A Comparison of Two Thoracic Manipulation Techniques to Improve Neck Pain
9. marts 2018 opdateret af: Tarang Jain, Northern Arizona University
A Comparison of Two Thoracic Manipulation Techniques to Improve Neck Pain: A Randomized Control Trial
The purpose of this study is to compare the short-term effects of two different thoracic spine thrust manipulation techniques on neck range-of-motion, pain, and self-reported disability in individuals experiencing neck pain.
Studieoversigt
Status
Suspenderet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The study will be conducted at the Musculoskeletal clinical facility in the Dept. of Physical Therapy and Athletic Training, Northern Arizona University, Flagstaff AZ. The investigators aim to test a maximum of 76 participants in this study. A phone screening will determine initial eligibility. If the participant meets the inclusion criteria and is not excluded after the phone screen, an appointment will be scheduled. Final eligibility will be determined in the initial session after the participant completes the outcome measures and is evaluated by a licensed physical therapist.
Participants will be involved in the study over a 4 week period. Each participant will be asked to attend 4 sessions, with one week in between each session as follows: Week 0 = baseline assessment and treatment 1; Week 1= treatment 2; Week 2 = treatment 3; and week 4 = follow-up assessment.
After completion of the baseline assessment, qualified participants will be randomly assigned to either a supine or prone thoracic spine thrust manipulation intervention.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
76
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Arizona
-
Flagstaff, Arizona, Forenede Stater, 86011
- Northern Arizona University
-
-
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
20 år til 50 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Between 20 and 50 years of age (inclusive)
- Primary complaint of neck pain with or without symptoms that spread down into one arm
- Overall rating of neck pain intensity is at least 3/10; the overall rating is the average of the participant's rating of current, least, and worst pain experienced over the previous 24 hours on separate numeric pain rating scales where 0 corresponds to "no pain" and 10 corresponds to "worst possible pain"
- Neck Disability Index (NDI) score > 10 points (measure of self-reported disability with a 0 to 50-point scale where higher scores indicate higher levels of disability)
- Proficient in speaking and reading English to complete outcome questionnaires
Exclusion Criteria:
- Neck pain related to a motor vehicle accident or other trauma within the previous 6 weeks
- Neck pain that spreads down into both arms
- Low back pain or thoracic origin of pain
- Nerve root involvement; defined as the presence of two or more neurological findings (e.g., decreased strength, diminished deep tendon reflex, or decreased sensation) at the same nerve root level
- Diagnosis of cervical spinal stenosis (narrowing of the central canal that contains the spinal cord)
- History of spinal tumors, spinal infection, cervical spine fracture, or previous neck surgery
- Pending legal action related to current episode of neck pain
Contraindications to thoracic spine thrust manipulation
- serious pathologies or conditions (tumor, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis, history of prolonged steroid use)
- hyperreflexia
- unsteadiness during gait
- nystagmus
- loss of visual acuity
- impaired sensation of the face
- altered taste
- the presence of pathological reflexes
- pregnancy or considering pregnancy
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: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Supine thoracic spine manipulation
Supine thoracic spine thrust manipulation (lying face-up on the treatment table) will be given 2 times at 3 treatment sessions (Weeks 0, 1, and 2)
|
The participant will be positioned so that small amplitude quick stretch can be applied to the least mobile area of the thoracic spine that is identified during the spinal segmental mobility testing.
The thoracic spine thrust manipulation will be applied at an appropriate range of motion as identified by the clinician.
|
|
Aktiv komparator: Seated thoracic spine manipulation
Seated thoracic spine thrust manipulation will be given 2 times at 3 treatment sessions (Weeks 0, 1, and 2).
|
The participant will be positioned so that small amplitude quick stretch can be applied to the least mobile area of the thoracic spine that is identified during the spinal segmental mobility testing.
The thoracic spine thrust manipulation will be applied at an appropriate range of motion as identified by the clinician.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Numerical Pain Rating Scale (NPRS)
Tidsramme: Change in NPRS scores at different time points (Baseline (Week 0) during initial visit before 1st treatment, Week 1, Week 2, and Week 3)
|
Each participant's neck pain intensity will be assessed by use of the Numeric Pain Rating Scale (NPRS of 0-10)
|
Change in NPRS scores at different time points (Baseline (Week 0) during initial visit before 1st treatment, Week 1, Week 2, and Week 3)
|
|
Neck Range of Motion
Tidsramme: Change in Neck ROM at different time points (Baseline (Week 0) during initial visit before 1st treatment, Week 1, Week 2, and Week 3)
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Cervical range of motion measured with the Goniometer
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Change in Neck ROM at different time points (Baseline (Week 0) during initial visit before 1st treatment, Week 1, Week 2, and Week 3)
|
|
Neck Disability Index (NDI)
Tidsramme: Change in NDI at different time points (Baseline (Week 0) during initial visit before 1st treatment, Week 1, Week 2, and Week 3)
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The Neck Disability Index (NDI) is a self-reported measure of disability consisting of a 0-50 point scale where higher scores indicate higher levels of disability
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Change in NDI at different time points (Baseline (Week 0) during initial visit before 1st treatment, Week 1, Week 2, and Week 3)
|
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Shortened version of the Disabilities of the Arm, Shoulder, and Hand questionnaire (Quick DASH)
Tidsramme: Change in QuickDASH scores at different time points (Baseline (Week 0) during initial visit before 1st treatment, Week 1, Week 2, and Week 3)
|
The shortened version of the Disabilities of the Arm, Shoulder, and Hand (Quick DASH) questionnaire is a self-report measure of function that can assess how neck pain may be impacting daily activities that require use of the upper limb
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Change in QuickDASH scores at different time points (Baseline (Week 0) during initial visit before 1st treatment, Week 1, Week 2, and Week 3)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: John Heick, PT, PhD, DPT, Northern Arizona University
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. november 2016
Primær færdiggørelse (Forventet)
1. november 2018
Studieafslutning (Forventet)
1. november 2018
Datoer for studieregistrering
Først indsendt
17. november 2016
Først indsendt, der opfyldte QC-kriterier
22. november 2016
Først opslået (Skøn)
23. november 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
13. marts 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. marts 2018
Sidst verificeret
1. marts 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 962801-1
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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