Healthy, Pain
Conditions
Brief summary
This interventional study aims to test gait biomechanics in healthy individuals with and without experimental knee pain. The main questions it aims to answer are: * How do gait patterns change during painful walking? * Can pain sensitivity testing and gait biomechanics predict experimental knee pain intensity? Participants will receive two knee injections: a) Hypertonic saline (painful condition) and b) Isotonic saline (control condition).
Detailed description
This study will be a randomized, crossover design where experimental knee pain will be provoked in healthy subjects using hypertonic saline injections to the infrapatellar fat pad (IFP). This will be controlled with a second injection of isotonic saline, which is non-painful. The participants will not be informed of the type of injection. Hypertonic saline injections to the IFP usually provoke pain lasting about 15 minutes. Within this timeframe, motion capture will be conducted to estimate the biomechanics of gait. During the motion capture the participants will perform five 10-meter walking trials and three jumps. This process will be replicated for the control condition. Additionally, the participants will have their pain sensitivity tested using cuff-pressure algometry before both IFP injections.
Interventions
0.25 mL injection with hypertonic saline (7%) to the infrapatellar fat pad.
Control injection with 0.25 mL isotonic saline (0.9%) to the infrapatellar fat pad.
Sponsors
Kristian Kjær Petersen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy men and women aged 18-45 years
Exclusion criteria
* Pregnancy * Drug addiction, defined as the use of cannabis, opioids, or other drugs * Previous or current neurologic or musculoskeletal illnesses * Current pain * Lack of ability to cooperate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain sensitivity. | Baseline | Cuff-pressure algometry will be used to estimate pressure detection and tolerance thresholds, temporal summation of pain, and conditioned pain modulation. |
| Infrared marker XYZ coordinates | Baseline | Marker-based motion capture with infrared cameras will be used to estimate placement of reflective markers in the XYZ planes measured in milimeters. Reflective markers will be placed from head-to-toe on anatomical landmarks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Pain catastrophizing Scale score | Baseline | 13 items summarized to a single score ranging from zero to 52 with higher scores reflecting more catastrophizing. |
| The Hospital Anxiety and Depression Scale | Baseline | 14 items summarized into two 7-item subscales measuring symptoms of anxiety and depression. Each subscale score ranges from zero to 21 with higher scores reflecting more severe symptoms. |
| Knee symptoms | Baseline | 42 items divided into five subscales: pain (9 items), activities of daily living (17 items), sport and recreation function (5 items), knee-related quality of life (4 items), and other symptoms (7 items). Each subscale is score from zero to 100 with higher scores reflecting increased severity of knee problems. |
| Ground reaction forces | Baseline | Ground reaction forces will be measured in Newton-meters with force plates embedded in the floor. |
| Ground reaction moments | Baseline | Ground reaction moments will be measured in Newton-meters with force plates embedded in the floor. |
| Muscle activation | Baseline | Muscle activation will be measured in micro-volts using wireless EMG on the muscles of the lower extremities. |
| Ground contact XZ location | Baseline | Ground contact XZ coordinate location will be measured in milimeters with force plates embedded in the floor. |
| The Pittsburgh Sleep Quality Index score | Baseline | 19 items summarized to a single score ranging from zero to 21 with higher scores reflecting worse quality of sleep. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity (NRS 0-10) | Baseline | Pain during intervention is measured continuously every 30 seconds on a numeric rating scale from 0 'no pain' to 10 'the worst pain imagineable' |
| Pain distribution | Baseline | Pain during intervention is marked on a body chart |
Countries
Denmark
Outcome results
None listed