Effect of Combined Interventions on Pressure Pain Threshold

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

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.

Study Overview

• Status: Completed
• Conditions: Osteo Arthritis Knee
• Intervention / Treatment: Procedure: end-range mobilization; Procedure: Non end-range mobilization; Procedure: Control

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hungary
  • Please Select
    • Harkány, Please Select, Hungary, 7815
      • Miklós Pozsgai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: End-range mobilization; End-range mobilization performed in end-position of the knee joint	Procedure: end-range mobilization; accessory technique applied on the tibiofemoral joint with the aim of increasing extensibility of the periarticular tissues
Experimental: Non end-range mobilization; Non end-range mobilization performed in loose-packed position of the knee joint	Procedure: Non end-range mobilization; accessory technique applied on the tibiofemoral joint with the aim of alleviating pain
Placebo Comparator: Control; Sham technique performed in loose-packed position of the knee joint	Procedure: Control; hands-on cutaneous technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of peripheral sensitivity	peripheral sensitivity (pressure pain threshold) assessed at the local knee	following 3-week rehabilitation
change of peripheral sensitivity	peripheral sensitivity (pressure pain threshold) assessed at the local knee	following 3-month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of central sensitivity	central sensitivity (pressure pain threshold) assessed at the ipsilateral m. extensor carpi radialis longus	following 3-week rehabilitation
change of central sensitivity	central sensitivity (pressure pain threshold) assessed at the ipsilateral m. extensor carpi radialis longus	following 3-month
change of general pain intensity	general pain intensity from the previous week using the Visual Analogue Scale	following 3-week rehabilitation
change of general pain intensity	general pain intensity from the previous week using the Visual Analogue Scale	following 3-month
change of Timed Up and Go test	short test for measuring physical performance	following 3-week rehabilitation
change of Timed Up and Go test	short test for measuring physical performance	following 3-month
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Pecs
• Investigators: Principal Investigator: Miklós Pozsgai, MSc, Zsigmondy Vilmos Spa and Balneological Hospital of Harkány

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• Moss P, Sluka K, Wright A. The initial effects of knee joint mobilization on osteoarthritic hyperalgesia. Man Ther. 2007 May;12(2):109-18. doi: 10.1016/j.math.2006.02.009. Epub 2006 Jun 13.

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2020
• Primary Completion (Actual): March 4, 2020
• Study Completion (Actual): March 4, 2020

Study Registration Dates

• First Submitted: March 4, 2020
• First Submitted That Met QC Criteria: March 13, 2020
• First Posted (Actual): March 17, 2020

Study Record Updates

• Last Update Posted (Actual): March 17, 2020
• Last Update Submitted That Met QC Criteria: March 13, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Conservative Treatment; Pain Threshold; Osteoarthritis, Knee; Musculoskeletal Manipulations
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: ML_PPT_PhysTher

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No