End-range Mobilization on Knee Osteoarthritis
End-range Mobilization Effecting Pain and Physical Function in the Management of Knee Osteoarthritis
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2020
CompletedStudy Start
First participant enrolled
February 12, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 12, 2020
CompletedFirst Posted
Study publicly available on registry
February 17, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 12, 2020
CompletedNovember 3, 2020
October 1, 2020
Same day
February 12, 2020
October 31, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
general pain intensity
measuring of general pain intensity with Visual Analogue Scale
at the end of the 3-week rehabilitation
Secondary Outcomes (8)
pain intensity during getting up from a chair
at the end of the 3-week rehabilitation
pain intensity during getting in car
at the end of the 3-week rehabilitation
pain intensity during turning while walking
at the end of the 3-week rehabilitation
pain intensity during stair descending
at the end of the 3-week rehabilitation
Flexion and extension passive range of motion
at the end of the 3-week rehabilitation
- +3 more secondary outcomes
Study Arms (2)
End-range mobilization
EXPERIMENTALEnd-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
Control
ACTIVE COMPARATORConservative therapy including aquatic exercises (5-times), land-based exercises (3-times), balneotherapy (5-times) and TENS therapy (3-times)
Interventions
Conservative therapy including aquatic exercises, land-based exercises, balneotherapy, TENS therapy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zsigmondy Vilmos Spa and Balneological Hospital of Harkány
Harkány, Please Select, 7815, Hungary
Related Publications (3)
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.
PMID: 22563589BACKGROUNDMcAlindon 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.
PMID: 24462672BACKGROUNDMaricar 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.
PMID: 19384739BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Miklós Pozsgai
Zsigmondy Vilmos Spa and Balneological Hospital of Harkány
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2020
First Posted
February 17, 2020
Study Start
February 12, 2020
Primary Completion
February 12, 2020
Study Completion
May 12, 2020
Last Updated
November 3, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share