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Classic and Sham Massage on Psychological and Physical Functional Variables in Athletes (MHams)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03178604
Recruitment Status : Completed
First Posted : June 7, 2017
Last Update Posted : November 12, 2019
Sponsor:
Information provided by (Responsible Party):
GEMMA V ESPÍ LÓPEZ, PhD, University of Valencia

Tracking Information
First Submitted Date  ICMJE June 3, 2017
First Posted Date  ICMJE June 7, 2017
Last Update Posted Date November 12, 2019
Actual Study Start Date  ICMJE June 1, 2017
Actual Primary Completion Date June 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2017)
Popliteal test [ Time Frame: 4 weeks ]
It is a specific test that is performed in supine position. The subject flexes the hip until it reaches 90º, while keeping the knee flexed. Subsequently, he takes the ankle and takes the knee to an extension position passively. In this position, one takes measure of the degrees that are lacking until the complete extension. During the test, it should be ensured that there are no compensations.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2018)
  • Hip flexion test [ Time Frame: 4 weeks ]
    It is performed with a knee and assesses the shortening of the hamstring muscles. The test is performed in supine position, and consists of flexing the hip in a slow and passive way until it reaches a flexion that the tightness or pain that the participant feels does not let go more. It should be noted that there is no knee flexion or any other type of compensation such as tilting of the pelvis. For the quantification we use a universal goniometer.
  • Range of motion [ Time Frame: 4 weeks ]
    Both legs (hip flexion, knee flexion and knee flexion) are measured by a universal goniometer, which has proven to be a valid and reliable instrument.
  • Lumbar flexibility [ Time Frame: 4 weeks ]
    By the Fingertip-to-Floor Test (FFT). The restraints placed barefoot on a platform 25 cm high, with feet together and flat and toes on the edge pointing forward. They are then asked to lean forward and try to reach the floor with their fingertips as much as possible without discomfort, keeping the knees and arms fully extended. The bending is maintained for 3 seconds and the vertical distance between the tip of the middle finger and the platform is measured. The best of 3 trials is used for analysis.
  • Emotional state of the athlete [ Time Frame: 4 weeks ]
    Through the Profile of Mood States Questionnaire (POMS). This scale contains a total of 58 adjectives, which includes 6 dimensions of moods: tension, depression, anger, vigor, fatigue and confusion.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2017)
  • Hip flexion test [ Time Frame: 4 weeks ]
    It is performed with a knee and assesses the shortening of the hamstring muscles. The test is performed in supine position, and consists of flexing the hip in a slow and passive way until it reaches a flexion that the tightness or pain that the participant feels does not let go more. It should be noted that there is no knee flexion or any other type of compensation such as tilting of the pelvis. For the quantification we use a universal goniometer.
  • Range of motion [ Time Frame: 4 weeks ]
    Both legs (hip flexion, knee flexion and knee flexion) are measured by a universal goniometer, which has proven to be a valid and reliable instrument.
  • Lumbar flexibility [ Time Frame: 4 weeks ]
    By the Fingertip-to-Floor Test (FFT). The restraints placed barefoot on a platform 25 cm high, with feet together and flat and toes on the edge pointing forward. They are then asked to lean forward and try to reach the floor with their fingertips as much as possible without discomfort, keeping the knees and arms fully extended. The bending is maintained for 3 seconds and the vertical distance between the tip of the middle finger and the platform is measured. The best of 3 trials is used for analysis.
  • Pain intensity [ Time Frame: 4 weeks ]
    Evaluated by the Visual Analogue Scale (VAS) in which the patients marked their level of intensity in a 10-cm horizontal line (0 = no pain to 10 = maximum wearable pain) at the assessment moment.
  • Emotional state of the athlete [ Time Frame: 4 weeks ]
    Through the Profile of Mood States Questionnaire (POMS). This scale contains a total of 58 adjectives, which includes 6 dimensions of moods: tension, depression, anger, vigor, fatigue and confusion.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Classic and Sham Massage on Psychological and Physical Functional Variables in Athletes
Official Title  ICMJE Comparison Between Classic and Sham Massage on Psychological and Physical Functional Variables in Athletes: A Randomized Pilot-Placebo Trial.
Brief Summary

In this study we intend to apply a treatment protocol for hamstrings that can be beneficial for a good recovery.

Initially, a sample of athletes with hamstring shortening was chosen. Once the sample is chosen, it will be divided into two groups: group 1 (G.1) who will receives a sham massage, group 2 (G.2) that receives the classic massage.

To finalize the study comparing the results of the two groups to observe the experimental protocol obtains better results.

Material and methods The sample of an athletic club. Recruiting subjects between 18 and 45 years old without other injuries of the lower limb. Subjects with shortening of the hamstring muscles are available through the specific shortening test.

This is a randomized controlled trial. Subjects were randomly assigned to two intervention groups (1 treatment and 1 placebo control). The intervention consists of 4 sessions for 1 month. The sessions have a duration of 45 minutes. Evaluations are performed at the beginning of treatment, at the end of treatment. Participants also perform strengthening exercises three days a week, a total of 3 sets with 15 repetitions each.

Group 1 receives a sham massage of the quadriceps and hamstrings. Group 2 receives a classic massage of the quadriceps and hamstrings. The assessments consist of knee and hip goniometry, lumbar and hamstring flexibility by finger-to-floor testing, and complete the questionnaire Mood Status Profile (POMS), Which evaluates the states of mind.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hamstring Contractures
Intervention  ICMJE
  • Other: Classic massage
    It involves applying the classic massage techniques: effleurage (gliding or sliding movement over the skin with a smooth continuous motion following the direction of the muscle fibers of the superficial muscles in a distal to proximal direction); petrissage (lifting, wringing, or squeezing of soft tissues in a kneading motion, or pressing or rolling of the tissues under or between the hands); tapotement (various parts of the hand striking the tissues at a fairly rapid rate). The general objective is to improve extensibility of muscle, tendon, fascia, joint capsule, and ligamentous structures.
  • Other: Sham massage
    This group received a placebo intervention at the same time as the other group, maintaining only soft touch with the participant without exerting any mechanical pressure.
Study Arms  ICMJE
  • Active Comparator: Classic massage
    Classic massage (CM) treatment based on petrissage. It applies: 1 minute of mild effleurage, 5 minutes of deep effleurage with the thumbs, 5 minutes of firm kneading and 1 minute of tapotement (20 minutes in total). This procedure was repeated for each muscle group.
    Intervention: Other: Classic massage
  • Active Comparator: Sham massage
    Sham massage (SM). 20 minutes in total soft effleurage was performed. This procedure was repeated for each muscle group.
    Intervention: Other: Sham massage
Publications * Not Provided

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: November 6, 2019)
20
Original Estimated Enrollment  ICMJE
 (submitted: June 3, 2017)
30
Actual Study Completion Date  ICMJE August 2, 2017
Actual Primary Completion Date June 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The sample comes from two athletic clubs of Valencia with subjects between 18 and 30 years old without lower limb injuries, with shortening of the hamstring muscles selected by the specific shortening test.

Exclusion Criteria:

  • Muscle-skeletal injuries in any part of the body are excluded from the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03178604
Other Study ID Numbers  ICMJE ID0015
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 GEMMA V ESPÍ LÓPEZ, PhD, University of Valencia
Study Sponsor  ICMJE University of Valencia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gemma V Espí López, Dr Faculty of Physiotherapy, University of Valencia, Spain
PRS Account University of Valencia
Verification Date November 2019

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