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/NCT06025929</url>
    </required_header>
    <id_info>
      <org_study_id>BIMLS/67/2017</org_study_id>
      <nct_id>NCT06025929</nct_id>
    </id_info>
    <brief_title>Effect of Different Mobilization Techniques With Common Use of Interferential Therapy in Patients With Knee OA</brief_title>
    <official_title>Effectiveness of Maitland Mobilization Versus Mulligan Mobilization Techniques With Common Use of Interferential Therapy in Patients With Knee Joint Osteoarthritis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>King Saud University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Burdwan Institute of Medical and Life Sciences (BIMLS)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>King Saud 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>
        This study aimed to determine the effects of different manual mobilization techniques on&#xD;
        pain, muscle strength, and functional limitations in individuals with knee osteoarthritis&#xD;
        (Knee OA). A double-blinded pretest-posttest experimental study. This research employed a&#xD;
        two-arm parallel group randomized comparative design. A total of thirty participants&#xD;
        diagnosed with knee osteoarthritis were randomly assigned and equally divided into groups 1&#xD;
        and 2, each containing 15 participants. Both Group 1 and Group 2 underwent Maitland and&#xD;
        Mulligan mobilization techniques, alongside a common Interferential therapy (IFT) regimen,&#xD;
        over the course of three sessions per week for a duration of four weeks. The assessment of&#xD;
        pain and functional disability outcomes was conducted through the application of The Western&#xD;
        Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores at the baseline and&#xD;
        four weeks following the intervention. To determine the effects of the intervention within&#xD;
        and between the groups, the outcome scores were subjected to analysis using both dependent&#xD;
        and independent t-tests.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Knee osteoarthritis (OA) is a prevalent disorder with significant global health implications,&#xD;
        its prevalence varying across populations due to intricate factors. Recent investigations&#xD;
        highlight an age-related increase in knee OA prevalence, particularly impacting those aged 60&#xD;
        and above, with projections indicating heightened impact due to aging demographics. Recent&#xD;
        pathogenesis studies illuminate the intricate molecular and cellular processes underlying&#xD;
        knee osteoarthritis (OA), encompassing cartilage degradation, subchondral bone changes, and&#xD;
        inflammation.Recent advancements have expanded knee osteoarthritis (OA) management, including&#xD;
        medical, surgical, and physiotherapy interventions. Pharmacological treatments such as&#xD;
        analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), and disease-modifying&#xD;
        osteoarthritis drugs (DMOADs) remain fundamental for pain alleviation and inflammation&#xD;
        reduction. Intra-articular therapies like corticosteroid injections and hyaluronic acid&#xD;
        supplements offer localized relief and potential disease-modifying effects.Surgical&#xD;
        interventions like total knee arthroplasty (TKA) provide pain relief and improved function&#xD;
        for end-stage OA. Minimally invasive techniques like partial knee replacements and&#xD;
        patient-specific implants aim to preserve joint function and enhance outcomes. Physiotherapy&#xD;
        and rehabilitation are crucial, in improving stability, muscle strength, and mobility.&#xD;
        Studies highlight tailored exercises, neuromuscular training, and proprioceptive exercises in&#xD;
        managing OA symptoms. The integration of these approaches underscores comprehensive knee OA&#xD;
        management, addressing pain, function, and quality of life. The outcomes of this study could&#xD;
        offer evidence-based recommendations for clinicians, aiding them in selecting the most&#xD;
        appropriate manual therapy approach to alleviate pain, enhance joint mobility, and improve&#xD;
        functional capacity in knee OA patients. Ultimately, this research seeks to contribute to the&#xD;
        optimization of knee OA management strategies, improving the well-being of those affected.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">April 10, 2017</start_date>
    <completion_date type="Actual">October 30, 2017</completion_date>
    <primary_completion_date type="Actual">September 14, 2017</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>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Functional limitations</measure>
      <time_frame>4 weeks</time_frame>
      <description>Functional limitations was assessed using the Western Ontario and McMaster Universities (WOMAC) index. It includes five questions about pain, two about stiffness, and 17 on degree of disability of activities of daily living. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">30</enrollment>
    <condition>Knee Osteoarthritis</condition>
    <arm_group>
      <arm_group_label>Maitland Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Maitland Group received Maitland's mobilization techninque in addition to an intereferential therapy.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Mulligan Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Mulligan Group received Mulligan's mobilization techninque in addition to an intereferential therapy.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Maitland's mobilization technique</intervention_name>
      <description>Maitland's mobilization technique was performed on the patients with its all components, such as 1. Distraction 2. Anteroposterior glides 3. Posteroanterior glides 4. Medial glides and 5. Lateral glides.</description>
      <arm_group_label>Maitland Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Mulligan's mobilization techniques</intervention_name>
      <description>Mulligan's mobilization technique was performed on the patients with its all components using a therapeutic belt, such as 1. Medial mobilization with movement (MWM) for Knee flexion 2. Medial mobilization with movement (MWM) for Knee extension 3. Lateral mobilization with movement (MWM) for Knee flexion 4. Lateral mobilization with movement (MWM) for Knee extension.</description>
      <arm_group_label>Mulligan Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Interferential Therapy (IFT)</intervention_name>
      <description>Interferential Therapy was performed on the patients with the following parameters: career frequency 4000Hz; waveform: rectangular; sweep time: 1 second rise and fall and 5 second stay; Treatment duration: 10 minutes; sweep frequency: 10 to 130 Hz. The current intensity was adjusted until the subject reported feeling a strong tingling sensation without causing muscle contraction. A aquatic gel was applied before straping the electopads over treatment area for smooth electrical conduction.</description>
      <arm_group_label>Maitland Group</arm_group_label>
      <arm_group_label>Mulligan Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Sub-acute or chronic osteoarthritis of knee.&#xD;
  &#xD;
            -  Age between 45-65 years.&#xD;
  &#xD;
            -  Gender Male and female.&#xD;
  &#xD;
            -  Subjects willing to participate in the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Presence of R.A, polyarthritis or systemic inflammatory arthropathies.&#xD;
  &#xD;
            -  History of total knee arthroplasty or major knee trauma injury.&#xD;
  &#xD;
            -  Fracture of lower limb within the past 6 months.&#xD;
  &#xD;
            -  Hip or ankle instability, excessive weakness, surgery or major trauma injury.&#xD;
  &#xD;
            -  Intra-articular steroid injection in knee joint within 3 months.&#xD;
  &#xD;
            -  Cognitive problems.&#xD;
  &#xD;
            -  Patient with severe cardiac or pulmonary disorders.&#xD;
  &#xD;
            -  Peripheral vascular disease.&#xD;
  &#xD;
            -  Tumour/malignancies/infections.&#xD;
  &#xD;
            -  Metallic implants in the lower limbs.&#xD;
  &#xD;
            -  Any severe deformity around the knee joint.&#xD;
  &#xD;
            -  Kellgren and Lawrence (KL) system47: up to grade 0-III.&#xD;
  &#xD;
            -  History of neurological and psychological disorders.&#xD;
  &#xD;
            -  High risk health status- e.g.- uncontrolled hypertension, diabetes, heart disease,&#xD;
               angina type pain, nocturnal dyspnoea, shortness of breathing, tachycardia etc.&#xD;
  &#xD;
            -  Contraindications of IFT and mobilization.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>45 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>AMIR IQBAL, MPT</last_name>
      <role>Study Chair</role>
      <affiliation>King Saud University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Department of Rehabilitation Sciences, College of applied Medical Science, King Saud University</name>
        <address>
          <city>Riyadh</city>
          <zip>11433</zip>
          <country>Saudi Arabia</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Saudi Arabia</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>King Saud University</investigator_affiliation>
      <investigator_full_name>AMIR IQBAL</investigator_full_name>
      <investigator_title>Prinicipal Investigator</investigator_title>
    </responsible_party>
    <keyword>Maitland mobilization</keyword>
    <keyword>Mulligan mobilization</keyword>
    <keyword>Knee pain</keyword>
    <keyword>Interferential therapy</keyword>
    <keyword>WOMAC</keyword>
    <keyword>Functional limitation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Osteoarthritis</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/NCT06025929
  org study id: BIMLS/67/2017
  nct id: NCT06025929
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  This study aimed to determine the effects of different manual mobilization techniques on
        pain, muscle strength, and functional limitations in individuals with knee osteoarthritis
        (Knee OA). A double-blinded pretest-posttest experimental study. This research employed a
        two-arm parallel group randomized comparative design. A total of thirty participants
        diagnosed with knee osteoarthritis were randomly assigned and equally divided into groups 1
        and 2, each containing 15 participants. Both Group 1 and Group 2 underwent Maitland and
        Mulligan mobilization techniques, alongside a common Interferential therapy (IFT) regimen,
        over the course of three sessions per week for a duration of four weeks. The assessment of
        pain and functional disability outcomes was conducted through the application of The Western
        Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores at the baseline and
        four weeks following the intervention. To determine the effects of the intervention within
        and between the groups, the outcome scores were subjected to analysis using both dependent
        and independent t-tests.
  Knee osteoarthritis (OA) is a prevalent disorder with significant global health implications,
        its prevalence varying across populations due to intricate factors. Recent investigations
        highlight an age-related increase in knee OA prevalence, particularly impacting those aged 60
        and above, with projections indicating heightened impact due to aging demographics. Recent
        pathogenesis studies illuminate the intricate molecular and cellular processes underlying
        knee osteoarthritis (OA), encompassing cartilage degradation, subchondral bone changes, and
        inflammation.Recent advancements have expanded knee osteoarthritis (OA) management, including
        medical, surgical, and physiotherapy interventions. Pharmacological treatments such as
        analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), and disease-modifying
        osteoarthritis drugs (DMOADs) remain fundamental for pain alleviation and inflammation
        reduction. Intra-articular therapies like corticosteroid injections and hyaluronic acid
        supplements offer localized relief and potential disease-modifying effects.Surgical
        interventions like total knee arthroplasty (TKA) provide pain relief and improved function
        for end-stage OA. Minimally invasive techniques like partial knee replacements and
        patient-specific implants aim to preserve joint function and enhance outcomes. Physiotherapy
        and rehabilitation are crucial, in improving stability, muscle strength, and mobility.
        Studies highlight tailored exercises, neuromuscular training, and proprioceptive exercises in
        managing OA symptoms. The integration of these approaches underscores comprehensive knee OA
        management, addressing pain, function, and quality of life. The outcomes of this study could
        offer evidence-based recommendations for clinicians, aiding them in selecting the most
        appropriate manual therapy approach to alleviate pain, enhance joint mobility, and improve
        functional capacity in knee OA patients. Ultimately, this research seeks to contribute to the
        optimization of knee OA management strategies, improving the well-being of those affected.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: Functional limitations
  time frame: 4 weeks
  description: Functional limitations was assessed using the Western Ontario and McMaster Universities (WOMAC) index. It includes five questions about pain, two about stiffness, and 17 on degree of disability of activities of daily living. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function.
  arm group label: Maitland Group
  arm group type: Experimental
  description: Maitland Group received Maitland's mobilization techninque in addition to an intereferential therapy.
  arm group label: Mulligan Group
  arm group type: Active Comparator
  description: Mulligan Group received Mulligan's mobilization techninque in addition to an intereferential therapy.
  intervention type: Other
  intervention name: Maitland's mobilization technique
  description: Maitland's mobilization technique was performed on the patients with its all components, such as 1. Distraction 2. Anteroposterior glides 3. Posteroanterior glides 4. Medial glides and 5. Lateral glides.
  arm group label: Maitland Group
  intervention type: Other
  intervention name: Mulligan's mobilization techniques
  description: Mulligan's mobilization technique was performed on the patients with its all components using a therapeutic belt, such as 1. Medial mobilization with movement (MWM) for Knee flexion 2. Medial mobilization with movement (MWM) for Knee extension 3. Lateral mobilization with movement (MWM) for Knee flexion 4. Lateral mobilization with movement (MWM) for Knee extension.
  arm group label: Mulligan Group
  intervention type: Other
  intervention name: Interferential Therapy (IFT)
  description: Interferential Therapy was performed on the patients with the following parameters: career frequency 4000Hz; waveform: rectangular; sweep time: 1 second rise and fall and 5 second stay; Treatment duration: 10 minutes; sweep frequency: 10 to 130 Hz. The current intensity was adjusted until the subject reported feeling a strong tingling sensation without causing muscle contraction. A aquatic gel was applied before straping the electopads over treatment area for smooth electrical conduction.
  arm group label: Maitland Group
  arm group label: Mulligan Group
  criteria: 
  gender: All
  minimum age: 45 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: AMIR IQBAL, MPT
  role: Study Chair
  affiliation: King Saud University
  facility: 
  country: Saudi Arabia
  responsible party type: Principal Investigator
  investigator affiliation: King Saud University
  investigator full name: AMIR IQBAL
  investigator title: Prinicipal Investigator
  mesh term: Osteoarthritis