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

NCT06962683 | Completed

• 1 other identifier: UBonn_WBS_BFR
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Muscle Mass

  BIA-/ DXA-Measurement

  Pre- to 6 weeks Post Surgery

Secondary Outcomes (1)

• Perceived Pain

  Pre- to 6 weeks Post Surgery

Study Arms (2)

Control Group

SHAM COMPARATOR

The first group will serve as the control group and will receive an additional daily Sham BFR intervention of 20mmHg postoperatively as part of routine clinical care.

Other: Sham-BFR

Intervention Group

EXPERIMENTAL

The second group will serve as the intervention group and will receive an additional daily passiveBFR intervention with 80% of the individual LOP postoperatively as part of routine clinical care.

Other: Blood-Flow-Restriction Training

Interventions

Blood-Flow-Restriction Training OTHER

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.

Also known as: BFR

Intervention Group

Sham-BFR OTHER

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The study includes all patients with a medical indication for spinal surgical therapy (including herniated disc, vertebral fracture, spinal stenosis, spondylodiscitis, etc).
• All participating patients have given their written informed consent to participate in the study.
• Patients aged between 18-85 years will be included.

You may not qualify if:

• Acute or chronic infections of the extremities.
• Pregnancy and lactation
• Inability to undergo surgery

Sponsors & Collaborators

• University Hospital, Bonn: lead

Study Sites (1)

University Hospital Bonn

Bonn, North Rhine-Westphalia, 53127, Germany

Location

MeSH Terms

Conditions

Muscular Atrophy; Pain, Postoperative; Spondylolisthesis; Discitis

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Spondylolysis; Spondylosis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylitis; Bone Diseases, Infectious; Infections

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med., B.Sc.

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: May 8, 2025
• Study Start: March 1, 2022
• Primary Completion: November 1, 2024
• Study Completion: January 1, 2025
• Last Updated: May 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)