Muscular DiseasesNCT02100241
Effectiveness Analysis of Active Stretching Versus Active Stretching With Low Frequency Currents
A study testing Active stretching in people with Muscular Diseases, run by Rodríguez, Francisco Piqueras, M.D. at 1 site in Spain.
Trial summary
The purpose of this study is to determine whether active stretching with low frequency currents are more effective than active stretching in the treatment of hamstring shortness syndrome in children. Read more about this study
- Who is it for?
- Ages 10 to 16 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscular Diseases
- What is being tested?
- Active stretching
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2012to Jun 2012
- 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 10 to 16 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- children between 10 to 16.
- children federated belonging to Football School of Jumilla.
- children whose result in the assessment of range of motion is less than 70º in the Straight Leg Raising Test.
- not afraid to present the application of electrotherapy.
- not have low back pain in last three months.
- not to be injured
Who cannot join
- children who have acute muscle injury or ligamentous.
- children with recent fractures or unconsolidated.
- children with ligamentous laxity.
- functional shortening suffering children
Trial locations and contacts
1 site in 1 country.
Spain1 site
Universidad Miguel Hernandez de Elche
Sant Joan d'Alacant, Alicante, 03550
About this study
The purpose of this study is to determine whether active stretching with low frequency currents are more effective than active stretching in the treatment of hamstring shortness syndrome in children.
Read the detailed description
In 2012 we studied 51 young footballers with Short Hamstring Syndrome in Spain. Three groups were formed:
- Stretching+Transcutaneous Electrical Nervous Stimulation (TENS);
- Active stretching;
- Conventional stretching.
Parameters: straight leg raise test (SLR), popliteal angle with the passive knee extension test (PKE) and the toe-touch test (TT).
The inter-group means were compared and clinically relevant parameters calculated [relative risk (RR), absolute risk reduction (ARR), relative risk reduction (RRR) and number needed to treat (NNT)].
- Conditions
- Muscular Diseases
- Being tested
- Active stretching
- Keywords
- Young adult, Muscle Stretching Exercises, Range of Motion, Articular
- Medical subject headings
- Muscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active stretchingProcedure or surgery
The participants performed three specific exercises of static active stretching of the hamstring muscles, maintaining the maximum tightness that was tolerable without pain for 15 seconds. Each exercise were performed twice, with a total of six repetitions.
| Study group | Role | What they receive |
|---|---|---|
| Active stretching with currents | Experimental | Active stretching performed while currents are applied on hamstring muscles. Receives: Procedure: Active stretching |
| Active stretching | Experimental | Active stretching are performed. Receives: Procedure: Active stretching |
| Control group | No intervention | Routine clinical practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of motion
Measured: a week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2014 (estimated)
- Study startApr 2012
- Primary completionApr 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscular DiseasesStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rodríguez, Francisco Piqueras, M.D.
- Responsible party
- Sponsor
- Investigators
- Francisco Piqueras, PT, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02100241
- Sponsor's protocol ID
- FPR2012
- Status last verified
- Mar 2014
- First submitted
- 19 Jul 2013
- Last updated
- 31 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Analysis of Active Stretching Versus Active Stretching With Low Frequency Currents
- ClinicalTrials.gov ID
- NCT02100241
- Acronym / sponsor ID
- FPR2012
- Conditions
- Muscular Diseases
- Keywords
- Young adult, Muscle Stretching Exercises, Range of Motion, Articular
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Rodríguez, Francisco Piqueras, M.D.
- Study start
- Apr 2012
- Primary completion
- Apr 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 31 Mar 2014 (estimated)
- 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.
The purpose of this study is to determine whether active stretching with low frequency currents are more effective than active stretching in the treatment of hamstring shortness syndrome in children.
Detailed description
In 2012 we studied 51 young footballers with Short Hamstring Syndrome in Spain. Three groups were formed:
- Stretching+Transcutaneous Electrical Nervous Stimulation (TENS);
- Active stretching;
- Conventional stretching.
Parameters: straight leg raise test (SLR), popliteal angle with the passive knee extension test (PKE) and the toe-touch test (TT).
The inter-group means were compared and clinically relevant parameters calculated [relative risk (RR), absolute risk reduction (ARR), relative risk reduction (RRR) and number needed to treat (NNT)].
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active stretching with currents | Experimental | Procedure: Active stretchingActive stretching performed while currents are applied on hamstring muscles. |
| Active stretching | Experimental | Procedure: Active stretchingActive stretching are performed. |
| Control group | No intervention | –Routine clinical practice |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- children between 10 to 16.
- children federated belonging to Football School of Jumilla.
- children whose result in the assessment of range of motion is less than 70º in the Straight Leg Raising Test.
- not afraid to present the application of electrotherapy.
- not have low back pain in last three months.
Key exclusion criteria (4 listed)
- children who have acute muscle injury or ligamentous.
- children with recent fractures or unconsolidated.
- children with ligamentous laxity.
- functional shortening suffering children
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 |
|---|---|---|
| Active stretchingThe participants performed three specific exercises of static active stretching of the hamstring muscles, maintaining the maximum tightness that was tolerable without pain for 15 seconds. Each exercise were performed twice, with a total of six repetitions. | Procedure or surgery | Active stretching, Active stretching with currents |
Primary outcome
Range of motion
Time frame: a week
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 31 Mar 2014.
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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.
Francisco Piqueras, PT principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active stretching in people with Muscular Diseases, run by Rodríguez, Francisco Piqueras, M.D. 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 6 inclusion and 4 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 31 Mar 2014. 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?
Range of motion (time frame: a week). 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 31 Mar 2014.