Clinical trial NCT03034681: Lumbosciatic Syndrome: Vojta Therapy vs. TENS
Official title: Lumbosciatic Syndrome: a Quasi-experimental Study on the Effectiveness of the Vojta Therapy vs. Transcutaneous Electrical Nerve Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbosciatic Syndrome
Pain
Functional Limitation
Vojta Therapy
Transcutaneous Electrical Nerve Stimulation
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
Collaborators: name: Research Support Unit at Hospital General Mancha Centro
First posted: 2017-01-27
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 .
Primary purpose: TREATMENT

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.

Detailed description: Lumbago/lumbosciatic (with or without radicular implication) is the second most frequent cause of primary medical care and the highest cause of disability in the entire world. This pathology is normally slight to moderate in the majority of cases, meaning that the therapeutical treatment tends to be conservative and thus the interest in increasing the range of non-invasive therapeutic possibilities is available.

Reflex Locomotion or Vojta Therapy began being used in 1959 for the rehabilitation of children with motor alterations and infants with a risk of cerebral palsy. Years later it was successfully applied to adults with neurological and motor alteration problems. Until now, there have been no studies on its use in pathologies of the spine and, in particular at a lumbar level.

A pre-/ post-intervention examination will be performed to obtain an objective clinical analysis (measurements of pain, disability, functionality and joint movement), by means of simple questionnaires completed by the patient (VAS scale, Oswestry and Roland-Morris questionnaires) and exploration techniques (Lasègue manoeuvre, Schöber test, fingertips to floor test and walking on heels and toes).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Pain
timeFrame: 1 year
Secondary outcomes:
measure: Disability
timeFrame: 1 year
measure: Flexibility
timeFrame: 1 year
measure: Radiculopathy
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: SESCAM
name: Lidia Juarez
role: PRINCIPAL_INVESTIGATOR
References: