Clinical trial NCT04917952: Effectiveness of Blood Flow Restriction Exercise Therapy to Reduce Pain in Knee Osteoarthritis Patients
Official title: Effectiveness of Blood Flow Restriction (BFR) Exercise Therapy to Reduce Pain in Knee Osteoarthritis (OA) Patients. A Double-blinded Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: chronic pain
Lead sponsor: University of West Attica
Sponsor class: OTHER
First posted: 2021-06-08
Enrollment: 42
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Resistance training of knee extensor muscles is being used in physiotherapy management in knee osteoarthritis (OA) to improve pain and physical function. Blood flow restriction (BFR) has been suggested to improve pain and increase muscle strength in healthy subjects and certain diseases. Although there are clinical studies suggesting improvements in knee osteoarthritis symptoms after 4-12 weeks of exercise with BFR, the acute effects of the intervention have not been known.

This study aims to assess the effectiveness of low load exercise therapy combined with BFR on acute pain reduction and within 24 hours post-intervention on people with knee OA compared to a placebo group.

This study will take place in Athens, Greece, as part of the postgraduate MSc program of the Physiotherapy department of the University of West Attica.

Detailed description: A double-blinded randomised clinical trial with a total of 42 participants will be randomly assigned to the intervention (n=21) or the control group (n=21).

The intervention group will complete a single exercise session with BFR 80%, 30% 1RM, while the control group will have sham BFR, 30% 1RM.

Pain Pressure Threshold (PPT) will be assessed with the use of a digital pressure dynamometer.

Eligibility criteria: Inclusion Criteria:

* Current osteoarthritis clinical diagnosis according to either European League Against Rheumatism (EULAR) or American College of Rheumatology (ACR) criteria
* VAS/NRS Knee pain ≥3/10 during activity

Exclusion Criteria:

* Previous experience with BFR
* Has followed knee exercise or kinesiotherapy program in the past 3 months
* New medicines in the past 3 months
* Any lower limb surgery in the past 6 months
* Knee arthroplasty surgery (Knee replacement)
* Any active healing process affecting walking (fracture, sprain, strain, etc.)
* Diagnosed with rheumatologic/neurologic disease affecting functionality
* Diagnosed or history of heart or vascular diseases
* Diagnosed with respiratory/metabolic disease
* Personal history of cancer
* Cognitive problems
* Pregnancy (only for female participants)
* Any other indication not to participate in exercise

Primary outcomes:
measure: Change of Pain Pressure Threshold (PPT) from baseline
timeFrame: At baseline, Post 5 minutes, Post 24 hours
Secondary outcomes:
measure: Change of Dynamic weight-bearing Assessment of Pain (DAP) from baseline
timeFrame: At baseline, Post 5 minutes, Post 24 hours
measure: Change of 30-second Chair Stand Test (30s-CST) from baseline
timeFrame: At baseline, Post 5 minutes, Post 24 hours
measure: Change of pain score from baseline with the use of reporting scales Visual Analogue Scale (VAS) / Numeric Rating Scale (NRS)
timeFrame: At baseline, Post 5 minutes, Post 24 hours
Other outcomes:
measure: Douleur Neuropathique 4 questionnaire (DN4 greek)
timeFrame: At least 72 hours prior the intervention
measure: Knee Osteoarthritis Outcome Scale (KOOS greek)
timeFrame: At least 72 hours prior the intervention
measure: 1 Repetition Maximum (1RM)
timeFrame: At least 72 hours prior the intervention
measure: Other demographics and medical notes
timeFrame: At least 72 hours prior the intervention
Locations:
Study officials:
affiliation: University of West Attica
name: George Gioftsos
role: STUDY_DIRECTOR
References: