P4ACE Trial for Persons With Chronic Knee Pain

NCT05623683 | Completed

• 1 other identifier: N-20220047
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Change from pre-walking to immediately post-walking in Numeric Pain Rating Scale (NPRS) for current knee pain

  The primary outcome is the self-reported clinical pain. The pre- and post-walking knee pain will be rated right before the commencement of the walking program and at the termination of the walking program respectively. Participants verbally select a value that corresponds with the intensity of pain that they experience. "0" means "no pain" and "10" means "pain as bad as you can imagine" or "worst pain imaginable". The NPRS, an 11-point (i.e., 0-10) measure of pain intensity, is recommended as a core outcome measure in clinical trials of chronic pain treatments and has excellent reliability and validity for adults with chronic musculoskeletal pain. On average, a change of 2 points or a change of approximately 30% in NPRS represented a clinically important difference in adults with chronic pain.

  pre-walking, immediately post-walking

Secondary Outcomes (4)

• Change from pre-walking to immediately post-walking in Cuff Pain Detection Threshold (cPDT)

  pre-walking, immediately post-walking

• Change from pre-walking to immediately post-walking in Cuff Pain Tolerance Threshold (cPTT)

  pre-walking, immediately post-walking

• Change from pre-walking to immediately post-walking in Temporal Summation of Pain (TSP)

  pre-walking, immediately post-walking

• Change from pre-walking to immediately post-walking in Conditioned Pain Modulation (CPM)

  pre-walking, immediately post-walking

Study Arms (2)

Intermittent Walking

ACTIVE COMPARATOR

Intermittent walking on the treadmill

Other: Intermittent Walking

Continuous Walking

ACTIVE COMPARATOR

Continuous walking on the treadmill

Other: Continuous Walking

Interventions

Intermittent Walking 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.

Intermittent Walking

Continuous Walking 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.

Continuous Walking

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• Aalborg University: collaborator

Study Sites (1)

Aalborg University

Aalborg, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Alison H Chang

  Aalborg University

  PRINCIPAL INVESTIGATOR

• Michael Rathleff

  Aalborg University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: November 12, 2022
• First Posted: November 21, 2022
• Study Start: April 20, 2023
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)