- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04270253
End-range Mobilization on Knee Osteoarthritis
End-range Mobilization Effecting Pain and Physical Function in the Management of Knee Osteoarthritis
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Please Select
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Harkány, Please Select, Hungary, 7815
- Zsigmondy Vilmos Spa and Balneological Hospital of Harkány
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
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ACTIVE_COMPARATOR: Control
Conservative therapy including aquatic exercises (5-times), land-based exercises (3-times), balneotherapy (5-times) and TENS therapy (3-times)
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Conservative therapy including aquatic exercises, land-based exercises, balneotherapy, TENS therapy
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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
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at the end of the 3-week rehabilitation
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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
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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
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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
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at the end of the 3-week rehabilitation
|
pain intensity during stair descending
Time Frame: at the end of the 3-week rehabilitation
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measuring of pain intensity during stair descending with Visual Analogue Scale
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at the end of the 3-week rehabilitation
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Flexion and extension passive range of motion
Time Frame: at the end of the 3-week rehabilitation
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Flexion and extension passive range of motion of the tibiofemoral joint
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at the end of the 3-week rehabilitation
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Quadriceps and hamstring muscles peak muscle force
Time Frame: at the end of the 3-week rehabilitation
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Quadriceps and hamstring muscles peak muscle force of both knees
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at the end of the 3-week rehabilitation
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6-minute walk test
Time Frame: at the end of the 3-week rehabilitation
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6-minute walk test measuring functional capacity
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at the end of the 3-week rehabilitation
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Timed Up and Go test
Time Frame: at the end of the 3-week rehabilitation
|
Timed Up and Go test measuring functional capacity
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at the end of the 3-week rehabilitation
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Hochberg MC, Altman RD, April KT, Benkhalti M, Guyatt G, McGowan J, Towheed T, Welch V, Wells G, Tugwell P; American College of Rheumatology. American College of Rheumatology 2012 recommendations for the use of nonpharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and knee. Arthritis Care Res (Hoboken). 2012 Apr;64(4):465-74. doi: 10.1002/acr.21596.
- McAlindon TE, Bannuru RR, Sullivan MC, Arden NK, Berenbaum F, Bierma-Zeinstra SM, Hawker GA, Henrotin Y, Hunter DJ, Kawaguchi H, Kwoh K, Lohmander S, Rannou F, Roos EM, Underwood M. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthritis Cartilage. 2014 Mar;22(3):363-88. doi: 10.1016/j.joca.2014.01.003. Epub 2014 Jan 24.
- Maricar N, Shacklady C, McLoughlin L. Effect of Maitland mobilization and exercises for the treatment of shoulder adhesive capsulitis: a single-case design. Physiother Theory Pract. 2009 Apr;25(3):203-17. doi: 10.1080/09593980902776654.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PozsgaiMMaitlandKnee
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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