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

November 6, 2019 updated by: GEMMA V ESPÍ LÓPEZ, PhD, University of Valencia

Comparison Between Classic and Sham Massage on Psychological and Physical Functional Variables in Athletes: A Randomized Pilot-Placebo Trial.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46010
        • Gemma Victoria Espí López

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
Active Comparator: Sham massage
Sham massage (SM). 20 minutes in total soft effleurage was performed. This procedure was repeated for each muscle group.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
4 weeks
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.
4 weeks
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.
4 weeks
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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Valencia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gemma V Espí López, Dr, Faculty of Physiotherapy, University of Valencia, Spain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 2, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 3, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 7, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ID0015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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