Osteo Arthritis KneeNCT04270253
End-range Mobilization on Knee Osteoarthritis
A study testing Conservative therapy and Manual therapy in people with Osteo Arthritis Knee, run by University of Pecs at 1 site in Hungary.
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. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- Conservative therapy and Manual therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteHungary
- Study dates
- 12 Feb 2020to 12 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- physiotherapy and other balneotherapy attendance within 6 months
- contraindication for conservative and manual therapy
- unstable heart condition
- complex regional pain syndrome
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Zsigmondy Vilmos Spa and Balneological Hospital of Harkány
Harkány, Please Select, 7815
About this study
Official title: End-range Mobilization Effecting Pain and Physical Function in the Management of Knee Osteoarthritis
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.
Read the 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.
- Conditions
- Osteo Arthritis Knee
- Being tested
- Conservative therapy, Manual therapy
- Keywords
- Musculoskeletal Manipulations, Osteoarthritis, Knee, Conservative Treatment
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservative therapyProcedure or surgery
Conservative therapy including aquatic exercises, land-based exercises, balneotherapy, TENS therapy
Manual therapyProcedure or surgery
End-range mobilization
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Conservative therapy; Procedure: 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) Receives: Procedure: Conservative therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
general pain intensity
measuring of general pain intensity with Visual Analogue Scale
Measured: at the end of the 3-week rehabilitation
Secondary outcomes (8)
pain intensity during getting up from a chair
measuring of pain intensity during getting up from a chair with Visual Analogue Scale
Measured: at the end of the 3-week rehabilitation
pain intensity during getting in car
measuring of pain intensity during getting in car with Visual Analogue Scale
Measured: at the end of the 3-week rehabilitation
pain intensity during turning while walking
measuring of pain intensity during turning while walking with Visual Analogue Scale
Measured: at the end of the 3-week rehabilitation
pain intensity during stair descending
measuring of pain intensity during stair descending with Visual Analogue Scale
Measured: at the end of the 3-week rehabilitation
Flexion and extension passive range of motion
Flexion and extension passive range of motion of the tibiofemoral joint
Measured: at the end of the 3-week rehabilitation
Quadriceps and hamstring muscles peak muscle force
Quadriceps and hamstring muscles peak muscle force of both knees
Measured: at the end of the 3-week rehabilitation
6-minute walk test
6-minute walk test measuring functional capacity
Measured: at the end of the 3-week rehabilitation
Timed Up and Go test
Timed Up and Go test measuring functional capacity
Measured: at the end of the 3-week rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start12 Feb 2020
- Primary completion12 Feb 2020
- Study completion12 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pecs
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Miklós Pozsgai, Study chair, Zsigmondy Vilmos Spa and Balneological Hospital of Harkány
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04270253
- Sponsor's protocol ID
- PozsgaiMMaitlandKnee
- Status last verified
- Oct 2020
- First submitted
- 12 Feb 2020
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22563589McAlindon 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.
PubMed 24462672Maricar 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.
PubMed 19384739
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- End-range Mobilization Effecting Pain and Physical Function in the Management of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04270253
- Acronym / sponsor ID
- PozsgaiMMaitlandKnee
- Conditions
- Osteo Arthritis Knee
- Keywords
- Musculoskeletal Manipulations, Osteoarthritis, Knee, Conservative Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of PecsUniversity, hospital or other
- Study start
- 12 Feb 2020 (actual)
- Primary completion
- 12 Feb 2020 (actual)
- Study completion
- 12 May 2020 (actual)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| End-range mobilization | Experimental | Procedure: Conservative therapy, Procedure: Manual therapyEnd-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 comparator | Procedure: Conservative therapyConservative therapy including aquatic exercises (5-times), land-based exercises (3-times), balneotherapy (5-times) and TENS therapy (3-times) |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conservative therapyConservative therapy including aquatic exercises, land-based exercises, balneotherapy, TENS therapy | Procedure or surgery | Control, End-range mobilization |
| Manual therapyEnd-range mobilization | Procedure or surgery | End-range mobilization |
Primary outcome
general pain intensity
Time frame: at the end of the 3-week rehabilitation
measuring of general pain intensity with Visual Analogue Scale
8 secondary outcomes
pain intensity during getting up from a chair
Time frame: at the end of the 3-week rehabilitation
pain intensity during getting in car
Time frame: at the end of the 3-week rehabilitation
pain intensity during turning while walking
Time frame: at the end of the 3-week rehabilitation
pain intensity during stair descending
Time frame: at the end of the 3-week rehabilitation
Flexion and extension passive range of motion
Time frame: at the end of the 3-week rehabilitation
Quadriceps and hamstring muscles peak muscle force
Time frame: at the end of the 3-week rehabilitation
6-minute walk test
Time frame: at the end of the 3-week rehabilitation
Timed Up and Go test
Time frame: at the end of the 3-week rehabilitation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Background: PubMed 22563589Hochberg 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.
- Background: PubMed 24462672McAlindon 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.
- Background: PubMed 19384739Maricar 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miklós Pozsgai study chair
Zsigmondy Vilmos Spa and Balneological Hospital of Harkány
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conservative therapy and Manual therapy in people with Osteo Arthritis Knee, run by University of Pecs at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
general pain intensity (time frame: at the end of the 3-week rehabilitation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04270253, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020.