- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01753271
Subacute Effects of Spinal Mobilization to Treat Subacromial Impingement
Subacute Effects of Cervicothoracic Spinal Manipulation in Addition to Shoulder Manual Therapy Plus Exercise Intervention in Individuals With Subacromial Impingement Syndrome: a Randomized, Controlled Clinical Trial Pilot Study
Specific Aims and Hypotheses Aims To investigate the incremental benefits of cervicothoracic spinal manipulation in addition to shoulder mobilization and exercise for improving range of motion, pain, physical function and fear avoidance beliefs in patients with subacromial shoulder impingement.
Hypotheses It is hypothesized that those subjects who receive spinal manipulation in addition to shoulder mobilization and exercise will achieve greater improvements in range of motion, pain, function and fear avoidance beliefs at two weeks following treatment conclusion, at 4 weeks following treatment conclusion, and at discharge when compared to the subjects who did not receive the spinal manipulation.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Illinois
-
Chicago, Illinois, Forenede Stater, 60612
- University of Illinois at Chicago
-
-
Tennessee
-
Elizabethton, Tennessee, Forenede Stater, 37643
- Physical Therapy Services
-
Johnson City, Tennessee, Forenede Stater, 37604
- East Tennessee State University
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- To be eligible, participants must meet the clinical prediction rule for unilateral subacromial shoulder impingement including: a) positive Hawkins-Kennedy impingement sign, b) positive painful arc sign, and c) weakness in external rotation with the arm at the side
Exclusion Criteria:
- Individuals with contraindications to treatment with mobilization and manipulation (Appendix A) will be excluded
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Thoracic Mobilization
thoracic mobilization in addition to shoulder mobilization plus exercise
|
|
|
Aktiv komparator: exercise only
shoulder mobilization plus exercise alone
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Shoulder Pain and Disability Index Change over time
Tidsramme: 2 weeks, 4 weeks, discharge
|
Patients will be followed for the duration of their physical therapy treatment.
An average of 12 visits over 6 weeks
|
2 weeks, 4 weeks, discharge
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Numeric Pain Rating Scale change over time
Tidsramme: 2 weeks, 4 weeks, discharge
|
Patients will be followed for the duration of their physical therapy treatment.
An average of 12 visits over 6 weeks
|
2 weeks, 4 weeks, discharge
|
|
Fear Avoidance Beliefs Questionnaire change over time
Tidsramme: 2 weeks, 4 weeks, discharge
|
Patients will be followed for the duration of their physical therapy treatment.
An average of 12 visits over 6 weeks
|
2 weeks, 4 weeks, discharge
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Shoulder range of motion change over time
Tidsramme: 2 weeks, 4 weeks, discharge
|
Patients will be followed for the duration of their physical therapy treatment.
An average of 12 visits over 6 weeks
|
2 weeks, 4 weeks, discharge
|
|
test of resistance change over time - number of repetitions performed
Tidsramme: 2 weeks, 4 weeks, discharge
|
The test is performed by asking the patient to hold the shoulder at 90 degrees of shoulder flexion and follow a 20cm wide spiral using their affected arm. The patient is asked to complete as many spiral movements as possible until stopped secondary to pain. The maximum number of repetitions to be performed is 20. Patients will be followed for the duration of their physical therapy treatment. An average of 12 visits over 6 weeks |
2 weeks, 4 weeks, discharge
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Alexis A Wright, Phd, High Point University
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 201208-122
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
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-
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