Proprioception Clinical Trial
Official title:
Does Spinal Manipulation Therapy Impact Lumbar Proprioception? A Double-blind Randomized Controlled Trial Examining the Influence of Spinal Manipulative Therapy (SMT) Versus a Sham and Non-sham Control Intervention on Proprioceptive Function
Spinal manipulation therapy (SMT) has long been a component of manual therapy and physical rehabilitation programs, especially as a modality for pain relief. However, the underlying physiological mechanisms for manipulation-related pain relief and functional improvement remain largely unexplored. To promote targeted treatments for musculoskeletal conditions and to better identify the indication and scope of SMT, its mechanisms must be better understood.
Status | Recruiting |
Enrollment | 310 |
Est. completion date | December 1, 2024 |
Est. primary completion date | April 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion criteria chronic LBP patients: - Aged between 18 and 50 - History of chronic (>3months) LBP clinically not attributable to "red flags" (i.e., infection, trauma, fractures, inflammatory spondylarthropathies). - Source of LBP clinically at the L4/5 or L5/S1 segment - No history of vestibular disorders - Body mass index (BMI) > 16 kg/m2 The presence of any one of the following exclusion criteria will lead to exclusion of the participant: Exclusion criteria chronic LBP patients: - Excessive consumption of alcohol or consumption of other drugs or analgesics within the last 24 h - Pregnancy or breastfeeding - Prior foot/ankle or spine surgery - chiropractic (or other manual) treatment in the last 2 weeks - facet joint, epidural or periradicular injections in the last 6 months - any contraindication to spinal manipulative interventions (or are deemed unable to tolerate SMT to both body sides) - Any neuromuscular diseases that might affect gait and posture and injuries of the motor system with permanent deformities - Body mass index (BMI) > 30 kg/m2 Inclusion criteria healthy controls: - Aged between 18 and 50 - No episode of musculoskeletal pain in the past 3 months - No history of chronic pain (longer than 3 months) - No history of vestibular disorders - Body mass index (BMI) > 16 kg/m2 The presence of any one of the following exclusion criteria will lead to exclusion of the participant: Exclusion criteria healthy controls: - Excessive consumption of alcohol or consumption of other drugs or analgesics within the last 24 h - Pregnancy or breastfeeding - Prior foot/ankle or spine surgery - chiropractic (or other manual) treatment in the last 2 weeks - Any neuromuscular diseases that might affect gait and posture and injuries of the motor system with permanent deformities Body mass index (BMI) > 30 kg/m2 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Department of Chiropractic Medicine, University of Zurich | Zurich |
Lead Sponsor | Collaborator |
---|---|
Balgrist University Hospital |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Postural sway (mm) | Postural sway will be measured using a force plate system | 15 minutes | |
Primary | Proprioceptive weighting ratio (value between 0 and 1) | The proprioceptive weighting ration will be calculated based on postural sway during vibrotactile stimulation on the ankle and paraspinal muscles | 15 minutes | |
Secondary | Tampa-Scale for Kinesiophobia for the general population (TSK-G) questionnaire score | The original 17-item version of the TSK-G creates scores ranging between 17 and 68 higher scores indicating more fear of movement | 10 minutes | |
Secondary | Belief score influence of manipulation on balance control | Subjects will be asked to rate how much they belief a manual intervention will affect their balance control (0 = no influence, 10 = maximal influence) | 1 minute | |
Secondary | PainDETECT questionnaire | painDETECT is a nine-item questionnaire that consists of seven sensory symptom items for pain that are graded from 0= never to 5= strongly, one temporal item on pain-course pattern graded -1 to +1, and one spatial item on pain radiation graded 0 for no radiation or +2 for radiating pain | 5 minutes | |
Secondary | Pain intensity on numeric rating scale (NRS pain, 0-10) | Subjects will be ask to rate their current pain intensity on a scale ranging from 0 (no pain) to 10 (worst pain imaginable) | 5 seconds |
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