Hamstring ContracturesMHamsNCT03178604
Classic and Sham Massage on Psychological and Physical Functional Variables in Athletes
A study testing Classic massage in people with Hamstring Contractures, run by University of Valencia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hamstring Contractures
- What is being tested?
- Classic massage
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2017to 2 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Muscle-skeletal injuries in any part of the body are excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Hamstring Contractures
- Being tested
- Classic massage, Sham massage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Classic massageOther
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.
Sham massageOther
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 group | Role | What they receive |
|---|---|---|
| Classic massage | Active comparator | 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. Receives: Other: Classic massage |
| Sham massage | Active comparator | Sham massage (SM). 20 minutes in total soft effleurage was performed. This procedure was repeated for each muscle group. Receives: Other: Sham massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Popliteal test
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.
Measured: 4 weeks
Secondary outcomes (4)
Hip flexion test
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.
Measured: 4 weeks
Range of motion
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.
Measured: 4 weeks
Lumbar flexibility
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.
Measured: 4 weeks
Emotional state of the athlete
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study start1 Jun 2017
- Primary completion30 Jun 2017
- Study completion2 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hamstring ContracturesStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GEMMA V ESPÍ LÓPEZ, PhD, University of Valencia
- Investigators
- Gemma V Espí López, Dr, Principal investigator, Faculty of Physiotherapy, University of Valencia, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03178604
- Sponsor's protocol ID
- ID0015
- Acronym
- MHams
- Status last verified
- Nov 2019
- First submitted
- 3 Jun 2017
- Last updated
- 12 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Classic and Sham Massage on Psychological and Physical Functional Variables in Athletes: A Randomized Pilot-Placebo Trial.
- ClinicalTrials.gov ID
- NCT03178604
- Acronym / sponsor ID
- MHams / ID0015
- Conditions
- Hamstring Contractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 2 Aug 2017 (actual)
- First posted
- 7 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Classic massage | Active comparator | Other: Classic massageClassic 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. |
| Sham massage | Active comparator | Other: Sham massageSham massage (SM). 20 minutes in total soft effleurage was performed. This procedure was repeated for each muscle group. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Muscle-skeletal injuries in any part of the body are excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Classic massageIt 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 | Classic massage |
| Sham massageThis 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. | Other | Sham massage |
Primary outcome
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 secondary outcomes
Hip flexion test
Time frame: 4 weeks
Range of motion
Time frame: 4 weeks
Lumbar flexibility
Time frame: 4 weeks
Emotional state of the athlete
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2019.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gemma V Espí López, Dr principal investigator
Faculty of Physiotherapy, University of Valencia, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Classic massage in people with Hamstring Contractures, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Popliteal test (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2019.