NCT04345055

Brief Summary

Introduction: the hamstring muscles has a great tendency to decrease its extensibility, originating a pathology with a own clinical entity, the Short Hamstring Syndrome (SHS), in addition to other problems on adjacent structures. All this present a great socioeconomic impact in the investigator's society. Various techniques have been demostrated to prduce an increase in flexibility, among which are the fascial techniques. Objective: to evaluate the immediate efficacy of the treatment of the lumbar fascia in the flexibility of the hamstring musculature. Methods: 41 women between 18 and 39 years old, in two groups. The experimental group received a technique of fascial stretching in the lumbar area while the control group participated in an off magnetotherapy machine. The hamstring flexibility in both lower limbs was measured by the Straight Leg Raising Test (SLR) and the Passive Popliteal Angle Test (PKE).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 14, 2020

Completed
Last Updated

April 14, 2020

Status Verified

April 1, 2020

Enrollment Period

Same day

First QC Date

April 6, 2020

Last Update Submit

April 9, 2020

Conditions

Keywords

hamstring muscleslumbar fasciaflexibility

Outcome Measures

Primary Outcomes (2)

  • Change from Straight Leg Raising Test (SLR)

    Test

    Pre-intervention and immediately after the intervention

  • Change from Passive Popliteal Angle Test (PKE)

    Test

    Pre-intervention and immediately after the intervention

Secondary Outcomes (1)

  • IPAQ

    Pre-intervention

Study Arms (2)

Fascial treatment

EXPERIMENTAL

Treatment the lumbar fasciae

Other: Treatment of the lumbar fasciae

Placebo group

PLACEBO COMPARATOR

Introduce in a machine off

Other: Placebo intervention

Interventions

Treat the lumbar facial with a manual technique

Fascial treatment

Introduce in a machine off

Placebo group

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female between 18 and 39 years old.
  • Signed informed consent

You may not qualify if:

  • Any alteration that prevents the normal communication between the patient and the therapist at the time of the study.
  • Have an injury in the hamstring muscles.
  • Have a chronic or acute lumbar pain in the moment of the realization.
  • Neurological or orthopedic desease.
  • Any important estructural alteration in the lower members that may be likely to alter the results under study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Católica San Antonio de Murcia

Murcia, 30107, Spain

Location

Study Officials

  • Juan Javier Bru Ruiz

    Universidad Católica San Antonio de Murcia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

April 6, 2020

First Posted

April 14, 2020

Study Start

March 1, 2019

Primary Completion

March 1, 2019

Study Completion

April 30, 2019

Last Updated

April 14, 2020

Record last verified: 2020-04

Locations