Knee Osteoarthritis
Conditions
Keywords
knee osteoarthritis, manual therapy, osteopathy
Brief summary
The purpose of this study is to determine if the use of osteopathic manual therapy can influence the vascular supply to the knee, knee range of motion, balance and knee pain, in a group of subjects with knee osteoarthritis. It is also the objective of this study to determine if there is a difference between the osteopathic evaluation and the combination of an osteopathic evaluation and treatment.
Interventions
OTHEROsteopathic evaluation
evaluation of movement and tissue mobility
OTHEROsteopathic evaluation with treatment
osteopathic evaluation followed by osteopathic manual therapy release of tissues identified as tight or restricted
Sponsors
Nova Scotia Health Authority
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Radiographic-confirmed knee osteoarthritis
Exclusion criteria
* Subjects who are unable to ambulate independently (without an aid) and safely the distance of a city block * Subjects who have an uncontrolled medical condition (e.g. heart (angina) or respiratory condition (asthma)) * Subjects who have a neurological condition (e.g. Parkinson's, Multiple Sclerosis) * Subjects who have both knees affected by osteoarthritis and have had previous surgery to both knees * Subjects who have knee OA in only one knee and that knee has had previous knee surgery * Subjects who have previous vascular surgery to either leg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Resistive Index (RI) | Participants attended one visit; The outcome measure (RI) was before and after an osteopathic session on the same day; The data collection of the 30 subjects took place between Jan to March 2010; each subject had outcomes measured on one day | Ultrasonographic examination provides a non-invasive method to assess blood flow dynamics. The resistive index (RI), calculated from arterial blood flow velocities, reflects vascular resistance. The RI was calculated by dividing the peak systolic velocity (PSV) minus the end-diastolic velocity by the peak systolic velocity, and is cited frequently in the literature for measuring hemodynamics of peripheral vessels. |
Secondary
| Measure | Time frame |
|---|---|
| The Knee Flexion Active Range of Motion, Balance and Pain (VAS) | Jan 2010 to March 2010 |
Countries
Canada
Participant flow
Recruitment details
Thirty subjects between the age of 48 and 80 years with radiographic confirmed knee OA were recruited. All data collection took place at the School of Health Sciences Room 658 Bethune building on South park St in Halifax Nova Scotia between January and March of 2010.
Participants by arm
| Arm | Count |
|---|---|
| Osteopathic Evaluation osteopathic evaluation: forward flexion test, hip drop test, the sitting forward flexion test, sitting diaphragm evaluation, sphenobasilar symphysis (SBS) listening, sacral listening, pelvic floor evaluation, peritoneal bag evaluation and global femoral artery evaluation | 15 |
| Osteopathic Evaluation With Treatment osteopathic evaluation of motion and tissue mobility followed by osteopathic manual therapy release of the tight or restricted tissues | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Osteopathic Evaluation With Treatment | Osteopathic Evaluation | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 8 Participants | 16 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 7 Participants | 14 Participants |
| Age, Continuous | 63.20 years STANDARD_DEVIATION 7.97 | 63.73 years STANDARD_DEVIATION 9.63 | 63.47 years STANDARD_DEVIATION 8.8 |
| Region of Enrollment Canada | 15 participants | 15 participants | 30 participants |
| Sex: Female, Male Female | 10 Participants | 12 Participants | 22 Participants |
| Sex: Female, Male Male | 5 Participants | 3 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Resistive Index (RI)
Ultrasonographic examination provides a non-invasive method to assess blood flow dynamics. The resistive index (RI), calculated from arterial blood flow velocities, reflects vascular resistance. The RI was calculated by dividing the peak systolic velocity (PSV) minus the end-diastolic velocity by the peak systolic velocity, and is cited frequently in the literature for measuring hemodynamics of peripheral vessels.
Time frame: Participants attended one visit; The outcome measure (RI) was before and after an osteopathic session on the same day; The data collection of the 30 subjects took place between Jan to March 2010; each subject had outcomes measured on one day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pre Test to the Osteopathic Evaluation | Resistive Index (RI) | 1.30 ratio | Standard Deviation 0.07 |
| Pre Test to the Osteopathic Evaluation With Treatment | Resistive Index (RI) | 1.40 ratio | Standard Deviation 0.09 |
| Same Day Post Test to Osteopathic Evaluation | Resistive Index (RI) | 1.30 ratio | Standard Deviation 0.06 |
| Post Test to Osteopathic Evaluation With Treatment | Resistive Index (RI) | 1.35 ratio | Standard Deviation 0.08 |
Comparison: A two factor mixed model Analysis of Variance (ANOVA) for Group (Evaluation vs. Treatment) with repeated measures (pre vs. post test) was employed to test for main effects and all interactions for the Resistive Indexp-value: <0.05ANOVA
Secondary
The Knee Flexion Active Range of Motion, Balance and Pain (VAS)
Time frame: Jan 2010 to March 2010