End-range Mobilization on Pressure Pain Threshold

Knee Osteoarthritis Clinical Trial

Official title:

End-range Mobilization Effecting Pressure Pain Threshold in Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04273906
• Other study ID #: MaitlandKneePPT
• Status: Completed
• Phase: N/A
• Start date: February 12, 2020
• Est. completion date: March 12, 2020

Study information

• Verified date: October 2020
• Source: University of Pecs
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 12, 2020
• Est. primary completion date: March 12, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• End-range mobilization
End-range mobilization performed in end-range of the tibiofemoral joints' flexion and extension
• Placebo technique
Hands-on technique performed in end-range of the tibiofemoral joints' flexion and extension

Locations

Country	Name	City	State
Hungary	Miklós Pozsgai	Harkány	Please Select

Sponsors (1)

Lead Sponsor	Collaborator
University of Pecs

Country where clinical trial is conducted

Hungary, 

References & Publications (8)

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):107-14. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Kidd BL. Osteoarthritis and joint pain. Pain. 2006 Jul;123(1-2):6-9. Epub 2006 May 22. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PPT of the knee	pressure pain threshold at the knee	30 minutes
Secondary	PPT of the m. Extensor Carpi Radialis Longus (ECRL)	pressure pain threshold at the ECRL	30 minutes
Secondary	General Pain Intensity	General Pain Intensity measured with Visual Analogue Scale (VAS)	30 minutes
Secondary	Timed Up and Go test	Timed Up and Go test measuring functional capacity	30 minutes
Secondary	Pain intensity during Timed Up and Go test	associated pain intensity during the Timed Up and Go test	30 minutes
Secondary	Passive tension of the knee	Passive tension of the knee at the beginning of pain	30 minutes