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CompletedNCT04273906Updated Oct 19, 2020

End-range Mobilization on Pressure Pain Threshold

An interventional study of End-range mobilization and Placebo technique in Knee Osteoarthritis, sponsored by University of Pecs. Completed at 1 site in Hungary. Open to female participants aged 60 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-10-19.

Sponsored by University of Pecs · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
60 Years to 80 Years
Sex
Female
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Knee Osteoarthritis

Keywords

  • Musculoskeletal Manipulations
  • Osteoarthritis, Knee
  • Pain Threshold
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 583 are open to participants now.

This study's enrollment of 40 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

University of Pecs is the lead sponsor of 100 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    End-range mobilization

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

    Procedure: End-range mobilization · Procedure: Placebo technique

  • Placebo comparator
    Placebo

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

    Procedure: End-range mobilization · Procedure: Placebo technique

Interventions

  • ProcedureEnd-range mobilization

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

  • ProcedurePlacebo technique

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

06

What researchers measure

Primary outcomes

  1. PPT of the knee

    pressure pain threshold at the knee

    Time frame: 30 minutes

Secondary outcomes

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

    pressure pain threshold at the ECRL

    Time frame: 30 minutes

  2. General Pain Intensity

    General Pain Intensity measured with Visual Analogue Scale (VAS)

    Time frame: 30 minutes

  3. Timed Up and Go test

    Timed Up and Go test measuring functional capacity

    Time frame: 30 minutes

  4. Pain intensity during Timed Up and Go test

    associated pain intensity during the Timed Up and Go test

    Time frame: 30 minutes

  5. Passive tension of the knee

    Passive tension of the knee at the beginning of pain

    Time frame: 30 minutes

07

Study locations

1 site
  • Miklós Pozsgai
    Harkány, Please Select 7815, Hungary
08

References and documents

Publications

  • 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. PubMed 16714085 ↗
  • 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. PubMed 20346403 ↗
  • 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. PubMed 11427321 ↗
  • 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. PubMed 18821657 ↗
  • 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. PubMed 22120461 ↗
  • 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. PubMed 14622705 ↗
  • 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. PubMed 29308949 ↗
  • 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. PubMed 25440203 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 19, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04273906
Lead sponsor
University of Pecs
Responsible party
Sponsor
First posted
Feb 18, 2020
Start date
Feb 12, 2020
Primary completion
Mar 12, 2020
Completion
Mar 12, 2020
Last update
Oct 19, 2020

Study contacts

Miklós Pozsgai
study chair · Zsigmondy Vilmos Spa and Balneological Hospital of Harkány

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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