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          Grants & Funding: The NIAMS Extramural Program
          Clinical Trials in the Spotlight
          The Relation of Altered Pain Processing to Impact Loading and Response to a Gait Retraining Treatment in Knee Osteoarthritis








The Relation of Altered Pain Processing to Impact Loading and Response to a Gait Retraining Treatment in Knee Osteoarthritis FacebookEmailPrintFacebookEmail     
    Clinical Trials in the Spotlight Main Page

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) supports a range of clinical trials studying new and existing interventions for prevention and treatment of arthritis, musculoskeletal, and skin diseases.  Investigators supported by the NIAMS need your help finding individuals to participate in clinical trials.  Participating in clinical trials allows you to play an active role as a volunteer in research and contribute to generating new knowledge about the disease/condition, and potentially future treatments.  The information below is designed to help you quickly learn about actively recruiting research studies for which you or someone you know may be eligible.

Study Description

Knee osteoarthritis (OA) is a major public health problem, causing substantial pain and functional limitations and affects ~12% of older adults. There are few effective non-invasive treatments to prevent disease progression or decrease pain. The current proposal will provide evidence-based information in order to design novel and effective rehabilitation treatments for knee osteoarthritis.

Non-invasive treatments are needed to improve quality of life and decrease the need for total knee arthroplasty. Abnormal mechanical loading is a well-recognized cause of knee OA and many rehabilitation treatments aim to improve abnormal loading. Impact loading is one such factor that can be intervened upon to potentially improve pain and function. While gait retraining strategies have been shown to improve the knee adduction moment, it is unknown if gait retraining can change impact loading and improve knee pain in older individuals with knee OA. Individuals with painful knee OA also demonstrate a heightened response to normally non-painful stimuli (i.e., sensitization) and impaired descending inhibition of pain, both of which contribute to greater pain severity. It is unknown, however, whether these alterations in the sensory nervous system also affect the motor efferent nervous system, with resulting adverse effects on motor function. Furthermore, the presence of altered pain processing may modify the effect of traditional rehabilitation strategies. Such insights would provide opportunities for tailoring individual rehabilitation strategies. The specific aims of the proposed work are: 1) To evaluate the relation of altered pain processing, independent of knee pain severity, to impact loading (e.g., peak impact force and loading rate from the ground reaction force) during walking, 2) To determine whether a gait retraining program decreases impact loading and knee pain in individuals with knee OA, and 3) To determine whether altered pain processing modifies the effect of gait retraining on impact loading.

Subjects will be randomized to either a control walking intervention or a walking program with gait retraining. The retraining will involve verbal feedback to soften footfalls and real-time visual feedback to decrease tibial acceleration (a correlate of knee loading) using an accelerometer while walking on a treadmill. Primary and secondary outcomes include measures of impact loading and knee pain, respectively. The proposed research is highly significant in that it will directly affect the clinical management of individuals with knee OA.

**ELIGIBILITY CRITERIA:**

Ages Eligible for Study:           45 Years and older (Adult, Older Adult)

Sexes Eligible for Study:          All

Accepts Healthy Volunteers:  No

**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

**Study Design:**

Allocation: Randomized

Intervention Model: Parallel Assignment

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose: Treatment

**Study Location(s):**

Northeastern University, Boston, Massachusetts, United States, 02115

**Study Website:**

https://clinicaltrials.gov/ct2/show/NCT04148807?term=Stefanik%2C+Joshua&draw=2&rank=1


Last Updated: March 2020


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