, cervical collars, relaxation training,
      strengthening exercises, and posture arrangement by body awareness are common therapeutic
      modalities. Basic Body Awareness Therapy (BBAT) is a method used by physiotherapists to
      increase patient awareness and control posture.The method is increasingly used in the
      treatment of painful conditions related to the chronic musculoskeletal system.However, there
      are not enough studies in the literature examining the effects of proprioceptive senses and
      postural control in patients with chronic neck pain. The aim of this study is to compare the
      effects of BBAT and conventional treatments (CT) on pain, balance and proprioceptive
      sensation of the cervical region in patients with chronic neck pain.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Balance
time frame: at the beginning of treatments
description: The balance assessed by the Sensorial Organization Test (SOT) in the Computerized Dynamic Posturography device.The results of the SOT are calculated according to anterior-posterior sways. A balance score ranging from 0 to 100 is achieved, where 0 indicates loss of balance and 100 indicates excellent stability.
measure: Balance
time frame: 6 weeks later
description: The balance assessed by the Sensorial Organization Test (SOT) in the Computerized Dynamic Posturography device.The results of the SOT are calculated according to anterior-posterior sways. A balance score ranging from 0 to 100 is achieved, where 0 indicates loss of balance and 100 indicates excellent stability.
measure: Balance
time frame: 11 weeks later
description: The balance assessed by the Sensorial Organization Test (SOT) in the Computerized Dynamic Posturography device.The results of the SOT are calculated according to anterior-posterior sways. A balance score ranging from 0 to 100 is achieved, where 0 indicates loss of balance and 100 indicates excellent stability.
measure: Balance
time frame: 17 weeks later
description: The balance assessed by the Sensorial Organization Test (SOT) in the Computerized Dynamic Posturography device.The results of the SOT are calculated according to anterior-posterior sways. A balance score ranging from 0 to 100 is achieved, where 0 indicates loss of balance and 100 indicates excellent stability.
measure: Neck proprioception
time frame: at the beginning of treatments
description: Proprioceptive sensation was evaluated using the Cervical Range of Motion Deluxe (CROM, Deluxe Performance Attainment Associates, Lindstrom, Minnesota, USA) device.Joint position error and deflection angles of the head in all 3 planes were measured with CROM device.
measure: Neck proprioception
time frame: 6 weeks later
description: Proprioceptive sensation was evaluated using the Cervical Range of Motion Deluxe (CROM, Deluxe Performance Attainment Associates, Lindstrom, Minnesota, USA) device.Joint position error and deflection angles of the head in all 3 planes were measured with CROM device.
measure: Neck proprioception
time frame: 11 weeks later
description: Proprioceptive sensation was evaluated using the Cervical Range of Motion Deluxe (CROM, Deluxe Performance Attainment Associates, Lindstrom, Minnesota, USA) device.Joint position error and deflection angles of the head in all 3 planes were measured with CROM device.
measure: Neck proprioception
time frame: 17 weeks later
description: Proprioceptive sensation was evaluated using the Cervical Range of Motion Deluxe (CROM, Deluxe Performance Attainment Associates, Lindstrom, Minnesota, USA) device.Joint position error and deflection angles of the head in all 3 planes were measured with CROM device.
measure: Pain severity
time frame: at the beginning of treatments
description: Visual Analogue Scale (VAS) was used to determine the severity of pain in the patients with neck pain. Patients were asked to indicate their pain levels on a scale of 0-10 cm. The value "0" indicates no pain while the value "10" indicates unbearable pain.
measure: Pain severity
time frame: 6 weeks later
description: Visual Analogue Scale (VAS) was used to determine the severity of pain in the patients with neck pain. Patients were asked to indicate their pain levels on a scale of 0-10 cm. The value "0" indicates no pain while the value "10" indicates unbearable pain.
measure: Pain severity
time frame: 11 weeks later
description: Visual Analogue Scale (VAS) was used to determine the severity of pain in the patients with neck pain. Patients were asked to indicate their pain levels on a scale of 0-10 cm. The value "0" indicates no pain while the value "10" indicates unbearable pain.
measure: Pain severity
time frame: 17 weeks later
description: Visual Analogue Scale (VAS) was used to determine the severity of pain in the patients with neck pain. Patients were asked to indicate their pain levels on a scale of 0-10 cm. The value "0" indicates no pain while the value "10" indicates unbearable pain.
measure: Neck disability level
time frame: at the beginning of treatments
description: The Neck Disability Index was used to determine the patients' neck disability levels. There are ten sections of the scale that question the severity of pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation, consisting of 6 questions. Item scores range from 0 (no disability) to 5 (total disability).
measure: Neck disability level
time frame: 6 weeks later
description: The Neck Disability Index was used to determine the patients' neck disability levels. There are ten sections of the scale that question the severity of pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation, consisting of 6 questions. Item scores range from 0 (no disability) to 5 (total disability).
measure: Neck disability level
time frame: 11 weeks later
description: The Neck Disability Index was used to determine the patients' neck disability levels. There are ten sections of the scale that question the severity of pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation, consisting of 6 questions. Item scores range from 0 (no disability) to 5 (total disability).
measure: Neck disability level
time frame: 17 weeks later
description: The Neck Disability Index was used to determine the patients' neck disability levels. There are ten sections of the scale that question the severity of pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation, consisting of 6 questions. Item scores range from 0 (no disability) to 5 (total disability).
arm group label: Group BBAT / CT
arm group type: Experimental
description: Group BBAT / CT started treatment with BBAT and received 2 days a week for 6 weeks. After the interval of 5-week, group BBAT / CT was treated with CT twice a week for 6 weeks.
arm group label: Group CT / BBAT
arm group type: Experimental
description: Group CT / BBAT started treatment with CT and received 2 days a week for 6 weeks. After the interval of 5-week, group CT / BBAT was treated with BBAT twice a week for 6 weeks.
intervention type: Other
intervention name: BBAT
description: The BBAT was applied by a trained and certified physiotherapist in this area for about an hour, two days a week, as a group therapy. The BBAT program includes movements related to daily activities such as lying, sitting, standing and walking. BBAT focuses on basic movement principles such as postural stability, energy adjustment in movements, comfortable breathing and coordination.
arm group label: Group BBAT / CT
arm group label: Group CT / BBAT
intervention type: Other
intervention name: CT
description: The CT program was applied two days a week for about an hour. The CT program includes active range of motion (ROM) exercises, stretching, isometric and resistant strengthening, posture exercises and relaxation training.
arm group label: Group BBAT / CT
arm group label: Group CT / BBAT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kamil Yılmaz, 1
role: Principal Investigator
affiliation: KTO Karatay University
facility: 
country: Turkey
responsible party type: Sponsor
mesh term: Somatosensory Disorders
mesh term: Neck Pain