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

NCT ID: NCT04332900

Last Updated: 2021-03-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2022-11-01

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

Conditions

Patellofemoral Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Control condition

In this condition there will not be any application of therapeutic approach.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention proximal condition

The proximal therapeutic approach will be the SERF strap (S.E.R.F. strap; DonJoy Orthopedics, Inc., vista, CA).

Group Type: EXPERIMENTAL

Elastic hip strap

Intervention Type: DEVICE

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.

Intervention distal condition

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).

Group Type: EXPERIMENTAL

Insole

Intervention Type: DEVICE

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).

Interventions

Elastic 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.

Intervention Type: DEVICE

Insole

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).

Intervention Type: DEVICE

Other Intervention Names

S.E.R.F. Strap; DonJoy Orthopedics, Inc, vista, CA; Propulsão Produtos Biomecânicos, Minas Gerais, Brasil

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

Sponsor Role: collaborator

Universidade Federal de Sao Carlos

OTHER

Sponsor Role: lead

Responsible Party

Larissa Rodrigues Souto

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Larissa R Souto, MSc

Role: CONTACT

larissasouto@live.com

+55(18)988052128

References

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.

Reference Type: DERIVED

PMID: 36064729 (View on PubMed)

Other Identifiers

2020/01599-7

Identifier Type: -

Identifier Source: org_study_id