End-range Mobilization on Knee Osteoarthritis

Osteo Arthritis Knee Clinical Trial

Official title:

End-range Mobilization Effecting Pain and Physical Function in the Management of Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04270253
• Other study ID #: PozsgaiMMaitlandKnee
• Status: Completed
• Phase: N/A
• Start date: February 12, 2020
• Est. completion date: May 12, 2020

Study information

• Verified date: October 2020
• Source: University of Pecs
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 12, 2020
• Est. primary completion date: February 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• Conservative therapy
Conservative therapy including aquatic exercises, land-based exercises, balneotherapy, TENS therapy
• Manual therapy
End-range mobilization

Locations

Country	Name	City	State
Hungary	Zsigmondy Vilmos Spa and Balneological Hospital of Harkány	Harkány	Please Select

Sponsors (1)

Lead Sponsor	Collaborator
University of Pecs

Country where clinical trial is conducted

Hungary, 

References & 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	general pain intensity	measuring of general pain intensity with Visual Analogue Scale	at the end of the 3-week rehabilitation
Secondary	pain intensity during getting up from a chair	measuring of pain intensity during getting up from a chair with Visual Analogue Scale	at the end of the 3-week rehabilitation
Secondary	pain intensity during getting in car	measuring of pain intensity during getting in car with Visual Analogue Scale	at the end of the 3-week rehabilitation
Secondary	pain intensity during turning while walking	measuring of pain intensity during turning while walking with Visual Analogue Scale	at the end of the 3-week rehabilitation
Secondary	pain intensity during stair descending	measuring of pain intensity during stair descending with Visual Analogue Scale	at the end of the 3-week rehabilitation
Secondary	Flexion and extension passive range of motion	Flexion and extension passive range of motion of the tibiofemoral joint	at the end of the 3-week rehabilitation
Secondary	Quadriceps and hamstring muscles peak muscle force	Quadriceps and hamstring muscles peak muscle force of both knees	at the end of the 3-week rehabilitation
Secondary	6-minute walk test	6-minute walk test measuring functional capacity	at the end of the 3-week rehabilitation
Secondary	Timed Up and Go test	Timed Up and Go test measuring functional capacity	at the end of the 3-week rehabilitation