Clinical trial NCT04273906: End-range Mobilization on Pressure Pain Threshold
Official title: End-range Mobilization Effecting Pressure Pain Threshold in Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Musculoskeletal Manipulations
Osteoarthritis, Knee
Pain Threshold
Lead sponsor: University of Pecs
Sponsor class: OTHER
First posted: 2020-02-18
Enrollment: 40
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pain in knee osteoarthritis (OA) represents increased pain intensity due to peripheral and central sensitivity. Pressure pain threshold (PPT) is a widely applied (used) method for measuring the magnitude of peripheral and central sensitivity in knee OA. Among several manual therapy techniques increasing PPT in knee OA, the effect of end-range mobilization has not been evaluated so far. The aim of this study was to investigate the immediate effect of end-range mobilization compared to placebo on increase of PPT and some function-related measures.

Detailed description: Knee osteoarthritis (OA) is the most common form of arthritis contributing to a major cause of disability worldwide. Although many mechanisms may contribute to knee pain severity, the patient-reported hyperalgesia can be attributed to peripheral and central sensitivity in knee OA. Pressure pain threshold (PPT) measurement is a simple and commonly applied method for measuring somatosensory function in musculoskeletal disorders, just as in knee OA. Many trials have shown a lower PPT value in knee OA underlining the presence of peripheral and central sensitivity compared to healthy controls.

Manual therapy techniques, as a preferred treatment option, may not only alleviate pain, but also increase pain tolerance to locally applied mechanical pressure. Positive results of different manual therapy techniques on increase of PPT has been reported in knee OA. End-range manual therapy is an option for the decrease of sensitivity in knee OA; however, the effect of end-range mobilization has not been evaluated so far in knee OA.

Eligibility criteria: Inclusion Criteria:

* the clinical classification criteria of knee OA according to the American College of Rheumatology
* Categorization of patients as End Of Range Problem based on Maitland manual therapy
* female patients aged between 60 and 80 years
* uni/bilateral moderate-to-severe symptomatic tibiofemoral knee osteoarthritis with radiographic evidence of Kellgren-Lawrence scale 2 or 3
* pain during weight-bearing activities at least within 6 months
* at least 90° knee flexion
* sufficient mental status.

Exclusion Criteria:

* acute inflammation of the knee
* total knee replacement in the opposite side
* severe degenerative lumbar spine disease (e.g. spondylolisthesis)
* systemic inflammatory arthritic or neurological condition
* physiotherapy/balneotherapy attendance or manual therapy within 3 months
* intraarticular injections in the prior 12 months
* use of walking aids
* contraindication for manual therapy
* complex regional pain syndrome
* cognitive impairment

Primary outcomes:
measure: PPT of the knee
timeFrame: 30 minutes
Secondary outcomes:
measure: PPT of the m. Extensor Carpi Radialis Longus (ECRL)
timeFrame: 30 minutes
measure: General Pain Intensity
timeFrame: 30 minutes
measure: Timed Up and Go test
timeFrame: 30 minutes
measure: Pain intensity during Timed Up and Go test
timeFrame: 30 minutes
measure: Passive tension of the knee
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Harkány
country: Hungary
facility: Miklós Pozsgai
state: Please Select
Study officials:
affiliation: Zsigmondy Vilmos Spa and Balneological Hospital of Harkány
name: Miklós Pozsgai
role: STUDY_CHAIR
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