The Effectiveness of Early Mobilisation on Back Pain in Patients Following Percutaneous Coronary Intervention

Percutaneous Coronary Intervention (PCI) is a common revascularization procedure for patients with coronary artery disease. Patients undergoing PCI are often required to remain in a supine position for several hours after the procedure to prevent complications at the vascular access site. Prolonged immobilization can lead to discomfort and back pain. Early mobilisation may help reduce back pain and improve patient comfort without increasing the risk of complications.

This study aims to evaluate the effectiveness of early mobilisation in reducing back pain among patients following Percutaneous Coronary Intervention.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Back Pain Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Murni Teguh Memorial Hospital

Medan, North Sumatra, 20231, Indonesia

About this study

Percutaneous Coronary Intervention (PCI) is widely performed to restore coronary blood flow in patients with coronary artery disease. After PCI, patients are commonly instructed to remain in a supine position for extended periods to reduce the risk of bleeding at the catheter insertion site. However, prolonged bed rest has been associated with several adverse effects, including lower back pain, discomfort, and reduced patient satisfaction.

Early mobilisation has been proposed as a strategy to reduce these complications while maintaining patient safety. Several studies suggest that allowing patients to mobilise earlier may reduce back pain and improve overall comfort without increasing vascular complications.

This interventional study aims to determine the effectiveness of early mobilisation in reducing back pain among patients following PCI. Participants will be divided into two groups: an intervention group receiving early mobilisation and a control group receiving standard post-PCI care. Back pain intensity will be measured using a validated pain scale at specific time intervals following the procedure.

The findings of this study are expected to provide evidence to support improved nursing care protocols and enhance patient comfort during post-PCI recovery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Men and women aged 30-75 years Patients who have undergone PCI through the femoral artery Stable blood pressure and heart rate after PCI Femoral sheath has been removed No major complications after PCI Able to communicate clearly Have not received pain medication No other musculoskeletal problems Willing to participate in the study Willing to sign the informed consent form

Exclusion criteria

Unable or unwilling to complete the study PCI performed through the radial artery PCI performed through the brachial artery Chronic back pain before PCI Musculoskeletal problems that affect movement Severe bleeding after PCI Hematoma after PCI

Treatment and study plan

Early Mobilisation

Other

Early mobilisation includes gradual mobilisation such as head-of-bed elevation and controlled body movement initiated earlier after Percutaneous Coronary Intervention (PCI) under nurse supervision to reduce back pain.

Standard Post-PCI Care

Other

Standard post-procedure care following Percutaneous Coronary Intervention (PCI), including routine bed rest according to hospital protocol without early mobilisation.

Primary outcomes

Back Pain Intensity

Time frame: Post-test: 4 hours after early mobilisation in the intervention group and 8 hours after femoral sheath removal in the control group

Back pain intensity measured using the Numeric Rating Scale (NRS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain.

Sponsors and collaborators

Lead sponsor

Universitas Sumatera Utara

Other

Registry information

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Mar 16, 2026
Registry last updated: Aug 31, 2026

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.

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

Completed