NCT04270253

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
Same day until next milestone

Study Start

First participant enrolled

February 12, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2020

Completed
Last Updated

November 3, 2020

Status Verified

October 1, 2020

Enrollment Period

Same day

First QC Date

February 12, 2020

Last Update Submit

October 31, 2020

Conditions

Keywords

Musculoskeletal ManipulationsOsteoarthritis, KneeConservative Treatment

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

EXPERIMENTAL

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

Procedure: Conservative therapyProcedure: Manual therapy

Control

ACTIVE COMPARATOR

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

Procedure: Conservative therapy

Interventions

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

ControlEnd-range mobilization

End-range mobilization

End-range mobilization

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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: 22563589BACKGROUND
  • 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.

    PMID: 24462672BACKGROUND
  • 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.

    PMID: 19384739BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Conservative TreatmentMusculoskeletal Manipulations

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsComplementary TherapiesPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Miklós Pozsgai

    Zsigmondy Vilmos Spa and Balneological Hospital of Harkány

    STUDY CHAIR

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

Locations