Effect of Combined Interventions on Pressure Pain Threshold
Effect of End-range Mobilization in Addition to Conservative Therapy on Decrease of Pressure Pain Threshold
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2020
CompletedStudy Start
First participant enrolled
March 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 4, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 4, 2020
CompletedFirst Posted
Study publicly available on registry
March 17, 2020
CompletedMarch 17, 2020
March 1, 2020
Same day
March 4, 2020
March 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (12)
change of central sensitivity
following 3-week rehabilitation
change of central sensitivity
following 3-month
change of general pain intensity
following 3-week rehabilitation
change of general pain intensity
following 3-month
change of Timed Up and Go test
following 3-week rehabilitation
- +7 more secondary outcomes
Study Arms (3)
End-range mobilization
EXPERIMENTALEnd-range mobilization performed in end-position of the knee joint
Non end-range mobilization
EXPERIMENTALNon end-range mobilization performed in loose-packed position of the knee joint
Control
PLACEBO COMPARATORSham technique performed in loose-packed position of the knee joint
Interventions
accessory technique applied on the tibiofemoral joint with the aim of increasing extensibility of the periarticular tissues
accessory technique applied on the tibiofemoral joint with the aim of alleviating pain
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Miklós Pozsgai
Harkány, Please Select, 7815, Hungary
Related Publications (4)
McAlindon TE, Bannuru RR, Sullivan MC, Arden NK, Berenbaum F, Bierma-Zeinstra SM, Hawker GA, Henrotin Y, Hunter DJ, Kawaguchi H, Kwoh K, Lohmander S, Rannou F, Roos EM, Underwood M. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthritis Cartilage. 2014 Mar;22(3):363-88. doi: 10.1016/j.joca.2014.01.003. Epub 2014 Jan 24.
PMID: 24462672BACKGROUNDBajaj 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.
PMID: 11427321BACKGROUNDImamura 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.
PMID: 18821657BACKGROUNDMoss 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.
PMID: 16777467BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Miklós Pozsgai, MSc
Zsigmondy Vilmos Spa and Balneological Hospital of Harkány
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2020
First Posted
March 17, 2020
Study Start
March 4, 2020
Primary Completion
March 4, 2020
Study Completion
March 4, 2020
Last Updated
March 17, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share