Effect of Combined Interventions on Pressure Pain Threshold

NCT ID: NCT04312035

Last Updated: 2020-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-04

Study Completion Date

2020-03-04

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.

Conditions

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Osteo Arthritis Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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End-range mobilization

End-range mobilization performed in end-position of the knee joint

Group Type EXPERIMENTAL

end-range mobilization

Intervention Type PROCEDURE

accessory technique applied on the tibiofemoral joint with the aim of increasing extensibility of the periarticular tissues

Non end-range mobilization

Non end-range mobilization performed in loose-packed position of the knee joint

Group Type EXPERIMENTAL

Non end-range mobilization

Intervention Type PROCEDURE

accessory technique applied on the tibiofemoral joint with the aim of alleviating pain

Control

Sham technique performed in loose-packed position of the knee joint

Group Type PLACEBO_COMPARATOR

Control

Intervention Type PROCEDURE

hands-on cutaneous technique

Interventions

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end-range mobilization

accessory technique applied on the tibiofemoral joint with the aim of increasing extensibility of the periarticular tissues

Intervention Type PROCEDURE

Non end-range mobilization

accessory technique applied on the tibiofemoral joint with the aim of alleviating pain

Intervention Type PROCEDURE

Control

hands-on cutaneous technique

Intervention Type PROCEDURE

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
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Pecs

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Miklós Pozsgai, MSc

Role: PRINCIPAL_INVESTIGATOR

Zsigmondy Vilmos Spa and Balneological Hospital of Harkány

Locations

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Miklós Pozsgai

Harkány, Please Select, Hungary

Site Status

Countries

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Hungary

References

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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.

Reference Type BACKGROUND
PMID: 24462672 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11427321 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18821657 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16777467 (View on PubMed)

Other Identifiers

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ML_PPT_PhysTher

Identifier Type: -

Identifier Source: org_study_id

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