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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04763798
Other study ID # CBAS-2019-12
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 11, 2020
Est. completion date February 20, 2021

Study information

Verified date February 2021
Source Universitat Internacional de Catalunya
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date February 20, 2021
Est. primary completion date January 11, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Straight-leg-raise (SLR)
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
Passive Knee extension test (PKE)
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
Maximum hip flexion (MHF)
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

Locations

Country Name City State
Spain Universitat Internacional de Catalunya Sant Cugat Del Vallès Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Universitat Internacional de Catalunya

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Modified back-saver sit-and-reach test 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 90ยบ. 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.
Primary Distal sensation 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.
Primary Force intensity applyed 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 Perceived sensation 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.