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Osteopathic Treatment for Chronic Low Back Pain (OTCLBP)

5 settembre 2018 aggiornato da: Rubens Alexandre da Silva Jr, Universidade Norte do Paraná

Comparison Between Two Osteopathic Techniques for Chronic Low Back Pain Treatment: a Randomized Crossover Trial.

The relevance of this study is to determine the efficacy of two osteopathic techniques - Thrust Technique and Muscle Energy Technique (MET) - in improving of neuromuscular component of the trunk and clinical symptoms in adult workers with Chronic Low Back Pain (CLBP). Few studies have investigated and compared the physiological responses of these techniques quantitatively, and no published study has compared their effects in low back pain subjects in terms of symptoms, postural balance and muscle activation. The main outcomes will be computed by electromyography measurement so that to assess the trunk neuromuscular activation pattern as well as by force platform parameters for determining of postural control. Clinical symptoms such as pain intensity, perception of disability and fear and avoidance will also be computed.

This is the first study to compare these two osteopathic techniques using the main biological outcomes related to trunk neuromuscular function.

Panoramica dello studio

Descrizione dettagliata

The purpose of this study is to assess the efficacy of two osteopathic techniques (Thrust and MET) on CLBP adult workers treatment.

A total of 15 male participants with chronic low back pain, volunteers, active workers aged from 35 to 55 years (in aging process) will be recruited by convenience from the community local. All participants will sign an informed consent form approved by the North of Parana University Ethics Committee for Research on Human Subjects. The intervention will follow the CONSORT recommendations for randomized controlled trials. All baseline testing and evaluation will be performed by a blinded evaluator to the study intervention. The sample will be randomized in two groups from crossover design: Group #1), which will receive the Thrust technique applied at the level of dysfunction; and Group #2, which will receive the Muscle Energy Technique, also applied at the level of dysfunction. The allocation will be printed in cards by sequentially numbered in opaque envelopes.

The treatment (intervention) will occur in 2 phases of 3 weeks each one. The participants will receive only one of techniques in each phase, and after one rest week (washout) they will receive the other technique (crossover), totaling 7 weeks. In this study, both techniques will be applied at the lumbar vertebral level that present the dysfunction which will be diagnosed in the specific evaluation, performed by two specialized physiotherapists in osteopathy. Before and after the manipulation (with Thrust or MET) all participants will be evaluated in 2 tasks - bipedal without load and bipedal with load (10% of body mass) - on the force platform. Parallel to the tasks, the recording of the measurements of EMG surface will be computed to determine the pattern of the trunk neuromuscular activation in amplitude of the RMS signal as well as muscle fatigue through the median frequency parameters.

Before performing the tasks on the force platform, a maximum voluntary isometric contraction will be performed for the back (paravertebral) and abdominal (rectus) muscles in order to normalize the signal EMG for determining of the level muscular activity during each task (with or without load). After the intervention, the immediate and final revaluations will include all the used measures in the initial evaluation, such as muscle activation of trunk (EMG), balance (force platform), and clinical symptoms of pain (Visual Analogue Scale and McGill Short Questionnaire), psychosomatic factors (Fear and Avoidance Believe Questionnaire) and disability (Roland Morris Questionnaire).

For the analysis a two-way ANOVA will be used for each dependent variable to compare the two groups (G1 versus G2) in both situations (pre and post-immediate, and after 15 days) in the clinical measurements, postural balance and EMG. The size effect also will be computed to determine the rate of the changes observed.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

10

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Parana
      • Londrina, Parana, Brasile, 86041-120
        • Laboratory of Functional Assessment and Human Motor Performance (LAFUP)

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 35 anni a 55 anni (Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Maschio

Descrizione

Inclusion Criteria:

  • Chronic low back pain at least for three months.
  • Low back pain of unknown mechanical origin without irradiation to the lower limbs.
  • Workers with chronic low back pain at least three months.
  • Do not be participating in rehabilitation programs.
  • Do not have practiced regular physical activity in the past 3 months.

Exclusion Criteria:

  • Manual therapy treatment in the past 90 days.
  • Discal herniation diagnosis.
  • Lumbar radiculopathy and / or nerve root compression.
  • Lumbar stenosis.
  • Lumbar surgery.
  • Nerve root entrapment.
  • Neurological and endocrine.
  • Osteoporosis.
  • Rheumatoid arthritis.
  • Spinal osteomyelitis.
  • Spondylolysis.
  • Spondylolisthesis.
  • Tumors.
  • Vertebral fracture.
  • No current sports or treatment in Physiotherapy, Pilates Method or Manual Therapy.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: G1 - Thrust manipulation
G1 - Thrust manipulation is an osteopathic technique. The Group 1 (G1) will receive the Thrust technique applied at the level of dysfunction. Subject in lateral decubitus, with one lower limb extended and the other in flexion, to the level of the targeted vertebra; upper trunk rotated back until the same vertebra; at the end of the range of movement will be applied the high speed and low amplitude impulse (Thrust).
Osteopathic manipulation with Thrust technique. The Group 1 (G1) will receive the Thrust technique applied at the level of dysfunction. Subject in lateral decubitus, with one lower limb extended and the other in flexion, to the level of the targeted vertebra; upper trunk rotated back until the same vertebra; at the end of the range of movement will be applied the high speed and low amplitude impulse (Thrust).
Comparatore attivo: G2 - Muscle Energy
G2 - Muscle Energy is a manual therapy technique based in muscular contraction and stretching. The Group 2 (G2) will receive the Muscle Energy technique applied at the level of dysfunction. Subject in lateral decubitus, with the upper and lower trunk flexed until the target vertebra, and upper trunk rotated back to the level of the same vertebra; lumbar in lateral flexion (using the subject's feet) until the target vertebra. Following the command the subject will perform an isometric contraction of 3-5 seconds against the therapist's hand (pushing the hand towards the floor), repeated 3 times.
Osteopathic manipulation with Muscle Energy technique. The Group 2 (G2) will receive the Muscle Energy technique applied at the level of dysfunction. Subject in lateral decubitus, with the upper and lower trunk flexed until the target vertebra, and upper trunk rotated back to the level of the same vertebra; lumbar in lateral flexion (using the subject's feet) until the target vertebra. Following the command the subject will perform an isometric contraction of 3-5 seconds against the therapist's hand (pushing the hand towards the floor), repeated 3 times.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Electromyography measurement - Root Mean Square (RMS)
Lasso di tempo: Change from baseline muscular activation at 3 weeks, in both phases
EMG estimates, Root Mean Square: RMS (in microvolts unit: uV) will be computed to evaluate the back and abdominal activation during the functional task.
Change from baseline muscular activation at 3 weeks, in both phases

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Electromyography measurement - Median Frequency (MF)
Lasso di tempo: Change from baseline muscular activation at 3 weeks, in both phases
EMG estimates, Median Frequency: MF (in Hertz: Hz) will be computed to evaluate the back and abdominal activation during the functional task.
Change from baseline muscular activation at 3 weeks, in both phases
Force platform measurement
Lasso di tempo: Change from baseline muscular activation at 3 weeks, in both phases
Force platform measurement during balance performance using centre of pressure measures to assess balance performance.
Change from baseline muscular activation at 3 weeks, in both phases

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Visual Analogic Scale
Lasso di tempo: Change from baseline muscular activation at 3 weeks, in both phases
Pain intensity measurement using Visual Analogue Scale (score of 0 to 10 intensity; being 10 of poor score for VAS).
Change from baseline muscular activation at 3 weeks, in both phases
Short Version of Pain Questionnaire McGill
Lasso di tempo: Change from baseline muscular activation at 3 weeks, in both phases
Pain measurement using Short Version of Pain Questionnaire McGill (score 0 to 78; while higher score is determined by poor condition related to pain).
Change from baseline muscular activation at 3 weeks, in both phases
Disability questionnaire
Lasso di tempo: Change from baseline muscular activation at 3 weeks, in both phases
Disability measurement using Roland Morris questionnaire.
Change from baseline muscular activation at 3 weeks, in both phases
Fear-avoidance questionnaire
Lasso di tempo: Change from baseline muscular activation at 3 weeks, in both phases
Fear-avoidance model measurement using Waddell questionnaire related to work and physical activity.
Change from baseline muscular activation at 3 weeks, in both phases

Collaboratori e investigatori

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Pubblicazioni e link utili

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Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 dicembre 2016

Completamento primario (Effettivo)

1 marzo 2017

Completamento dello studio (Effettivo)

1 aprile 2017

Date di iscrizione allo studio

Primo inviato

25 novembre 2016

Primo inviato che soddisfa i criteri di controllo qualità

1 dicembre 2016

Primo Inserito (Stima)

6 dicembre 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

7 settembre 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 settembre 2018

Ultimo verificato

1 settembre 2018

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • rubens@unopar.br

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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