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Effectiveness Comparison of Thoracic Thrust Manipulation in People With Neck or Low Back Pain

27. oktober 2021 oppdatert av: Alexander Achalandabaso, University of Jaén

Comparison of the Effectiveness of the Thoracic Thrust Manipulation in People With Neck or Low Back Pain

Objective:

To compare the effectiveness of thoracic thrust manipulation, together with massages techniques and stretching, between people with neck pain versus people with low back pain.

Methods:

The research will be performed from August 2021 to October 2021 at the University of Alcala de Henares. (Madrid)

A minimum of forty-six (46) volunteers will participate in this research, and they will be divided in two groups of twenty-three (23). One group will be formed by candidates suffering from neck pain (group A) and the other one by candidate with low back pain (group B).

Both groups will receive the same treatment and specific stretching exercises as applicable in accordance to the pain area, e.g.: group A will get the massage and the stretching exercises more suitable for the neck pain and group B the same but for the low back pain. Nevertheless both groups will receive the same technical thrust manipulation in thoracic area.

All these treatments will be applied of the volunteers at the University of Alcalá.

The treatment includes the following activities:

  1. Twenty (20) minutes massage in the pain area, as applicable.
  2. Technical thrust manipulation in thoracic area.
  3. Ten (10) minutes stretching in accordance to the pain area treated. The stretching shall be repeated twice a week by each volunteer.

A total of six (6) sessions will be carried out during six (6) weeks, one session per week.

Pain, disability, kinesiophobia, HRQoL will be assessed as follow:

  1. Before first session. (In this evaluation will be also analyzed demographic variables i.e.: height, weight, age, gender, academic level, smoker/no smoker)
  2. Between third and fourth session.
  3. After sixth session.
  4. Four weeks after sixth session.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

60

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Spania
    • Madrid
      • Alcalá De Henares, Madrid, Spania, 28801
        • Alicia Masip

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Age between 18 and 65 years
  • Non-specific neck/low back pain for the last three (3) months before the first session.

Exclusion Criteria:

  • Previous surgery in the areas covered by this research (neck and/or low back)
  • Red flags: Cancer or tumor, fracture...
  • Scoliosis or osteoporosis
  • Neck or low back pain with radiculopathy symptoms
  • Central nervous system involvement
  • Fear to manipulation
  • Neck pain associated with whiplash injuries on the last six (6) months
  • Pregnant women
  • Not understand, write and speak Spanish fluently

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: A group: neck pain
Annen: Massage and stretching on neck area and thoracic thrust manipulation
  1. Twenty (20) minutes massage in the neck area. The volunteer will be in prone position during the massage.
  2. Technical thrust manipulation in thoracic area. For this technique the volunteer will be in supine position with their arms folded on the chest (making a "V"). The therapist will locate one hand on the spinous processes to be treated, and the other one on the arms of the patient to make easier the manipulation.
  3. Ten (10) minutes specific stretching for the neck area. These stretching exercises shall be repeated twice a week by each volunteer. Stretching will be made on the trapezius superior, musculus levator scapulae and sternocleidomastoideus holding the position thirty (30) seconds. Each muscle stretch shall be repeated three times.
Eksperimentell: B group: low back pain
Annen: Massage and stretching on low back area and thoracic thrust manipulation
  1. Twenty (20) minutes massage in the low back area. The volunteer will be in prone position during the massage.
  2. Technical thrust manipulation in thoracic area. For this technique the volunteer will be in supine position with their arms folded on the chest (making a "V"). The therapist will locate one hand on the spinous processes to be treated, and the other one on the arms of the patient to make easier the manipulation.
  3. Ten (10) minutes specific stretching for the low back area. These stretching exercises shall be repeated twice a week by each volunteer. Stretching activities will be: cat-cow pose, lower back stretches and knee twist holding the position thirty (30) seconds. Each muscle stretch shall be repeated three times.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Neck and Low Back Pain
Tidsramme: Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement
using a Visual Analogue Scale (VAS) from 0 to 10
Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Neck Pain related disability
Tidsramme: Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement
Using the Neck Disability Index (NID) Questionnaire
Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement
Change in Health related quality of life (HRQoL)
Tidsramme: Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement
Using the SF-12 Quality of Life Questionnaire
Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement
Change in kinesiophobia
Tidsramme: Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement
Using the fear avoidance beliefs (FAB) questionnaire
Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement
Change in Low Back Pain related disability
Tidsramme: Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement
Using the Oswestry Disability Index (ODI) Questionnaire
Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Jaén

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

4. august 2021

Primær fullføring (Faktiske)

29. september 2021

Studiet fullført (Faktiske)

27. oktober 2021

Datoer for studieregistrering

Først innsendt

7. juli 2021

Først innsendt som oppfylte QC-kriteriene

28. juli 2021

Først lagt ut (Faktiske)

29. juli 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. oktober 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. oktober 2021

Sist bekreftet

1. oktober 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • Alcalá

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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