Effect of Combined Interventions on Pressure Pain Threshold

Study Overview
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Brief Summary
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The effect of mobilizations on decrease of peripheral and central sensitivity has been proven in KOA. Furthermore, the effect of conservative therapy has also been proven in the increase of pain threshold in KOA. However, no study has investigated the effect of these interventions combined till date in KOA. The aim of the present study is to investigate the short-term and long-term effect of end-range mobilization in addition to conservative therapy on decrease of pressure pain threshold in KOA.

Detailed Description
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The positive effect of different manual mobilizations have been proven in the management of knee osteoarthritis (KOA). Pressure pain threshold, as a measure of somatosensory function, is a well-applied measurement technique for the pain perception in KOA. The effect of mobilizations on decrease of peripheral and central sensitivity has been proven in KOA. Furthermore, few studies has revealed the effect of conservative therapy as an effective intervention in the increase of pain threshold. However, no study has investigated the effect of these interventions combined till date in KOA, which could give a long-lasting effect in the decrease of sensitization in KOA. Therefore, the aim of the present study is to investigate the short-term and long-term effect of end-range mobilization in addition to conservative therapy on decrease of pressure pain threshold in KOA.

Official Title
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Effect of End-range Mobilization in Addition to Conservative Therapy on Decrease of Pressure Pain Threshold

Conditions
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Osteo Arthritis Knee

Intervention / Treatment
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* Procedure: end-range mobilization
* Procedure: Non end-range mobilization
* Procedure: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical classification criteria of knee osteoarthritis according to the American College of Rheumatology categorization as End of Range Problem based on Maitland manual therapy unilateral/bilateral moderate-to-severe symptomatic tibiofemoral KOA 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 class II. obesity (body mass index>35kg/m2) 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 aid contraindication for manual therapy complex regional pain syndrome cognitive impairment

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

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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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 knee joint | Procedure: end-range mobilization<br>* accessory technique applied on the tibiofemoral joint with the aim of increasing extensibility of the periarticular tissues<br>|
| Experimental: Non end-range mobilization<br>Non end-range mobilization performed in loose-packed position of the knee joint | Procedure: Non end-range mobilization<br>* accessory technique applied on the tibiofemoral joint with the aim of alleviating pain<br>|
| Placebo Comparator: Control<br>Sham technique performed in loose-packed position of the knee joint | Procedure: Control<br>* hands-on cutaneous technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of peripheral sensitivity | peripheral sensitivity (pressure pain threshold) assessed at the local knee | following 3-week rehabilitation | 
| change of peripheral sensitivity | peripheral sensitivity (pressure pain threshold) assessed at the local knee | following 3-month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of central sensitivity | central sensitivity (pressure pain threshold) assessed at the ipsilateral m. extensor carpi radialis longus | following 3-week rehabilitation | 
| change of central sensitivity | central sensitivity (pressure pain threshold) assessed at the ipsilateral m. extensor carpi radialis longus | following 3-month | 
| change of general pain intensity | general pain intensity from the previous week using the Visual Analogue Scale | following 3-week rehabilitation | 
| change of general pain intensity | general pain intensity from the previous week using the Visual Analogue Scale | following 3-month | 
| change of Timed Up and Go test | short test for measuring physical performance | following 3-week rehabilitation | 
| change of Timed Up and Go test | short test for measuring physical performance | following 3-month | 
| change of pain intensity during physical performance | pain intensity measured during the previously mentioned physical performance test using the 0-10 Numerating Pain Rating Scale, where 0 indicate no pain and 10 indicate worst imaginable pain | following 3-week rehabilitation | 
| change of pain during physical performance | pain intensity measured during the previously mentioned physical performance test using the 0-10 Numerating Pain Rating Scale, where 0 indicate no pain and 10 indicate worst imaginable pain | following 3-month | 
| degree of knee flexion during passive movement at the onset of knee pain | measurement of degree of knee flexion during passive movement at the onset of knee pain | following 3-week rehabilitation | 
| degree of knee flexion during passive movement at the onset of knee pain | measurement of degree of knee flexion during passive movement at the onset of knee pain | following 3-month | 
| strength of resistance of passive knee flexion at the onset of knee pain | measurement of strength of resistance arising from the anterior located tissues around the knee during passive knee flexion at the onset of pain | following 3-week rehabilitation | 
| strength of resistance of passive knee flexion at the onset of knee pain | measurement of strength of resistance arising from the anterior located tissues around the knee during passive knee flexion at the onset of pain | following 3-month | 

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