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Osteo Arthritis KneeNCT04312035

Effect of Combined Interventions on Pressure Pain Threshold

A study testing end-range mobilization and Non end-range mobilization in people with Osteo Arthritis Knee, run by University of Pecs at 1 site in Hungary.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 60 to 80 years, women only
Conditions the study is for
Osteo Arthritis Knee
What is being tested?
end-range mobilization and Non end-range mobilization
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteHungary
Study dates
4 Mar 2020to 4 Mar 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • intraarticular injections in the prior 12 months
  • use of walking aid
  • contraindication for manual therapy
  • complex regional pain syndrome
  • cognitive impairment

Trial locations and contacts

1 site in 1 country.

Hungary1 site

  • Miklós Pozsgai

    Harkány, Please Select, 7815

Other trials in Hungary

About this study

Official title: 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.

Read the 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.

Being tested
end-range mobilization, Non end-range mobilization, Control
Keywords
Musculoskeletal Manipulations, Osteoarthritis, Knee, Pain Threshold, Conservative Treatment
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • end-range mobilizationProcedure or surgery

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

  • Non end-range mobilizationProcedure or surgery

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

  • ControlProcedure or surgery

    hands-on cutaneous technique

Study groups in NCT04312035
Study groupRoleWhat they receive
End-range mobilizationExperimentalEnd-range mobilization performed in end-position of the knee joint
Receives: Procedure: end-range mobilization
Non end-range mobilizationExperimentalNon end-range mobilization performed in loose-packed position of the knee joint
Receives: Procedure: Non end-range mobilization
ControlPlacebo comparatorSham technique performed in loose-packed position of the knee joint
Receives: Procedure: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change of peripheral sensitivity

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

    Measured: following 3-week rehabilitation

  2. change of peripheral sensitivity

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

    Measured: following 3-month

Secondary outcomes (12)

  1. change of central sensitivity

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

    Measured: following 3-week rehabilitation

  2. change of central sensitivity

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

    Measured: following 3-month

  3. change of general pain intensity

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

    Measured: following 3-week rehabilitation

  4. change of general pain intensity

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

    Measured: following 3-month

  5. change of Timed Up and Go test

    short test for measuring physical performance

    Measured: following 3-week rehabilitation

  6. change of Timed Up and Go test

    short test for measuring physical performance

    Measured: following 3-month

  7. 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

    Measured: following 3-week rehabilitation

  8. 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

    Measured: following 3-month

  9. 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

    Measured: following 3-week rehabilitation

  10. 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

    Measured: following 3-month

  11. 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

    Measured: following 3-week rehabilitation

  12. 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

    Measured: following 3-month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2020
  2. Study start4 Mar 2020
  3. Primary completion4 Mar 2020
  4. Study completion4 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04312035
Sponsor's protocol ID
ML_PPT_PhysTher
Status last verified
Mar 2020
First submitted
4 Mar 2020
Last updated
17 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 24462672

  • 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.

    PubMed 11427321

  • 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.

    PubMed 18821657

  • 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.

    PubMed 16777467

Questions about this trial

What is this clinical trial studying?

A study testing end-range mobilization and Non end-range mobilization in people with Osteo Arthritis Knee, run by University of Pecs at 1 site in Hungary.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change of peripheral sensitivity (time frame: following 3-week rehabilitation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04312035, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.

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