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End-range Mobilization on Knee Osteoarthritis

NCT ID: NCT04270253

Last Updated: 2020-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-12

Study Completion Date

2020-05-12

Brief Summary

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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

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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.

Conditions

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Osteo Arthritis Knee

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Conservative therapy

Intervention Type PROCEDURE

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

Manual therapy

Intervention Type PROCEDURE

End-range mobilization

Control

Conservative therapy including aquatic exercises (5-times), land-based exercises (3-times), balneotherapy (5-times) and TENS therapy (3-times)

Group Type ACTIVE_COMPARATOR

Conservative therapy

Intervention Type PROCEDURE

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

Interventions

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Conservative therapy

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

Intervention Type PROCEDURE

Manual therapy

End-range mobilization

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pecs

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Miklós Pozsgai

Role: STUDY_CHAIR

Zsigmondy Vilmos Spa and Balneological Hospital of Harkány

Locations

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Zsigmondy Vilmos Spa and Balneological Hospital of Harkány

Harkány, Please Select, Hungary

Site Status

Countries

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Hungary

References

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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.

Reference Type BACKGROUND
PMID: 22563589 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24462672 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19384739 (View on PubMed)

Other Identifiers

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PozsgaiMMaitlandKnee

Identifier Type: -

Identifier Source: org_study_id