NCT03034681

Brief Summary

This pilot "pre-post" quasi-experimental study evaluates for the first time the effectiveness of Vojta Therapy in treating lumbosciatic and compares it with the transcutaneous electrical nerve stimulation (TENS) procedure. Patients who agree will be distributed alternately in order of arrival to a Physiotherapy Unit, in such a way that half of the sample will be treated using TENS and the other half with Vojta.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2011

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

January 1, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

January 16, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 27, 2017

Completed
Last Updated

February 1, 2017

Status Verified

January 1, 2017

Enrollment Period

5 months

First QC Date

January 16, 2017

Last Update Submit

January 31, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pain

    To quantify pain, the investigators used two aggregated measures coming independently from the Visual Analogical Scale (VAS) and the Oswestry questionnaire. The Oswestry questionnaire has a scale both for back pain and for lower leg pain. VAS measures the intensity of pain subjectively described by the patient, with maximum reproducibility amongst observers. It consists in a graduated scale from 0 cm (extreme "no pain") to 10 cm (extreme "unbearable pain"), in which the patient establishes the point on the scale that best describes the intensity of the pain. It is universally used and relates well to descriptive scales, with good sensitivity and reliability

    1 year

Secondary Outcomes (3)

  • Disability

    1 year

  • Flexibility

    1 year

  • Radiculopathy

    1 year

Study Arms (2)

Vojta

OTHER

Vojta therapy consists in activating certain overall and innate locomotion patterns or complexes: reflex creeping and reflex rolling, which provokes the contraction of striated muscle in the entire body in a determined coordination with the central nervous system (CNS). These patterns are triggered from different positions (prone, supine and side lying) and only with certain stimulation. They contain all the locomotion components: automatic postural control, uprighting and phase movements. This therapy allows for the changing from pathological patterns to painless and cheaper patterns. This group received 15 sessions of treatment. Treatment lasted 30 minutes per sesion.

Other: Physiotherapy technique: Vojta Therapy

TENS

ACTIVE COMPARATOR

TENS procedure used at our unit consists in applying a high frequency current (80Hz), which is the most effective way to combat pain, for a phase duration of 60-200 microseconds at a comfortable range. Electrodes are placed on the skin over the sciatic nerve path, the (-) cathode on the most painful area as it is the most stimulating and the (+) another is placed distal. This group received 15 sessions of treatment. Treatment lasted 30 minutes per sesion.

Other: Physiotherapy technique: TENS

Interventions

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with acute, sub-acute or chronic lumbosciatic by a rehabilitation doctor were referred by said doctor to the Physiotherapy Unit, as candidates for either of the therapeutical procedures.

You may not qualify if:

  • Patients with lumbosciatic resulting from a specific pathology (infection, metastasis, neoplasia, osteoporosis, fracture or inflammatory arthropathy).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lidia Juarez

    SESCAM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The patients were recruited as follows: the rehabilitation doctor evaluated and diagnosed the patient and referred them to the Physiotherapy Unit (PTU) with a prescription for "TENS or Vojta" treatment. It was at the PTU of the health centre where the patient was informed of the possibility of taking part in the study. Patients who agree were allocated alternately in order of arrival to the PTU, in such a way that half of the sample was treated using TENS and the other half with Vojta therapy .
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist and clinical profesor

Study Record Dates

First Submitted

January 16, 2017

First Posted

January 27, 2017

Study Start

January 1, 2011

Primary Completion

June 1, 2011

Study Completion

December 1, 2011

Last Updated

February 1, 2017

Record last verified: 2017-01