End-range Mobilization on Time Curve of Pressure Pain Threshold

NCT ID: NCT04629625

Last Updated: 2022-09-08

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

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-10

Study Completion Date

2021-05-01

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 technique for measuring the magnitude of peripheral and central sensitivity in knee OA. Despite several manual therapy techniques has been proven to increase PPT in knee OA, the effect of end-range mobilization on the time curve of PPT has not been evaluated so far in knee OA. The aim of this study was to investigate the effect of end-range mobilization on the time curve of PPT and some function-related measures in knee OA.

Detailed Description

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Knee osteoarthritis (OA) is the most common form of arthritis leading to a major 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. Amongst quantitative sensory testing methods, 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 presented lower PPT in knee OA compared to healthy controls underlining the presence of peripheral and central sensitivity.

The different joint-based mobilization techniques may not only alleviate pain, but also increase pain tolerance to the locally applied mechanical pressure. Positive results of these techniques on increase of PPT has been reported in knee OA; however, the time curve of PPT has not evaluated so far in knee OA. Therefore, the aim of this study was to investigate the effect of end-range mobilization on the time curve of PPT and some function-related measures 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

SINGLE

Participants

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 BIOLOGICAL

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

Non end-range mobilization

Non end-range mobilization performed in tibiofemoral joints' loose position

Group Type ACTIVE_COMPARATOR

Non end-range mobilization

Intervention Type BIOLOGICAL

Non end-range mobilization performed in tibiofemoral joints' loose position

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

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 BIOLOGICAL

Non end-range mobilization

Non end-range mobilization performed in tibiofemoral joints' loose position

Intervention Type BIOLOGICAL

Placebo

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

Intervention Type BIOLOGICAL

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 manual therapy
* unilateral/bilateral symptomatic tibiofemoral knee osteoarthritis with radiographic evidence of Kellgren-Lawrence scale between 1 and 3
* pain during weight-bearing activities at least within 6 months
* sufficient mental status

Exclusion Criteria

* acute inflammation of the knee
* class II. obesity (body mass index, BMI\>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 aids
* contraindication for manual therapy
* complex regional pain syndrome
* cognitive impairment
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

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

Harkány Thermal Rehabilitation Centre

Locations

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Harkány Thermal Rehabilitation Centre

Harkány, Please Select, Hungary

Site Status

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_Time Curve

Identifier Type: -

Identifier Source: org_study_id

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