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Effect of Therapeutic Techniques on Leg Stretching in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT03958084
Recruitment Status : Recruiting
First Posted : May 21, 2019
Last Update Posted : March 25, 2020
Sponsor:
Collaborator:
Santa Catarina Federal University
Information provided by (Responsible Party):
Alessandro Haupenthal, Universidade Federal de Santa Catarina

Tracking Information
First Submitted Date  ICMJE May 17, 2019
First Posted Date  ICMJE May 21, 2019
Last Update Posted Date March 25, 2020
Estimated Study Start Date  ICMJE April 20, 2020
Estimated Primary Completion Date September 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
Range of motion [ Time Frame: 10 minutes ]
The study has as main variable the range of motion of the hamstrings measured in degrees, through the test of the Elevation of the Extended Leg. The amplitude reached in the pre- and post-test was recorded by means of a photogrammetry and analyzed by a free postural evaluation program that provides the researcher with calculating linear and angular measurements through spatially defined anatomical points.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Therapeutic Techniques on Leg Stretching in Healthy Subjects
Official Title  ICMJE Effect of Different Therapeutic Techniques on the Flexibility of ischiotíbial in Healthy Individuals
Brief Summary There are physiotherapy techniques, known as lumbar mobilization, proprioceptive neuromuscular facilitation, massage therapy, windsheets and foam roller that present good results in stretching the legs. This study aims to evaluate which of these techniques has a better result in leg stretching. It is believed that massage therapy and lumbar mobilization will provide better results.
Detailed Description A randomized clinical trial blind crossover. The aim of this study is comparing the immediate effect of five interventions on the flexibility of hamstrings in healthy individuals. Participants will be assessed pre and post intervention through the extended leg elevation test and photogrammetry. The techniques of unilateral lumbar mobilization, proprioceptive neuromuscular facilitation, massage, ventosa therapy and foam roller will be applied on different days with a 48-hour interval between interventions. The techniques will be compared using the repeated measures ANOVA after verification of normality by the Shapiro-Wilk test, adopting the significance level of 5% and 95% confidence interval.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Healthy
  • Adult
Intervention  ICMJE Diagnostic Test: Straight Leg Raise
The assessment of the flexibility of the hamstring will be realized through the test of straight leg raise (SLR). The SLR is a passive test performed unilaterally.
Study Arms  ICMJE
  • Experimental: Massage group
    The deep massage will be applied for three minutes in the ischiotíbial muscles, only in the left limb, towards the muscular fibers. The volunteers will be placed in a ventral decubitus position on the stretcher.
    Intervention: Diagnostic Test: Straight Leg Raise
  • Experimental: Ventosa therapy group
    The negative pressure ventosa therapy slide winds will be applied for three minutes in the oval direction in the posterior region of the thigh to contemplate the full extent of the ischiotíbial muscles, only in the left limb. The volunteers will be placed in a ventral decubitus position on the stretcher.
    Intervention: Diagnostic Test: Straight Leg Raise
  • Experimental: Foam roller group
    The foam roller is a self-applied intervention for three minutes where the volunteers will be positioned on bench press on the floor of the room, with the left thigh posteriorly on the foam roller and the leg extended, the right lower limb will be in flexion of hip and knee, only the right foot and the right and left hands will touch the ground. Volunteers will be instructed to move so that they move forward and backward, causing the roller to travel the full length of the hamstring muscles.
    Intervention: Diagnostic Test: Straight Leg Raise
  • Experimental: Lumbar mobilization group
    Unilateral lumbar mobilization of grade III at the frequency of 2Hz at the joint L4 / L5 of the ipsilateral side of the limb tested. The frequency was guaranteed by a metronome set at 120 beats per minute. Three sets of 1 minute of mobilization were performed with a 30 second interval, totaling a time of 4 minutes and 30 seconds of intervention. The technique was performed with the patient in the ventral decubitus position.
    Intervention: Diagnostic Test: Straight Leg Raise
  • Experimental: Proprioceptive neuromuscular facilitation group
    Patient in dorsal decubitus, the examiner lifted the participant's leg up to the referred maximum amplitude. He then asked the patient for an isometric contraction of the hamstring muscles against the researcher's resistance for 10 seconds. After contraction, the researcher asked the patient to relax for 10 seconds. Then the member is repositioned passively by the researcher until the new amplitude limit reached. The technique was performed in 2 sets of 4 repetitions with an interval of 1 minute, totaling in an approximate time of 4 minutes of intervention.
    Intervention: Diagnostic Test: Straight Leg Raise
  • No Intervention: Control group
    The patient remained lying down in the ventral position for 4 minutes. the patient remained lying down in the ventral position for 4 minutes.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 20, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2020
Estimated Primary Completion Date September 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 to 35 years of age.
  • No pain in the posterior thigh.

Exclusion Criteria:

  • Volunteers who present deep venous thrombosis.
  • Cutaneous allergy.
  • Cutaneous lesion.
  • Posterior thigh edema.
  • Lower limb prosthesis.
  • Shoulder or wrist injuries.
  • Phobia of the techniques.
  • Scarring in the posterior region of the thigh
  • Have performed myofacial release or stretches during the days of intervention.
  • Pilates and yoga practitioners
  • No attend every day intervention.
  • Injury of hamstrings in the last year.
  • Previous injuries to the spine or lower limbs in the last 6 months.
  • Symptoms of low back pain or hip joint.
  • Diabetes mellitus, since people with diabetes have limited responses in the elevated leg elevation test.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Alessandro Haupenthal, Teacher 55(48)99028190 alessandro.haupenthal@ufsc.br
Contact: Cassia Rodrigues Schuster, Student 55(48)996390975 cassiarschuster@hotmail.com
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03958084
Other Study ID Numbers  ICMJE 1;771;454
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Alessandro Haupenthal, Universidade Federal de Santa Catarina
Study Sponsor  ICMJE Alessandro Haupenthal
Collaborators  ICMJE Santa Catarina Federal University
Investigators  ICMJE
Principal Investigator: Alessandro Haupenthal, Teacher Santa Catarina Federal University
PRS Account Universidade Federal de Santa Catarina
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP