Clinical trial NCT04312035: Effect of Combined Interventions on Pressure Pain Threshold
Official title: Effect of End-range Mobilization in Addition to Conservative Therapy on Decrease of Pressure Pain Threshold
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteo Arthritis Knee
Keywords: Musculoskeletal Manipulations
Osteoarthritis, Knee
Pain Threshold
Conservative Treatment
Lead sponsor: University of Pecs
Sponsor class: OTHER
First posted: 2020-03-17
Enrollment: 60
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: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: change of peripheral sensitivity
timeFrame: following 3-week rehabilitation
measure: change of peripheral sensitivity
timeFrame: following 3-month
Secondary outcomes:
measure: change of central sensitivity
timeFrame: following 3-week rehabilitation
measure: change of central sensitivity
timeFrame: following 3-month
measure: change of general pain intensity
timeFrame: following 3-week rehabilitation
measure: change of general pain intensity
timeFrame: following 3-month
measure: change of Timed Up and Go test
timeFrame: following 3-week rehabilitation
measure: change of Timed Up and Go test
timeFrame: following 3-month
measure: change of pain intensity during physical performance
timeFrame: following 3-week rehabilitation
measure: change of pain during physical performance
timeFrame: following 3-month
measure: degree of knee flexion during passive movement at the onset of knee pain
timeFrame: following 3-week rehabilitation
measure: degree of knee flexion during passive movement at the onset of knee pain
timeFrame: following 3-month
measure: strength of resistance of passive knee flexion at the onset of knee pain
timeFrame: following 3-week rehabilitation
measure: strength of resistance of passive knee flexion at the onset of knee pain
timeFrame: following 3-month
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, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Bajaj P, Bajaj P, Graven-Nielsen T, Arendt-Nielsen L. Osteoarthritis and its association with muscle hyperalgesia: an experimental controlled study. Pain. 2001 Aug;93(2):107-114. doi: 10.1016/S0304-3959(01)00300-1.
citation: Imamura M, Imamura ST, Kaziyama HH, Targino RA, Hsing WT, de Souza LP, Cutait MM, Fregni F, Camanho GL. Impact of nervous system hyperalgesia on pain, disability, and quality of life in patients with knee osteoarthritis: a controlled analysis. Arthritis Rheum. 2008 Oct 15;59(10):1424-31. doi: 10.1002/art.24120.
citation: Moss P, Sluka K, Wright A. The initial effects of knee joint mobilization on osteoarthritic hyperalgesia. Man Ther. 2007 May;12(2):109-18. doi: 10.1016/j.math.2006.02.009. Epub 2006 Jun 13.