UnknownNot Applicable

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

30 participantsStarted 2021-11-01

Plain-language 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

Who can participate

Age range

40 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 su…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pain intensity

Timeframe: The Pain intensity will be assessed immediately after the first valid attempt of the level-walking task in the Control Condition

Pain intensity

Timeframe: The Pain intensity will be assessed immediately after the second valid attempt of the level-walking task in the Control Condition

Pain intensity

Timeframe: The Pain intensity will be assessed immediately after the third valid attempt of the level-walking task in the Control Condition

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

Pain intensity

Timeframe: The Pain intensity will be assessed immediately after the second valid attempt of the level-walkingtask in the Intervention Proximal Condition

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

Trial details

NCT IDNCT04332900

SponsorUniversidade Federal de Sao Carlos

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-05-01

Contact for this trial

Larissa R Souto, MSc

+55(18)988052128 larissasouto@live.com

View on ClinicalTrials.gov More Patellofemoral Osteoarthritis trials

Plain-language summary

Who can participate

Age range

40 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Pain intensity

Timeframe: The Pain intensity will be assessed immediately after the first valid attempt of the level-walking task in the Control Condition

Pain intensity

Timeframe: The Pain intensity will be assessed immediately after the second valid attempt of the level-walking task in the Control Condition

Pain intensity

Timeframe: The Pain intensity will be assessed immediately after the third valid attempt of the level-walking task in the Control Condition

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

Pain intensity

Timeframe: The Pain intensity will be assessed immediately after the second valid attempt of the level-walkingtask in the Intervention Proximal Condition

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