Low Back Pain, Mechanical Clinical Trial
Official title:
Efficacy of a Physiotherapy Intervention by Electrotherapy Combined With Myofascial Therapy for the Improvement of Lumbar Region Mobility in Federated Padel Players. A Pilot Study
NCT number | NCT03867292 |
Other study ID # | MIOTENS |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 10, 2019 |
Est. completion date | June 20, 2019 |
Verified date | January 2020 |
Source | Investigación en Hemofilia y Fisioterapia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Introduction. The lumbar region is one of the locations with the highest incidence of
injuries in the paddle players. The crossed hands myofascial technique is used to release the
restrictions of the thoracolumbar fascia, improving its mobility. The electrotherapy
technique of TENS consists in the application of a low frequency current for the recovery,
capitalization and oxygenation of the muscle, thus improving mobility and pain.
Aim. To evaluate the efficacy of an intervention by electrotherapy combined with myofascial
therapy, in the lumbar region, for a mobility improvement in older paddle-tennis federated
players.
Study design. Randomized, multicenter, simple blind, clinical trial with follow-up period.
Methods. 30 players paddle will be assigned to the two study groups: experimental
(intervention through therapy myofascial and electrotherapy) and control (intervention by
electrotherapy). The intervention will have a duration of 4 weeks, with 2 sessions per week,
lasting 15 minutes. There will be three evaluations: pre-intervention, post-intervention and
follow-up. The variable of study is the mobility of the lumbar spine in the movements of
flexion and extension (assessed by the employment of tests of Schober and
Fingertip-to-floor). The analysis of normality be performed with the Kolmogorov-Smirnof, and
in case of homogeneity of the groups is used in parametric tests: test t-student for paired
data (difference between the different assessments) and ANOVA of mean repeated (intra-and
intersujeto).
Expected results. Improvement of the mobility of the lumbar spine in the movements of flexion
and extension.
Status | Completed |
Enrollment | 30 |
Est. completion date | June 20, 2019 |
Est. primary completion date | April 15, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Padel players - With federal sheet - Male - Over 18 years - Currently participate in regional and / or national competitions Exclusion Criteria: - Present a medical diagnosis of musculoskeletal pathology - Not signed the informed consent document. |
Country | Name | City | State |
---|---|---|---|
Spain | Universidad Europea de Madrid | Madrid | Comunity Of Madrid |
Lead Sponsor | Collaborator |
---|---|
Investigación en Hemofilia y Fisioterapia |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline low back flexion after treatment and at a month | Low back flexion will be measured with the Schober test. The subject will remain standing and the evaluator will mark an imaginary line that connects both posterior superior iliac spines (near the Venus pits). A second mark will be placed 10 cm above the first mark and, finally, we will make a third mark 5 cm below the first mark. Next, the subject will be asked to bend to the maximum, keeping the knees extended. When the maximum flexion is reached, the increase in the distance between the skin marks will be measured. The unit of measurement is the centimeter (the greater the distance, the greater the mobility in the flexion of the lumbar spine). | Screening visit, within the first seven days after treatment and after one month follow-up visit | |
Secondary | Change from baseline low back extension after treatment and at a month | Low back extension will be measured with the Schober test. The subject will remain standing and the evaluator will mark an imaginary line that connects both posterior superior iliac spines (near the Venus pits). A second mark will be placed 10 cm above the first mark and, finally, we will make a third mark 5 cm below the first mark. Next, the subject will be asked to lean back to the maximum, keeping the knees extended. When the maximum extension is reached, the decrease in the distance between the skin marks will be measured. The unit of measurement is the centimeter (at a lower distance, greater mobility in extension of the lumbar spine). | Screening visit, within the first seven days after treatment and after one month follow-up visit | |
Secondary | Change from baseline low back flexion after treatment and at a month | Low back flexion will be measured with the Fingertip-to-floor test. With the subject standing on a platform 20 cm high (without shoes and with their feet together), you will be asked to lean towards flexion, while keeping your knees, arms and fingers fully extended. The vertical distance between the tip of the middle finger and the platform shall be measured with a flexible measuring tape and expressed in centimeters. The vertical distance (measured in centimeters) between the platform and the tip of the middle finger will be positive when the subject does not reach the platform and negative when it can go further. | Screening visit, within the first seven days after treatment and after one month follow-up visit |
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