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

NCT04332900 | Unknown DMC

• 1 other identifier: 2020/01599-7
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Conditions

Patellofemoral Osteoarthritis

Keywords

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

Outcome Measures

Primary Outcomes (18)

• Pain intensity

  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

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

• Pain intensity

  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

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

• Pain intensity

  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

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

• Pain intensity

  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

  The Pain intensity will be assessed immediately after the first valid attempt of the level-walking task in the Intervention Proximal Condition

• Pain intensity

  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

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

• Pain intensity

  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

  The Pain intensity will be assessed immediately after the third valid attempt of the level-walking task in the Intervention Proximal Condition

• Pain intensity

  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

  The Pain intensity will be assessed immediately after the first valid attempt of the level-walking task in the Intervention Distal Condition

• Pain intensity

  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

  The Pain intensity will be assessed immediately after the second valid attempt of the level-walking task in the Intervention Distal Condition

• Pain intensity

  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

  The Pain intensity will be assessed immediately after the third valid attempt of the level-walking task in the Intervention Distal Condition

• Pain intensity

  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

  The Pain intensity will be assessed immediately after the first valid attempt of the stepping manoeuvre in the Control Condition

• Pain intensity

  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

  The Pain intensity will be assessed immediately after the second valid attempt of the stepping manoeuvre in the Control Condition

• Pain intensity

  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

  The Pain intensity will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Control Condition

• Pain intensity

  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

  The Pain intensity will be assessed immediately after the first valid attempt of the stepping manoeuvre in the Intervention Proximal Condition

• Pain intensity

  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

  The Pain intensity will be assessed immediately after the second valid attempt of the stepping manoeuvre in the Intervention Proximal Condition

• Pain intensity

  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

  The Pain intensity will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Intervention Proximal Condition

• Pain intensity

  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

  The Pain intensity will be assessed immediately after the first valid attempt of the stepping manoeuvre in the Intervention Distal Condition

• Pain intensity

  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

  The Pain intensity will be assessed immediately after the second valid attempt of the stepping manoeuvre in the Intervention Distal Condition

• Pain intensity

  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

  The Pain intensity will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Intervention Distal Condition

Secondary Outcomes (74)

• A global rating of change change (GRC) questionnaire

  The GRC will be assessed immediately after the third valid attempt of the level-walking task in the Intervention Proximal Condition

• A global rating of change change (GRC) questionnaire

  The GRC will be assessed immediately after the third valid attempt of the level-walking task in the Intervention Distal Condition

• 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 Proximal Condition

• 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

• 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 level-walking tasks in the Intervention Proximal Condition

Study Arms (3)

Control condition

NO INTERVENTION

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

Intervention proximal condition

EXPERIMENTAL

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

Device: Elastic hip strap

Intervention distal condition

EXPERIMENTAL

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).

Device: Insole

Interventions

Elastic hip strap 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.

Also known as: S.E.R.F. Strap; DonJoy Orthopedics, Inc, vista, CA

Intervention proximal condition

Insole 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).

Also known as: Propulsão Produtos Biomecânicos, Minas Gerais, Brasil

Intervention distal condition

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal de Sao Carlos: lead
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator

Related Publications (1)

• 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.

  PMID: 36064729 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain

Interventions

Foot Orthoses

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Central Study Contacts

Larissa R Souto, MSc

CONTACT

+55(18)988052128; larissasouto@live.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: randomised cross-over desing

Study Record Dates

• First Submitted: February 16, 2020
• First Posted: April 3, 2020
• Study Start: November 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: November 1, 2022
• Last Updated: March 22, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share