Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06502587

Effects of Blood Flow Restriction Training With Low Intensity Exercises in Knee Osteoarthritis

The aim of the study is to examine the effects of blood flow restriction training(BFRT) with low intensity exercises on pain, range of motion and quality of life in Knee Osteoarthritis. A randomized clinical trial will be conducted at Lahore general hospital. Non-probability convenience sampling will be used, and 36 subjects, age 40-65 years will be randomly allocated into two groups by lottery method after meeting the inclusion criteria.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

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

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lahore General Hospital

Lahore, Punjab Province, 54000, Pakistan

Location status: Recruiting

Location contact

Efra Akdas, MSPT(OMPT)

PRINCIPAL_INVESTIGATOR

Iqra Khan, Mphil

CONTACT

[email protected]

03354671744

About this study

The aim of the study is to examine the effects of blood flow restriction training(BFRT) with low intensity exercises on pain, range of motion and quality of life in Knee Osteoarthritis. A randomized clinical trial will be conducted at Lahore general hospital. Non-probability convenience sampling will be used, and 36 subjects, age 40-65 years will be randomly allocated into two groups by lottery method after meeting the inclusion criteria. Both groups will receive Ultrasound therapy for 7 minutes, as common treatment. Group A will be treated with Blood flow restriction training with low intensity exercises and Group B will be treated with baseline treatment only. 3 sessions per week and total 12 sessions for 4 weeks. The outcome measures will be conducted through NPRS, Womac index for osteoarthritis,kellgren and lawrence scale and goniometry before and after 4 weeks. Data will be analyzed using SPSS software version 26.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Both Male and Female age between 40 to 65 years diagnosed with womac ostearthritis index having acute knee pain.
  • Patients with history of osteoarthritis (of grade 1 and 2 with KL(kellgren and Lawerence)) grading system for knee Osteoarthritis
  • Pain in and around knee measuring through Numeric Pain rating Scale(NPRS)>4(14)

Exclusion criteria

Patient with history of

  • hypertension
  • diabetes
  • sickle cell anemia
  • renal compromise
  • obesity
  • open fracture,
  • increased intracranial pressure
  • pregnancy
  • cancer or tumor,
  • extremity with dialysis access,
  • extremity fracture
  • peripheral vascular compromise
  • DVT(Deep vein thrombosis) & pulmonary embolism deformity of hip & back

Treatment and study plan

Blood Flow Restriction training

Other

we will apply blood flow restriction training with low intensity exercises like knee flexion ,knee extension and straight leg raise 10 repetitions 2 sets a day and 3 times/week a rest interval of 2 minutes between exercises, for 30 minutes of this whole procedure.

total 12 sessions given in 4 weeks each session of maximum 30 minutes

ultrasound therapy

Other

All subjects will be given Ultrasound therapy as per patient requirement with 1.5 Watts/cm^2 in continuous mode around knee joint. Conservative exercises(quads isometric exercise, pillow squeeze, heel raise, straight leg raise and side leg raise) will be applied for 3 times per week (daily one set of 10 repetitions) They will be given this treatment for 3 times per week

Primary outcomes

  1. NPRS Numeric pain rating scale

    Time frame: 4th week

    The NPRS is a self-reported, or clinician administered, measurement tool consisting of a numerical point scale with extreme anchors of 'no pain' to 'extreme pain'. The scale is typically set up on a horizontal or vertical line, ranges most commonly from 0-10 or 0-100, and can be administered in written or verbal form. The patient is asked to rate his/her pain intensity and a particular time frame or descriptor is established (e.g. within the last 24 h, today, worst pain, average pain, or least pain)

Secondary outcomes

  1. Womac index for knee osteoarthritis

    Time frame: 4th week

    WOMAC measures three separate dimensions: Pain (5 questions), Stiffness (2 questions), and Pain, stiffness, and physical function were measured by WOMAC. This instrument is validated and recommended by the Osteoarthritis Research Society as the measure of choice when assessing health status in older adults with knee OA. Rating scale ranges from 0 (none) to 4 (extreme), with higher total scores indicating greater dysfunction.The WOMAC addresses symptoms and functional disability in separate scales . Also, the WOMAC is a patient questionnaire.

  2. Knee Related QOL (QUALITY OF LIFE) Subscale From KOOS

    Time frame: 4th week

    The Knee injury and Osteoarthritis Outcome Score (KOOS) was developed as an extension of the WOMAC Osteoarthritis Index with the purpose of evaluating short-term and long-term symptoms and function in subjects with knee injury and osteoarthritis The KOOS holds five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). The effect size is generally largest for the subscale QOL followed by the subscale Pain. The KOOS is a valid, reliable and responsive self-administered instrument that can be used for short-term and long-term follow-up of several types of knee injury including osteoarthritis

  3. Universal goniometer

    Time frame: 4th week

    The most common tool for measuring ROM has been the universal goniometer (UG; full-circle manual goniometer. The advantage with the UG is its low cost, but both hands are needed to perform the measurements

Study contacts

Contact information is provided by the study sponsor or research team.

Imran Amjad

CONTACT

[email protected]

03324390125

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Blood Flow Restriction Training With Low Intensity Exercises on Pain,Range of Motion and Quality of Life in Knee Osteoarthritis

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 16, 2024
Registry last updated
Jul 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.