End-range Mobilization on Pressure Pain Threshold

Study Overview
=================
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.

Official Title
-----------------
End-range Mobilization Effecting Pressure Pain Threshold in Knee Osteoarthritis

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Procedure: End-range mobilization
* Procedure: Placebo technique


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: End-range mobilization<br>End-range mobilization performed in end-position of the tibiofemoral joints' flexion and extension for 2*3 min | Procedure: End-range mobilization<br>* End-range mobilization performed in end-range of the tibiofemoral joints' flexion and extension<br>Procedure: Placebo technique<br>* Hands-on technique performed in end-range of the tibiofemoral joints' flexion and extension<br>|
| Placebo Comparator: Placebo<br>Hands-on treatment technique performed in end-range of the tibiofemoral joints' flexion and extension for 2*3 min | Procedure: End-range mobilization<br>* End-range mobilization performed in end-range of the tibiofemoral joints' flexion and extension<br>Procedure: Placebo technique<br>* Hands-on technique performed in end-range of the tibiofemoral joints' flexion and extension<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PPT of the knee | pressure pain threshold at the knee | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PPT of the m. Extensor Carpi Radialis Longus (ECRL) | pressure pain threshold at the ECRL | 30 minutes | 
| General Pain Intensity | General Pain Intensity measured with Visual Analogue Scale (VAS) | 30 minutes | 
| Timed Up and Go test | Timed Up and Go test measuring functional capacity | 30 minutes | 
| Pain intensity during Timed Up and Go test | associated pain intensity during the Timed Up and Go test | 30 minutes | 
| Passive tension of the knee | Passive tension of the knee at the beginning of pain | 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Musculoskeletal Manipulations, Osteoarthritis, Knee, Pain Threshold