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Manual Therapy and Exercise in Low Back Pain

Effects of a Procedure Programme in Patients With Non-specific Low Back Pain. Comparative Intervention Based on Therapeutic Exercise, Therapeutic Exercise With Kinesio Tape and Manual Therapy Prior to the Therapeutic Exercise

Non-specific low back pain is one of the main causes of disability for health care worldwide. The effectiveness of therapeutic exercise, of kinesio tape and of manual therapy in the treatment of low back pain is evaluated, but not a comparison of these techniques. Moreover, can these techniques be combined?

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Non-specific low back pain is one of the main causes of disability for health care worldwide. Nowadays, the mostly used technique to research low back muscular activity is electromyography.

Among the published studies, the effectiveness of therapeutic exercise, of kinesio tape and of manual therapy in the treatment of low back pain is evaluated, but not a comparison of these techniques.

The main objective that is aimed by this thesis, is the evaluation of muscular activation in the reduction of non-specific low back pain through a 12 weeks procedure programme, which includes therapeutic exercise combined with other treatment techniques, and assessing the psycho-social characteristics of pain.

This study's population will be composed by at least 16 individuals per group, both male and female, with ages among 20 and 80.

Participants will be randomly and blindly divided in three groups of intervention. The three groups will be: the experimental group or EXP Group (all participants subject to therapeutic exercise), the experimental group, which will also be subject to manual therapy (MT Group) and finally, the experimental group, which will also be subject to kinesio tape work (KT Group).

Tipo di studio

Interventistico

Iscrizione (Effettivo)

50

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

      • Valencia, Spagna
        • FundaciónUcv

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 20 anni a 50 anni (Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Patients diagnosed with low back pain.
  • Patients who are in Stage 1 of the Oswestry scale.
  • Not receiving pharmacological treatment such as anti-inflammatories or corticosteroids
  • Be able to understand the exercises and spanish language.

Exclusion Criteria:

  • Having any back surgery.
  • Be taking any medication at the time of the study.
  • Have a pathology in which exercise is contraindicated (spondylolisthesis, spondylolysis, spondyloarthrosis).
  • Be in a state of gestation or if there is the possibility of being.
  • Present or have presented some oncological process.

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 parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Experimental Group (EXP group)
The experimental group (EXP Group) is going to follow a programme of stabilisation through specific therapeutic exercises of the lumbopelvic centre. Two weekly sessions will be programmed for 12 weeks, making a total of 24 sessions. Each sesión will have a duration of 60 minutes, the first 5 minutes for a warm-up and the last 10 for a cool-down phase of active stretching. All patients will start learning how to activate the abdominal muscles in the first training session. The exercise progression will be adapted according to the capacity of each patient, considering their pain levels. The exercices will be made in 1 to 3 series of among 8 and 15 repetitions and the isometric contractions for 5 to 10 seconds. The rests between series will be of 30 seconds, and between exercies of 2-3 minutes.
All patients will start learning how to activate the abdominal muscles in the first training session. The exercise progression will be adapted according to the capacity of each patient, considering their pain levels. The exercises will be made in 1 to 3 series of among 8 and 15 repetitions and the isometric contractions for 5 to 10 seconds. The rests between series will be of 30 seconds, and between exercises of 2-3 minutes.
Altri nomi:
  • manipolazione muscoloscheletrica
  • kinesiotaping
Comparatore attivo: Experimental Group and Manual Therapy (MT Group)
Additionally to the core exercises previously exposed in Group EXP, Group MT will lay on the stretcher first, where the physiotherapist will work on a manual therapy thrust. The patient will receive an impulse technique in lateral decubitus position, with high velocity and low range on both sides.
All patients will start learning how to activate the abdominal muscles in the first training session. The exercise progression will be adapted according to the capacity of each patient, considering their pain levels. The exercises will be made in 1 to 3 series of among 8 and 15 repetitions and the isometric contractions for 5 to 10 seconds. The rests between series will be of 30 seconds, and between exercises of 2-3 minutes.
Altri nomi:
  • manipolazione muscoloscheletrica
  • kinesiotaping
Comparatore attivo: Experimental Group and Kinesio Tape (KT Group)
The experimental group plus kinesio tape (KT Group) will go previously through physiotherapy, where a kinesio tape band will be applied (kinesio tape "Nondolens" 5cm x 5cm black color), in Y technique, by applying the KT base in neutral position of the lumbar spine without any tension on the tape.
All patients will start learning how to activate the abdominal muscles in the first training session. The exercise progression will be adapted according to the capacity of each patient, considering their pain levels. The exercises will be made in 1 to 3 series of among 8 and 15 repetitions and the isometric contractions for 5 to 10 seconds. The rests between series will be of 30 seconds, and between exercises of 2-3 minutes.
Altri nomi:
  • manipolazione muscoloscheletrica
  • kinesiotaping

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Oswestry
Lasso di tempo: (12 weeks)
The Oswestry (ODI) test will be made to all participants at three months. The results of this scale will provide the necessary information to know the degree of symptomatology of the patient and will therefore help in the planification and procedure to the patient. That is why, it has been established that all participants in Stage 1 of the test are subsidiaries to make all the treatment modes of the study (manual therapy and exercise). This way, we are able to rise the homogeneity that imposes a diagnostic label such as the chronic low back pain.
(12 weeks)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Kinesiophobia (TKS)
Lasso di tempo: (12 weeks)

The mostly used questionnaire to evaluate kinesiophobia is the TKS (Tampa Kinesiophobia Scale) questionnaire, which we will use to measure which is the fear to movement of patients of low back pain. This scale includes work related lesions, lesions due to repetitive effort, relapses and the avoidance-fear. The questionnaire is composed of 17 items in which there is a differentiation between the negative an positive elements.

This questionnaire will be filled in based on a Likert scale which ranges between 0 and 5, being 0 never and 5 always. The total punctuation ranges between 17 and 68, the higher the rate, the higher the degree of kinesiophobia.

(12 weeks)
Catastrophism (PCS)
Lasso di tempo: (12 weeks)
To quantify the degree of catastrophism in the present study, the validated spanish version will be used as the pain catastrophism scale (PCS). The PCS is a 13-item self-report scale of 13 items, that presents same factor structure composed of the factors of rumination, despair and magnification. For each of these factors, it is given a value of 0 (without agreement) to 4 (always), so that at the end the examiner obtains a score between 0 and 52. Low scores indicate a low level of catastrophism and high values show high levels of catastrophism.
(12 weeks)
Self-efficacy: questionnaire
Lasso di tempo: (12 weeks)
To assess self-efficacy, it will be used the Chronic Pain Self-Efficacy Questionnaire, which assesses a person's belief in their ability to perform a specific behavior. It consists of 19 items, a Likert-type scale and a response range of 0 to 10, where 0 is equivalent to feeling totally incapable, 5 moderately incapable and 10 fully capable. The result determines that the higher the score, the greater the degree of self-efficacy.
(12 weeks)
Visual analog scale (VAS)
Lasso di tempo: (12 weeks)
The VAS from 0 to 100, the scale considered to be the most representative, with the VAS being the best option due to its easy understanding and handling. This scale constitutes an effective tool to subjectively quantify this range, more discriminating than the scale that establishes its values from 0 to 10. This way, 0 will be considered as non-existent pain reflected by the individual and 10 as the worst pain imaginable by the patient.
(12 weeks)
Pressure algometry
Lasso di tempo: (12 weeks)
Pressure algometry is considered a useful method to calculate the degree of sensitization of deep tissues. It will be carried out using an algometer, which in this study will consist of a manometer attached to a cylindrical rubber tip. The manometer measures the pressure applied through the rubber and the patient should signal when this pressure starts being painful. This way, it will be established the pressure pain threshold (PPT). Algometry is a widely studied and validated technique to quantify sensitivity in the diagnosis of symptomatic points and myofascial trigger points. The reliability of pressure algometry is relatively high, presenting coefficients of 0.9 and 0.95.
(12 weeks)
Electromyography
Lasso di tempo: (12 weeks)

to obtain an objective measure of the muscle activation, surface electromyography will be used to evaluate the main core muscles - basically the transverse abdomen.

The electromyograph to be used will be the FREEEMG model of the brand BTS Bioengineering. It is a wireless electromyograph with probes attached to the prefilled electrodes, which collect the information. No additional hardware is required, as the same software processes the information taken. The data resolution is 16 bit and the acquisition frequency of 1 kHz.

(12 weeks)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Direttore dello studio: Juan Vicente Mampel, Phd, Fundación Universidad Católica de Valencia San Vicente Mártir

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

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 (Effettivo)

1 marzo 2021

Completamento primario (Effettivo)

23 dicembre 2021

Completamento dello studio (Effettivo)

23 dicembre 2021

Date di iscrizione allo studio

Primo inviato

19 ottobre 2020

Primo inviato che soddisfa i criteri di controllo qualità

9 giugno 2021

Primo Inserito (Effettivo)

14 giugno 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

28 gennaio 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 gennaio 2022

Ultimo verificato

1 gennaio 2022

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • UCV/2019-2020/138

Piano per i dati dei singoli partecipanti (IPD)

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

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

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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