NCT04273906

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 (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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Feb 2020

Shorter than P25 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

February 12, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

February 12, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 18, 2020

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2020

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

29 days

First QC Date

February 12, 2020

Last Update Submit

October 15, 2020

Conditions

Knee Osteoarthritis

Keywords

Musculoskeletal ManipulationsOsteoarthritis, KneePain Threshold

Outcome Measures

Primary Outcomes (1)

  • PPT of the knee

    pressure pain threshold at the knee

    30 minutes

Secondary Outcomes (5)

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

    30 minutes

  • General Pain Intensity

    30 minutes

  • Timed Up and Go test

    30 minutes

  • Pain intensity during Timed Up and Go test

    30 minutes

  • Passive tension of the knee

    30 minutes

Study Arms (2)

End-range mobilization

EXPERIMENTAL

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

Procedure: End-range mobilizationProcedure: Placebo technique

Placebo

PLACEBO COMPARATOR

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

Procedure: End-range mobilizationProcedure: Placebo technique

Interventions

End-range mobilizationPROCEDURE

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

End-range mobilizationPlacebo
Placebo techniquePROCEDURE

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

End-range mobilizationPlacebo

Eligibility Criteria

Age60 Years - 80 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale patients are enrolled due to patient characteristics from other study
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 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

    Zsigmondy Vilmos Spa and Balneological Hospital of Harkány

    STUDY CHAIR

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

February 12, 2020

First Posted

February 18, 2020

Study Start

February 12, 2020

Primary Completion

March 12, 2020

Study Completion

March 12, 2020

Last Updated

October 19, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

HU(1)