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Effectiveness of a Walking Intervention on Impact Loading and Pain

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Northeastern University

Status

Enrolling

Conditions

Knee Pain Chronic
Osteoarthritis, Knee

Treatments

Behavioral: Progressive Walking Program
Behavioral: Progressive Walking with Gait Retraining

Study type

Interventional

Funder types

Other

Identifiers

NCT04148807
18-11-15

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

45+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

40 participants in 2 patient groups

Progressive walking program with gait retraining
Experimental group
Description:
Participant will receive 8 gait-retraining intervention sessions.
Treatment:
Behavioral: Progressive Walking with Gait Retraining
Progressive walking program
Active Comparator group
Description:
Participant receives 8 sessions of a graded walking program.
Treatment:
Behavioral: Progressive Walking Program

Trial contacts and locations

1

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Central trial contact

Joshua Stefanik, MSPT, PhD

Data sourced from clinicaltrials.gov

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