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NCT Number: NCT04270253

End-range Mobilization on 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.

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Key information

Conditions

Osteo Arthritis Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zsigmondy Vilmos Spa and Balneological Hospital of Harkány

Harkány, Please Select, 7815, Hungary

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Conservative therapy

Procedure

Conservative therapy including aquatic exercises, land-based exercises, balneotherapy, TENS therapy

Manual Therapy

Procedure

End-range mobilization

Primary outcomes

  1. general pain intensity

    Time frame: at the end of the 3-week rehabilitation

    measuring of general pain intensity with Visual Analogue Scale

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 6-minute walk test

    Time frame: at the end of the 3-week rehabilitation

    6-minute walk test measuring functional capacity

  8. Timed Up and Go test

    Time frame: at the end of the 3-week rehabilitation

    Timed Up and Go test measuring functional capacity

Sponsors and collaborators

Lead sponsor

University of Pecs

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 17, 2020
Registry last updated
Nov 3, 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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