The Comparison of Hip and Knee Focused Exercises Versus Hip and Knee Focused Exercises With the Use of Blood Flow Restriction Training in Adults With Patellofemoral Pain

NCT04340453 | Completed DMC

• 1 other identifier: ΕΕΒΚ/ΕΠ/2019/86
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Hip and Knee strengthening exercises are implemented in Patellofemoral Pain (PFP) rehabilitation but exercising in high loads to achieve muscle changes in strength may lead to increased patellofemoral joint stress. Low load training with Blood Flow Restriction (BFR) may allow for exercise strength benefits to proximal and distal muscles with reduced joint stress and by promoting hypoalgesia. The purpose of this study is to compare hip and knee focused exercises with and without BFR training in adults with PFP. The main outcome of this study is function ability which will be measured with the Kujala Anterior Knee pain Scale translated in the Greek language at four weeks post intervention and at two months follow up. Our null hypothesis is that there will be no difference between groups for primary and secondary outcomes measured at four weeks and two months post intervention.

Conditions

Patellofemoral Pain Syndrome

Keywords

Patellofemoral Pain; Exercise; Rehabilitation; Blood Flow Restriction training; physical therapy; physiotherapy

Outcome Measures

Primary Outcomes (1)

• "change" is being assessed for Function The Greek version of the Kujala Anterior Knee Pain Scale (AKPS)

  The AKPS is a 13-item questionnaire that documents response to six different activities such as walking, running, jumping, stair climbing, squatting and prolonged sitting with knee bent, as well as patients symptoms, such as limping, inability to weight bear on the affected limb, swelling, abnormal patella movement, muscle atrophy and limitations of flexion of knee joint. The AKPS asks about the duration of symptoms and limb(s) affected. The maximum score is 100 (no pain/disability/limitation) and the minimum 0 (worst possible function). This questionnaire has been previously used in PFP studies and is found to be a valid and reliable measure for PFP patients with a minimally clinical significant difference (MCID) of 10points. The Greek version has been found to have good internal consistency (Cronbach's a=0.942), test-retest reliability (ICC=0.921) and concurrent validity (r\>0.7)

  baseline, 4 weeks (end of treatment), 2 months (follow up)

Secondary Outcomes (6)

• "change" is being assessed. Pain with the Visual Analog Scale

  baseline, 4 weeks (end of treatment), 2 months (follow up)

• "change" is being assessed. Pain with single leg squatting (shallow-deep)

  baseline, 4 weeks (end of treatment), 2 months (follow up)

• "change" is being assessed. Kinesiophobia: The Tampa scale of Kinesiophobia (TSK)

  baseline, 4 weeks (end of treatment), 2 months (follow up)

• "change" is being assessed. Catastrophizing: The Pain Catastrophizing Scale (PCS)

  baseline, 4 weeks (end of treatment), 2 months (follow up)

• "change" is being assessed. Maximum pain free flexion angle using the decline step down test

  baseline, 4 weeks (end of treatment), 2 months (follow up)

Study Arms (2)

Group 1 (Hip and Knee Exercise Program)

ACTIVE COMPARATOR

Standard exercise physiotherapy treatment of a Hip and Knee Exercise Program plus stretching.

Other: Hip and Knee Exercise Program; Other: stretching

Group 2 (BFR-training hip and knee exercise group)

EXPERIMENTAL

BFR-training hip and knee exercise group plus stretching.

Other: Exercise with Blood Flow restriction training; Other: stretching

Interventions

Exercise with Blood Flow restriction training OTHER

3 times a week for 4 weeks to a total of 12 sessions. BFR cuff (Sports Rehab Tourniquet©) will be used, with a width of 10cm and a length of 116cm or 84cm depending on the diameter of the participants thigh. Therapy sessions will be supervised and in groups. Exercises focus on strengthening the hip extensors and abductors, as well as the quadriceps both in open and closed kinetic chain. Exercises will be carried out using will be set at a load of 30% of 1RM with a limb occlusion pressure (LOP) of 70%. The first set will consist of 30reps. followed by 3 sets of 15reps. at 2:2 (con/ecc) at 60bpm by Metronome app. with auditory cue. Rest between sets will be 30sec and between exercises 2min. Cuffs will be deflated during the resting period between exercises and re-inflated at the beginning of the next exercise. Exercise progression will be individualized based on assessments at the beginning of each week. The duration has been estimated to be approximately 60min. including LOP estimation.

Also known as: BFR training

Group 2 (BFR-training hip and knee exercise group)

Hip and Knee Exercise Program OTHER

A supervised hip and knee strengthening exercise protocol with a combination of stretching, 3 times a week for 4 weeks to a total of 12 sessions. Exercises focus on hip extensors, abductors, as well as the quadriceps and hamstrings strength. Open Kinetic Chain (OKC) exercises will be executed first followed by CKC exercises. Exercises using weights or mechanical resistance will be set at a load of 70% of 1RM and 3 sets of 10 rep. for each exercise. Elastic band exercises will be set at 10RM for 3 sets. Tempo will be set by the Metronome app installed on a Smartphone at 1:2 (con/ecc) at 60bpm with auditory cue. Rest between sets will be 30sec and between exercises 2min. Exercise progression will be individualized based on assessments at the beginning of each week. The duration of each session is estimated to be approximately 45min, with the exception of the first session of each week which is estimated to be 80min due to the addition of strength testing

Also known as: Standard treatment

Group 1 (Hip and Knee Exercise Program)

stretching OTHER

Both groups will receive stretching of the hamstrings, plantar flexors, quadriceps and Iliotibial Band (ITB) in the same manor at the end of each session. Passive stretching will be executed by the physiotherapist with 3x30sec stretch for each muscle group

Group 1 (Hip and Knee Exercise Program); Group 2 (BFR-training hip and knee exercise group)

Eligibility Criteria

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

You may qualify if:

• Volunteers to be included can be either male or female, must be 18-40 years of age and should have at least a 4 week, history of peri or retro-patella non traumatic pain, with intensity of worst pain during the previous week at 3cm on the Visual Analogue Scale (VAS).
• Pain should be aggravated by at least two of the following functional tasks: squatting, kneeling, prolonged sitting, stair ascending or descending, hopping or running.
• During physical examination pain must be present with either palpation of the patella facets or with the patella compression test or a deep squat.
• Volunteers with bilateral symptoms will be documented but the limb with the worst pain will be used for analysis.

You may not qualify if:

• Volunteers with the following characteristics will also be excluded:
• History or current meniscus ligament or other knee injury and/or surgery.
• Other knee pathology such as knee osteoarthritis, Osgood- Schlatter or Sinding-Larsen-Johanssen syndrome or tendinopathy of muscles surrounding the knee. Knee instability, feeling of "giving way", history of subluxation or dislocation of the knee joint or joint edema.
• Extended use of NSAID or cortisone.
• Referred pain from lumbar spine or another region.
• Patella dysplasia, rheumatoid arthritis or neurological syndromes or diseases
• During clinical examination volunteers with pain located on the patella tendon that is eliminated with isometric contraction, the pes anserinus, the Iliotibial Band (ITB), or with a positive medial or lateral patella apprehension test will also be excluded
• Volunteers that had previous treatment for PFP in the past 6 months will also be excluded to avoid non responders and carryover effects from previous treatments.
• Volunteers with unexplained chest pains
• Cardiovascular disease, renal disease, vascular surgery or disease
• Deep Venous Thrombosis (DVT) or high risk for DVT, resent surgery ≤6 months, - High blood pressure (≥140/90mmHg) dizzy spells, history of fainting or dizziness with exercise
• Pregnancy
• Any contraindication to exercise

Sponsors & Collaborators

• European University Cyprus: lead

Study Sites (1)

European University Cyprus

Nicosia, Engomi, 2404, Cyprus

Location

MeSH Terms

Conditions

Patellofemoral Pain Syndrome; Motor Activity

Interventions

Exercise; Blood Flow Restriction Therapy; Papaverine

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Benzylisoquinolines; Alkaloids; Heterocyclic Compounds; Opiate Alkaloids; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Antonis Constantinou, PhDcan

  European University Cyprus

  PRINCIPAL INVESTIGATOR

• Dimitris Stasinopoulos, PhD

  European University Cyprus

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: participants and care providers were only blinded to the other groups intervention. The Investigator and outcomes assessor are blinded to patient allocation and data code.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, MSc, PhD(can), Department of health Sciences , Physiotherapy Programme, European University Cyprus, Cyprus member of Cyprus Musculoskeletal and Sports Trauma Research Centre (CYMUSTREC)

Model Details: This a randomized controlled trial with first primary end point at four weeks and second primary end point at two months. Participants will be allocated randomly into one of two intervention groups. Group1 (Knee and hip focused exercises) Group 2 (knee and hip focused exercises with BFR)

Study Record Dates

• First Submitted: April 6, 2020
• First Posted: April 9, 2020
• Study Start: November 29, 2019
• Primary Completion: December 21, 2019
• Study Completion: February 29, 2020
• Last Updated: April 9, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 6 months after publication date and only upon agreement by the authors that there will be no further changes and/or analysis may data be shared.
• Access Criteria: It is to the authors discretion to share study data to other researchers.

Locations

CY (1)