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Completed

NCT Number: NCT04629625

End-range Mobilization on Time Curve of 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 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.

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Key information

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harkány Thermal Rehabilitation Centre, Harkány, Please Select, Hungary

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About this study

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.

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 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

Treatment and study plan

End-range mobilization

Biological

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

Non end-range mobilization

Biological

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

Placebo

Biological

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

    Time frame: every 2nd day for the following 6-day

    pressure pain threshold at the ECRL

  3. Timed Up and Go test

    Time frame: 30 minutes

    Timed Up and Go test measuring functional capacity

  4. Timed Up and Go test

    Time frame: every 2nd day for the following 6-day

    Timed Up and Go test measuring functional capacity

  5. Strength of passive tension of the knee

    Time frame: 30 minutes

    Strength of passive tension of the knee measured in Newton at the beginning of pain

  6. Strength of passive tension of the knee

    Time frame: every 2nd day for the following 6-day

    Strength of passive tension of the knee measured in Newton at the beginning of pain

  7. Pressure Pain Threshold measurement of the knee

    Time frame: every 2nd day for the following 6-day

    pressure pain threshold measurement of the knee via hand-held algometer

Sponsors and collaborators

Lead sponsor

University of Pecs

Other

Registry information

Official study title

The Effect of End-range Mobilization on Time Curve of Pressure Pain Threshold in Knee Osteoarthritis

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 16, 2020
Registry last updated
Sep 8, 2022

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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