P4ACE Trial for Persons With Chronic Knee Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-20

Study Completion Date

2024-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this single-blind, cross-over clinical trial is to compare the immediate effect of intermittent vs. continuous walking on clinical and mechanistic pain profiles in persons with knee osteoarthritis (OA). In this cross-over trial, participants will perform two types of walking on a treadmill. Intermittent walking will involve 3 blocks of 10 minutes with 2 blocks of 5-minute rest (sitting on a chair) in-between. Continuous walking will involve resting for 10 minutes (sitting in a chair) before walking on the treadmill for 1 continuous block of 30 minutes.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effect on Knee Joint Loads of Analgesic Use Compared With Exercise in Patients With Knee Osteoarthritis - An RCT

NCT01638962

Osteoarthritis, Knee

COMPLETED NA

Comparing the Effects of Upper and Lower Body Aerobic Exercise on Pain in Individuals With Chronic Knee Pain

NCT05315934

Chronic Knee Pain

COMPLETED NA

The Arthritis, Diet, and Activity Promotion Trial

NCT00979043

Knee Osteoarthritis

COMPLETED NA

Exercise and Pain Sensitivity

NCT01351558

Knee Pain

TERMINATED NA

Pain Informed Movement for People With Knee Osteoarthritis

NCT05730829

Knee Osteoarthritis

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study objectives are to compare the immediate effect of intermittent vs. continuous walking on clinical and mechanistic pain profiles in persons with knee osteoarthritis (OA). The investigators hypothesize that continuous walking will result in greater increases in clinical pain and mechanistic pain sensitivity than intermittent walking. Physical activity (PA) has been recommended as the first-line management strategy for people with chronic knee pain. Walking is an accessible, low-cost, joint-friendly form of PA and is widely advocated for older adults with knee complaints. However, movement-evoked pain is a commonly cited barrier for PA engagement. On one hand, a bout of PA may produce short-term analgesia and reduce pain. On the other hand, excessive or prolonged PA may exacerbate symptoms and lead to avoidance/fear of subsequent PA. Besides the total PA volume, how it is accumulated could also impact joint health. It is biomechanically plausible that shorter and frequent activities are more beneficial to articular tissues than longer and infrequent activities. Compared to intermittent loading, prolonged continuous loading had a detrimental effect on the biomechanical functions of articular cartilage in a bovine model. Findings of this study will provide insight on the relations between patterns of PA and pain profiles.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Knee Osteoarthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

CROSSOVER

This is a randomized, controlled, single-blinded trial, with a 2-arm crossover design.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

To blind the participants, they will be told that both walking interventions are equally likely to cause a decrease, no change, or an increase in knee pain, and we will compare potential differences between the two walking interventions.

To blind the outcome assessor, the assessor will assess outcomes in a different place from the place where the intervention takes place.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intermittent Walking

Intermittent walking on the treadmill

Group Type ACTIVE_COMPARATOR

Intermittent Walking

Intervention Type OTHER

Wearing comfortable clothes and their usual walking shoes, participants will walk on a treadmill to accrue 30 minutes of walking. Participants will be instructed not to use the treadmill side rails for balance or support during walking. Participants will walk on the treadmill for 3 blocks of 10 minutes with 2 blocks of 5-minute rest (sitting on a chair) in-between. A safety button to stop the treadmill will be available to the participants, so they can stop walking anytime. If participants feel that they are about to lose balance, they are allowed to hold on to the side rails to regain balance and terminate the trial.

Continuous Walking

Continuous walking on the treadmill

Group Type ACTIVE_COMPARATOR

Continuous Walking

Intervention Type OTHER

Wearing comfortable clothes and their usual walking shoes, participants will walk on a treadmill to accrue 30 minutes of walking. Participants will be instructed not to use the treadmill side rails for balance or support during walking. Participants will rest for 10 minutes (sitting in a chair) before walking on the treadmill for 1 continuous block of 30 minutes. A safety button to stop the treadmill will be available to the participants, so they can stop walking anytime. If participants feel that they are about to lose balance, they are allowed to hold on to the side rails to regain balance and terminate the trial.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intermittent Walking

Wearing comfortable clothes and their usual walking shoes, participants will walk on a treadmill to accrue 30 minutes of walking. Participants will be instructed not to use the treadmill side rails for balance or support during walking. Participants will walk on the treadmill for 3 blocks of 10 minutes with 2 blocks of 5-minute rest (sitting on a chair) in-between. A safety button to stop the treadmill will be available to the participants, so they can stop walking anytime. If participants feel that they are about to lose balance, they are allowed to hold on to the side rails to regain balance and terminate the trial.

Intervention Type OTHER

Continuous Walking

Wearing comfortable clothes and their usual walking shoes, participants will walk on a treadmill to accrue 30 minutes of walking. Participants will be instructed not to use the treadmill side rails for balance or support during walking. Participants will rest for 10 minutes (sitting in a chair) before walking on the treadmill for 1 continuous block of 30 minutes. A safety button to stop the treadmill will be available to the participants, so they can stop walking anytime. If participants feel that they are about to lose balance, they are allowed to hold on to the side rails to regain balance and terminate the trial.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* men or women aged 45-75 years
* BMI ≤ 35 kg/m2
* frequent movement-related knee pain (knee pain on more than half the days of the past month)
* no morning stiffness or morning stiffness lasting \< 30-min
* self-reported unilateral or bilateral knee pain of ≥ 3 and ≤ 7 on a 0-10 numeric pain rating scale (NPRS)
* knee pain duration ≥ 12 months
* physically able to walk unassisted on a treadmill at ≥ 4 km/hour for 30 minutes
* own a smart phone
* willing and able to wear an activity monitor and answer electronic survey questions delivered via a smart phone over a 10-day period.

Exclusion Criteria

* intra-articular steroid injections in the previous 3 months
* intra-articular hyaluronic acid injection in the previous 6 months
* any arthroscopic or surgical knee procedures (e.g., partial meniscectomy) in the past 12 months
* lumbar radiculopathy
* neurological, vestibular, or visual dysfunction affecting walking balance and mobility
* plan for total knee arthroplasty in the next 12 months

Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No