<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/NCT04482075</url>
  </required_header>
  <id_info>
    <org_study_id>00002</org_study_id>
    <nct_id>NCT04482075</nct_id>
  </id_info>
  <brief_title>Relationship Between Pressure Pain Threshold and Pain Intensity, Affect and Disability in CLBP</brief_title>
  <official_title>Cross-modality Matching Between Pressure Pain Threshold and Subjective Ratings of Pain Intensity, Affect and Disability in Patients With Chronic Low Back Pain.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dow University of Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dow University of Health Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The association between pressure pain threshold and different aspects of low back pain has&#xD;
      garnered attention over the years. However, since most of such studies in the past employed&#xD;
      cross sectional designs, a longitudinal study design with follow-up measurements is required&#xD;
      to further investigate this relationship. Studying this relationship will not only offer&#xD;
      insights into the phenomenon of pain but may also bring us one step closer to achieving the&#xD;
      seemingly insurmountable goal of objectively measuring back pain and its different&#xD;
      dimensions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is aimed to examine and evaluate the true extent of the relationship between&#xD;
      pressure pain threshold (PPT) and different aspects of somatic pain, by studying the&#xD;
      interplay between PPT and different variables, and by further exploring the predictive&#xD;
      capability of PPT values to estimate pain intensity, pain affect and disability associated&#xD;
      with chronic low back pain (CLBP). In order to estimate these dimensions a calculator based&#xD;
      on mathematical equations using different predictive models will be developed. This tool&#xD;
      (calculator) will take into account PPT reading from the lower back region and some other&#xD;
      variables having confounding effects on PPT and pain, and will be able to predict pain&#xD;
      intensity, affect and associated disability with reasonable accuracy. Patients with chronic&#xD;
      low back pain shall be the target population and shall be recruited through referrals from&#xD;
      the medical Out-Patients Department of Institute of Physical Medicine &amp; Rehabilitation, Dow&#xD;
      University of Health Sciences and Department of Rehabilitation Medicine PNS-Shifa Hospital,&#xD;
      Karachi, Pakistan after initial screening in accordance with the inclusion and exclusion&#xD;
      criteria. Screened patients shall then be briefed about the research project. After&#xD;
      explaining the study objectives, procedures, potential benefits and discomforts, written&#xD;
      informed consent shall be obtained from the patients. Only upon their agreement shall they&#xD;
      become study participants and undergo assessments. The study participants shall receive&#xD;
      handouts to document Depression and Anxiety, Pain Intensity, Pain Affect, and Disability.&#xD;
      Pressure pain threshold (PPT) shall be measured using a manual Algometer. These measurements&#xD;
      shall be followed by a session of physiotherapy treatment, after which Pain Intensity, Pain&#xD;
      Affect, and Disability shall be recorded again.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2019</start_date>
  <completion_date type="Actual">January 16, 2021</completion_date>
  <primary_completion_date type="Actual">December 23, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pressure threshold meter</measure>
    <time_frame>Up to 2 weeks</time_frame>
    <description>Its a type of force gauge which consists of a rubber-tipped plunger with a surface area of usually 1cm square, connected to the force gauge (body) via a metal rod. The force gauge is usually calibrated in Newtons or Kilograms per cm2 with a range of up to 10 kgs. The exerted pressure on the plunger is transmitted to the gauge through the metal rod, which in turn moves the indicator needle in the clockwise direction with a magnitude corresponding to the force applied. The indicator needle remains in this position until the zeroing knob is pressed, which brings the needle back to its starting position. This allows the examiner to record the last reading of the pressure applied after removing the device from the body.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Analogue scale (VAS) - pain intensity</measure>
    <time_frame>Up to 2 weeks</time_frame>
    <description>Visual Analogue scale furnished with specific anchors to measure pain intensity. It is a continuous scale that is considered as a unidimensional measure of the pain experience. It consists of a 100 mm straight line, anchored by descriptors such as 'no pain at all' (0mm) and 'worst pain imaginable' (100mm) at both extremes. The respondent marks the line which corresponds to the current state of pain. Scoring is done with the help of a ruler and the whole process takes about a minute to complete. VAS demonstrates ratio-scale properties and it can be adapted to assess dimensions other than intensity such as unpleasantness (affective dimension) associated with pain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Analogue scale (VAS) - pain affect</measure>
    <time_frame>Up to 2 weeks</time_frame>
    <description>Visual analogue scale fine-tuned to measure pain affect with specific anchors. In general, the same technique used for assessing the pain intensity may be used to assess the pain affect. It consists of a 100 mm straight line, anchored by descriptors such as ''not bad at all'' (0mm) and ''the most unpleasant feeling possible for me'' (100mm) at both extremes. The respondent marks the line which corresponds to the current state of pain. Scoring is done with the help of a ruler and the whole process takes about a minute to complete.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disability Rating Index (DRI)</measure>
    <time_frame>Up to 2 weeks</time_frame>
    <description>This article focuses on the Disability Rating Index (DRI), a patient-reported outcome measure developed by Salén et al. in 1994, with the aim of measuring the physical disability of respondents within a clinical setting. The DRI evaluates a respondent's disability by assessing activity and participation limitations. It covers 12 non-specific activities of daily life, each one self-rated on a visual analogue scale of 0-100 mm, providing a score of 0-100 for each activity, where 0 represents no difficulty in performing the specific task and 100 indicates an inability to perform the task at all.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Saltin-Grimby Physical Activity Level Scale (SGPALS)</measure>
    <time_frame>At baseline</time_frame>
    <description>It's a four-level questionnaire to assess leisure-time physical activity (PA). It is anchored by descriptors such as &quot;physically inactive&quot; (0) and &quot;regular hard physical training for competitive sports&quot; (4).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression, Anxiety and Stress Scale (DASS-21)</measure>
    <time_frame>Up to 2 weeks</time_frame>
    <description>This is a set of three self-report scales designed to measure the emotional states of depression, anxiety &amp; stress. The minimum score lies between 0 - 3 (normal) and the maximum score 14 and above (Extremely Severe). For Anxiety 0 - 3 (normal) and the maximum score 10 and above (Extremely Severe) and For Stress 0 - 7 (normal) and the maximum score 17 and above (Extremely Severe).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Pain Threshold</condition>
  <condition>Low Back Pain</condition>
  <condition>Pain Measurement</condition>
  <arm_group>
    <arm_group_label>SEGMENTAL STABILISATION TRAINING (SST)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Segmental Stabilisation Training is an established treatment technique for chronic low back pain</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>segmental stability training</intervention_name>
    <description>SEGMENTAL STABILISATION TRAINING (SST): This part of the therapy shall involve Isometric co-contraction of Lumbar Transversus abdominis and Lumbar Multifidus. The patient shall perform 10 repetitions of abdominal drawing-in manoeuvre with 30-40% Maximal Voluntary Contraction (MVC) with a 10-second hold in specific prescribed positions.</description>
    <arm_group_label>SEGMENTAL STABILISATION TRAINING (SST)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult males with low back pain with an age group of 18-50 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Individuals having low back pain for less than 3 months.&#xD;
&#xD;
          2. Individuals with specific underlying pathology as the cause of CLBP. (Active&#xD;
             oncological disease, Known disc derangement, cauda equina syndrome, spinal trauma i.e.&#xD;
             fracture, neuropathy i.e. sciatica or severe root compression, spinal structural&#xD;
             deformity, infection, inﬂammatory joint disease, spinal stenosis, spondylolysis,&#xD;
             spondylolisthesis).&#xD;
&#xD;
          3. Individuals having neurological diseases (including central and peripheral diseases);&#xD;
             metabolic diseases (i.e. diabetes and hypothyroidism); coagulopathies (i.e.&#xD;
             haemophilia).&#xD;
&#xD;
          4. Individuals with fibromyalgia syndrome (FMS); myofascial pain syndrome (MPS);&#xD;
             allodynia (stroking hyperalgesia).&#xD;
&#xD;
          5. Individuals suffering from aphasia or suffering from deafness, blindness or muteness.&#xD;
&#xD;
          6. Individuals with skin disease (i.e. psoriasis, scleroderma, leprosy, etc.) or skin&#xD;
             lesions (i.e. abrasion/laceration/ bruise) in the low back region.&#xD;
&#xD;
          7. Individuals having oral temperature of 100 F or above.&#xD;
&#xD;
          8. Individuals who have undergone spinal surgery.&#xD;
&#xD;
          9. Individuals scoring 28+ for depression, 20+ for anxiety, 34+ for stress on DASS-21.&#xD;
&#xD;
         10. Individuals in whom prone lying causes significant discomfort (i.e. dyspnoea etc.).&#xD;
&#xD;
         11. Individuals who do not perceive pressure pain below 10 kg/cm2 during PPT testing.&#xD;
&#xD;
         12. Individuals evincing bruising to PPT testing.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Adult males with low back pain with an age group of 18-50 years.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rasim Ul Hasanat Qureshi, MSPT</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dow University of Health Sciences</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shahzad Ali Syed, MSAPT</last_name>
    <role>Study Director</role>
    <affiliation>Dow University of Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institute of Physical medicine &amp; Rehabilitation, Dow University of Health Sciences</name>
      <address>
        <city>Karachi</city>
        <state>Sindh</state>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>February 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>August 17, 2021</last_update_submitted>
  <last_update_submitted_qc>August 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>
    <mesh_term>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/NCT04482075
org study id: 00002
nct id: NCT04482075
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The association between pressure pain threshold and different aspects of low back pain has
      garnered attention over the years. However, since most of such studies in the past employed
      cross sectional designs, a longitudinal study design with follow-up measurements is required
      to further investigate this relationship. Studying this relationship will not only offer
      insights into the phenomenon of pain but may also bring us one step closer to achieving the
      seemingly insurmountable goal of objectively measuring back pain and its different
      dimensions.
This study is aimed to examine and evaluate the true extent of the relationship between
      pressure pain threshold (PPT) and different aspects of somatic pain, by studying the
      interplay between PPT and different variables, and by further exploring the predictive
      capability of PPT values to estimate pain intensity, pain affect and disability associated
      with chronic low back pain (CLBP). In order to estimate these dimensions a calculator based
      on mathematical equations using different predictive models will be developed. This tool
      (calculator) will take into account PPT reading from the lower back region and some other
      variables having confounding effects on PPT and pain, and will be able to predict pain
      intensity, affect and associated disability with reasonable accuracy. Patients with chronic
      low back pain shall be the target population and shall be recruited through referrals from
      the medical Out-Patients Department of Institute of Physical Medicine & Rehabilitation, Dow
      University of Health Sciences and Department of Rehabilitation Medicine PNS-Shifa Hospital,
      Karachi, Pakistan after initial screening in accordance with the inclusion and exclusion
      criteria. Screened patients shall then be briefed about the research project. After
      explaining the study objectives, procedures, potential benefits and discomforts, written
      informed consent shall be obtained from the patients. Only upon their agreement shall they
      become study participants and undergo assessments. The study participants shall receive
      handouts to document Depression and Anxiety, Pain Intensity, Pain Affect, and Disability.
      Pressure pain threshold (PPT) shall be measured using a manual Algometer. These measurements
      shall be followed by a session of physiotherapy treatment, after which Pain Intensity, Pain
      Affect, and Disability shall be recorded again.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Pressure threshold meter
time frame: Up to 2 weeks
description: Its a type of force gauge which consists of a rubber-tipped plunger with a surface area of usually 1cm square, connected to the force gauge (body) via a metal rod. The force gauge is usually calibrated in Newtons or Kilograms per cm2 with a range of up to 10 kgs. The exerted pressure on the plunger is transmitted to the gauge through the metal rod, which in turn moves the indicator needle in the clockwise direction with a magnitude corresponding to the force applied. The indicator needle remains in this position until the zeroing knob is pressed, which brings the needle back to its starting position. This allows the examiner to record the last reading of the pressure applied after removing the device from the body.
measure: Visual Analogue scale (VAS) - pain intensity
time frame: Up to 2 weeks
description: Visual Analogue scale furnished with specific anchors to measure pain intensity. It is a continuous scale that is considered as a unidimensional measure of the pain experience. It consists of a 100 mm straight line, anchored by descriptors such as 'no pain at all' (0mm) and 'worst pain imaginable' (100mm) at both extremes. The respondent marks the line which corresponds to the current state of pain. Scoring is done with the help of a ruler and the whole process takes about a minute to complete. VAS demonstrates ratio-scale properties and it can be adapted to assess dimensions other than intensity such as unpleasantness (affective dimension) associated with pain.
measure: Visual Analogue scale (VAS) - pain affect
time frame: Up to 2 weeks
description: Visual analogue scale fine-tuned to measure pain affect with specific anchors. In general, the same technique used for assessing the pain intensity may be used to assess the pain affect. It consists of a 100 mm straight line, anchored by descriptors such as ''not bad at all'' (0mm) and ''the most unpleasant feeling possible for me'' (100mm) at both extremes. The respondent marks the line which corresponds to the current state of pain. Scoring is done with the help of a ruler and the whole process takes about a minute to complete.
measure: Disability Rating Index (DRI)
time frame: Up to 2 weeks
description: This article focuses on the Disability Rating Index (DRI), a patient-reported outcome measure developed by Salén et al. in 1994, with the aim of measuring the physical disability of respondents within a clinical setting. The DRI evaluates a respondent's disability by assessing activity and participation limitations. It covers 12 non-specific activities of daily life, each one self-rated on a visual analogue scale of 0-100 mm, providing a score of 0-100 for each activity, where 0 represents no difficulty in performing the specific task and 100 indicates an inability to perform the task at all.
measure: Saltin-Grimby Physical Activity Level Scale (SGPALS)
time frame: At baseline
description: It's a four-level questionnaire to assess leisure-time physical activity (PA). It is anchored by descriptors such as "physically inactive" (0) and "regular hard physical training for competitive sports" (4).
measure: Depression, Anxiety and Stress Scale (DASS-21)
time frame: Up to 2 weeks
description: This is a set of three self-report scales designed to measure the emotional states of depression, anxiety & stress. The minimum score lies between 0 - 3 (normal) and the maximum score 14 and above (Extremely Severe). For Anxiety 0 - 3 (normal) and the maximum score 10 and above (Extremely Severe) and For Stress 0 - 7 (normal) and the maximum score 17 and above (Extremely Severe).
arm group label: SEGMENTAL STABILISATION TRAINING (SST)
arm group type: Other
description: Segmental Stabilisation Training is an established treatment technique for chronic low back pain
intervention type: Other
intervention name: segmental stability training
description: SEGMENTAL STABILISATION TRAINING (SST): This part of the therapy shall involve Isometric co-contraction of Lumbar Transversus abdominis and Lumbar Multifidus. The patient shall perform 10 repetitions of abdominal drawing-in manoeuvre with 30-40% Maximal Voluntary Contraction (MVC) with a 10-second hold in specific prescribed positions.
arm group label: SEGMENTAL STABILISATION TRAINING (SST)
criteria: 
gender: Male
gender based: Yes
gender description: Adult males with low back pain with an age group of 18-50 years.
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Rasim Ul Hasanat Qureshi, MSPT
role: Principal Investigator
affiliation: Dow University of Health Sciences
last name: Shahzad Ali Syed, MSAPT
role: Study Director
affiliation: Dow University of Health Sciences
facility: 
country: Pakistan
responsible party type: Sponsor
mesh term: Back Pain
mesh term: Low Back Pain
mesh term: Pain