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Proximal and Distal Therapeutic Approach in Pain and Lower Limb Kinematic in People With Patellofemoral Osteoarthritis

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04332900
Enrollment
30
Registered
2020-04-03
Start date
2021-11-01
Completion date
2022-11-01
Last updated
2021-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patellofemoral Osteoarthritis

Keywords

Knee osteoarthritis, Patellofemoral joint, Gait, Pain, Quality of life, Physiotherapy

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

Interventions

DEVICEElastic hip strap

The SERF Strap consist of a thin, elastic material that is secured to the proximal aspect of the leg, wraps in a spiral fashion around the thigh, and is anchored around the pelvis. The line of action of the SERF Strap pulls the hip into abdcution and external rotation.

DEVICEInsole

Foot orthoses with semi-rigid arch support and medial elevation at the forefoot and at the rearfoot by 7° each that is made from a block of ethyl vinyl acetate with a thermo-moldable polymer (shore hardness of 45 A) and is manufactured through an automated computer numeric control machine (CNC routers).

Sponsors

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
CollaboratorOTHER_GOV
Universidade Federal de Sao Carlos
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Masking description

Due to the nature of the study only the person that will process and analyze the data could be blinded regarding the procedures and interventions of the study.

Intervention model description

randomised cross-over desing

Eligibility

Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Pain intensityThe Pain intensity will be assessed immediately after the first valid attempt of the level-walking task in the Control ConditionThis variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable

Secondary

MeasureTime frameDescription
Acceptable state of the patient's symptomsThe 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 ConditionThe participants will answered this following question: Considering your usual level of pain and also your functional impairment to perform tasks on a day-to-day basis, if you performed this functional task (gait or step-down test) with the application of this intervention (elastic band on the hip or foot orthosis) going forward, would you consider your current state to be satisfactory? Participants will could answered yes or no.
Ease of performing a taskThe Ease of performing a task will be assessed immediately after the third valid attempt of the level-walking task in the Control ConditionParticipants will answer the following question: How easy was this task? and then they will respond according to the scale (markedly difficult; somewhat difficult; neither difficult nor easy; somewhat easy; markedly easy)
Knee confidenceThe knee confidence will be assessed immediately after the third valid attempt of the level-walking task in the Control ConditionThe knee confidence using a 100mm VAS, with the question phrased as how confident did you feel completing that task? (terminal descriptors 0mm=very confident, 100mm=not confidente at all).
A global rating of change change (GRC) questionnaireThe GRC will be assessed immediately after the third valid attempt of the level-walking task in the Intervention Proximal ConditionThe GRC questionnaire is a 15 point self-report scale with criteria ranging from a 'very great deal worse' to a 'very great deal better.' The GRC is a valid and useful method for assessing the overall change in the quality of life of a person.
Lower limb kinematics - Peak of Hip Medial RotationThe 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 ConditionFor the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.
Lower limb kinematics - Peak of Rearfoot EversionThe 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 ConditionFor the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.
Lower limb kinematics - Peak of Hip AdductionThe 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 ConditionFor the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.

Contacts

Primary ContactLarissa R Souto, MSc
larissasouto@live.com+55(18)988052128

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026