Anterior Knee Pain SyndromeNCT03771495
The Immediate Effects of Passive Hip Joint Mobilization on Hip Muscle Strength in Patients With Anterior Knee Pain
A study testing Joint Mobilization and Laying on of Hands in people with Anterior Knee Pain Syndrome and Patellofemoral Pain Syndrome, run by Sheffield Hallam University at 1 site in Austria.
Trial summary
The aim of the study is to assess the immediate effects of passive hip joint mobilisation (in comparison to a sham mobilisation) on eccentric hip abductor/external rotator muscle strength on the basis of manual muscle testing with a hand-held-dynamometer within a double-blinded cross-over study design. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Anterior Knee Pain Syndrome, Patellofemoral Pain Syndrome
- What is being tested?
- Joint Mobilization and Laying on of Hands
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteAustria
- Study dates
- 21 Dec 2018to 30 Apr 2019
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- diagnosis: anterior knee pain
- Prescription for physiotherapeutic treatment of anterior knee pain
- signs of functional hip impairment:
- impaired hip kinematics during single leg squat
- reduced passive hip joint mobility in comparison to the other, unaffected side
- manually weak tested hip abductors/external rota-tors in comparison to the other, unaffected side
Who cannot join
- intraarticular knee pathology
- preceding trauma/operation of lower extremity on affected side
- spinal disorders associated with low back pain, lumbar referred pain or nerve root irritation
- severe and/or recurring ankle sprains in recent history (significant enough, that it required a period of immobilization)
- other relevant comorbidities such as neurologic/rheumatologic/psychiatric diseases, osteoporosis and malign disorders
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: What Are the Immediate Effects of Passive Hip Joint Mobilization on Hip Abductor/External Rotator Muscle Strength in Patients With Anterior Knee Pain and Impaired Hip Function
The aim of the study is to assess the immediate effects of passive hip joint mobilisation (in comparison to a sham mobilisation) on eccentric hip abductor/external rotator muscle strength on the basis of manual muscle testing with a hand-held-dynamometer within a double-blinded cross-over study design. Patients with anterior knee pain and signs of impaired hip function will be recruited in Vienna and surrounding area, measurements/data collection will be conducted by two experienced physiotherapists in a physiotherapy group practice in 1150 Vienna.
- Being tested
- Joint Mobilization, Laying on of Hands
- Keywords
- mobilization, muscle strength, hip abductors, hip external rotators
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Joint MobilizationOther
Manual Therapy Intervention, commonly used by physiotherapists
Laying on of HandsOther
Sham Hip Joint Mobilization
| Study group | Role | What they receive |
|---|---|---|
| Hip Joint Mobilization | Experimental | passive accessory movement on femur in anterior/posterior direction, grade III for four minutes and passive physiological movement of the most restricted hip joint movement, grade III for one minute (without pain), and a verbal education of hypothesized underlying effect mechanisms. Receives: Other: Joint Mobilization |
| Laying on of Hands | Sham comparator | grade I, very small amplitude without encountering any tissue resistance for five minutes, thus effectively a Laying on of Hands, with a verbal education of hypothesized underlying effect mechanisms. Receives: Other: Laying on of Hands |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Strength
muscle strength data obtained from torque measurements of the hip abductor/external rotator muscles of participants before and after intervention via manual muscle testing (using a hand-held dynamometer)
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start21 Dec 2018
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anterior Knee Pain SyndromeStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Hallam University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sionnadh McLean, Study director, Sheffield Hallam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03771495
- Sponsor's protocol ID
- G Pflügler 09-18
- Status last verified
- Jun 2019
- First submitted
- 7 Dec 2018
- Last updated
- 7 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pfluegler G, Borkovec M, Kasper J, McLean S. The immediate effects of passive hip joint mobilization on hip abductor/external rotator muscle strength in patients with anterior knee pain and impaired hip function. A randomized, placebo-controlled crossover trial. J Man Manip Ther. 2021 Feb;29(1):14-22. doi: 10.1080/10669817.2020.1765625. Epub 2020 May 26.
PubMed 32452284
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Are the Immediate Effects of Passive Hip Joint Mobilization on Hip Abductor/External Rotator Muscle Strength in Patients With Anterior Knee Pain and Impaired Hip Function
- ClinicalTrials.gov ID
- NCT03771495
- Acronym / sponsor ID
- G Pflügler 09-18
- Keywords
- mobilization, muscle strength, hip abductors, hip external rotators
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Sheffield Hallam UniversityUniversity, hospital or other
- Study start
- 21 Dec 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 11 Dec 2018 (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.
The aim of the study is to assess the immediate effects of passive hip joint mobilisation (in comparison to a sham mobilisation) on eccentric hip abductor/external rotator muscle strength on the basis of manual muscle testing with a hand-held-dynamometer within a double-blinded cross-over study design. Patients with anterior knee pain and signs of impaired hip function will be recruited in Vienna and surrounding area, measurements/data collection will be conducted by two experienced physiotherapists in a physiotherapy group practice in 1150 Vienna.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hip Joint Mobilization | Experimental | Other: Joint Mobilizationpassive accessory movement on femur in anterior/posterior direction, grade III for four minutes and passive physiological movement of the most restricted hip joint movement, grade III for one minute (without pain), and a verbal education of hypothesized underlying effect mechanisms. |
| Laying on of Hands | Sham comparator | Other: Laying on of Handsgrade I, very small amplitude without encountering any tissue resistance for five minutes, thus effectively a Laying on of Hands, with a verbal education of hypothesized underlying effect mechanisms. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- diagnosis: anterior knee pain
- Prescription for physiotherapeutic treatment of anterior knee pain
- signs of functional hip impairment:
- impaired hip kinematics during single leg squat
- reduced passive hip joint mobility in comparison to the other, unaffected side
Key exclusion criteria (6 listed)
- intraarticular knee pathology
- preceding trauma/operation of lower extremity on affected side
- spinal disorders associated with low back pain, lumbar referred pain or nerve root irritation
- severe and/or recurring ankle sprains in recent history (significant enough, that it required a period of immobilization)
- other relevant comorbidities such as neurologic/rheumatologic/psychiatric diseases, osteoporosis and malign disorders
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 |
|---|---|---|
| Joint MobilizationManual Therapy Intervention, commonly used by physiotherapists | Other | Hip Joint Mobilization |
| Laying on of HandsSham Hip Joint Mobilization | Other | Laying on of Hands |
Primary outcome
Muscle Strength
Time frame: 10 minutes
muscle strength data obtained from torque measurements of the hip abductor/external rotator muscles of participants before and after intervention via manual muscle testing (using a hand-held dynamometer)
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 7 Jun 2019.
- Derived from this study: PubMed 32452284Pfluegler G, Borkovec M, Kasper J, McLean S. The immediate effects of passive hip joint mobilization on hip abductor/external rotator muscle strength in patients with anterior knee pain and impaired hip function. A randomized, placebo-controlled crossover trial. J Man Manip Ther. 2021 Feb;29(1):14-22. doi: 10.1080/10669817.2020.1765625. Epub 2020 May 26.
- Individual participant dataSharing planned: Undecided
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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.
Sionnadh McLean study director
Sheffield Hallam University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Joint Mobilization and Laying on of Hands in people with Anterior Knee Pain Syndrome and Patellofemoral Pain Syndrome, run by Sheffield Hallam University at 1 site in Austria.
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 6 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 7 Jun 2019. 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 Austria. 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. Some participants in this study may receive a placebo. 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?
Muscle Strength (time frame: 10 minutes). 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 NCT03771495, which also lists 1 linked publication.
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 7 Jun 2019.