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

Not Applicable

• Conditions: Patellofemoral Osteoarthritis
• Interventions: Device: Insole; Device: Elastic hip strap

• Registration Number: NCT04332900
• Lead Sponsor: Universidade Federal de Sao Carlos

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

Study Timeline

• Study First Submitted: 2020-02-16
• Study First Submitted QC: 2020-04-02
• Study First Posted: 2020-04-03
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-17
• Last Update Posted: 2021-03-22
• Study Start: 2021-11-01
• Primary Completion: 2022-05-01
• Study Completion: 2022-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intervention distal condition	Insole	The distal therapeutic approach will be a pair of foot orthoses with semi-rigid arch support and medial elevation at the forefoot and at the rearfoot by 7° each (Propulsão Produtos Biomecânicos, Minas Gerais, Brazil).
Intervention proximal condition	Elastic hip strap	The proximal therapeutic approach will be the SERF strap (S.E.R.F. strap; DonJoy Orthopedics, Inc., vista, CA).

Primary Outcome Measures

Name	Time	Method
Pain intensity	The Pain intensity will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Intervention Distal Condition	This 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 Outcome Measures

Name	Time	Method
Lower limb kinematics - Peak of Hip Medial Rotation	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	For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.
A global rating of change change (GRC) questionnaire	The GRC will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Intervention Distal Condition	The 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.
Knee confidence	The knee confidence will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Intervention Distal Condition	The 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).
Acceptable state of the patient's symptoms	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	The 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".
Lower limb kinematics - Peak of Rearfoot Eversion	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	For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.
Ease of performing a task	The Ease of performing a task will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Intervention Distal Condition	Participants 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)
Lower limb kinematics - Peak of Hip Adduction	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	For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.