ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
617-358-3037
Adult Trials: 18+ Years
- ≥ 50 years of age
- A confirmed clinical diagnosis of osteoarthritis of the knee based on American College of Rheumatology criteria (confirmed by the participant's physician).
- WOMAC Pain subscale NRS ≥ 4 (on a 0-10 scale) in the index knee
- BMI ≤ 40 kg/m2
- Able to walk unassisted for at least 20 minutes
- Can speak and understand English
- Available for the study duration
- Own a smartphone
- Contraindication to exercise
- Other pain in lower back or legs that is greater than knee pain
- Cancer being treated except non-melanoma skin cancer
- History of other disease that may involve the index joint including inflammatory joint
disease such as rheumatoid arthritis, seronegative spondyloarthropathy (eg, ankylosing
spondylitis, psoriatic arthritis, inflammatory bowel disease related arthropathy),
crystalline disease (eg, gout or pseudogout), endocrinopathies, metabolic joint
diseases, lupus erythematosus, joint infections, Paget's disease, or tumors.
- Any knee surgery in the previous 6 months
- Previous knee osteotomy, uni-compartmental replacement, or total knee replacement in
either knee
- Total joint replacement in any lower extremity joint
- Planned major treatment for knee OA (e.g., surgery, injections, physical therapy)
during the study period
- Corticosteroid or hyaluronic acid injections in either knee in the previous 3 months
- Neurological conditions that impacts motor functioning, for e.g., stroke, Parkinson's
disease, Alzheimer's disease, Multiple Sclerosis, diabetic neuropathy, etc.
- Pregnant
- Received physical therapy for knee OA within past 6 months
- Use assistive devices (such as a cane or walker) at home
- Known or suspected non-compliance, drug or alcohol abuse
- Participation in another clinical trial
- Persons who are investigational site staff members directly involved in the conduct of
the study and their family members, site staff members otherwise supervised by the
Investigators.
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| Descriptive Information | |||||||
|---|---|---|---|---|---|---|---|
| Brief Title ICMJE | Wearable Sensors in Knee OA | ||||||
| Official Title ICMJE | Wearable Sensor-based Outcomes Following Physical Therapy in Knee Osteoarthritis: A Feasibility Study (WESENS-OA) | ||||||
| Brief Summary | This is a single-arm clinical trial to investigate wearable sensors for assessing outcomes following physical therapy in people with knee osteoarthritis. | ||||||
| Detailed Description | This is a longitudinal, single arm, interventional, 19-week study to investigate the utility of digital assessments to measure the efficacy of physical therapy for reducing pain and improving function in people with knee osteoarthritis. A total of 60 participants will be included. Participants will receive a supervised in-clinic physical therapy program for 12 weeks and will undergo multiple laboratory functional 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 at home with the same wrist and lumbar wearable sensors. After completion of the physical therapy program, there will be an additional 6-week monitoring period to measure persistence of the treatment effect during which time participants will continue to follow an exercise program at home. Outcomes will be assessed at baseline, 6 week, 12 weeks, and 18 weeks. The primary objective will be to measure the effect of physical therapy on functional performance and pain using both patient reported outcomes questionnaires and digital metrics obtained from the laboratory assessments and wearable sensors worn at home. Pain phenotyping questionnaires and quantitative sensory testing assessments will be used to evaluate the effect of specific pain phenotypes in treatment response. | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Not Applicable | ||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: Single-arm interventional study Masking: None (Open Label)Masking Description: Since this is a single-arm study, no masking is included. Primary Purpose: Treatment
| ||||||
| Condition ICMJE | Knee Osteoarthritis | ||||||
| Intervention ICMJE | Behavioral: Physical Therapy
Neuromuscular and strength training, OA education, pain education, manual therapy, and physical activity goal setting Other Name: Exercise | ||||||
| Study Arms ICMJE | Experimental: Physical Therapy
12 week in-person exercise-based physical therapy Intervention: Behavioral: Physical Therapy | ||||||
| Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
| Recruitment Information | |||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||
| Estimated Enrollment ICMJE | 60 | ||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||
| Estimated Study Completion Date ICMJE | December 31, 2021 | ||||||
| Estimated Primary Completion Date | July 31, 2021 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||||
| Sex/Gender ICMJE |
| ||||||
| Ages ICMJE | 50 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT04243096 | ||||||
| Other Study ID Numbers ICMJE | Not Provided | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
| ||||||
| IPD Sharing Statement ICMJE |
| ||||||
| Responsible Party | Boston University Charles River Campus | ||||||
| Study Sponsor ICMJE | Boston University Charles River Campus | ||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | Boston University Charles River Campus | ||||||
| Verification Date | January 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||