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Completed

NCT Number: NCT04312035

Effect of Combined Interventions on 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.

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Key information

Age range

60 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Miklós Pozsgai

Harkány, Please Select, 7815, Hungary

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

end-range mobilization

Procedure

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

Non end-range mobilization

Procedure

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

Control

Procedure

hands-on cutaneous technique

Primary outcomes

  1. change of peripheral sensitivity

    Time frame: following 3-week rehabilitation

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

  2. change of peripheral sensitivity

    Time frame: following 3-month

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

Secondary outcomes

  1. change of central sensitivity

    Time frame: following 3-week rehabilitation

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

  2. change of central sensitivity

    Time frame: following 3-month

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

  3. change of general pain intensity

    Time frame: following 3-week rehabilitation

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

  4. change of general pain intensity

    Time frame: following 3-month

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

  5. change of Timed Up and Go test

    Time frame: following 3-week rehabilitation

    short test for measuring physical performance

  6. change of Timed Up and Go test

    Time frame: following 3-month

    short test for measuring physical performance

  7. change of pain intensity during physical performance

    Time frame: following 3-week rehabilitation

    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

  8. change of pain during physical performance

    Time frame: following 3-month

    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

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

    Time frame: following 3-week rehabilitation

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

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

    Time frame: following 3-month

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

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

    Time frame: following 3-week rehabilitation

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

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

    Time frame: following 3-month

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

Sponsors and collaborators

Lead sponsor

University of Pecs

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 17, 2020
Registry last updated
Mar 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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