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Knee OsteoarthritisNCT06502587

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

A study testing blood flow restriction training and ultrasound therapy in people with Knee Osteoarthritis, run by Riphah International University at 1 site in Pakistan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 40 to 65 years
Conditions the study is for
Knee Osteoarthritis
What is being tested?
blood flow restriction training and ultrasound therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 sitePakistan
Study dates
23 Nov 2023to 20 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • hypertension
  • diabetes
  • sickle cell anemia
  • renal compromise
  • obesity
  • open fracture,
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Imran Amjad contact

03324390125

imran.amjad@riphah.edu.pk

Pakistan1 site, 1 recruiting

  • Lahore General Hospital

    Lahore, Punjab Province, 54000

    Iqra Khan, Mphil, 03354671744, Iqrakhan485@gmail.com

    Efra Akdas, MSPT(OMPT)

    Recruiting

Other trials in Pakistan

About this study

Official title: Effects of Blood Flow Restriction Training With Low Intensity Exercises on Pain,Range of Motion and Quality of Life 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.

Read the detailed description

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.

Being tested
blood flow restriction training, ultrasound therapy
Keywords
Blood flow restriction training, Knee Osteoarthritis, Pain, Quality of life, Range of motion
Medical subject headings
Osteoarthritis, Knee, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • blood flow restriction trainingOther

    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 therapyOther

    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

Study groups in NCT06502587
Study groupRoleWhat they receive
blood flow restriction trainingExperimentalwe will apply blood flow restriction training with low intensity exercises on patients with knee osteoarthritis to check pain,quality of life and range of motion.
Receives: Other: blood flow restriction training
ultrasound application onlyActive comparatorin this group we will apply ultrasound therapy on knee joint for 7 minutes.
Receives: Other: ultrasound therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. NPRS Numeric pain rating scale

    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)

    Measured: 4th week

Secondary outcomes (3)

  1. Womac index for knee osteoarthritis

    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.

    Measured: 4th week

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

    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

    Measured: 4th week

  3. Universal goniometer

    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

    Measured: 4th week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2024
  2. Study start23 Nov 2023
  3. Primary completion20 Jul 2024 (estimated)
  4. Study completion20 Jul 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06502587
Sponsor's protocol ID
REC/RCR&AHS/23/01112
Status last verified
Jul 2024
First submitted
11 Jun 2024
Last updated
16 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Prathap Kumar J, Arun Kumar M, Venkatesh D. Healthy gait: Review of anatomy and physiology of knee joint. International Journal of Current Research and Review. 2020;12(6):1-8.

  • Van Cant J, Dawe-Coz A, Aoun E, Esculier JF. Quadriceps strengthening with blood flow restriction for the rehabilitation of patients with knee conditions: A systematic review with meta-analysis. J Back Musculoskelet Rehabil. 2020;33(4):529-544. doi: 10.3233/BMR-191684.

    PubMed 32310159

  • Ferlito JV, Pecce SAP, Oselame L, De Marchi T. The blood flow restriction training effect in knee osteoarthritis people: a systematic review and meta-analysis. Clin Rehabil. 2020 Nov;34(11):1378-1390. doi: 10.1177/0269215520943650. Epub 2020 Aug 10.

    PubMed 32772865

  • Ferraz RB, Gualano B, Rodrigues R, Kurimori CO, Fuller R, Lima FR, DE Sa-Pinto AL, Roschel H. Benefits of Resistance Training with Blood Flow Restriction in Knee Osteoarthritis. Med Sci Sports Exerc. 2018 May;50(5):897-905. doi: 10.1249/MSS.0000000000001530.

    PubMed 29266093

  • Grantham B, Korakakis V, O'Sullivan K. Does blood flow restriction training enhance clinical outcomes in knee osteoarthritis: A systematic review and meta-analysis. Phys Ther Sport. 2021 May;49:37-49. doi: 10.1016/j.ptsp.2021.01.014. Epub 2021 Feb 3.

    PubMed 33582442

  • Kaya PDCBK, Alpozgen AZ. EFFECTS OF BLOOD FLOW RESTRICTION METHOD IN KNEE PATHOLOGIES. TAM METİN KİTABI. 2022:21.

  • Wang HN, Chen Y, Cheng L, Cai YH, Li W, Ni GX. Efficacy and Safety of Blood Flow Restriction Training in Patients With Knee Osteoarthritis: A Systematic Review and Meta-Analysis. Arthritis Care Res (Hoboken). 2022 Jan;74(1):89-98. doi: 10.1002/acr.24787. Epub 2021 Dec 17.

    PubMed 34549541

  • Pitsillides A, Stasinopoulos D, Mamais I. Blood flow restriction training in patients with knee osteoarthritis: Systematic review of randomized controlled trials. J Bodyw Mov Ther. 2021 Jul;27:477-486. doi: 10.1016/j.jbmt.2021.04.015. Epub 2021 Apr 23.

    PubMed 34391274

  • Li S, Shaharudin S, Abdul Kadir MR. Effects of Blood Flow Restriction Training on Muscle Strength and Pain in Patients With Knee Injuries: A Meta-Analysis. Am J Phys Med Rehabil. 2021 Apr 1;100(4):337-344. doi: 10.1097/PHM.0000000000001567.

    PubMed 33727516

  • Mahmoud WS, Osailan A, Ahmed AS, Elnaggar RK, Radwan NL. Optimal parameters of blood flow restriction and resistance training on quadriceps strength and cross-sectional area and pain in knee osteoarthritis. Isokinetics and Exercise Science. 2021;29(4):393-402.

  • NADIA AF, ABDALLAH MM, FADEL MEM, MOHAMMED MM. Effect of Low Load Resistance Blood Flow Restriction Training on Knee Osteoarthritis. The Medical Journal of Cairo University. 2018;86(December):4297-306.

  • Rolff S, Korallus C, Hanke AA. [Rehabilitation with the aid of blood flow restriction training]. Unfallchirurg. 2020 Mar;123(3):180-186. doi: 10.1007/s00113-020-00770-1. German.

    PubMed 32030478

Questions about this trial

What is this clinical trial studying?

A study testing blood flow restriction training and ultrasound therapy in people with Knee Osteoarthritis, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Imran Amjad (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

NPRS Numeric pain rating scale (time frame: 4th week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06502587, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.

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