Clinical trial NCT04332900: Proximal and Distal Therapeutic Approach in Pain and Lower Limb Kinematic in People With Patellofemoral Osteoarthritis
Official title: Comparison of Immediate Effects of a Proximal and Distal Therapeutic Approach in Pain and Lower Limb Kinematic During Functional Tasks in People With Patellofemoral Osteoarthritis: A Crossover Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patellofemoral Osteoarthritis
Keywords: Knee osteoarthritis
Patellofemoral joint
Gait
Pain
Quality of life
Physiotherapy
Lead sponsor: Universidade Federal de Sao Carlos
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2020-04-03
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: randomised cross-over desing
Primary purpose: OTHER

Brief summary: This is a crossover study that will investigate the immediate effects of a proximal therapeutic approach (SERF strap) and a distal one (foot orthoses) on knee pain intensity, global change, symptoms, ease of performance and confidence after each task and lower limb kinematics (hip adduction and internal hip rotation peak, rearfoor eversion peak) during functional taks (level-ground walking and stepping manoeuvres) in people with patellofemoral ostheoartritis

Detailed description: It will be enroled in this study 30 participants with patellofemoral ostheoartritis. The participants will be assessed during level walking at a self-selected speed and the stepping manoeuvre test under the three conditions that will be randomized: i) the control condition; ii) intervention proximal condition; and iii) intervention distal condition. The control condition refers to the condition in which no interventions will be administered. In both the intervention proximal condition and intervention distal condition, the respective therapeutic approach will be administered. For each functional task, three valid attempts will be collected. The primary outcome of this study is knee pain intensity and the secondary outcomes are both self-reported measures and kinematic variables measures. The self-reported measures are global change, symptoms, ease of performance and confidence, while the kinematic variables measures are hip adduction and internal hip rotation peak and rearfoor eversion peak

Eligibility criteria: Inclusion Criteria:

* Present anterior or retro patellar pain aggravated by two or more activities that overload the patellofemoral joint, such as going up and down stairs, squatting, remaining in the sitting position for long periods, getting up from the sitting position, kneeling or during physical exercise;
* Reporting pain of at least 3 on an 11-point scale (0 for no pain and 10 for the worst possible pain) during the activities described above and on most days during the last month;
* Have evidence of osteophyte formation in the patellofemoral joint on radiographs in the profile and axial skyline views through the Kellgren-Lawrence (K-L) grade ≥ 2, with minimal impairment in the tibiofemoral joint (KL \<2);
* Body mass index (BMI) \<35 Kg / m². Participants with unilateral or bilateral symptoms will be included in the study.

Exclusion Criteria:

* Current use or in the last 12 months of foot orthoses;
* Previous history of fracture or recurrent subluxation of the patella;
* Arthroscopic surgery or knee infiltrations in the last 3 months;
* Osteoarthritis known in other weight-bearing joints, including the spine;
* History of surgery on the hip, knee, ankle and foot joints;
* History of ankle sprain in the last 12 months;
* Osteotomy in the lower limbs;
* Current physical therapy in the lower limbs or in the last 6 weeks;
* Use of a cane or other walking aid;
* Any physical disability that is a contraindication for carrying out the evaluations and;
* Punctuation that suggests dementia according to the Mini-Mental State Examination, taking into account the education of the participants.

Primary outcomes:
measure: Pain intensity
timeFrame: The Pain intensity will be assessed immediately after the first valid attempt of the level-walking task in the Control Condition
measure: Pain intensity
timeFrame: The Pain intensity will be assessed immediately after the second valid attempt of the level-walking task in the Control Condition
measure: Pain intensity
timeFrame: The Pain intensity will be assessed immediately after the third valid attempt of the level-walking task in the Control Condition
measure: Pain intensity
timeFrame: The Pain intensity will be assessed immediately after the first valid attempt of the level-walking task in the Intervention Proximal Condition
measure: Pain intensity
timeFrame: The Pain intensity will be assessed immediately after the second valid attempt of the level-walkingtask in the Intervention Proximal Condition
measure: Pain intensity
timeFrame: The Pain intensity will be assessed immediately after the third valid attempt of the level-walking task in the Intervention Proximal Condition
measure: Pain intensity
timeFrame: The Pain intensity will be assessed immediately after the first valid attempt of the level-walking task in the Intervention Distal Condition
measure: Pain intensity
timeFrame: The Pain intensity will be assessed immediately after the second valid attempt of the level-walking task in the Intervention Distal Condition
measure: Pain intensity
timeFrame: The Pain intensity will be assessed immediately after the third valid attempt of the level-walking task in the Intervention Distal Condition
measure: Pain intensity
timeFrame: The Pain intensity will be assessed immediately after the first valid attempt of the stepping manoeuvre in the Control Condition
measure: Pain intensity
timeFrame: The Pain intensity will be assessed immediately after the second valid attempt of the stepping manoeuvre in the Control Condition
measure: Pain intensity
timeFrame: The Pain intensity will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Control Condition
measure: Pain intensity
timeFrame: The Pain intensity will be assessed immediately after the first valid attempt of the stepping manoeuvre in the Intervention Proximal Condition
measure: Pain intensity
timeFrame: The Pain intensity will be assessed immediately after the second valid attempt of the stepping manoeuvre in the Intervention Proximal Condition
measure: Pain intensity
timeFrame: The Pain intensity will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Intervention Proximal Condition
measure: Pain intensity
timeFrame: The Pain intensity will be assessed immediately after the first valid attempt of the stepping manoeuvre in the Intervention Distal Condition
measure: Pain intensity
timeFrame: The Pain intensity will be assessed immediately after the second valid attempt of the stepping manoeuvre in the Intervention Distal Condition
measure: Pain intensity
timeFrame: The Pain intensity will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Intervention Distal Condition
Secondary outcomes:
measure: A global rating of change change (GRC) questionnaire
timeFrame: The GRC will be assessed immediately after the third valid attempt of the level-walking task in the Intervention Proximal Condition
measure: A global rating of change change (GRC) questionnaire
timeFrame: The GRC will be assessed immediately after the third valid attempt of the level-walking task in the Intervention Distal Condition
measure: A global rating of change change (GRC) questionnaire
timeFrame: The GRC will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Intervention Proximal Condition
measure: A global rating of change change (GRC) questionnaire
timeFrame: The GRC will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Intervention Distal Condition
measure: Acceptable state of the patient's symptoms
timeFrame: The Acceptable state of the patient's symptoms will be assessed immediately after the third valid attempt of the level-walking tasks in the Intervention Proximal Condition
measure: Acceptable state of the patient's symptoms
timeFrame: The Acceptable state of the patient's symptoms will be assessed immediately after the third valid attempt of the level-walking tasks in the Intervention Distal Condition
measure: Acceptable state of the patient's symptoms
timeFrame: The Acceptable state of the patient's symptoms will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Intervention Proximal Condition
measure: Acceptable state of the patient's symptoms
timeFrame: The Acceptable state of the patient's symptoms will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Intervention Distal Condition
measure: Ease of performing a task
timeFrame: The Ease of performing a task will be assessed immediately after the third valid attempt of the level-walking task in the Control Condition
measure: Ease of performing a task
timeFrame: The Ease of performing a task will be assessed immediately after the third valid attempt of the level-walking task in the Intervention Proximal Condition
measure: Ease of performing a task
timeFrame: The Ease of performing a task will be assessed immediately after the third valid attempt of the level-walking task in the Intervention Distal Condition
measure: Ease of performing a task
timeFrame: The Ease of performing a task will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Control Condition
measure: Ease of performing a task
timeFrame: The Ease of performing a task will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Intervention Proximal Condition
measure: Ease of performing a task
timeFrame: The Ease of performing a task will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Intervention Distal Condition
measure: Knee confidence
timeFrame: The knee confidence will be assessed immediately after the third valid attempt of the level-walking task in the Control Condition
measure: Knee confidence
timeFrame: The knee confidence will be assessed immediately after the third valid attempt of the level-walking task in the Intervention Proximal Condition
measure: Knee confidence
timeFrame: The knee confidence will be assessed immediately after the third valid attempt of the level-walking task in the Intervention Distal Condition
measure: Knee confidence
timeFrame: The knee confidence will assessed immediately after the third valid attempt of the stepping manoeuvre in the Control Condition
measure: Knee confidence
timeFrame: The knee confidence will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Intervention Proximal Condition
measure: Knee confidence
timeFrame: The knee confidence will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Intervention Distal Condition
measure: Lower limb kinematics - Peak of Hip Adduction
timeFrame: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the stance phase of the level-walking of the first valid attempt in the Control Condition
measure: Lower limb kinematics - Peak of Hip Adduction
timeFrame: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the stance phase of the gait of the second valid attempt in the Control Condition
measure: Lower limb kinematics - Peak of Hip Adduction
timeFrame: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the stance phase of the level-walking of the third valid attempt in the Control Condition
measure: Lower limb kinematics - Peak of Hip Adduction
timeFrame: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the stance phase of the level-walking of the first valid attempt in the Intervention Proximal Condition
measure: Lower limb kinematics - Peak of Hip Adduction
timeFrame: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the stance phase of the level-walking of the second valid attempt in the Intervention Proximal Condition
measure: Lower limb kinematics - Peak of Hip Adduction
timeFrame: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the stance phase of the level-walking of the third valid attempt in the Intervention Proximal Condition
measure: Lower limb kinematics - Peak of Hip Adduction
timeFrame: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the stance phase of the level-walking of the first valid attempt in the Intervention Distal Condition
measure: Lower limb kinematics - Peak of Hip Adduction
timeFrame: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the stance phase of the level-walking of the second valid attempt in the Intervention Distal Condition
measure: Lower limb kinematics - Peak of Hip Adduction
timeFrame: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the stance phase of the level-walking of the third valid attempt in the Intervention Distal Condition
measure: Lower limb kinematics - Peak of Hip Medial Rotation
timeFrame: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the stance phase of the level-walking of the first valid attempt in the Control Condition
measure: Lower limb kinematics - Peak of Hip Medial Rotation
timeFrame: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the stance phase of the level-walking of the second valid attempt in the Control Condition
measure: Lower limb kinematics - Peak of Hip Medial Rotation
timeFrame: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the stance phase of the level-walking of the third valid attempt in the Control Condition
measure: Lower limb kinematics - Peak of Hip Medial Rotation
timeFrame: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the stance phase of the level-walking of the first valid attempt in the Intervention Proximal Condition
measure: Lower limb kinematics - Peak of Hip Medial Rotation
timeFrame: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the stance phase of the level-walking of the second valid attempt in the Intervention Proximal Condition
measure: Lower limb kinematics - Peak of Hip Medial Rotation
timeFrame: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the stance phase of the level-walking of the third valid attempt in the Intervention Proximal Condition
measure: Lower limb kinematics - Peak of Hip Medial Rotation
timeFrame: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the stance phase of the level-walking of the first valid attempt in the Intervention Distal Condition
measure: Lower limb kinematics - Peak of Hip Medial Rotation
timeFrame: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the stance phase of the level-walking of the second valid attempt in the Intervention Distal Condition
measure: Lower limb kinematics - Peak of Hip Medial Rotation
timeFrame: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the stance phase of the level-walking of the third valid attempt in the Intervention Distal Condition
measure: Lower limb kinematics - Peak of Rearfoot Eversion
timeFrame: The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the stance phase of the level-walking of the first valid attempt in the Control Condition
measure: Lower limb kinematics - Peak of Rearfoot Eversion
timeFrame: The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the stance phase of the level-walking of the second valid attempt in the Control Condition
measure: Lower limb kinematics - Peak of Rearfoot Eversion
timeFrame: The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the stance phase of the level-walking of the third valid attempt in the Control Condition
measure: Lower limb kinematics - Peak of Rearfoot Eversion
timeFrame: The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the stance phase of the level-walking of the first valid attempt in the Intervention Proximal Condition
measure: Lower limb kinematics - Peak of Rearfoot Eversion
timeFrame: The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the stance phase of the level-walking of the second valid attempt in the Intervention Proximal Condition
measure: Lower limb kinematics - Peak of Rearfoot Eversion
timeFrame: The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the stance phase of the level-walking of the third valid attempt in the Intervention Proximal Condition
measure: Lower limb kinematics - Peak of Rearfoot Eversion
timeFrame: The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the stance phase of the level-walking of the first valid attempt in the Intervention Distal Condition
measure: Lower limb kinematics - Peak of Rearfoot Eversion
timeFrame: The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the stance phase of the level-walking of the second valid attempt in the Intervention Distal Condition
measure: Lower limb kinematics - Peak of Rearfoot Eversion
timeFrame: The Lower limb kinematics - Peak of Rearfoot of Eversion will be assessed during the stance phase of the level-walking of the third valid attempt in the Intervention Distal Condition
measure: Lower limb kinematics - Peak of Hip Adduction
timeFrame: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the first valid attempt of the stepping manoeuvre in the Control Condition
measure: Lower limb kinematics - Peak of Hip Adduction
timeFrame: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the second valid attempt of the stepping manoeuvre in the Control Condition
measure: Lower limb kinematics - Peak of Hip Adduction
timeFrame: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the third valid attempt of the stepping manoeuvre in the Control Condition
measure: Lower limb kinematics - Peak of Hip Adduction
timeFrame: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the first valid attempt of the stepping manoeuvre in the Intervention Proximal Condition
measure: Lower limb kinematics - Peak of Hip Adduction
timeFrame: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the second valid attempt of the stepping manoeuvre in the Intervention Proximal Condition
measure: Lower limb kinematics - Peak of Hip Adduction
timeFrame: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the third valid attempt of the stepping manoeuvre in the Intervention Proximal Condition
measure: Lower limb kinematics - Peak of Hip Adduction
timeFrame: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the first valid attempt of the stepping manoeuvre in the Intervention Distal Condition
measure: Lower limb kinematics - Peak of Hip Adduction
timeFrame: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the second valid attempt of the stepping manoeuvre in the Intervention Distal Condition
measure: Lower limb kinematics - Peak of Hip Adduction
timeFrame: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the third valid attempt of the stepping manoeuvre in the Intervention Distal Condition
measure: Lower limb kinematics - Peak of Hip Medial Rotation
timeFrame: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the first valid attempt of the stepping manoeuvre in the Control Condition
measure: Lower limb kinematics - Peak of Hip Medial Rotation
timeFrame: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the second valid attempt of the stepping manoeuvre in the Control Condition
measure: Lower limb kinematics - Peak of Hip Medial Rotation
timeFrame: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the third valid attempt of the stepping manoeuvre in the Control Condition
measure: Lower limb kinematics - Peak of Hip Medial Rotation
timeFrame: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the first valid attempt of the stepping manoeuvre in the Intervention Proximal Condition
measure: Lower limb kinematics - Peak of Hip Medial Rotation
timeFrame: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the second valid attempt of the stepping manoeuvre in the Intervention Proximal Condition
measure: Lower limb kinematics - Peak of Hip Medial Rotation
timeFrame: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the third valid attempt of the stepping manoeuvre in the Intervention Proximal Condition
measure: Lower limb kinematics - Peak of Hip Medial Rotation
timeFrame: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the first valid attempt of the stepping manoeuvre in the Intervention Distal Condition
measure: Lower limb kinematics - Peak of Hip Medial Rotation
timeFrame: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the second valid attempt of the stepping manoeuvre in the Intervention Distal Condition
measure: Lower limb kinematics - Peak of Hip Medial Rotation
timeFrame: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the third valid attempt of the stepping manoeuvre in the Intervention Distal Condition
measure: Lower limb kinematics - Peak of Rearfoot Eversion
timeFrame: The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the first valid attempt of the stepping manoeuvre in the Control Condition
measure: Lower limb kinematics - Peak of Rearfoot Eversion
timeFrame: The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the second valid attempt of the stepping manoeuvre in the Control Condition
measure: Lower limb kinematics - Peak of Rearfoot Eversion
timeFrame: The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the third valid attempt of the stepping manoeuvre in the Control Condition
measure: Lower limb kinematics - Peak of Rearfoot Eversion
timeFrame: The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the first valid attempt of the stepping manoeuvre in the Intervention Proximal Condition
measure: Lower limb kinematics - Peak of Rearfoot Eversion
timeFrame: The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the second valid attempt of the stepping manoeuvre in the Intervention Proximal Condition
measure: Lower limb kinematics - Peak of Rearfoot Eversion
timeFrame: The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the third valid attempt of the stepping manoeuvre in the Intervention Proximal Condition
measure: Lower limb kinematics - Peak of Rearfoot Eversion
timeFrame: The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the first valid attempt of the stepping manoeuvre in the Intervention Distal Condition
measure: Lower limb kinematics - Peak of Rearfoot Eversion
timeFrame: The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the second valid attempt of the stepping manoeuvre in the Intervention Distal Condition
measure: Lower limb kinematics - Peak of Rearfoot Eversion
timeFrame: The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the third valid attempt of the stepping manoeuvre in the Intervention Distal Condition
Other outcomes:
Locations:
Study officials:
References:
citation: Souto LR, Serrao PRMDS, Pisani GK, Tessarin BM, da Silva HF, Machado EM, de Oliveira Sato T, Serrao FV. Immediate effects of hip strap and foot orthoses on self-reported measures and lower limb kinematics during functional tasks in individuals with patellofemoral osteoarthritis: protocol for a randomised crossover clinical trial. Trials. 2022 Sep 5;23(1):746. doi: 10.1186/s13063-022-06676-0.