Augmenting Standard Rehabilitation With Blood Flow Restriction for Chronic Achilles Tendinopathy

NCT07699497 | Active Not Recruiting

• 1 other identifier: 04-2025-300683
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic insertional Achilles tendinopathy is a common overuse condition that can be slow to improve with traditional loading-based rehab (e.g., eccentric loading, activity modification, graded return to function). Outcomes are often variable, and persistent symptoms can limit how much load patients can tolerate early in rehab. This outpatient randomized controlled trial will compare standard-of-care rehabilitation alone versus standard-of-care rehabilitation plus blood flow restriction (BFR) training in adults with chronic insertional Achilles tendinopathy. BFR uses an external cuff to partially restrict blood flow during low-load resistance exercise, aiming to produce strength and hypertrophy adaptations with less mechanical stress than high-load training. Evidence supporting BFR's physiologic effects and safety in musculoskeletal rehab is summarized in clinical research literature. Participants will be randomized (stratified by baseline activity level and symptom severity) to receive the same rehab program, with the experimental group performing strengthening with BFR using Smart Tools Plus cuffs applied at the proximal thigh and set to 40-80% limb occlusion pressure. The primary outcome will be the VISA-A score (a validated measure of Achilles tendinopathy severity), with secondary outcomes including pain ratings, functional performance tests (e.g., single-leg heel raise endurance, hopping/time-to fatigue), and calf strength via handheld dynamometry.

Conditions

Achilles Tendinopathy (AT)

Keywords

Insertional Achilles tendinopathy; Blood flow restriction; Progressive loading; Eccentric exercise

Outcome Measures

Primary Outcomes (1)

• VISA-A (Victorian Institute of Sport Assessment-Achilles) Score

  Description: Patient-reported outcome assessing Achilles tendinopathy severity; total score ranges 0-100 with higher scores indicating fewer symptoms/better function. This tool is validated for Achilles tendinopathy and commonly used in research/clinical settings.

  Baseline (pre-intervention) and Week 8 (end of intervention period)

Secondary Outcomes (4)

• Pain Rating (Numeric Pain Rating Scale or Visual Analog Scale)

  Baseline (pre-intervention) and Week 8 (end of intervention period)

• Single-Leg Heel Raise Endurance Test

  Baseline (pre-intervention) and Week 8 (end of intervention period)

• Hopping Test (or Time-to-Fatigue Hopping Test)

  Baseline (pre-intervention) and Week 8 (end of intervention period)

• Calf Muscle Strength (Handheld Dynamometry)

  Baseline (pre-intervention) and Week 8 (end of intervention period)

Study Arms (2)

Standard Rehabilitation

ACTIVE COMPARATOR

Participants receive standard-of-care rehabilitation for chronic insertional Achilles tendinopathy, including eccentric loading, activity modification, and gradual return to function

Behavioral: Standard-of-Care Rehabilitation Program for Chronic Insertional Achilles Tendinopathy

Standard Rehabilitation + Blood Flow Restriction (BFR)

EXPERIMENTAL

Participants receive the same standard-of-care rehabilitation plus blood flow restriction (BFR) training applied during exercise sets using Smart Tools Plus (LLC, USA) cuffs placed on the proximal thigh with a protective sleeve. Limb occlusion pressure (LOP) is set individually at 40-80% immediately before exercise and applied during the entire exercise set.

Behavioral: Standard-of-Care Rehabilitation Program for Chronic Insertional Achilles Tendinopathy; Device: Blood Flow Restriction (BFR) Training Device

Interventions

Standard-of-Care Rehabilitation Program for Chronic Insertional Achilles Tendinopathy BEHAVIORAL

Participants complete a standardized outpatient rehabilitation program for chronic insertional Achilles tendinopathy. Standard care includes progressive tendon/calf loading using an eccentric-loading emphasis, education and symptom-guided activity modification, and a graded return-to-function progression. The program is delivered under physical therapy supervision using standard exercise tools, with progression based on participant tolerance and clinical response.

Standard Rehabilitation; Standard Rehabilitation + Blood Flow Restriction (BFR)

Blood Flow Restriction (BFR) Training Device DEVICE

Blood flow restriction (BFR) is applied during low-load resistance exercise using Smart Tools Plus cuffs and limb sleeves. The sleeve is used to protect the skin/soft tissue beneath the cuff, and the cuff is placed around the proximal thigh (right and left as applicable). Individual limb occlusion pressure (LOP) is determined immediately prior to exercise; cuff pressure is set to 40%-80% of LOP and maintained during the entire exercise set. Participants are monitored during BFR application for adverse signs/symptoms (e.g., excessive pain, numbness/paresthesia, abnormal discoloration), and BFR is stopped if safety concerns arise.

Standard Rehabilitation + Blood Flow Restriction (BFR)

Eligibility Criteria

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

You may qualify if:

• Age 18-65 years
• Chronic insertional Achilles tendinopathy (symptoms \>3 months but \<3 years)
• VISA-A score \<80
• Confirmed diagnosis via:
• Palpation pain within 2 cm of calcaneal insertion
• Positive single leg-hop test
• Ultrasound or MRI evidence of structural tendon changes (hypoechoic areas, thickening, or Doppler flow)
• No prior BFR training as part of rehab within the last 3 months

You may not qualify if:

• Inability to give informed consent
• Uncontrolled blood pressure (\>160/100 mmHg)
• Uncontrolled diabetes
• Familial hypercholesterolemia
• History of deep vein thrombosis
• History of blood clots
• Hypercoagulable states
• Cancer
• Active infection
• History of sickle cell anemia
• Peripheral vascular disease
• Morbid obesity (BMI \>40)
• End-stage renal disease requiring dialysis
• Alcohol use disorder / alcohol abuse
• Claustrophobia

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of Medicine, Assiut University

Asyut, Egypt

Location

Related Publications (6)

• Minniti MC, Statkevich AP, Kelly RL, Rigsby VP, Exline MM, Rhon DI, Clewley D. The Safety of Blood Flow Restriction Training as a Therapeutic Intervention for Patients With Musculoskeletal Disorders: A Systematic Review. Am J Sports Med. 2020 Jun;48(7):1773-1785. doi: 10.1177/0363546519882652. Epub 2019 Nov 11.

  PMID: 31710505 BACKGROUND

• Robinson JM, Cook JL, Purdam C, Visentini PJ, Ross J, Maffulli N, Taunton JE, Khan KM; Victorian Institute Of Sport Tendon Study Group. The VISA-A questionnaire: a valid and reliable index of the clinical severity of Achilles tendinopathy. Br J Sports Med. 2001 Oct;35(5):335-41. doi: 10.1136/bjsm.35.5.335.

  PMID: 11579069 BACKGROUND

• Pringels L, Capelleman R, Van den Abeele A, Burssens A, Planckaert G, Wezenbeek E, Vanden Bossche L. Effectiveness of reducing tendon compression in the rehabilitation of insertional Achilles tendinopathy: a randomised clinical trial. Br J Sports Med. 2025 Apr 24;59(9):640-650. doi: 10.1136/bjsports-2024-109138.

  PMID: 40011018 BACKGROUND

• Picon-Martinez M, Chulvi-Medrano I, Cortell-Tormo JM, Alonso-Aubin DA, Alakhdar Y, Laurentino G. Acute Effects of Resistance Training with Blood Flow Restriction on Achilles Tendon Thickness. J Hum Kinet. 2021 Mar 31;78:101-109. doi: 10.2478/hukin-2021-0032. eCollection 2021 Mar.

  PMID: 34025868 BACKGROUND

• Centner C, Lauber B, Seynnes OR, Jerger S, Sohnius T, Gollhofer A, Konig D. Low-load blood flow restriction training induces similar morphological and mechanical Achilles tendon adaptations compared with high-load resistance training. J Appl Physiol (1985). 2019 Dec 1;127(6):1660-1667. doi: 10.1152/japplphysiol.00602.2019. Epub 2019 Nov 14.

  PMID: 31725362 BACKGROUND

• Burton I, McCormack A. Blood Flow Restriction Resistance Training in Tendon Rehabilitation: A Scoping Review on Intervention Parameters, Physiological Effects, and Outcomes. Front Sports Act Living. 2022 Apr 25;4:879860. doi: 10.3389/fspor.2022.879860. eCollection 2022.

  PMID: 35548459 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapy Research Fellow, Assiut University, EGYPT

Study Record Dates

• First Submitted: February 8, 2026
• First Posted: July 13, 2026
• Study Start: August 1, 2025
• Primary Completion: June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)