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Post-surgery Muscle Preservation and Pain Reduction Through Blood Flow Restriction Training in Orthopedic Spinal Surgery

NCT06962683 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-05-08

No results posted yet for this study

Summary

This project investigates the effects of the Blood-Flow-Restriction (BFR) training method on postoperative muscle atrophy and pain after spinal surgery. Two groups are formed for this purpose. The intervention group receives a everyday BFR training during the postoperative stay at an individually measured occlusion pressure of 60-80%. The control group performs sham-BFR training at a fixed occlusion pressure of 20mmHg. The examinations are carried out before and several times after the operation (longest follow-up: 6 months). Among other things, muscle mass, muscle strength, pain perception and quality of life are assessed using questionnaires.

Conditions

  • Muscle Atrophy
  • Postoperative Pain
  • Spondylolisthesis
  • Spondylodiskitis

Interventions

OTHER

Blood-Flow-Restriction Training

For the pBFR intervention, the Personalized Tourniquet System for Blood Flow Restriction from Delfi Medical Innovations Inc. (Vancouver, Canada) were used. The cuffs were applied to both lower extremities as far proximally as possible and were connected to the control device. Before starting the training program, the individual LOP was measured of both lower limb in a restring, laying position by the control device. The Intervention-Group performed the training at 80% of their individual LOP. The training was performed alternately on both lower extremities. The time intervals were set at five minutes occlusion and five minutes rest. Each leg received five intervals of BFR-induced occlusion training, resulting in a total 50 minutes of daily training. During the entire training period, the patient was in a resting position, laying in the hospital bed.

OTHER

Sham-BFR

For the sham-BFR intervention, the Personalized Tourniquet System for Blood Flow Restriction from Delfi Medical Innovations Inc. (Vancouver, Canada) were used. The cuffs were applied to both lower extremities as far proximally as possible and were connected to the control device. Before starting the training program, the individual LOP was measured of both lower limb in a restring, laying position by the control device. The Control-Group was trained with a fixed pressure of 20 mmHg, independent of their individual LOP. The training was performed alternately on both lower extremities. The time intervals were set at five minutes occlusion and five minutes rest. Each leg received five intervals of BFR-induced occlusion training, resulting in a total 50 minutes of daily training. During the entire training period, the patient was in a resting position, laying in the hospital bed.

Sponsors & Collaborators

  • University Hospital, Bonn

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2024-11-01
Completion
2025-01-01

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06962683 on ClinicalTrials.gov