Clinical trial NCT05623683: P4ACE Trial for Persons With Chronic Knee Pain
Official title: Pain Profiles and Patterns of Physical Activity in Persons With Chronic Knee Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Aalborg University
First posted: 2022-11-21
Enrollment: 20
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a randomized, controlled, single-blinded trial, with a 2-arm crossover design.
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from pre-walking to immediately post-walking in Numeric Pain Rating Scale (NPRS) for current knee pain
timeFrame: pre-walking, immediately post-walking
Secondary outcomes:
measure: Change from pre-walking to immediately post-walking in Cuff Pain Detection Threshold (cPDT)
timeFrame: pre-walking, immediately post-walking
measure: Change from pre-walking to immediately post-walking in Cuff Pain Tolerance Threshold (cPTT)
timeFrame: pre-walking, immediately post-walking
measure: Change from pre-walking to immediately post-walking in Temporal Summation of Pain (TSP)
timeFrame: pre-walking, immediately post-walking
measure: Change from pre-walking to immediately post-walking in Conditioned Pain Modulation (CPM)
timeFrame: pre-walking, immediately post-walking
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University
Study officials:
affiliation: Aalborg University
name: Alison H Chang
role: PRINCIPAL_INVESTIGATOR
affiliation: Aalborg University
name: Michael Rathleff
role: STUDY_DIRECTOR
References: