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/NCT06023498</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY23020172</org_study_id>
      <secondary_id>R01AT012534</secondary_id>
      <nct_id>NCT06023498</nct_id>
    </id_info>
    <brief_title>Optimizing Impact of Manual Therapy on Lumbar Spinal Stenosis</brief_title>
    <official_title>Optimizing Impact of Manual Therapy and Exercise on Lumbar Spinal Stenosis With Neurogenic Claudication: A Multi-Site Feasibility Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Pittsburgh</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Boston Medical Center</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>VA Pittsburgh Healthcare System</agency>
        <agency_class>U.S. Fed</agency_class>
      </collaborator>
      <collaborator>
        <agency>Syracuse VA Medical Center</agency>
        <agency_class>U.S. Fed</agency_class>
      </collaborator>
      <collaborator>
        <agency>Orlando VA Healthcare System</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>National Center for Complementary and Integrative Health (NCCIH)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Pittsburgh</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>
        Lumbar spinal stenosis, a common condition in older adults, can cause pain and difficulty&#xD;
        walking (i.e., intermittent neurogenic claudication - INC). Patients with INC not&#xD;
        infrequently undergo spinal surgery that fails to help them 1/3-1/2 the time. The purpose of&#xD;
        this multi-site feasibility study is to prepare for the conduct of a randomized controlled&#xD;
        trial to test the efficacy of manual therapy, exercise, and intramuscular electroacupuncture&#xD;
        in reducing pain and improving walking ability for those with INC, and ultimately limiting&#xD;
        the need for surgical referrals.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Decompressive laminectomy (DL), the most common spinal surgery in older adults, is performed&#xD;
        to alleviate lumbar spinal stenosis (LSS) and reduce associated pain, paresthesias, and/or&#xD;
        weakness when walking (i.e., intermittent neurogenic claudication - INC). The PI's recent&#xD;
        prospective cohort study of 193 older veterans followed for 12 months following DL revealed&#xD;
        that over 50% of participants did not experience significant functional improvement. Similar&#xD;
        rates of failed surgery have been reported in non-veteran populations. Since the vast&#xD;
        majority of DLs are performed electively, non-surgical treatment is recommended as an initial&#xD;
        step. Two clinical trials have demonstrated modest efficacy of manual therapy and exercise&#xD;
        (MTE) for people with INC that was sustained in one trial, but not in the other. Recent&#xD;
        clinical practice guidelines recommend adding acupuncture as a non-surgical pain management&#xD;
        strategy and highlight the need for high quality evidence to support this recommendation. The&#xD;
        investigators' clinical experience and preliminary research data regarding the efficacy of&#xD;
        electroacupuncture (specifically, intramuscular electroacupuncture [IMEA]) in these patients&#xD;
        are promising. Ultimately, the study team wishes to conduct a randomized controlled clinical&#xD;
        trial to optimize and sustain the efficacy of MTE by potentially a) increasing the robustness&#xD;
        of the initial response via addition of IMEA and b) its durability via boosters. This&#xD;
        two-site feasibility study will be conducted at Boston Medical Center and the Orlando VA&#xD;
        Medical Center, chosen because of their sociodemographic diversity and prevalence of patients&#xD;
        with multiple comorbidities, characteristics that will ultimately facilitate broad&#xD;
        generalizability of study findings. The study team will evaluate the feasibility of&#xD;
        recruiting, randomizing and retaining participants; fidelity of intervention delivery;&#xD;
        participant adherence to prescribed interventions; and the accuracy and completeness of data&#xD;
        collection procedures. Sixty participants (30 per site) with imaging-identified LSS and INC&#xD;
        who have not had lumbar surgery, will be randomized to receive 1) MTE for 3 months (10&#xD;
        sessions over 12 weeks) followed by a 6-months observation period; 2) MTE for 3 months&#xD;
        followed by monthly MTE booster sessions for 6-months; OR 3) MTE + IMEA for 3 months followed&#xD;
        by monthly MTE + IMEA for 6-months. The primary outcome (Brigham Spinal Stenosis&#xD;
        questionnaire) for the future efficacy trial will be measured at baseline, 3 months (primary&#xD;
        endpoint), 6 and 9 months. The study also will measure community mobility (life space),&#xD;
        emotional functioning (PHQ8 and GAD7), pain medications, and other key parameters relevant to&#xD;
        older adults with LSS and INC (e.g., smoking, BMI, medical comorbidity). Fidelity will be&#xD;
        optimized by delivering standardized provider training, conducting regular review of&#xD;
        participant provider intervention sessions and documentation, and monthly all-site huddles.&#xD;
        The study also will monitor participant attendance and home exercise compliance. If the study&#xD;
        demonstrates feasibility (primary outcome for this study) of the proposed methods, the study&#xD;
        team will be positioned to test a new model of care for patients with LSS and INC designed to&#xD;
        optimize their function and quality of life and save substantial morbidity and healthcare&#xD;
        resources.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">February 1, 2024</start_date>
    <completion_date type="Anticipated">July 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">January 31, 2026</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>
      <intervention_model_description>Randomized controlled clinical trial - feasibility study</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>Performance-based outcomes measures will be collected by a research coordinator who is masked to participant group assignment.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Number of participants recruited and retained after 9 months of participation</measure>
      <time_frame>Number of participants recruited at each of two study sites over a period of 12 months (duration of recruitment period) - assessed at 12 months after recruitment starts; number of participants retained at each site after 9 months of study participation</time_frame>
      <description>Number of participants recruited and retained at each site</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Median number of intervention sessions attended</measure>
      <time_frame>3 months (at completion of initial intervention) and 9 months (at completion of follow up period)</time_frame>
      <description>Median number of intervention sessions attended at each site</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Rate of missing data</measure>
      <time_frame>Baseline, 3 months, and 9 months</time_frame>
      <description>Percentage of study data that are not entered into data collection system</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Lumbar Spinal Stenosis</condition>
    <arm_group>
      <arm_group_label>Manual Therapy and Exercise (MTE)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will be asked to attend 10 sessions of manual therapy that will be administered by a chiropractic physician and will consist of movements designed to enhance flexibility and muscle health. Session will last ~ 20 minutes.&#xD;
  The home exercise program (HEP) will consist of a light aerobic program (either walking with the lumbar spine in slight flexion while supported by a wheeled walker, going up and down a flight of stairs, using a treadmill, or using an exercise bicycle), neural mobilization self-stretches, individualized muscular stretches and core strengthening exercises. Participants will be encouraged to do the HEP 1-2 times per day, starting with 5 minutes and working up to 30 minutes.&#xD;
  During the subsequent 6 months, there will be no additional treatment administered. Participants will be asked to continue their HEP.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>MTE Plus MTE Boosters</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will be asked to attend 10 sessions of manual therapy that will be administered by a chiropractic physician and will consist of movements designed to enhance flexibility and muscle health. Session will last ~ 20 minutes.&#xD;
  The home exercise program (HEP) will consist of a light aerobic program (either walking with the lumbar spine in slight flexion while supported by a wheeled walker, going up and down a flight of stairs, using a treadmill, or using an exercise bicycle), neural mobilization self-stretches, individualized muscular stretches and core strengthening exercises. Participants will be encouraged to do the HEP 1-2 times per day, starting with 5 minutes and working up to 30 minutes.&#xD;
  During the subsequent 6 months, participants will be asked to return for monthly MTE booster sessions, and they will be asked to continue their HEP.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>MTE and Intramuscular Electroacupuncture (IMEA) Plus MTE and IM Boosters</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will be asked to attend 10 sessions of manual therapy that will be administered by a chiropractic physician and will consist of movements designed to enhance flexibility and muscle health. Session will last ~ 20 minutes.&#xD;
  Participants also will be asked to attend weekly intramuscular electroacupuncture (IMEA) sessions administered by a licensed acupuncturist. 30-gauge acupuncture needles will be placed in the muscles of the lower back and buttocks and gentle pulsing electrical stimulation will be delivered for 20 minutes.&#xD;
  The home exercise program (HEP) will be identical to that in the MTE and the MTE + Boosters groups.&#xD;
  During the subsequent 6 months, participants will be asked to return for monthly MTE and IMEA boosters. Participants also will be asked to continue their HEP.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Manual Therapy and Exercise</intervention_name>
      <description>The 20-minute manual therapy procedures will include:&#xD;
  Distraction-manipulation: manually assisted segmental lumbar traction manipulation using a specialized treatment table&#xD;
  Neural mobilization: rhythmic stretches of the sciatic and femoral nerves75&#xD;
  Hip, sacroiliac and lumbar facet mobilizations to improve joint mobility&#xD;
  Soft tissue mobilization of lumbopelvic and lower extremity muscles using manual pressure over taut bands/myofascial trigger points and post-isometric (contract-relax) stretching techniques.</description>
      <arm_group_label>MTE Plus MTE Boosters</arm_group_label>
      <arm_group_label>MTE and Intramuscular Electroacupuncture (IMEA) Plus MTE and IM Boosters</arm_group_label>
      <arm_group_label>Manual Therapy and Exercise (MTE)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Intramuscular Electroacupuncture</intervention_name>
      <description>As described previously</description>
      <arm_group_label>MTE and Intramuscular Electroacupuncture (IMEA) Plus MTE and IM Boosters</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Intermittent neurogenic claudication (INC), defined as pain or discomfort with walking&#xD;
               or prolonged standing that radiates beyond the spinal area and is relieved with&#xD;
               sitting (ascertained using a structured interview)&#xD;
  &#xD;
                 -  Average pain/discomfort severity &gt; moderate&#xD;
  &#xD;
                 -  Advanced imaging (e.g., MRI, CT scan, CT-myelogram) evidence of lumbar spinal&#xD;
                    stenosis (extracted from electronic medical record, or outside report provided by&#xD;
                    participant; advanced imaging will not be performed as part of our study&#xD;
                    procedures)&#xD;
  &#xD;
                 -  Able to commit to 9 months of study participation&#xD;
  &#xD;
                 -  English speaking&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Red flags indicative of serious underlying illness requiring urgent care (e.g., fever,&#xD;
               change in bowel/ bladder function, sudden severe change in pain, unintentional weight&#xD;
               loss, new leg weakness)&#xD;
  &#xD;
            -  Walking capacity over 2 miles&#xD;
  &#xD;
            -  Other conditions that significantly impact mobility (e.g., painful conditions such as&#xD;
               advanced hip/knee osteoarthritis with pain more severe than INC pain, Parkinson's&#xD;
               disease, stroke, vascular claudication, angina pectoris, pulmonary disease, morbid&#xD;
               obesity (i.e., BMI &gt; 40).&#xD;
  &#xD;
            -  Prior lumbar surgery, because of its negative impact on spinal biomechanics;&#xD;
  &#xD;
            -  Positive screen for dementia (i.e., Folstein Mini-Mental State Examination);&#xD;
  &#xD;
            -  Acute medical or psychiatric illness, or active substance abuse that renders the&#xD;
               patient incapable of being a reliable study participant;&#xD;
  &#xD;
            -  Prohibitive communication impairment (e.g., severe hearing or visual impairment)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
      <investigator_full_name>Debra Weiner</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>Spinal Stenosis</mesh_term>
      <mesh_term>Constriction, Pathologic</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/NCT06023498
  org study id: STUDY23020172
  secondary id: R01AT012534
  nct id: NCT06023498
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Lumbar spinal stenosis, a common condition in older adults, can cause pain and difficulty
        walking (i.e., intermittent neurogenic claudication - INC). Patients with INC not
        infrequently undergo spinal surgery that fails to help them 1/3-1/2 the time. The purpose of
        this multi-site feasibility study is to prepare for the conduct of a randomized controlled
        trial to test the efficacy of manual therapy, exercise, and intramuscular electroacupuncture
        in reducing pain and improving walking ability for those with INC, and ultimately limiting
        the need for surgical referrals.
  Decompressive laminectomy (DL), the most common spinal surgery in older adults, is performed
        to alleviate lumbar spinal stenosis (LSS) and reduce associated pain, paresthesias, and/or
        weakness when walking (i.e., intermittent neurogenic claudication - INC). The PI's recent
        prospective cohort study of 193 older veterans followed for 12 months following DL revealed
        that over 50% of participants did not experience significant functional improvement. Similar
        rates of failed surgery have been reported in non-veteran populations. Since the vast
        majority of DLs are performed electively, non-surgical treatment is recommended as an initial
        step. Two clinical trials have demonstrated modest efficacy of manual therapy and exercise
        (MTE) for people with INC that was sustained in one trial, but not in the other. Recent
        clinical practice guidelines recommend adding acupuncture as a non-surgical pain management
        strategy and highlight the need for high quality evidence to support this recommendation. The
        investigators' clinical experience and preliminary research data regarding the efficacy of
        electroacupuncture (specifically, intramuscular electroacupuncture [IMEA]) in these patients
        are promising. Ultimately, the study team wishes to conduct a randomized controlled clinical
        trial to optimize and sustain the efficacy of MTE by potentially a) increasing the robustness
        of the initial response via addition of IMEA and b) its durability via boosters. This
        two-site feasibility study will be conducted at Boston Medical Center and the Orlando VA
        Medical Center, chosen because of their sociodemographic diversity and prevalence of patients
        with multiple comorbidities, characteristics that will ultimately facilitate broad
        generalizability of study findings. The study team will evaluate the feasibility of
        recruiting, randomizing and retaining participants; fidelity of intervention delivery;
        participant adherence to prescribed interventions; and the accuracy and completeness of data
        collection procedures. Sixty participants (30 per site) with imaging-identified LSS and INC
        who have not had lumbar surgery, will be randomized to receive 1) MTE for 3 months (10
        sessions over 12 weeks) followed by a 6-months observation period; 2) MTE for 3 months
        followed by monthly MTE booster sessions for 6-months; OR 3) MTE + IMEA for 3 months followed
        by monthly MTE + IMEA for 6-months. The primary outcome (Brigham Spinal Stenosis
        questionnaire) for the future efficacy trial will be measured at baseline, 3 months (primary
        endpoint), 6 and 9 months. The study also will measure community mobility (life space),
        emotional functioning (PHQ8 and GAD7), pain medications, and other key parameters relevant to
        older adults with LSS and INC (e.g., smoking, BMI, medical comorbidity). Fidelity will be
        optimized by delivering standardized provider training, conducting regular review of
        participant provider intervention sessions and documentation, and monthly all-site huddles.
        The study also will monitor participant attendance and home exercise compliance. If the study
        demonstrates feasibility (primary outcome for this study) of the proposed methods, the study
        team will be positioned to test a new model of care for patients with LSS and INC designed to
        optimize their function and quality of life and save substantial morbidity and healthcare
        resources.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized controlled clinical trial - feasibility study
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  masking description: Performance-based outcomes measures will be collected by a research coordinator who is masked to participant group assignment.
  measure: Number of participants recruited and retained after 9 months of participation
  time frame: Number of participants recruited at each of two study sites over a period of 12 months (duration of recruitment period) - assessed at 12 months after recruitment starts; number of participants retained at each site after 9 months of study participation
  description: Number of participants recruited and retained at each site
  measure: Median number of intervention sessions attended
  time frame: 3 months (at completion of initial intervention) and 9 months (at completion of follow up period)
  description: Median number of intervention sessions attended at each site
  measure: Rate of missing data
  time frame: Baseline, 3 months, and 9 months
  description: Percentage of study data that are not entered into data collection system
  arm group label: Manual Therapy and Exercise (MTE)
  arm group type: Experimental
  description: Participants will be asked to attend 10 sessions of manual therapy that will be administered by a chiropractic physician and will consist of movements designed to enhance flexibility and muscle health. Session will last ~ 20 minutes.
  The home exercise program (HEP) will consist of a light aerobic program (either walking with the lumbar spine in slight flexion while supported by a wheeled walker, going up and down a flight of stairs, using a treadmill, or using an exercise bicycle), neural mobilization self-stretches, individualized muscular stretches and core strengthening exercises. Participants will be encouraged to do the HEP 1-2 times per day, starting with 5 minutes and working up to 30 minutes.
  During the subsequent 6 months, there will be no additional treatment administered. Participants will be asked to continue their HEP.
  arm group label: MTE Plus MTE Boosters
  arm group type: Experimental
  description: Participants will be asked to attend 10 sessions of manual therapy that will be administered by a chiropractic physician and will consist of movements designed to enhance flexibility and muscle health. Session will last ~ 20 minutes.
  The home exercise program (HEP) will consist of a light aerobic program (either walking with the lumbar spine in slight flexion while supported by a wheeled walker, going up and down a flight of stairs, using a treadmill, or using an exercise bicycle), neural mobilization self-stretches, individualized muscular stretches and core strengthening exercises. Participants will be encouraged to do the HEP 1-2 times per day, starting with 5 minutes and working up to 30 minutes.
  During the subsequent 6 months, participants will be asked to return for monthly MTE booster sessions, and they will be asked to continue their HEP.
  arm group label: MTE and Intramuscular Electroacupuncture (IMEA) Plus MTE and IM Boosters
  arm group type: Experimental
  description: Participants will be asked to attend 10 sessions of manual therapy that will be administered by a chiropractic physician and will consist of movements designed to enhance flexibility and muscle health. Session will last ~ 20 minutes.
  Participants also will be asked to attend weekly intramuscular electroacupuncture (IMEA) sessions administered by a licensed acupuncturist. 30-gauge acupuncture needles will be placed in the muscles of the lower back and buttocks and gentle pulsing electrical stimulation will be delivered for 20 minutes.
  The home exercise program (HEP) will be identical to that in the MTE and the MTE + Boosters groups.
  During the subsequent 6 months, participants will be asked to return for monthly MTE and IMEA boosters. Participants also will be asked to continue their HEP.
  intervention type: Other
  intervention name: Manual Therapy and Exercise
  description: The 20-minute manual therapy procedures will include:
  Distraction-manipulation: manually assisted segmental lumbar traction manipulation using a specialized treatment table
  Neural mobilization: rhythmic stretches of the sciatic and femoral nerves75
  Hip, sacroiliac and lumbar facet mobilizations to improve joint mobility
  Soft tissue mobilization of lumbopelvic and lower extremity muscles using manual pressure over taut bands/myofascial trigger points and post-isometric (contract-relax) stretching techniques.
  arm group label: MTE Plus MTE Boosters
  arm group label: MTE and Intramuscular Electroacupuncture (IMEA) Plus MTE and IM Boosters
  arm group label: Manual Therapy and Exercise (MTE)
  intervention type: Other
  intervention name: Intramuscular Electroacupuncture
  description: As described previously
  arm group label: MTE and Intramuscular Electroacupuncture (IMEA) Plus MTE and IM Boosters
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Principal Investigator
  investigator affiliation: University of Pittsburgh
  investigator full name: Debra Weiner
  investigator title: Professor
  mesh term: Spinal Stenosis
  mesh term: Constriction, Pathologic