Clinical trial NCT04270253: 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
Overall status: COMPLETED
Phase: NA
Conditions: Osteo Arthritis Knee
Keywords: Musculoskeletal Manipulations
Osteoarthritis, Knee
Conservative Treatment
Lead sponsor: University of Pecs
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: general pain intensity
timeFrame: at the end of the 3-week rehabilitation
Secondary outcomes:
measure: pain intensity during getting up from a chair
timeFrame: at the end of the 3-week rehabilitation
measure: pain intensity during getting in car
timeFrame: at the end of the 3-week rehabilitation
measure: pain intensity during turning while walking
timeFrame: at the end of the 3-week rehabilitation
measure: pain intensity during stair descending
timeFrame: at the end of the 3-week rehabilitation
measure: Flexion and extension passive range of motion
timeFrame: at the end of the 3-week rehabilitation
measure: Quadriceps and hamstring muscles peak muscle force
timeFrame: at the end of the 3-week rehabilitation
measure: 6-minute walk test
timeFrame: at the end of the 3-week rehabilitation
measure: Timed Up and Go test
timeFrame: at the end of the 3-week rehabilitation
Other outcomes:
Locations:
city: Harkány
country: Hungary
facility: Zsigmondy Vilmos Spa and Balneological Hospital of Harkány
state: Please Select
Study officials:
affiliation: Zsigmondy Vilmos Spa and Balneological Hospital of Harkány
name: Miklós Pozsgai
role: STUDY_CHAIR
References:
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.
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.
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.