End-range Mobilization on Knee Osteoarthritis
Primary Purpose
Osteo Arthritis Knee
Status
Completed
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
Conservative therapy
Manual therapy
Sponsored by
About this trial
This is an interventional treatment trial for Osteo Arthritis Knee focused on measuring Musculoskeletal Manipulations, Osteoarthritis, Knee, Conservative Treatment
Eligibility Criteria
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
Sites / Locations
- Zsigmondy Vilmos Spa and Balneological Hospital of Harkány
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
End-range mobilization
Control
Arm Description
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 (5-times), land-based exercises (3-times), balneotherapy (5-times) and TENS therapy (3-times)
Outcomes
Primary Outcome Measures
general pain intensity
measuring of general pain intensity with Visual Analogue Scale
Secondary Outcome Measures
pain intensity during getting up from a chair
measuring of pain intensity during getting up from a chair with Visual Analogue Scale
pain intensity during getting in car
measuring of pain intensity during getting in car with Visual Analogue Scale
pain intensity during turning while walking
measuring of pain intensity during turning while walking with Visual Analogue Scale
pain intensity during stair descending
measuring of pain intensity during stair descending with Visual Analogue Scale
Flexion and extension passive range of motion
Flexion and extension passive range of motion of the tibiofemoral joint
Quadriceps and hamstring muscles peak muscle force
Quadriceps and hamstring muscles peak muscle force of both knees
6-minute walk test
6-minute walk test measuring functional capacity
Timed Up and Go test
Timed Up and Go test measuring functional capacity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04270253
Brief Title
End-range Mobilization on Knee Osteoarthritis
Official Title
End-range Mobilization Effecting Pain and Physical Function in the Management of Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
February 12, 2020 (Actual)
Primary Completion Date
February 12, 2020 (Actual)
Study Completion Date
May 12, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pecs
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee
Keywords
Musculoskeletal Manipulations, Osteoarthritis, Knee, Conservative Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
End-range mobilization
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Conservative therapy including aquatic exercises (5-times), land-based exercises (3-times), balneotherapy (5-times) and TENS therapy (3-times)
Intervention Type
Procedure
Intervention Name(s)
Conservative therapy
Intervention Description
Conservative therapy including aquatic exercises, land-based exercises, balneotherapy, TENS therapy
Intervention Type
Procedure
Intervention Name(s)
Manual therapy
Intervention Description
End-range mobilization
Primary Outcome Measure Information:
Title
general pain intensity
Description
measuring of general pain intensity with Visual Analogue Scale
Time Frame
at the end of the 3-week rehabilitation
Secondary Outcome Measure Information:
Title
pain intensity during getting up from a chair
Description
measuring of pain intensity during getting up from a chair with Visual Analogue Scale
Time Frame
at the end of the 3-week rehabilitation
Title
pain intensity during getting in car
Description
measuring of pain intensity during getting in car with Visual Analogue Scale
Time Frame
at the end of the 3-week rehabilitation
Title
pain intensity during turning while walking
Description
measuring of pain intensity during turning while walking with Visual Analogue Scale
Time Frame
at the end of the 3-week rehabilitation
Title
pain intensity during stair descending
Description
measuring of pain intensity during stair descending with Visual Analogue Scale
Time Frame
at the end of the 3-week rehabilitation
Title
Flexion and extension passive range of motion
Description
Flexion and extension passive range of motion of the tibiofemoral joint
Time Frame
at the end of the 3-week rehabilitation
Title
Quadriceps and hamstring muscles peak muscle force
Description
Quadriceps and hamstring muscles peak muscle force of both knees
Time Frame
at the end of the 3-week rehabilitation
Title
6-minute walk test
Description
6-minute walk test measuring functional capacity
Time Frame
at the end of the 3-week rehabilitation
Title
Timed Up and Go test
Description
Timed Up and Go test measuring functional capacity
Time Frame
at the end of the 3-week rehabilitation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miklós Pozsgai
Organizational Affiliation
Zsigmondy Vilmos Spa and Balneological Hospital of Harkány
Official's Role
Study Chair
Facility Information:
Facility Name
Zsigmondy Vilmos Spa and Balneological Hospital of Harkány
City
Harkány
State/Province
Please Select
ZIP/Postal Code
7815
Country
Hungary
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22563589
Citation
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.
Results Reference
background
PubMed Identifier
24462672
Citation
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.
Results Reference
background
PubMed Identifier
19384739
Citation
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.
Results Reference
background
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End-range Mobilization on Knee Osteoarthritis
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