End-range Mobilization on Pressure Pain Threshold

NCT ID: NCT04273906

Last Updated: 2020-10-19

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-12

Study Completion Date

2020-03-12

Brief Summary

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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

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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.

Conditions

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Knee Osteoarthritis

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 tibiofemoral joints' flexion and extension for 2\*3 min

Group Type EXPERIMENTAL

End-range mobilization

Intervention Type PROCEDURE

End-range mobilization performed in end-range of the tibiofemoral joints' flexion and extension

Placebo technique

Intervention Type PROCEDURE

Hands-on technique performed in end-range of the tibiofemoral joints' flexion and extension

Placebo

Hands-on treatment technique performed in end-range of the tibiofemoral joints' flexion and extension for 2\*3 min

Group Type PLACEBO_COMPARATOR

End-range mobilization

Intervention Type PROCEDURE

End-range mobilization performed in end-range of the tibiofemoral joints' flexion and extension

Placebo technique

Intervention Type PROCEDURE

Hands-on technique performed in end-range of the tibiofemoral joints' flexion and extension

Interventions

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End-range mobilization

End-range mobilization performed in end-range of the tibiofemoral joints' flexion and extension

Intervention Type PROCEDURE

Placebo technique

Hands-on technique performed in end-range of the tibiofemoral joints' flexion and extension

Intervention Type PROCEDURE

Eligibility Criteria

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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
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

Role: STUDY_CHAIR

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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Kidd BL. Osteoarthritis and joint pain. Pain. 2006 Jul;123(1-2):6-9. doi: 10.1016/j.pain.2006.04.009. Epub 2006 May 22. No abstract available.

Reference Type BACKGROUND
PMID: 16714085 (View on PubMed)

Wise BL, Niu J, Zhang Y, Wang N, Jordan JM, Choy E, Hunter DJ. Psychological factors and their relation to osteoarthritis pain. Osteoarthritis Cartilage. 2010 Jul;18(7):883-7. doi: 10.1016/j.joca.2009.11.016. Epub 2010 Mar 24.

Reference Type BACKGROUND
PMID: 20346403 (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)

Wylde V, Palmer S, Learmonth ID, Dieppe P. Somatosensory abnormalities in knee OA. Rheumatology (Oxford). 2012 Mar;51(3):535-43. doi: 10.1093/rheumatology/ker343. Epub 2011 Nov 24.

Reference Type BACKGROUND
PMID: 22120461 (View on PubMed)

Hendiani JA, Westlund KN, Lawand N, Goel N, Lisse J, McNearney T. Mechanical sensation and pain thresholds in patients with chronic arthropathies. J Pain. 2003 May;4(4):203-11. doi: 10.1016/s1526-5900(03)00557-1.

Reference Type BACKGROUND
PMID: 14622705 (View on PubMed)

Kaya Mutlu E, Ercin E, Razak Ozdincler A, Ones N. A comparison of two manual physical therapy approaches and electrotherapy modalities for patients with knee osteoarthritis: A randomized three arm clinical trial. Physiother Theory Pract. 2018 Aug;34(8):600-612. doi: 10.1080/09593985.2018.1423591. Epub 2018 Jan 8.

Reference Type BACKGROUND
PMID: 29308949 (View on PubMed)

Khademi-Kalantari K, Mahmoodi Aghdam S, Akbarzadeh Baghban A, Rezayi M, Rahimi A, Naimee S. Effects of non-surgical joint distraction in the treatment of severe knee osteoarthritis. J Bodyw Mov Ther. 2014 Oct;18(4):533-9. doi: 10.1016/j.jbmt.2013.12.001. Epub 2013 Dec 11.

Reference Type BACKGROUND
PMID: 25440203 (View on PubMed)

Other Identifiers

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MaitlandKneePPT

Identifier Type: -

Identifier Source: org_study_id

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