Clinical trial NCT04148807: Effectiveness of a Walking Intervention on Impact Loading and Pain
Official title: Effectiveness of a Walking Intervention on Impact Loading and Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis, Knee
Knee Pain Chronic
Lead sponsor: Northeastern University
Sponsor class: OTHER
First posted: 2019-11-04
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study investigates the feasibility of a gait-retraining program for older adults with knee osteoarthritis. The study will enroll 40 participants, with 20 receiving a gait retraining intervention and 20 receiving a graded walking program without gait retraining.

Detailed description: Knee osteoarthritis (OA) is a chronic condition affecting \~12% of older adults in the United States and is a leading cause of disability. Knee pain is a common clinical manifestation that leads individuals with OA to seek medical care. Current rehabilitation approaches (e.g., bracing, taping, foot orthoses, strengthening, etc.) aim to reduce knee joint loading, a well-accepted risk factor for knee OA and pain, but are not always effective. Altering gait mechanics to reduce knee loading has also been suggested. Gait retraining studies for individuals with knee OA have focused on increasing trunk lean and toe out angle to reduce the knee adduction moment (a surrogate measure of joint loading). However, these strategies create an abnormal gait pattern and may not be the best long-term solutions due to the potential injury to other joints which may limit their overall effectiveness and applicability to clinical practice. Impact loading, another mechanical factor related to knee OA, has been reduced using gait retraining strategies in runners with knee pain. It is unknown if gait retraining strategies to decrease impact loading can reduce symptoms of knee OA. Thus, the purpose of this study is to determine the feasibility of a gait retraining program focusing on decreasing impact loading in individuals with knee OA.

At baseline, following 8 intervention sessions, and at 1-month follow-up, participants will complete questionnaires, undergo three-dimensional gait analysis, and assessment of pressure pain threshold.

Note: For participants enrolled during COVID-19 outbreak, only questionnaires will be collected at follow-up assessments.

Eligibility criteria: Inclusion Criteria:

Subjects with a clinical definition of knee OA using NICE guidelines:

* Age ≥ 45
* Walking related joint pain in the last week that averages ≥ 4 on 11-point numeric rating scale, where 0 = no pain and 10 = worst pain possible
* History of knee pain for at least 3 months
* Morning stiffness in the morning lasting less than 30 minutes

Exclusion Criteria:

* Walk with an assistive device
* Current use of oral opiates or centrally acting pain medications
* History of lower extremity surgery
* Underwent an intra-articular knee joint injection in the past 3 months
* Suffer from inflammatory arthritis or other conditions that affect lower extremity functions
* Currently receiving treatment for their knee and unwilling to stop this treatment for the duration of the study
* Currently pregnant
* Skin allergies to adhesives

Primary outcomes:
measure: Recruitment rate
timeFrame: through study completion, an average of 2 years
measure: Enrollment rate
timeFrame: through study completion, an average of 2 years
measure: Retention
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
measure: Withdrawals/Terminated
timeFrame: through study completion, an average of 2 years
measure: Adverse events (AE)/Unanticipated problems (UP)
timeFrame: through study completion, an average of 2 years
measure: Vertical average loading rate
timeFrame: Change from baseline to conclusion of intervention, an average of 1-month
measure: Vertical instantaneous loading rate
timeFrame: Change from baseline to conclusion of intervention, an average of 1-month
measure: Knee Pain with Activities
timeFrame: Change from baseline to conclusion of intervention, an average of 1-month
measure: Knee Pain Severity
timeFrame: Change from baseline to conclusion of intervention, an average of 1-month
measure: Pressure pain threshold
timeFrame: Change from baseline to conclusion of intervention, an average of 1-month
Other outcomes:
Locations:
city: Boston
country: United States
facility: Northeastern University
state: Massachusetts
Study officials:
References: