NCT04629625

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2020

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2020

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 16, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

September 8, 2022

Status Verified

September 1, 2022

Enrollment Period

3 months

First QC Date

October 28, 2020

Last Update Submit

September 4, 2022

Conditions

Knee Osteoarthritis

Keywords

Musculoskeletal ManipulationsOsteoarthritis, KneePain Threshold

Outcome Measures

Primary Outcomes (1)

  • PPT of the knee

    pressure pain threshold of the knee

    30 minutes

Secondary Outcomes (7)

  • PPT of the m. Extensor Carpi Radialis Longus (ECRL)

    30 minutes

  • PPT of the m. Extensor Carpi Radialis Longus (ECRL)

    every 2nd day for the following 6-day

  • Timed Up and Go test

    30 minutes

  • Timed Up and Go test

    every 2nd day for the following 6-day

  • Strength of passive tension of the knee

    30 minutes

  • +2 more secondary outcomes

Study Arms (3)

End-range mobilization

EXPERIMENTAL

End-range mobilization performed in end-position of the tibiofemoral joints' flexion and extension for 2\*3 min

Biological: End-range mobilization

Non end-range mobilization

ACTIVE COMPARATOR

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

Biological: Non end-range mobilization

Placebo

PLACEBO COMPARATOR

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

Biological: Placebo

Interventions

End-range mobilizationBIOLOGICAL

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

End-range mobilization
Non end-range mobilizationBIOLOGICAL

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

Non end-range mobilization
PlaceboBIOLOGICAL

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

Placebo

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Harkány Thermal Rehabilitation Centre

Harkány, Please Select, 7815, Hungary

Location

Miklós Pozsgai

Harkány, Please Select, 7815, Hungary

Location

Related Publications (8)

  • 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.

    PMID: 16714085BACKGROUND

  • 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.

    PMID: 20346403BACKGROUND

  • 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.

    PMID: 11427321BACKGROUND

  • 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.

    PMID: 18821657BACKGROUND

  • 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.

    PMID: 22120461BACKGROUND

  • 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.

    PMID: 14622705BACKGROUND

  • 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.

    PMID: 29308949BACKGROUND

  • 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.

    PMID: 25440203BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Miklós Pozsgai

    Harkány Thermal Rehabilitation Centre

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2020

First Posted

November 16, 2020

Study Start

October 10, 2020

Primary Completion

January 2, 2021

Study Completion

May 1, 2021

Last Updated

September 8, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

HU(2)