- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04981574
Effectiveness Comparison of Thoracic Thrust Manipulation in People With Neck or Low Back Pain
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:
- Twenty (20) minutes massage in the pain area, as applicable.
- Technical thrust manipulation in thoracic area.
- 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:
- Before first session. (In this evaluation will be also analyzed demographic variables i.e.: height, weight, age, gender, academic level, smoker/no smoker)
- Between third and fourth session.
- After sixth session.
- Four weeks after sixth session.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Madrid
-
Alcalá De Henares, Madrid, Spanien, 28801
- Alicia Masip
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: A group: neck pain
|
|
Eksperimentel: B group: low back pain
|
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Alcalá
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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