<?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>IRCT20220510054807N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-05-17</date_registration>
      <primary_sponsor>Faisal Institute of Health Sciences</primary_sponsor>
      <public_title>EFFECTIVENESS OF PNF STRETCHING WITH OR WITHOUT VOODOO FLOSS BAND ON HAMSTRING FLEXIBILITY IN PATIENTS WITH NON-SPECIFIC CHRONIC LOW BACK PAIN.</public_title>
      <acronym></acronym>
      <scientific_title>EFFECTIVENESS OF PNF STRETCHING WITH OR WITHOUT VOODOO FLOSS BAND ON HAMSTRING FLEXIBILITY IN PATIENTS WITH NON-SPECIFIC CHRONIC LOW BACK PAIN</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-05-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63447</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Non-Specific chronic low back pain can be defined as pain in the lower lumbar region caused by strain or poor posture in the lumbar area associated with or caused by Hamstring tightness..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1:",Base line Treatment includes TENS (Transcutaneous Electrical Nerve Stimulation) will be used on lower back before actual treatment protocol,10 minutes in continuous mode (100 Hz with pulse duration of 50-100 micro second) and Therapeutic  Ultrasound with 3 MHz for 10 minutes at 50% intensity (1.0 w/cm square, pulsed 50%). PNF(Hold-Relax) Stretching with Voodoo floss band, Voodoo floss band is a latex band black color has  2 inch width and 7 feet length is used to wrap around thighs with 50% stretch to compress blood flow around hamstring muscles and then PNF hold relax stretching technique is performed. Voodoo floss band will be wrapped around hamstrings , PNF includes Passive hamstring stretch by therapist held for 7 seconds, then 3 seconds isometric contract, 5 second relaxation, The physiotherapist then passively stretch the muscle until a mild stretch sensation is reported , 5 repetitions, , Each repetition is separated by 20 seconds , 3 sessions per week on alternative days for 4 weeks. Intervention 2: Intervention group 2:",Base line Treatment includes TENS (Transcutaneous Electrical Nerve Stimulation) will be used on lower back before actual treatment protocol,10 minutes in continuous mode (100 Hz with pulse duration of 50-100 micro second) and Therapeutic  Ultrasound with 3 MHz for 10 minutes at 50% intensity (1.0 w/cm square, pulsed 50%).PNF( Hold-Relax) Stretching   includes Passive hamstring stretch by therapist held for 7 seconds, then 3 seconds isometric contract, 5 second relaxation, The physiotherapist then passively stretch the muscle until a mild stretch sensation is reported , 5 repetitions, , Each repetition is separated by 20 seconds , 3 sessions per week on alternative days for 4 weeks.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Farwa Ahmad Khan Rai</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>673-A,Canal Road E, A Block, Peoples Colony no:1, Faisal Hospital, Faisalabad</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>38000</zip>
        <telephone>009241856999</telephone>
        <email>farwa6095@gmail.com</email>
        <affiliation>Faisal Institute of Health Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Ramesha Tahir ;PT</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>673-A,Canal Road E,  Faisal Hospital, Peoples Colony No :1 Faisalabad, Punjab, Pakistan</address>
        <city>Faisalabad</city>
        <country1>Pakistan</country1>
        <zip>03822</zip>
        <telephone>+92 41 8536999</telephone>
        <email>drramishatahir@gmail.com</email>
        <affiliation>Faisal Institute of Health Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 18-45 Years
Both Genders
Persons who sit for more than 3 hours
patients with past three months of Non-specific Mechanical Chronic low back pain
Pain above 3 on NPRS
During SLR  having pain at &gt;70 degree
persons with minimum of 11 or more ODI score
less than 6cm difference on MMST</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Persons with disc herniations
Patients with sciatic nerve pain are excluded
patients with fracture
Persons who had a surgery in past six months
Major surgeries like total Hip arthroplasty are also excluded
spinal trauma caused by accidents are excluded
pregnancy
Psychologically un-cooperative
Malignancy</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1:",Base line Treatment includes TENS (Transcutaneous Electrical Nerve Stimulation) will be used on lower back before actual treatment protocol,10 minutes in continuous mode (100 Hz with pulse duration of 50-100 micro second) and Therapeutic  Ultrasound with 3 MHz for 10 minutes at 50% intensity (1.0 w/cm square, pulsed 50%). PNF(Hold-Relax) Stretching with Voodoo floss band, Voodoo floss band is a latex band black color has  2 inch width and 7 feet length is used to wrap around thighs with 50% stretch to compress blood flow around hamstring muscles and then PNF hold relax stretching technique is performed. Voodoo floss band will be wrapped around hamstrings , PNF includes Passive hamstring stretch by therapist held for 7 seconds, then 3 seconds isometric contract, 5 second relaxation, The physiotherapist then passively stretch the muscle until a mild stretch sensation is reported , 5 repetitions, , Each repetition is separated by 20 seconds , 3 sessions per week on alternative days for 4 weeks</i_keyword>
      <i_keyword>Intervention group 2:",Base line Treatment includes TENS (Transcutaneous Electrical Nerve Stimulation) will be used on lower back before actual treatment protocol,10 minutes in continuous mode (100 Hz with pulse duration of 50-100 micro second) and Therapeutic  Ultrasound with 3 MHz for 10 minutes at 50% intensity (1.0 w/cm square, pulsed 50%).PNF( Hold-Relax) Stretching   includes Passive hamstring stretch by therapist held for 7 seconds, then 3 seconds isometric contract, 5 second relaxation, The physiotherapist then passively stretch the muscle until a mild stretch sensation is reported , 5 repetitions, , Each repetition is separated by 20 seconds , 3 sessions per week on alternative days for 4 weeks</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Straight leg raise test was used to measure the hamstring flexibilty in patients with Non-Specific Mechanical  Chronic  Low Back Pain. Timepoint: 3time points including Baseline, 2nd Week Post Treatment, 4th Week Post Treatment. Method of measurement: SLR will be  measured by Universal Goniometer.</prim_outcome>
      <prim_outcome>NPRS(Numeric Pain Rating Scale was be utilized to measure the intensity of pain. Pain intensity was rated 0-10 at a horizontal bar. NPRS consists of 11 points, which range from 0=no pain, 1-4=mild pain, 4-7=moderate pain, 7-10=severe pain. Timepoint: 3  time points including Baseline, 2nd Week Post Treatment, 4th Week Post Treatment. Method of measurement: NPRS will be utilized to assess pain.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Lumbar Flexion Range of motion is assessed by the use of Modified-Modified Schober's Test. This test uses Tape measure to measure the lumbar flexion range. To measure the range of motion, the therapist puts his thumbs on the inferior margin of the subject’s PSIS. An ink mark is drawn along the midline of the lumbar spine horizontal to the PSIS (lower landmark). While the therapist holds the tape firmly against the subject’s skin, he marks a second line 15 cm above the original one (higher landmark). Then the subject is asked to do an active anterior flexion of the trunk without increasing the pain. The new distance between the lower and higher landmarks is then measured. The subject returns to the neutral position. The difference in the initial distance between the skin markings in the neutral position and the new measurements made in the flexion position is used to indicate the amount of lumbar flexion. Timepoint: 3 time points, Baseline, 2nd Week post treatment,4th week post treatment. Method of measurement: MMST(Modified-Modified Schober's Test) will be  utilized to measure Lumbar Flexion range.</sec_outcome>
      <sec_outcome>ODI (Oswestry Disability Index) is a questionnair which measure low back pain function disability. It is a gold standard of low back functional outcome. There are 10 sections in this questionnair.Each section  has six questions that score 0 to 5. Total score of all the sections is 50.Patients will fill the Questionnair and the scored will be (total possible score ) will be divided by 50 and then will be multiplied to 100 to get the percentage.0-20%=indicates minimal disability, 21-40%=Moderate Disability, 41-60%=Severe Disability, 61-80%=Crippled, 81-100%=These patients are either bed bound or exaggerating there symptoms. Timepoint: 3 Time Points Baseline, 2nd Week post treatment, 4th week post treatment. Method of measurement: ODI (Oswestry Disability Index) questionnaire will be utilized to measure Low back function.</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 Financed</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-03-20</approval_date>
        <contact_name>Ethics committee of Faisal Institute of Health Sciences</contact_name>
        <contact_address>673-A Lower canal Road E , Block A Peoples Colony no 1, Faisal Hospital, Faisalabad Faisalabad Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
