Effect of Combined Interventions on Pressure Pain Threshold

Osteo Arthritis Knee Clinical Trial

Official title:

Effect of End-range Mobilization in Addition to Conservative Therapy on Decrease of Pressure Pain Threshold

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04312035
• Other study ID #: ML_PPT_PhysTher
• Status: Completed
• Phase: N/A
• Start date: March 4, 2020
• Est. completion date: March 4, 2020

Study information

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

Clinical Trial Summary

The effect of mobilizations on decrease of peripheral and central sensitivity has been proven in KOA. Furthermore, the effect of conservative therapy has also been proven in the increase of pain threshold in KOA. However, no study has investigated the effect of these interventions combined till date in KOA.

The aim of the present study is to investigate the short-term and long-term effect of end-range mobilization in addition to conservative therapy on decrease of pressure pain threshold in KOA.

Description:

The positive effect of different manual mobilizations have been proven in the management of knee osteoarthritis (KOA). Pressure pain threshold, as a measure of somatosensory function, is a well-applied measurement technique for the pain perception in KOA. The effect of mobilizations on decrease of peripheral and central sensitivity has been proven in KOA. Furthermore, few studies has revealed the effect of conservative therapy as an effective intervention in the increase of pain threshold. However, no study has investigated the effect of these interventions combined till date in KOA, which could give a long-lasting effect in the decrease of sensitization in KOA.

Therefore, the aim of the present study is to investigate the short-term and long-term effect of end-range mobilization in addition to conservative therapy on decrease of pressure pain threshold in KOA.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 4, 2020
• Est. primary completion date: March 4, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years to 80 Years

Eligibility

Inclusion Criteria:

• clinical classification criteria of knee osteoarthritis according to the American College of Rheumatology

• categorization as End of Range Problem based on Maitland manual therapy

• unilateral/bilateral moderate-to-severe symptomatic tibiofemoral KOA 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

• class II. obesity (body mass index>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 aid

• contraindication for manual therapy

• complex regional pain syndrome

• cognitive impairment

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• end-range mobilization
accessory technique applied on the tibiofemoral joint with the aim of increasing extensibility of the periarticular tissues
• Non end-range mobilization
accessory technique applied on the tibiofemoral joint with the aim of alleviating pain
• Control
hands-on cutaneous technique

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 (4)

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

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

McAlindon TE, Bannuru RR, Sullivan MC, Arden NK, Berenbaum F, Bierma-Zeinstra SM, Hawker GA, Henrotin Y, Hunter DJ, Kawaguchi H, Kwoh K, Lohmander S, Rannou F, Roos EM, Underwood M. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthritis Cartilage. 2014 Mar;22(3):363-88. doi: 10.1016/j.joca.2014.01.003. Epub 2014 Jan 24. — View Citation

Moss P, Sluka K, Wright A. The initial effects of knee joint mobilization on osteoarthritic hyperalgesia. Man Ther. 2007 May;12(2):109-18. Epub 2006 Jun 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of peripheral sensitivity	peripheral sensitivity (pressure pain threshold) assessed at the local knee	following 3-week rehabilitation
Primary	change of peripheral sensitivity	peripheral sensitivity (pressure pain threshold) assessed at the local knee	following 3-month
Secondary	change of central sensitivity	central sensitivity (pressure pain threshold) assessed at the ipsilateral m. extensor carpi radialis longus	following 3-week rehabilitation
Secondary	change of central sensitivity	central sensitivity (pressure pain threshold) assessed at the ipsilateral m. extensor carpi radialis longus	following 3-month
Secondary	change of general pain intensity	general pain intensity from the previous week using the Visual Analogue Scale	following 3-week rehabilitation
Secondary	change of general pain intensity	general pain intensity from the previous week using the Visual Analogue Scale	following 3-month
Secondary	change of Timed Up and Go test	short test for measuring physical performance	following 3-week rehabilitation
Secondary	change of Timed Up and Go test	short test for measuring physical performance	following 3-month
Secondary	change of pain intensity during physical performance	pain intensity measured during the previously mentioned physical performance test using the 0-10 Numerating Pain Rating Scale, where 0 indicate no pain and 10 indicate worst imaginable pain	following 3-week rehabilitation
Secondary	change of pain during physical performance	pain intensity measured during the previously mentioned physical performance test using the 0-10 Numerating Pain Rating Scale, where 0 indicate no pain and 10 indicate worst imaginable pain	following 3-month
Secondary	degree of knee flexion during passive movement at the onset of knee pain	measurement of degree of knee flexion during passive movement at the onset of knee pain	following 3-week rehabilitation
Secondary	degree of knee flexion during passive movement at the onset of knee pain	measurement of degree of knee flexion during passive movement at the onset of knee pain	following 3-month
Secondary	strength of resistance of passive knee flexion at the onset of knee pain	measurement of strength of resistance arising from the anterior located tissues around the knee during passive knee flexion at the onset of pain	following 3-week rehabilitation
Secondary	strength of resistance of passive knee flexion at the onset of knee pain	measurement of strength of resistance arising from the anterior located tissues around the knee during passive knee flexion at the onset of pain	following 3-month