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| Name | Class |
|---|---|
| Boston University | OTHER |
| Pfizer | INDUSTRY |
| Eli Lilly and Company | INDUSTRY |
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This is a single-arm clinical trial to investigate the outcome of exercise-based physical therapy in people with knee osteoarthritis through the use of wearable sensors.
This is a longitudinal, single arm, 19-week study to investigate the utility of digital assessments to measure the efficacy of exercise-based physical therapy (PT) for reducing pain and improving function in people with knee osteoarthritis (OA).
A total of 60 participants will be included. Participants will receive a supervised exercise-based PT for 12 weeks and will undergo multiple assessments of strength, balance, gait and joint movement while being monitored with a motion capture system and wrist and lumbar wearable sensors. Additionally, participants' activities will be monitored in the real world with the same wrist and lumbar wearable sensors. After completion of the PT program, participants will be monitored for an additional 6-week period to measure persistence of treatment effect. During that time, they will continue to follow an exercise program at home.
The primary objective will be to measure the effect of exercise-based PT on functional performance and pain reduction using both patient reported outcomes questionnaires (PROs) and digital metrics obtained from the laboratory assessments and wearable sensors worn in the real world. Pain phenotyping questionnaires and quantitative sensory testing assessments will also be used to evaluate the effect of specific pain phenotypes in treatment response.
A substudy will be undertaken to assess reproducibility of sensor-based measures during physical performance testing across at-home and in-lab implementation, as well as, reproducibility of these measures over repeated at-home implementation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise-based Physical Therapy | Experimental | 12 week in-person exercise-based physical therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise-based Physical Therapy | Behavioral | Exercises for pain modulation, strengthening, and neuromuscular control |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensor Derived Cadence | number of steps/min during the clinic-based 28-meter walk test from lower back sensor | Change from baseline to 12 weeks |
| Sensor Derived Stride Duration | duration of one stride during gait (sec) during the clinic-based 28-meter walk test | Change from baseline to 12 weeks |
| Sensor Derived Step Duration | duration of one step during gait (sec) during the clinic-based 28-meter walk test from lower back sensor | Change from baseline to 12 weeks |
| Sensor Derived Stance Time | Duration of stance phase (i.e., duration of time the foot is in contact with the ground in a step) during gait (sec) during the clinic-based 28-meter walk test from lower back sensor | Change from baseline to 12 weeks |
| Sensor Derived Total Double Support Time | time when both feet are on the ground in one gait cycle (sec) during the clinic-based 28-meter walk test from lower back sensor | Change from baseline to 12 weeks |
| Sensor Derived Swing Time | duration of swing phase during gait (sec) during the clinic-based 28-meter walk test from lower back sensor | Change from baseline to 12 weeks |
| Sensor Derived Single Limb Support Time | time when one foot is on the ground in one gait cycle (sec) during the clinic-based 28-meter walk test from lower back sensor |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Function (KOOS ADL) | Knee injury and Osteoarthritis Outcome Scale ADL Score (0-100, higher score indicate better outcome) | Change from baseline to 12 weeks |
| Knee Pain (KOOS Pain) | Knee injury and Osteoarthritis Outcome Scale Pain Score (0-100, higher score indicate better outcome) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Sit to Stand | number of chair stands per day measured using lumbar sensor | Change from baseline to 12 weeks |
| Gait Bouts | number of gait bouts per day measured using lumbar sensor |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deepak Kumar, PT, PhD | Boston University | Principal Investigator |
| Tuhina Neogi, MD, PhD | Boston University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston University | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37778085 | Derived | Lee S, Neogi T, Costello KE, Senderling B, Stefanik JJ, Frey-Law L, Kumar D. Association of mechanical temporal summation of pain with muscle co-contraction during walking in people with knee osteoarthritis. Clin Biomech (Bristol). 2023 Dec;110:106105. doi: 10.1016/j.clinbiomech.2023.106105. Epub 2023 Sep 22. | |
| 36734316 | Derived |
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Individual participant data that underlie the results reported in publication(s), after deidentification.
Beginning 9 months and ending 36 months following publication(s).
Data will only be shared for individual participant data meta-analyses. Data will be shared with investigators who propose a methodologically sound proposal and whose proposed use of the data has been approved by an independent review committee identified for this purpose.
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| ID | Title | Description |
|---|---|---|
| FG000 | Exercise-based Physical Therapy | 12 week in-person exercise-based physical therapy Exercise-based Physical Therapy: Exercises for pain modulation, strengthening, and neuromuscular control |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Exercise-based Physical Therapy | 12 week in-person exercise-based physical therapy Exercise-based Physical Therapy: Exercises for pain modulation, strengthening, and neuromuscular control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sensor Derived Cadence | number of steps/min during the clinic-based 28-meter walk test from lower back sensor | Posted | Mean | 95% Confidence Interval | steps/min | Change from baseline to 12 weeks |
|
|
1 year, 10months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exercise-based Physical Therapy | 12 week in-person exercise-based physical therapy Exercise-based Physical Therapy: Exercises for pain modulation, strengthening, and neuromuscular control |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Arrest | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin Irritation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
All sensor-based results are preliminary. Further optimization of the algorithm is underway.
Sensor-based measures for sit-to-stand were only available from a few participants and hence those data should be interpreted with caution.
The serious adverse events were unrelated to the study participation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Deepak Kumar, PT, PhD | Boston University | 617-358-3037 | kumard@bu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 14, 2021 | Jun 11, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 1, 2021 | Jun 11, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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Single-arm interventional study
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Since this is a single-arm study, no masking is included.
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| Change from baseline to 12 weeks |
| Sensor Derived Step Length | length of a step during gait (m) during the clinic-based 28-meter walk test from lower back sensor | Change from baseline to 12 weeks |
| Sensor Derived Gait Speed | walking speed (m/s) during the clinic-based 28-meter walk test from lower back sensor | Change from baseline to 12 weeks |
| Sensor Derived Duration of Sit to Stand | time taken to complete a chair stand (sec) from lower back sensor | Change from baseline to 12 weeks |
| Sensor Derived Sit to Stand Acceleration | peak acceleration during chair stand (m/s^2) from lower back sensor | Change from baseline to 12 weeks |
| Sensor Derived Sit to Stand Deceleration | peak deceleration during chair stand (m/s^2) from lower back sensor | Change from baseline to 12 weeks |
| Change from baseline to 12 weeks |
| Moderate to Vigorous Physical Activity (MVPA) | time spent in moderate and vigorous intensity activity per day extracted from a wrist worn sensor (GT9X Link) | Change from baseline to 12 weeks |
| Time Taken to Complete 28-meter Walk Test | time taken to complete 28-meter walk test (s) from stopwatch during the clinic-based 28-meter walk test | Change from baseline to 12 weeks |
| First Peak of Knee Index | Knee loading index for study knee during walking at self-selected pace from 3D motion capture (%Bodyweight*height) | Change from baseline to 12 weeks |
| Knee Co-contraction | Peak medial quadriceps-medial hamstrings co-contraction during loading response during walking at self-selected pace. Higher values reflect greater co-activation of these muscles. | Change from baseline to 12 weeks |
| Knee Frontal Plane Excursion | abduction-adduction range during stance phase of gait measured using 3D motion capture (degrees) | Change from baseline to 12 weeks |
| Knee Sagittal Plane Excursion | flexion-extension range for study knee during stance phase of gait measured during walking at self-selected pace using 3D motion capture (degrees) | Change from baseline to 12 weeks |
| Trunk Angle | peak trunk forward flexion angle during sit-to-stand measured using 3D motion capture (degrees) | Change from baseline to 12 weeks |
| Global Assessment | Patient Global Assessment of OA (PGA-OA) (range 0-100, higher score indicates better outcome) | Change from baseline to 12 weeks |
| Step Up Test | number of step ups completed in 15 seconds | Change from baseline to 12 weeks |
| Stair Climbing Test (SCT) | Time taken to go up and down a flight of stairs (sec) | Change from baseline to 12 weeks |
| Short Physical Performance Battery (SPPB) | Short Physical Performance Battery total score. This is a functional test where several different activities (e.g., balance, walking, getting up from a chair) are performed and scored by the examiner. The total score is the sum of scores across all of the activities. Range is 0-12. Higher scores reflect better physical function. | Change from baseline to 12 weeks |
| 6-minute Walk Test (6MWT) | distance covered walking in 6 minutes (m) | Change from baseline to 12 weeks |
| 5-time Sit to Stand (5STS) | time taken to complete 5 chair stands (sec) | Change from baseline to 12 weeks |
| Change from baseline to 12 weeks |
| Total Sleep Time | total sleep time per day measured using wrist-worn sensor (minutes) | Change from baseline to 12 weeks |
| Sleep Interference | Daily Sleep Interference Scale (DSIS) (0-10 numeric rating scale, higher number indicates greater interference in sleep due to pain) | Change from baseline to 12 weeks |
| Peak Extensor Isometric Torque | peak extensor muscle torque from isometric strength testing (Nm/kg) | Change from baseline to 12 weeks |
| Pressure Pain Threshold (PPT) | pressure at which pain is initially felt (kg/m2) | Change from baseline to 12 weeks |
| Temporal Summation (TS) | presence of wind up phenomenon in response to multiple pressure stimuli (yes/no) | Change from baseline to 12 weeks |
| Conditioned Pain Modulation (CPM) | reduction in pain sensitivity with application of second pain stimulus (yes/no) | Change from baseline to 12 weeks |
| Knee Pain | Numeric rating scale for pain (0-10, higher score indicates worse pain) | Change from baseline to 12 weeks |
| Knee Pain During Nominated Activity | Numeric rating scale for pain during nominated activity (0-10, higher score indicates worse pain) | Change from baseline to 12 weeks |
| Symptoms - KOOS Symptoms | Knee injury and osteoarthritis outcome score Symptoms scale (0-100, higher scores indicates better outcome) | Change from baseline to 12 weeks |
| QOL - KOOS QOL | Knee injury and osteoarthritis outcome score quality of life scale (0-100, higher scores indicates better outcome) | Change from baseline to 12 weeks |
| S/R - KOOS S/R | Knee injury and osteoarthritis outcome score sports/recreation scale (0-100, higher scores indicates better outcome) | Change from baseline to 12 weeks |
| Depressive Symptoms | Center for Epidemiologic Studies Depression Scale (range 0-60, higher score indicate more depressive symptoms) | Change from baseline to 12 weeks |
| Number of Painful Joints | number of painful joints in the body | Change from baseline to 12 weeks |
| Rose MJ, Neogi T, Friscia B, Torabian KA, LaValley MP, Gheller M, Adamowicz L, Georgiev P, Viktrup L, Demanuele C, Wacnik PW, Kumar D. Reliability of Wearable Sensors for Assessing Gait and Chair Stand Function at Home in People With Knee Osteoarthritis. Arthritis Care Res (Hoboken). 2023 Sep;75(9):1939-1948. doi: 10.1002/acr.25096. Epub 2023 Mar 7. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m2 |
|
|
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| Primary | Sensor Derived Stride Duration | duration of one stride during gait (sec) during the clinic-based 28-meter walk test | Posted | Mean | 95% Confidence Interval | second | Change from baseline to 12 weeks |
|
|
|
|
| Primary | Sensor Derived Step Duration | duration of one step during gait (sec) during the clinic-based 28-meter walk test from lower back sensor | Posted | Mean | 95% Confidence Interval | second | Change from baseline to 12 weeks |
|
|
|
|
| Primary | Sensor Derived Stance Time | Duration of stance phase (i.e., duration of time the foot is in contact with the ground in a step) during gait (sec) during the clinic-based 28-meter walk test from lower back sensor | Posted | Mean | 95% Confidence Interval | second | Change from baseline to 12 weeks |
|
|
|
|
| Primary | Sensor Derived Total Double Support Time | time when both feet are on the ground in one gait cycle (sec) during the clinic-based 28-meter walk test from lower back sensor | Posted | Mean | 95% Confidence Interval | seconds | Change from baseline to 12 weeks |
|
|
|
|
| Primary | Sensor Derived Swing Time | duration of swing phase during gait (sec) during the clinic-based 28-meter walk test from lower back sensor | Posted | Mean | 95% Confidence Interval | seconds | Change from baseline to 12 weeks |
|
|
|
|
| Primary | Sensor Derived Single Limb Support Time | time when one foot is on the ground in one gait cycle (sec) during the clinic-based 28-meter walk test from lower back sensor | Posted | Mean | 95% Confidence Interval | seconds | Change from baseline to 12 weeks |
|
|
|
|
| Primary | Sensor Derived Step Length | length of a step during gait (m) during the clinic-based 28-meter walk test from lower back sensor | Posted | Mean | 95% Confidence Interval | meters | Change from baseline to 12 weeks |
|
|
|
|
| Primary | Sensor Derived Gait Speed | walking speed (m/s) during the clinic-based 28-meter walk test from lower back sensor | Posted | Mean | 95% Confidence Interval | m/s | Change from baseline to 12 weeks |
|
|
|
|
| Primary | Sensor Derived Duration of Sit to Stand | time taken to complete a chair stand (sec) from lower back sensor | these data were only available from a few participants due to issues with the algorithm | Posted | Mean | 95% Confidence Interval | seconds | Change from baseline to 12 weeks |
|
|
|
| Primary | Sensor Derived Sit to Stand Acceleration | peak acceleration during chair stand (m/s^2) from lower back sensor | these data were only available from a few participants due to issues with the algorithm | Posted | Mean | 95% Confidence Interval | meters per second squared | Change from baseline to 12 weeks |
|
|
|
| Primary | Sensor Derived Sit to Stand Deceleration | peak deceleration during chair stand (m/s^2) from lower back sensor | these data were only available from a few participants due to issues with the algorithm | Posted | Mean | 95% Confidence Interval | meters per second squared | Change from baseline to 12 weeks |
|
|
|
| Secondary | Physical Function (KOOS ADL) | Knee injury and Osteoarthritis Outcome Scale ADL Score (0-100, higher score indicate better outcome) | Posted | Mean | 95% Confidence Interval | score on a scale | Change from baseline to 12 weeks |
|
|
|
|
| Secondary | Knee Pain (KOOS Pain) | Knee injury and Osteoarthritis Outcome Scale Pain Score (0-100, higher score indicate better outcome) | Posted | Mean | 95% Confidence Interval | score on a scale | Change from baseline to 12 weeks |
|
|
|
|
| Secondary | Moderate to Vigorous Physical Activity (MVPA) | time spent in moderate and vigorous intensity activity per day extracted from a wrist worn sensor (GT9X Link) | Posted | Mean | 95% Confidence Interval | minutes | Change from baseline to 12 weeks |
|
|
|
|
| Secondary | Time Taken to Complete 28-meter Walk Test | time taken to complete 28-meter walk test (s) from stopwatch during the clinic-based 28-meter walk test | Posted | Mean | 95% Confidence Interval | second | Change from baseline to 12 weeks |
|
|
|
| Secondary | First Peak of Knee Index | Knee loading index for study knee during walking at self-selected pace from 3D motion capture (%Bodyweight*height) | Posted | Mean | 95% Confidence Interval | %Newton*meter | Change from baseline to 12 weeks |
|
|
|
|
| Secondary | Knee Co-contraction | Peak medial quadriceps-medial hamstrings co-contraction during loading response during walking at self-selected pace. Higher values reflect greater co-activation of these muscles. | Posted | Mean | 95% Confidence Interval | arbitrary units | Change from baseline to 12 weeks |
|
|
|
|
| Secondary | Knee Frontal Plane Excursion | abduction-adduction range during stance phase of gait measured using 3D motion capture (degrees) | Posted | Mean | 95% Confidence Interval | Degrees | Change from baseline to 12 weeks |
|
|
|
|
| Secondary | Knee Sagittal Plane Excursion | flexion-extension range for study knee during stance phase of gait measured during walking at self-selected pace using 3D motion capture (degrees) | Posted | Mean | 95% Confidence Interval | degree | Change from baseline to 12 weeks |
|
|
|
|
| Secondary | Trunk Angle | peak trunk forward flexion angle during sit-to-stand measured using 3D motion capture (degrees) | Posted | Mean | 95% Confidence Interval | degree | Change from baseline to 12 weeks |
|
|
|
|
| Secondary | Global Assessment | Patient Global Assessment of OA (PGA-OA) (range 0-100, higher score indicates better outcome) | Posted | Mean | 95% Confidence Interval | score on a scale | Change from baseline to 12 weeks |
|
|
|
|
| Secondary | Step Up Test | number of step ups completed in 15 seconds | Posted | Mean | 95% Confidence Interval | repetitions | Change from baseline to 12 weeks |
|
|
|
|
| Secondary | Stair Climbing Test (SCT) | Time taken to go up and down a flight of stairs (sec) | Posted | Mean | 95% Confidence Interval | seconds | Change from baseline to 12 weeks |
|
|
|
|
| Secondary | Short Physical Performance Battery (SPPB) | Short Physical Performance Battery total score. This is a functional test where several different activities (e.g., balance, walking, getting up from a chair) are performed and scored by the examiner. The total score is the sum of scores across all of the activities. Range is 0-12. Higher scores reflect better physical function. | Posted | Mean | 95% Confidence Interval | score on a scale | Change from baseline to 12 weeks |
|
|
|
|
| Secondary | 6-minute Walk Test (6MWT) | distance covered walking in 6 minutes (m) | Posted | Mean | 95% Confidence Interval | meters | Change from baseline to 12 weeks |
|
|
|
|
| Secondary | 5-time Sit to Stand (5STS) | time taken to complete 5 chair stands (sec) | Posted | Mean | 95% Confidence Interval | seconds | Change from baseline to 12 weeks |
|
|
|
|
| Other Pre-specified | Number of Sit to Stand | number of chair stands per day measured using lumbar sensor | Not Posted | Change from baseline to 12 weeks | Participants |
| Other Pre-specified | Gait Bouts | number of gait bouts per day measured using lumbar sensor | Not Posted | Change from baseline to 12 weeks | Participants |
| Other Pre-specified | Total Sleep Time | total sleep time per day measured using wrist-worn sensor (minutes) | Not Posted | Change from baseline to 12 weeks | Participants |
| Other Pre-specified | Sleep Interference | Daily Sleep Interference Scale (DSIS) (0-10 numeric rating scale, higher number indicates greater interference in sleep due to pain) | Not Posted | Change from baseline to 12 weeks | Participants |
| Other Pre-specified | Peak Extensor Isometric Torque | peak extensor muscle torque from isometric strength testing (Nm/kg) | Not Posted | Change from baseline to 12 weeks | Participants |
| Other Pre-specified | Pressure Pain Threshold (PPT) | pressure at which pain is initially felt (kg/m2) | Not Posted | Change from baseline to 12 weeks | Participants |
| Other Pre-specified | Temporal Summation (TS) | presence of wind up phenomenon in response to multiple pressure stimuli (yes/no) | Not Posted | Change from baseline to 12 weeks | Participants |
| Other Pre-specified | Conditioned Pain Modulation (CPM) | reduction in pain sensitivity with application of second pain stimulus (yes/no) | Not Posted | Change from baseline to 12 weeks | Participants |
| Other Pre-specified | Knee Pain | Numeric rating scale for pain (0-10, higher score indicates worse pain) | Not Posted | Change from baseline to 12 weeks | Participants |
| Other Pre-specified | Knee Pain During Nominated Activity | Numeric rating scale for pain during nominated activity (0-10, higher score indicates worse pain) | Not Posted | Change from baseline to 12 weeks | Participants |
| Other Pre-specified | Symptoms - KOOS Symptoms | Knee injury and osteoarthritis outcome score Symptoms scale (0-100, higher scores indicates better outcome) | Not Posted | Change from baseline to 12 weeks | Participants |
| Other Pre-specified | QOL - KOOS QOL | Knee injury and osteoarthritis outcome score quality of life scale (0-100, higher scores indicates better outcome) | Not Posted | Change from baseline to 12 weeks | Participants |
| Other Pre-specified | S/R - KOOS S/R | Knee injury and osteoarthritis outcome score sports/recreation scale (0-100, higher scores indicates better outcome) | Not Posted | Change from baseline to 12 weeks | Participants |
| Other Pre-specified | Depressive Symptoms | Center for Epidemiologic Studies Depression Scale (range 0-60, higher score indicate more depressive symptoms) | Not Posted | Change from baseline to 12 weeks | Participants |
| Other Pre-specified | Number of Painful Joints | number of painful joints in the body | Not Posted | Change from baseline to 12 weeks | Participants |
| 1 |
| 60 |
| 2 |
| 60 |
| 4 |
| 60 |
| Spinal Tumor | Surgical and medical procedures | Non-systematic Assessment |
|
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| D012216 |
| Rheumatic Diseases |
| D001519 | Behavior |