<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20200511047391N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-27</date_registration>
      <primary_sponsor>Riphah International University</primary_sponsor>
      <public_title>Effect of general exercise, motor control exercise and spinal manipulative therapy in treatment of  low back pain</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of general exercise, motor control exercise and spinal manipulative therapy for chronic low back pain: A randomized trial.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-11-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/48237</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomisation is done through simple random sampling. Concealment of allocation through sealed envelope, Blinding description: An accessor will be hired who will access the initials and outcome of the patients at the end of the study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic low back pain.</hc_freetext>
      <i_freetext>Intervention 1: General exercise group determine:•	How physically active the participant is•	How troublesome the back problem is•	The ability of the participant to perform the exercises.  Participant will attend eight sessions of one hour, twice a week, for four weeks. The exercises will be performed under the supervision of a physical therapist in classes of up to 12 people. The intensity of the exercises will be progressing over the 8 treatments with participants being encouraged to improve their own performance rather than competing with other members of the class. The main aims of the program will be to improve physical function and confidence in using the spine, and to teach participants how to cope with their back problems.The exercises aim to:•	Strengthen the main muscle groups of the body, including the abdominal and trunk muscles,•	Stretch the main muscle groups •	Increase cardiovascular fitness with low-impact aerobic exercises. The classes will start with Warm-up and Stretching: After about seven to ten minutes, stretching exercises are started. Warm-down and Relaxation:These are similar to the warm-up exercises, but should allow the body gradually to slow down and cool down.After a warm-down session, there will be a short relaxation session and then, at the end of the class, a brief educational message will be provided as a ‘‘tip of the day’’. Intervention 2: Participants allocating to the motor control exercise group will be prescribing exercises aiming to:•	Improve function of specific trunk muscles thought to control inter-segmental movement of the spine, including transversus abdominis, multifidus, the diaphragm and pelvic floor muscles.Initially participants are going to teach how to contract the transversus abdominis and multifidus muscles in isolation from the more superficial trunk muscles, but in conjunction with the pelvic floor muscles. •	Proper engagement of your TVA and Pelvic Floor feels like a gentle upward and inward pulling. Inhale to prepare. Exhale as you gently pull upward on pelvic floor and inward with tummy to spine. Inhale to release the muscles. Multifidus Activation:  The difficulty of the tasks will be progressing by incorporating more functional positions and training the coordination of all trunk muscles during functional.When treating participants in both exercise groups, physical therapists will apply principles of cognitive-behavioural therapy.Participants in both exercise groups will be encouraged to exercise at home at least once a day and to finish all 8 training sessions regardless of the extent of recovery. Intervention 3: Participants allocating to the spinal manipulative therapy group will get treated with:•	Joint mobilization or manipulation techniques applying to the lumber spine. •Grade I-IV joint mobilization may be useful as a pre-test for the appropriateness of manipulation, as a pre-treatment for manipulation, or as a substitute for manipulation in patients where manipulation might be contraindicated. Grade V mobilization should be construed as joint manipulation or adjusting. The particular dose and techniques will be at the discretion of the treating physical therapist, based on:•	Each participant’s physical examination findings. Participants in this group will not get exercises or a home exercise program, and they will get advice to avoid pain-aggravating activities. Manipulative therapy will discontinue if the participant completely recover before the 8 sessions are complete, as is standard clinical practice.The physical therapist will qualify to apply all three interventions. Participants in all groups are going to ask not to seek other treatments and where possible not to change current medications for the 4 week trial period.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
all collected deidentified IPD

When:
most probably starting 6 months after publication

To whom:
For researchers

Conditions:
for research purposes

Where to obtain:
Through email

How to obtain:
Data will be available through email.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ammara Khalid</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>St.no 2, house no. 10 Chaudhary colony Faisalabad road okara,pakistan</address>
        <city>Okara</city>
        <country1>Pakistan</country1>
        <zip>56300</zip>
        <telephone>+92 44 2662064</telephone>
        <email>ammarakhalid33@gmail.com</email>
        <affiliation>Riphah International University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ammara Khalid</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>St.no 2, house no. 10 Chaudhary colony Faisalabad road okara,pakistan</address>
        <city>Okara</city>
        <country1>Pakistan</country1>
        <zip>56300</zip>
        <telephone>+92 44 2662064</telephone>
        <email>ammarakhalid33@gmail.com</email>
        <affiliation>Riphah International University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>o	Non-specific low back pain for at least 3 months
o	Age between 18 and 80 years
o	Written informed voluntary consent</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>o	Neurological signs
o	Specific spinal pathology (e.g. malignancy, or inflammatory joint or bone disease)
o	Back surgery.
o	Serious low back pathology</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M54.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Low back pain</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>General exercise group determine:•	How physically active the participant is•	How troublesome the back problem is•	The ability of the participant to perform the exercises.  Participant will attend eight sessions of one hour, twice a week, for four weeks. The exercises will be performed under the supervision of a physical therapist in classes of up to 12 people. The intensity of the exercises will be progressing over the 8 treatments with participants being encouraged to improve their own performance rather than competing with other members of the class. The main aims of the program will be to improve physical function and confidence in using the spine, and to teach participants how to cope with their back problems.The exercises aim to:•	Strengthen the main muscle groups of the body, including the abdominal and trunk muscles,•	Stretch the main muscle groups •	Increase cardiovascular fitness with low-impact aerobic exercises. The classes will start with Warm-up and Stretching: After about seven to ten minutes, stretching exercises are started. Warm-down and Relaxation:These are similar to the warm-up exercises, but should allow the body gradually to slow down and cool down.After a warm-down session, there will be a short relaxation session and then, at the end of the class, a brief educational message will be provided as a ‘‘tip of the day’’.</i_keyword>
      <i_keyword>Participants allocating to the motor control exercise group will be prescribing exercises aiming to:•	Improve function of specific trunk muscles thought to control inter-segmental movement of the spine, including transversus abdominis, multifidus, the diaphragm and pelvic floor muscles.Initially participants are going to teach how to contract the transversus abdominis and multifidus muscles in isolation from the more superficial trunk muscles, but in conjunction with the pelvic floor muscles. •	Proper engagement of your TVA and Pelvic Floor feels like a gentle upward and inward pulling. Inhale to prepare. Exhale as you gently pull upward on pelvic floor and inward with tummy to spine. Inhale to release the muscles. Multifidus Activation:  The difficulty of the tasks will be progressing by incorporating more functional positions and training the coordination of all trunk muscles during functional.When treating participants in both exercise groups, physical therapists will apply principles of cognitive-behavioural therapy.Participants in both exercise groups will be encouraged to exercise at home at least once a day and to finish all 8 training sessions regardless of the extent of recovery.</i_keyword>
      <i_keyword>Participants allocating to the spinal manipulative therapy group will get treated with:•	Joint mobilization or manipulation techniques applying to the lumber spine. •Grade I-IV joint mobilization may be useful as a pre-test for the appropriateness of manipulation, as a pre-treatment for manipulation, or as a substitute for manipulation in patients where manipulation might be contraindicated. Grade V mobilization should be construed as joint manipulation or adjusting. The particular dose and techniques will be at the discretion of the treating physical therapist, based on:•	Each participant’s physical examination findings. Participants in this group will not get exercises or a home exercise program, and they will get advice to avoid pain-aggravating activities. Manipulative therapy will discontinue if the participant completely recover before the 8 sessions are complete, as is standard clinical practice.The physical therapist will qualify to apply all three interventions. Participants in all groups are going to ask not to seek other treatments and where possible not to change current medications for the 4 week trial period.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Function. Timepoint: Once before intervention and one after the discharge that is 4 weeks. Method of measurement: Patient-Specific Functional Scale.</prim_outcome>
      <prim_outcome>Pain. Timepoint: Once before intervention and one after the discharge that is 4 weeks. Method of measurement: Numerical pain rating scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Secondary outcome is Disability measured by:•	Oswestry Disability Index. Timepoint: Once at the start of the study and once at the end of the study that is after 4 weeks. Method of measurement: Disability measured by Oswestry Disability Index.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>self funded</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-10-08</approval_date>
        <contact_name>Ethics committee of Riphah College of Rehabilitation and Allied health science</contact_name>
        <contact_address>28-M Quaid-e-Azam Industrial Estate Kot Lakhpat, Lahore, Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
