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Manipulative Therapy Techniques to Treat Chronic Low Back Pain

3. oktober 2015 opdateret af: Adelaida María Castro-Sánchez, Universidad de Almeria

Short-term Effect of Manipulative Therapy Techniques in People With Chronic Low Back Pain: A Randomized Controlled Trial.

The purpose of this study is to analyze the effectiveness of a three manipulative therapy techniques in People with Chronic Low Back Pain.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Objective: To analyze the effectiveness of a three manipulative therapy techniques in individuals with chronic non-specific low back pain of mechanical etiology.

Design: Randomized clinical trial. Setting: Almeria, South Spain. Participants: Sixty two with chronic non-specific low back pain will be randomly assigned to an experimental or control group.

Intervention: For 3-week, the experimental group will undergo treatment comprising 3 sessions (1/week) of manipulative therapy techniques in the lumbar and sacral areas, and the control group will receive a functional technique in the lumbar area.

Main Outcome Measures: Oswestry disability index, pain visual analogue scale, Tampa scale for kinesiophobia, Roland-Morris disability questionnaire, McQuade test, quality of life scores and the range of trunk anteflexion motion, which were all assessed before the treatment and immediately after the last treatment session.

The primary outcome measure is the change in the RMDQ score at the end of the 3 weeks study period. A difference of 2.5 point is considered to be the minimum clinically important difference in the RMDQ score. A sample size of 62 patients (31 per group) would enable detection of a 2.5 point difference between groups given 80-90% power, a 5% (two-tailed) significance level, and a conservative standard derivation of 5 points. Key baseline demographic variables and clinical measure scores will be compared between groups by using independent Student t tests for continuous data and chi-square tests for categorical data. Separate 2x2 mixed model ANOVA with repeated measurements for the time factor need to be conducted in order to test between-groups differences in visual analogue scale, McQuade test, range of trunk anteflexion motion, Oswestry disability index, Roland Morris disability questionnaire, Tampa scale for kinesiophobia, and quality of life as the dependent variables, with group (functional technique or three manipulative therapy techniques) as the between subjects variable and time (baseline, post-treatment). A paired t-test will perform to test within-group differences in score changes from pre- to post-treatment. Effect size will test using Cohen's d. p = 0.05 will be considered significant in all tests.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

62

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Spanien
      • Almeria, Spanien, 04120
        • Adelaida María Castro-Sánchez

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

25 år til 55 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Low back pain for ≥ 3 months.
  • Score ≥4 on the Roland Morris disability questionnaire.
  • No undergoing another physical therapy treatment.
  • Inability to achieve lumbar muscle flexion-relaxation in trunk flexion

Exclusion Criteria:

  • Clinical signs of radiculopathy.
  • Presence of lumbar stenosis.
  • Fibromyalgia.
  • Spondylolisthesis.
  • History of spinal surgery.
  • Treatment with corticosteroids in the past two weeks.
  • Disease of the central or peripheral nervous system.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Manipulative Therapy Techniques
Manipulative Therapy Techniques involve three techniques on lumbar and sacral areas. This protocol will be administered one a week for 3 weeks.
Andet: Manipulative Therapy Techniques
  • Global Technical bilateral pelvis: The technique involves inserting a small spine rotation and make a slack in three stages.
  • Indirect technique of lumbar roll in rotation for bilateral L3: to reduce the slack and make the body drop simultaneously, together with a high speed contraction pectoral muscles and triceps, iliac crest leading caudad which produces a rotation of the vertebra underlying joint space opening.
  • Dog-technic on D12: this technique reduces the slack in the abdomen toward the hand in contact with D12. Next, the therapist conducted a thrust in the direction of the reduction.
Aktiv komparator: Functional Technique
Manipulative Therapy Technique involves one technique on lumbar area. This protocol will be administered one a week for 3 weeks.
Andet: Functional Technique
The therapist presses the two anterior superior iliac spines to open the back of the pelvis, this maintained throughout the technique. Then patient is asked to breathe deeply and exhale, sacrum makes a flexion-extension respectively. These movements should be symmetrical and of equal duration in time.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Roland Morris Disability Questionnaire (RMDQ)
Tidsramme: At baseline, 3 weeks and 7 weeks
The Roland Morris disability questionnaire is a self-administered disability measurement scored on a 24-point scale from 0 = no disability to 24 = severe disability.
At baseline, 3 weeks and 7 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Oswestry Disability Index (ODI)
Tidsramme: At baseline, 3 weeks and 7 weeks
The Oswestry disability index evaluates daily life activity limitations in 10 dimensions, each scored on a 6-point scale (0-5 points); the total points scored are expressed as a percentage, used to classify individuals as minimally disabled (0-10%), moderately disabled (20-40%), severely disabled (40-60%), crippled (60-80%), or bedbound (80-100%).
At baseline, 3 weeks and 7 weeks
Visual Analogue Scale (VAS)
Tidsramme: At baseline, 3 weeks and 7 weeks
The visual analogue scale for pain intensity ranged from 0 = no pain to 10 = worst imaginable pain.
At baseline, 3 weeks and 7 weeks
Tampa Scale for Kinesiophobia (TSK)
Tidsramme: At baseline, 3 weeks and 7 weeks
The Tampa Scale for Kinesiophobia comprises 17 items on the fear of movement or recurrent lesion, each scored on a 4-point Likert scale from "completely disagree" to "completely agree".
At baseline, 3 weeks and 7 weeks
Quality of Life
Tidsramme: At baseline, 3 weeks and 7 weeks
SF-36 Health Questionnaire scores range from 0 to 100% and indicate the self-perceived health-related quality of life.
At baseline, 3 weeks and 7 weeks
Isometric Resistance of Abdominal Muscles
Tidsramme: At baseline, 3 weeks and 7 weeks
The McQuade test measures the isometric resistance of abdominal muscles in seconds.
At baseline, 3 weeks and 7 weeks
Lumbar Mobility in Flexion
Tidsramme: At baseline, 3 weeks and 7 weeks
Lumbar mobility in flexion was determined by measuring the distance from the tip of the third finger to the floor with a tape measure.
At baseline, 3 weeks and 7 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Universidad de Almeria

Samarbejdspartnere

Universidad de Granada
Universidad Rey Juan Carlos

Efterforskere

  • Studieleder: Adelaida M Castro-Sánchez, PhD, Universidad de Almeria

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2013

Primær færdiggørelse (Faktiske)

1. oktober 2013

Studieafslutning (Faktiske)

1. november 2013

Datoer for studieregistrering

Først indsendt

20. februar 2013

Først indsendt, der opfyldte QC-kriterier

20. februar 2013

Først opslået (Skøn)

21. februar 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. oktober 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. oktober 2015

Sidst verificeret

1. november 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • UAL-1

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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