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End-range Mobilization on Time Curve of Pressure Pain Threshold

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
End-range mobilization
Non end-range mobilization
Placebo
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)All SexesDoes 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 manual therapy
  • unilateral/bilateral symptomatic tibiofemoral knee osteoarthritis with radiographic evidence of Kellgren-Lawrence scale between 1 and 3
  • pain during weight-bearing activities at least within 6 months
  • sufficient mental status

Exclusion Criteria:

  • acute inflammation of the knee
  • class II. obesity (body mass index, BMI>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 aids
  • contraindication for manual therapy
  • complex regional pain syndrome
  • cognitive impairment

Sites / Locations

  • Harkány Thermal Rehabilitation Centre
  • Miklós Pozsgai

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

End-range mobilization

Non end-range mobilization

Placebo

Arm Description

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

Non end-range mobilization performed in tibiofemoral joints' loose position

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 of the knee

Secondary Outcome Measures

PPT of the m. Extensor Carpi Radialis Longus (ECRL)
pressure pain threshold at the ECRL
PPT of the m. Extensor Carpi Radialis Longus (ECRL)
pressure pain threshold at the ECRL
Timed Up and Go test
Timed Up and Go test measuring functional capacity
Timed Up and Go test
Timed Up and Go test measuring functional capacity
Strength of passive tension of the knee
Strength of passive tension of the knee measured in Newton at the beginning of pain
Strength of passive tension of the knee
Strength of passive tension of the knee measured in Newton at the beginning of pain
Pressure Pain Threshold measurement of the knee
pressure pain threshold measurement of the knee via hand-held algometer

Full Information

First Posted
October 28, 2020
Last Updated
September 4, 2022
Sponsor
University of Pecs
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1. Study Identification

Unique Protocol Identification Number
NCT04629625
Brief Title
End-range Mobilization on Time Curve of Pressure Pain Threshold
Official Title
The Effect of End-range Mobilization on Time Curve of Pressure Pain Threshold in Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
October 10, 2020 (Actual)
Primary Completion Date
January 2, 2021 (Actual)
Study Completion Date
May 1, 2021 (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
No

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 technique for measuring the magnitude of peripheral and central sensitivity in knee OA. Despite several manual therapy techniques has been proven to increase PPT in knee OA, the effect of end-range mobilization on the time curve of PPT has not been evaluated so far in knee OA. The aim of this study was to investigate the effect of end-range mobilization on the time curve of PPT and some function-related measures in knee OA.
Detailed Description
Knee osteoarthritis (OA) is the most common form of arthritis leading to a major 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. Amongst quantitative sensory testing methods, 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 presented lower PPT in knee OA compared to healthy controls underlining the presence of peripheral and central sensitivity. The different joint-based mobilization techniques may not only alleviate pain, but also increase pain tolerance to the locally applied mechanical pressure. Positive results of these techniques on increase of PPT has been reported in knee OA; however, the time curve of PPT has not evaluated so far in knee OA. Therefore, the aim of this study was to investigate the effect of end-range mobilization on the time curve of PPT and some function-related measures 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
Participant
Allocation
Randomized
Enrollment
66 (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
Non end-range mobilization
Arm Type
Active Comparator
Arm Description
Non end-range mobilization performed in tibiofemoral joints' loose position
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
Biological
Intervention Name(s)
End-range mobilization
Intervention Description
End-range mobilization performed in end-range of the tibiofemoral joints' flexion and extension
Intervention Type
Biological
Intervention Name(s)
Non end-range mobilization
Intervention Description
Non end-range mobilization performed in tibiofemoral joints' loose position
Intervention Type
Biological
Intervention Name(s)
Placebo
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 of 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
PPT of the m. Extensor Carpi Radialis Longus (ECRL)
Description
pressure pain threshold at the ECRL
Time Frame
every 2nd day for the following 6-day
Title
Timed Up and Go test
Description
Timed Up and Go test measuring functional capacity
Time Frame
30 minutes
Title
Timed Up and Go test
Description
Timed Up and Go test measuring functional capacity
Time Frame
every 2nd day for the following 6-day
Title
Strength of passive tension of the knee
Description
Strength of passive tension of the knee measured in Newton at the beginning of pain
Time Frame
30 minutes
Title
Strength of passive tension of the knee
Description
Strength of passive tension of the knee measured in Newton at the beginning of pain
Time Frame
every 2nd day for the following 6-day
Title
Pressure Pain Threshold measurement of the knee
Description
pressure pain threshold measurement of the knee via hand-held algometer
Time Frame
every 2nd day for the following 6-day

10. Eligibility

Sex
All
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 manual therapy unilateral/bilateral symptomatic tibiofemoral knee osteoarthritis with radiographic evidence of Kellgren-Lawrence scale between 1 and 3 pain during weight-bearing activities at least within 6 months sufficient mental status Exclusion Criteria: acute inflammation of the knee class II. obesity (body mass index, BMI>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 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
Harkány Thermal Rehabilitation Centre
Official's Role
Study Chair
Facility Information:
Facility Name
Harkány Thermal Rehabilitation Centre
City
Harkány
State/Province
Please Select
ZIP/Postal Code
7815
Country
Hungary
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
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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
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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
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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 Time Curve of Pressure Pain Threshold

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