End-range Mobilization on Knee Osteoarthritis

October 31, 2020 updated by: University of Pecs

End-range Mobilization Effecting Pain and Physical Function in the Management of Knee Osteoarthritis

Different manual therapy techniques and conservative therapy have been used separately for alleviation of pain and improvement of physical function in patients with knee osteoarthritis (KOA). However, no study has reported the effect of combination of these treatment modalities in the management of KOA. The aim of this study was to investigate the effect of end-range mobilization added to conservative therapy versus conservative therapy alone on decrease of pain and improvement of functional status in KOA.

Study Overview

Detailed Description

Knee osteoarthritis (KOA) is a musculoskeletal condition affecting older people. It is characterized by pain and loss of physical function, which has a negative impact on patients' quality of life. The different international guidelines recommend several non-invasive treatment modalities for the management of KOA. Conservative therapy including land-based exercises, aquatic exercises, Transcutaneous Electro Neuro Stimulation (TENS) therapy and balneotherapy has been reported positively in the management of patients with KOA (1, 2). Manual therapy is also a preferred treatment modality with the aim of alleviation of pain, improvement of joint mobility and therefore the physical condition (1, 2). Out of manual therapy techniques, end-range mobilization is a well applied treatment technique in the management of different musculoskeletal conditions (3). Till date, the effect of end-range mobilization has not been investigated so far in knee OA.

Therefore, the aim of this study was to investigate the effect of end-range mobilization added to conservative therapy versus conservative therapy alone on decrease of pain and improvement of functional status in KOA.

Study Type

Interventional

Enrollment (Actual)

30

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

    • Please Select
      • Harkány, Please Select, Hungary, 7815
        • Zsigmondy Vilmos Spa and Balneological Hospital of Harkány

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 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • KOA according to the American College of Rheumatology
  • categorization as End Of Range Problem based on Maitland's classification.
  • at least half year existing and at least 3 pain scores measured with Visual Analogue Scale (VAS) during weight-bearing activities
  • bilateral, moderate-to-severe symptomatic tibiofemoral knee OA with radiographic evidence
  • at least 90 degree passive knee flexion range
  • sufficient mental status

Exclusion Criteria:

  • acute inflammation of the knee
  • intraarticular injections within the last 3 months
  • total knee replacement in the opposite side
  • class II. obesity (body mass index, BMI>35kg/m2)
  • severe degenerative lumbar spine disease (e.g. spondylolisthesis)
  • systemic inflammatory arthritic or neurological condition
  • physiotherapy and other balneotherapy attendance within 6 months
  • contraindication for conservative and manual therapy
  • unstable heart condition
  • complex regional pain syndrome

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: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: End-range mobilization
End-range mobilization applied 6 times for 2*2 min in end-range of flexion and extension end-range of the tibiofemoral and patellofemoral joint beside the same conservative therapy, as used for the Control
Conservative therapy including aquatic exercises, land-based exercises, balneotherapy, TENS therapy
End-range mobilization
ACTIVE_COMPARATOR: Control
Conservative therapy including aquatic exercises (5-times), land-based exercises (3-times), balneotherapy (5-times) and TENS therapy (3-times)
Conservative therapy including aquatic exercises, land-based exercises, balneotherapy, TENS therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
general pain intensity
Time Frame: at the end of the 3-week rehabilitation
measuring of general pain intensity with Visual Analogue Scale
at the end of the 3-week rehabilitation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain intensity during getting up from a chair
Time Frame: at the end of the 3-week rehabilitation
measuring of pain intensity during getting up from a chair with Visual Analogue Scale
at the end of the 3-week rehabilitation
pain intensity during getting in car
Time Frame: at the end of the 3-week rehabilitation
measuring of pain intensity during getting in car with Visual Analogue Scale
at the end of the 3-week rehabilitation
pain intensity during turning while walking
Time Frame: at the end of the 3-week rehabilitation
measuring of pain intensity during turning while walking with Visual Analogue Scale
at the end of the 3-week rehabilitation
pain intensity during stair descending
Time Frame: at the end of the 3-week rehabilitation
measuring of pain intensity during stair descending with Visual Analogue Scale
at the end of the 3-week rehabilitation
Flexion and extension passive range of motion
Time Frame: at the end of the 3-week rehabilitation
Flexion and extension passive range of motion of the tibiofemoral joint
at the end of the 3-week rehabilitation
Quadriceps and hamstring muscles peak muscle force
Time Frame: at the end of the 3-week rehabilitation
Quadriceps and hamstring muscles peak muscle force of both knees
at the end of the 3-week rehabilitation
6-minute walk test
Time Frame: at the end of the 3-week rehabilitation
6-minute walk test measuring functional capacity
at the end of the 3-week rehabilitation
Timed Up and Go test
Time Frame: at the end of the 3-week rehabilitation
Timed Up and Go test measuring functional capacity
at the end of the 3-week rehabilitation

Collaborators and Investigators

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

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.

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)

February 12, 2020

Study Completion (ACTUAL)

May 12, 2020

Study Registration Dates

First Submitted

February 12, 2020

First Submitted That Met QC Criteria

February 12, 2020

First Posted (ACTUAL)

February 17, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 3, 2020

Last Update Submitted That Met QC Criteria

October 31, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

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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