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End-range Mobilization on Pressure Pain Threshold

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
End-range mobilization
Placebo technique
Sponsored by
University of Pecs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Musculoskeletal Manipulations, Osteoarthritis, Knee, Pain Threshold

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Miklós Pozsgai

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

End-range mobilization

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

PPT of the knee
pressure pain threshold at the knee

Secondary Outcome Measures

PPT of the m. Extensor Carpi Radialis Longus (ECRL)
pressure pain threshold at the ECRL
General Pain Intensity
General Pain Intensity measured with Visual Analogue Scale (VAS)
Timed Up and Go test
Timed Up and Go test measuring functional capacity
Pain intensity during Timed Up and Go test
associated pain intensity during the Timed Up and Go test
Passive tension of the knee
Passive tension of the knee at the beginning of pain

Full Information

First Posted
February 12, 2020
Last Updated
October 15, 2020
Sponsor
University of Pecs
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1. Study Identification

Unique Protocol Identification Number
NCT04273906
Brief Title
End-range Mobilization on Pressure Pain Threshold
Official Title
End-range Mobilization Effecting Pressure Pain Threshold in Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
February 12, 2020 (Actual)
Primary Completion Date
March 12, 2020 (Actual)
Study Completion Date
March 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pecs

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Musculoskeletal Manipulations, Osteoarthritis, Knee, Pain Threshold

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
End-range mobilization
Arm Type
Experimental
Arm Description
End-range mobilization performed in end-position of the tibiofemoral joints' flexion and extension for 2*3 min
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Hands-on treatment technique performed in end-range of the tibiofemoral joints' flexion and extension for 2*3 min
Intervention Type
Procedure
Intervention Name(s)
End-range mobilization
Intervention Description
End-range mobilization performed in end-range of the tibiofemoral joints' flexion and extension
Intervention Type
Procedure
Intervention Name(s)
Placebo technique
Intervention Description
Hands-on technique performed in end-range of the tibiofemoral joints' flexion and extension
Primary Outcome Measure Information:
Title
PPT of the knee
Description
pressure pain threshold at the knee
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
PPT of the m. Extensor Carpi Radialis Longus (ECRL)
Description
pressure pain threshold at the ECRL
Time Frame
30 minutes
Title
General Pain Intensity
Description
General Pain Intensity measured with Visual Analogue Scale (VAS)
Time Frame
30 minutes
Title
Timed Up and Go test
Description
Timed Up and Go test measuring functional capacity
Time Frame
30 minutes
Title
Pain intensity during Timed Up and Go test
Description
associated pain intensity during the Timed Up and Go test
Time Frame
30 minutes
Title
Passive tension of the knee
Description
Passive tension of the knee at the beginning of pain
Time Frame
30 minutes

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female patients are enrolled due to patient characteristics from other study
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miklós Pozsgai
Organizational Affiliation
Zsigmondy Vilmos Spa and Balneological Hospital of Harkány
Official's Role
Study Chair
Facility Information:
Facility Name
Miklós Pozsgai
City
Harkány
State/Province
Please Select
ZIP/Postal Code
7815
Country
Hungary

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16714085
Citation
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.
Results Reference
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PubMed Identifier
20346403
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.
Results Reference
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PubMed Identifier
11427321
Citation
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.
Results Reference
background
PubMed Identifier
18821657
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.
Results Reference
background
PubMed Identifier
22120461
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.
Results Reference
background
PubMed Identifier
14622705
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. doi: 10.1016/s1526-5900(03)00557-1.
Results Reference
background
PubMed Identifier
29308949
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.
Results Reference
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PubMed Identifier
25440203
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.
Results Reference
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End-range Mobilization on Pressure Pain Threshold

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