End-range Mobilization on Pressure Pain Threshold

October 15, 2020 updated by: University of Pecs

End-range Mobilization Effecting 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 (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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

40

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
        • 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

Female

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 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

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: Double

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
Procedure: End-range mobilization
End-range mobilization performed in end-range of the tibiofemoral joints' flexion and extension
Procedure: Placebo technique
Hands-on technique 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
Procedure: End-range mobilization
End-range mobilization performed in end-range of the tibiofemoral joints' flexion and extension
Procedure: Placebo technique
Hands-on technique performed in end-range of the tibiofemoral joints' flexion and extension

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 at 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
General Pain Intensity
Time Frame: 30 minutes
General Pain Intensity measured with Visual Analogue Scale (VAS)
30 minutes
Timed Up and Go test
Time Frame: 30 minutes
Timed Up and Go test measuring functional capacity
30 minutes
Pain intensity during Timed Up and Go test
Time Frame: 30 minutes
associated pain intensity during the Timed Up and Go test
30 minutes
Passive tension of the knee
Time Frame: 30 minutes
Passive tension of the knee at the beginning of pain
30 minutes

Collaborators and Investigators

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

Sponsor

University of Pecs

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)

February 12, 2020

Primary Completion (Actual)

March 12, 2020

Study Completion (Actual)

March 12, 2020

Study Registration Dates

First Submitted

February 12, 2020

First Submitted That Met QC Criteria

February 13, 2020

First Posted (Actual)

February 18, 2020

Study Record Updates

Last Update Posted (Actual)

October 19, 2020

Last Update Submitted That Met QC Criteria

October 15, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MaitlandKneePPT

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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