- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04763798
Efficacy of Hamstring Stretching According to the Neural or Muscle Tissue Involvement
Background: Muscle stretching is a technique widely used in the clinical practice of physiotherapy and in the field of sports. In the bibliography we find a multitude of stretches and procedures described, some of them being similar to neurodynamic tests, which could direct their effect to a neural and not a musculoskeletal structure. The structural differentiation manoeuvre has been shown to be able to discriminate the increase in tension on the nerve.
Objective: To evaluate the short-term efficacy on ischiosural muscle elongation of three modalities of ischiosural stretching according to neural or muscular involvement, in subjects without previous pathology.
Design: Cross sectional study. Methods: A randomised, blinded, assessor-blinded clinical trial was performed. According to the sample size calculation, a total of 35 subjects will be recruited from the International University of Catalonia. Each subject will undergo three hamstring stretching techniques on their dominant leg, Straight-leg-raise (SLR), Passive knee extension (PKE) and Maximun hip flexion (MHF) with an interval of one week on the dominant leg. Muscle elongation in each stretching modality will be assessed with the modified black saver sit and reach test and whether the technique generates a neural or musculoskeletal response when performing the structural differentiation manoeuvre.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background: Muscle stretching is a technique widely used in the clinical practice of physiotherapy and in the field of sports. In the bibliography we find a multitude of stretches and procedures described, some of them being similar to neurodynamic tests, which could direct their effect to a neural and not a musculoskeletal structure. The structural differentiation manoeuvre has been shown to be able to discriminate the increase in tension on the nerve.
Objective: To evaluate the short-term efficacy on ischiosural muscle elongation of three modalities of ischiosural stretching according to neural or muscular involvement, in subjects without previous pathology.
Design: Cross sectional study.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Barcelona
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Sant Cugat Del Vallès, Barcelona, Spain, 08195
- Universitat Internacional de Catalunya
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy subjects over 18 years old who signed the informed consent.
Exclusion Criteria:
- The exclusion criteria were as follows: 1) injury in the thigh 6 months previously, 2) diagnosis of any orthopaedic problem or surgery in the lower limbs, 3) back pain or previous surgery in the spine or 4) systemic or neurological disorders.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Dominant
All subjects will receive the three stretching techniques on dominant leg.
Interventions will be performed in three different days and only one of the three stretching exercises will be performed in each session.
The rest period between sessions will be one week.
Stretching exercises will be perform in a random order.
A random-number generator will be used for randomization
|
The stretched lower limb was on a mobile support and the contralateral limb was stabilized with a belt on the bench.
For the SLR, the knee was kept in full extension and then, hip flexion was performed until a marked resistance.
All stretching modalities were applied until a marked resistance was felt by the physical therapist (end-feel) or until the point of maximal tolerance referred by subjects.The stretch lasted 30 seconds followed by 15 seconds rest period and the procedure was repeated 5 times.
Each stretching was applied for 5 minutes
The stretched lower limb was on a mobile support and the contralateral limb was stabilized with a belt on the bench. For the PKE, the hip was kept in 90º flexion and then, knee extension was performed. All stretching modalities were applied until a marked resistance was felt by the physical therapist (end-feel) or until the point of maximal tolerance referred by subjects. The stretches lasted 30 seconds followed by 15 seconds rest period and the procedure was repeated 5 times. Each stretching was applied for 5 minutes The stretched lower limb was on a mobile support and the contralateral limb was stabilized with a belt on the bench. For MHF, a maximal hip flexion was performed and then, knee extension was applied. All stretching modalities were applied until a marked resistance was felt by the physical therapist (end-feel) or until the point of maximal tolerance referred by subjects. The stretches lasted 30 seconds followed by 15 seconds rest period and the procedure was repeated 5 times. Each stretching was applied for 5 minutes |
|
Active Comparator: Non dominant
All subjects will receive the three stretching techniques on non dominant leg.
Interventions will be performed in three different days and only one of the three stretching exercises will be performed in each session.
The rest period between sessions will bé one week.
Stretching exercises will be perform in a random order.
A random-number generator will bé used for randomization
|
The stretched lower limb was on a mobile support and the contralateral limb was stabilized with a belt on the bench.
For the SLR, the knee was kept in full extension and then, hip flexion was performed until a marked resistance.
All stretching modalities were applied until a marked resistance was felt by the physical therapist (end-feel) or until the point of maximal tolerance referred by subjects.The stretch lasted 30 seconds followed by 15 seconds rest period and the procedure was repeated 5 times.
Each stretching was applied for 5 minutes
The stretched lower limb was on a mobile support and the contralateral limb was stabilized with a belt on the bench. For the PKE, the hip was kept in 90º flexion and then, knee extension was performed. All stretching modalities were applied until a marked resistance was felt by the physical therapist (end-feel) or until the point of maximal tolerance referred by subjects. The stretches lasted 30 seconds followed by 15 seconds rest period and the procedure was repeated 5 times. Each stretching was applied for 5 minutes The stretched lower limb was on a mobile support and the contralateral limb was stabilized with a belt on the bench. For MHF, a maximal hip flexion was performed and then, knee extension was applied. All stretching modalities were applied until a marked resistance was felt by the physical therapist (end-feel) or until the point of maximal tolerance referred by subjects. The stretches lasted 30 seconds followed by 15 seconds rest period and the procedure was repeated 5 times. Each stretching was applied for 5 minutes |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Modified back-saver sit-and-reach test
Time Frame: Through study completion, an average of 3 weeks.
|
subjects will perform a single-leg sit-and-reach on a bench.
The untested leg will be placed on the floor with knee at approximately 90º.
A measuring tape will be placed on the bench.
Subjects aligned the sole of the foot of the tested leg with the 50-cm mark on the measuring tape.
Thereafter, subjects will be asked to reach forward as far as possible while maintaining the knees, arms, and fingers fully extended, and keep in the two hands on tip of each other and palms down
|
Through study completion, an average of 3 weeks.
|
|
Distal sensation
Time Frame: Through study completion, an average of 3 weeks.
|
Passive ankle dorsiflexion was performed as distal sensation manoeuvre at the final position of all stretching modalities.
Subjects were asked to indicate if the sensation during the stretching was modified during the ankle dorsiflexion (neural response) or was the same (musculoskeletal response)
|
Through study completion, an average of 3 weeks.
|
|
Force intensity applyed
Time Frame: Through study completion, an average of 3 weeks.
|
The intensity of the force applied during each stretching modality was measured by a manual dynamometer (MicroFET2, Hoggan Scientific, Salt Lake City, Utah).
The dynamometer was applied on the distal leg, proximal to the ankle joint.
The physiotherapist performed the stretching until a marked resistance was felt and then, the force was registered.
|
Through study completion, an average of 3 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived sensation
Time Frame: Through study completion, an average of 3 weeks.
|
After the stretching application, all subjects were asked about their perceived sensation.
They were asked about the intensity of the tension sensation during the technique.
A numeric scale, ranging from 0 ("no tension") to 10 ("worst tension imaginable") was used to indicate the intensity of tension sensation during the stretching technique.
|
Through study completion, an average of 3 weeks.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Carlos L López de Celis, Dr, Universitat Internacional de Catalunya
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CBAS-2019-12
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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