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Effect of Combined Interventions on Pressure Pain Threshold

Primary Purpose

Osteo Arthritis Knee

Status

Completed

Phase

Not Applicable

Locations

Hungary

Study Type

Interventional

Intervention

end-range mobilization

Non end-range mobilization

Control

About this trial

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

Eligibility Criteria

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

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

Sites / Locations

Miklós Pozsgai

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

End-range mobilization

Non end-range mobilization

Control

Arm Description

End-range mobilization performed in end-position of the knee joint

Non end-range mobilization performed in loose-packed position of the knee joint

Sham technique performed in loose-packed position of the knee joint

Outcomes

Primary Outcome Measures

change of peripheral sensitivity

peripheral sensitivity (pressure pain threshold) assessed at the local knee

change of peripheral sensitivity

peripheral sensitivity (pressure pain threshold) assessed at the local knee

Secondary Outcome Measures

change of central sensitivity

central sensitivity (pressure pain threshold) assessed at the ipsilateral m. extensor carpi radialis longus

change of central sensitivity

central sensitivity (pressure pain threshold) assessed at the ipsilateral m. extensor carpi radialis longus

change of general pain intensity

general pain intensity from the previous week using the Visual Analogue Scale

change of general pain intensity

general pain intensity from the previous week using the Visual Analogue Scale

change of Timed Up and Go test

short test for measuring physical performance

change of Timed Up and Go test

short test for measuring physical performance

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

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

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

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

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

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

Full Information

NCT ID

NCT04312035

First Posted

March 4, 2020

Last Updated

March 13, 2020

Sponsor

University of Pecs

1. Study Identification

Unique Protocol Identification Number

NCT04312035

Brief Title

Effect of Combined Interventions on Pressure Pain Threshold

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

March 4, 2020 (Actual)

Primary Completion Date

March 4, 2020 (Actual)

Study Completion Date

March 4, 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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteo Arthritis Knee

Keywords

Musculoskeletal Manipulations, Osteoarthritis, Knee, Pain Threshold, Conservative Treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

60 (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 knee joint

Arm Title

Non end-range mobilization

Arm Type

Experimental

Arm Description

Non end-range mobilization performed in loose-packed position of the knee joint

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

Sham technique performed in loose-packed position of the knee joint

Intervention Type

Procedure

Intervention Name(s)

end-range mobilization

Intervention Description

accessory technique applied on the tibiofemoral joint with the aim of increasing extensibility of the periarticular tissues

Intervention Type

Procedure

Intervention Name(s)

Non end-range mobilization

Intervention Description

accessory technique applied on the tibiofemoral joint with the aim of alleviating pain

Intervention Type

Procedure

Intervention Name(s)

Control

Intervention Description

hands-on cutaneous technique

Primary Outcome Measure Information:

Title

change of peripheral sensitivity

Description

peripheral sensitivity (pressure pain threshold) assessed at the local knee

Time Frame

following 3-week rehabilitation

Title

change of peripheral sensitivity

Description

peripheral sensitivity (pressure pain threshold) assessed at the local knee

Time Frame

following 3-month

Secondary Outcome Measure Information:

Title

change of central sensitivity

Description

central sensitivity (pressure pain threshold) assessed at the ipsilateral m. extensor carpi radialis longus

Time Frame

following 3-week rehabilitation

Title

change of central sensitivity

Description

central sensitivity (pressure pain threshold) assessed at the ipsilateral m. extensor carpi radialis longus

Time Frame

following 3-month

Title

change of general pain intensity

Description

general pain intensity from the previous week using the Visual Analogue Scale

Time Frame

following 3-week rehabilitation

Title

change of general pain intensity

Description

general pain intensity from the previous week using the Visual Analogue Scale

Time Frame

following 3-month

Title

change of Timed Up and Go test

Description

short test for measuring physical performance

Time Frame

following 3-week rehabilitation

Title

change of Timed Up and Go test

Description

short test for measuring physical performance

Time Frame

following 3-month

Title

change of pain intensity during physical performance

Description

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

Time Frame

following 3-week rehabilitation

Title

change of pain during physical performance

Description

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

Time Frame

following 3-month

Title

degree of knee flexion during passive movement at the onset of knee pain

Description

measurement of degree of knee flexion during passive movement at the onset of knee pain

Time Frame

following 3-week rehabilitation

Title

degree of knee flexion during passive movement at the onset of knee pain

Description

measurement of degree of knee flexion during passive movement at the onset of knee pain

Time Frame

following 3-month

Title

strength of resistance of passive knee flexion at the onset of knee pain

Description

measurement of strength of resistance arising from the anterior located tissues around the knee during passive knee flexion at the onset of pain

Time Frame

following 3-week rehabilitation

Title

strength of resistance of passive knee flexion at the onset of knee pain

Description

measurement of strength of resistance arising from the anterior located tissues around the knee during passive knee flexion at the onset of pain

Time Frame

following 3-month

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Miklós Pozsgai, MSc

Organizational Affiliation

Zsigmondy Vilmos Spa and Balneological Hospital of Harkány

Official's Role

Principal Investigator

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

Citations:

PubMed Identifier

24462672

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.

Results Reference

background

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

16777467

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. doi: 10.1016/j.math.2006.02.009. Epub 2006 Jun 13.

Results Reference

background

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Effect of Combined Interventions on Pressure Pain Threshold

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