End-range Mobilization on Time Curve of Pressure Pain Threshold

September 4, 2022 updated by: University of Pecs

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
    • Please Select
      • Harkány, Please Select, Hungary, 7815
        • Harkány Thermal Rehabilitation Centre
      • Harkány, Please Select, Hungary, 7815
        • Miklós Pozsgai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: End-range mobilization
End-range mobilization performed in end-position of the tibiofemoral joints' flexion and extension for 2*3 min
Biological: End-range mobilization
End-range mobilization performed in end-range of the tibiofemoral joints' flexion and extension
Placebo Comparator: Placebo
Hands-on treatment technique performed in end-range of the tibiofemoral joints' flexion and extension for 2*3 min
Biological: Placebo
Hands-on technique performed in end-range of the tibiofemoral joints' flexion and extension
Active Comparator: Non end-range mobilization
Non end-range mobilization performed in tibiofemoral joints' loose position
Biological: Non end-range mobilization
Non end-range mobilization performed in tibiofemoral joints' loose position

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PPT of the knee
Time Frame: 30 minutes
pressure pain threshold of the knee
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PPT of the m. Extensor Carpi Radialis Longus (ECRL)
Time Frame: 30 minutes
pressure pain threshold at the ECRL
30 minutes
Timed Up and Go test
Time Frame: 30 minutes
Timed Up and Go test measuring functional capacity
30 minutes
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
every 2nd day for the following 6-day
Timed Up and Go test
Time Frame: every 2nd day for the following 6-day
Timed Up and Go test measuring functional capacity
every 2nd day for the following 6-day
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
30 minutes
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
every 2nd day for the following 6-day
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
every 2nd day for the following 6-day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pecs

Investigators

  • Study Chair: Miklós Pozsgai, Harkány Thermal Rehabilitation Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2020

Primary Completion (Actual)

January 2, 2021

Study Completion (Actual)

May 1, 2021

Study Registration Dates

First Submitted

October 28, 2020

First Submitted That Met QC Criteria

November 9, 2020

First Posted (Actual)

November 16, 2020

Study Record Updates

Last Update Posted (Actual)

September 8, 2022

Last Update Submitted That Met QC Criteria

September 4, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MaitlandKneePPT_Time Curve

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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