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Completed

NCT Number: NCT04273906

End-range Mobilization on Pressure Pain Threshold

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.

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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

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

end-range mobilization

Procedure

End-range mobilization performed in end-range of the tibiofemoral joints' flexion and extension

Placebo technique

Procedure

Hands-on technique performed in end-range of the tibiofemoral joints' flexion and extension

Primary outcomes

  1. PPT of the knee

    Time frame: 30 minutes

    pressure pain threshold at the knee

Secondary outcomes

  1. PPT of the m. Extensor Carpi Radialis Longus (ECRL)

    Time frame: 30 minutes

    pressure pain threshold at the ECRL

  2. General Pain Intensity

    Time frame: 30 minutes

    General Pain Intensity measured with Visual Analogue Scale (VAS)

  3. Timed Up and Go test

    Time frame: 30 minutes

    Timed Up and Go test measuring functional capacity

  4. Pain intensity during Timed Up and Go test

    Time frame: 30 minutes

    associated pain intensity during the Timed Up and Go test

  5. Passive tension of the knee

    Time frame: 30 minutes

    Passive tension of the knee at the beginning of pain

Sponsors and collaborators

Lead sponsor

University of Pecs

Other

Registry information

Official study title

End-range Mobilization Effecting Pressure Pain Threshold in Knee Osteoarthritis

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 18, 2020
Registry last updated
Oct 19, 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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