- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00978094
Validation of a Novel Sham Cervical Spinal Manipulation Procedure
Validation of a Novel Sham Cervical Spinal Manipulation Procedure.
Primary hypotheses:
Ho1: In chronic neck pain patients, randomly treated with either a "sham" or "real" cervical manipulation procedure, the probability of perceiving a Real Manipulation Procedure is equal to the probability of obtaining a Real Manipulation Procedure, AND, Ho2: Spinal tenderness will remain unchanged following the treatment procedure for both groups.
Secondary (null) hypotheses:
- Neck pain, cervical ranges of motion and paraspinal EMG responses to pressure pain will remain unchanged in both groups;
- there will be no differences between groups with respect to 2a) neck joint cavitations and 2b) forces across the cervical spine measured during the manoeuvres.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
- Develop a randomized controlled clinical trial design to optimize the testing of the effects of a sham vs real cervical manipulation.
- Use novel modifications of both a sham a real manipulation to create "procedures" designed to optimize group equivalence in the RCT design. Then, evaluate the accuracy of 'patient post-treatment perception of treatment type' versus actual administered treatment (primary outcome #1).
- Quantitatively evaluate group differences in local soft-tissue tenderness by algometry (primary outcome #2), as well as changes in self-reported neck pain, ranges of motion, myoelectric responses in selected neck muscles and forces imparted during the procedures.
- Evaluate the occurrence of neck joint cavitation during the manoeuvres comprising these procedures.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studieorter
-
-
Ontario
-
Toronto, Ontario, Kanada, M2H 3J1
- Canadian Memorial Chiropractic College
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- 21-55 years old with chronic neck pain, Males/Females
- Between 30-60 NRS 101 Scale
- ≥ 4 weeks mechanical neck pain
Exclusion Criteria:
- Cervical Spine Surgery
- Medically uncontrolled High Blood Pressure
- Past History of Stroke
- Upper Respiratory Infection within 4 weeks
- Current Symptoms of Dizziness
- Tinnitus, Blurred Vision, Vertigo, Sensory Motor Disturbance
- Current use of anticoagulant therapy
- Connective Tissue Disorder
- Primary Fibromyalgia or myofascial pain
- Metabolic/Neoplastic Bone Disease
Studieplan
Hur är studien utformad?
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
The perception by subjects as to whether they received a real treatment (YES/NO)
Tidsram: 10 mins
|
10 mins
|
Change scores of the pressure algometry
Tidsram: 10 mins
|
10 mins
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Current Neck Pain, Ranges of Motion, MES Response will be analysed by comparing baseline, 15-and 120-minute score
Tidsram: approximately 1 hours +
|
approximately 1 hours +
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Howard Vernon, BA, DC, PhD, FCCS, FCCRS, CMCC
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 072155
- 1R21AT004396-01A1 (U.S.S. NIH-anslag/kontrakt)
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