A Comparison of Two Thoracic Manipulation Techniques to Improve Neck Pain
9. März 2018 aktualisiert von: 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.
Studienübersicht
Status
Suspendiert
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Voraussichtlich)
76
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Arizona
-
Flagstaff, Arizona, Vereinigte Staaten, 86011
- Northern Arizona University
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
20 Jahre bis 50 Jahre (Erwachsene)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver 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.
|
|
Aktiver 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Numerical Pain Rating Scale (NPRS)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: Change in NDI at different time points (Baseline (Week 0) during initial visit before 1st treatment, Week 1, Week 2, and Week 3)
|
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
|
Change in NDI at different time points (Baseline (Week 0) during initial visit before 1st treatment, Week 1, Week 2, and Week 3)
|
|
Shortened version of the Disabilities of the Arm, Shoulder, and Hand questionnaire (Quick DASH)
Zeitfenster: 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)
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: John Heick, PT, PhD, DPT, Northern Arizona University
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. November 2016
Primärer Abschluss (Voraussichtlich)
1. November 2018
Studienabschluss (Voraussichtlich)
1. November 2018
Studienanmeldedaten
Zuerst eingereicht
17. November 2016
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
22. November 2016
Zuerst gepostet (Schätzen)
23. November 2016
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
13. März 2018
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
9. März 2018
Zuletzt verifiziert
1. März 2018
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 962801-1
Plan für individuelle Teilnehmerdaten (IPD)
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