A study of how transcutaneous electrical nerve stimulation can be used to decrease pain in patients who have undergone a sternotomy incision

Transcutaneous electrical nerve stimulation for post-sternotomy pain

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12394749

Enrollment

Registered

2021-09-11

Start date

2021-09-12

Completion date

Unknown

Last updated

2021-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain in post-sternotomy patients Surgery

Interventions

Eligible participants will be equally divided into three groups through a computer-generated randomization sequence prepared before the start of the study. The groups will be as follows:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients above the age of 18 years 2. Both male and female patients 3. Elective cardiac surgery via longitudinal median sternotomy 4. Consenting to participate in the study

Exclusion criteria

Exclusion criteria: 1. Previous history of chronic pain, drug or alcohol abuse 2. Pre-operative use of narcotics (except for standard protocol pre-operative morphine administered prior to the surgery in question) 3. Pre-operative use of TENS 4. Pre-operative shoulder pain or decrease in shoulder ROM 5. Cancer or metastatic disease 6. Patients with a pacemaker 7. Pregnancy 8. Epilepsy 9. Surgeon reported cognitive impairments 10. Previous sternotomy procedures 11. Other types of incisions different from sternotomies 12. Prolonged mechanical ventilation

Design outcomes

Primary

Measure	Time frame
1. Pain measured using the Numerical Rating Scale – 11 (NRS-11) at rest and on coughing and during shoulder movements, at baseline (prior to surgery) then twice daily from day 1 – day 4 post-operatively and once after 3 months. In the intervention and placebo groups this will be done twice daily before and after TENS application. 2. Pain-free active shoulder flexion and abduction shoulder movements will be measured using a universal inclinometer at baseline (prior to surgery) then twice daily on days 1 - 4 post-operatively and after 3 months.	—

Measure

Time frame

1. Pain measured using the Numerical Rating Scale – 11 (NRS-11) at rest and on coughing and during shoulder movements, at baseline (prior to surgery) then twice daily from day 1 – day 4 post-operatively and once after 3 months. In the intervention and placebo groups this will be done twice daily before and after TENS application. 2. Pain-free active shoulder flexion and abduction shoulder movements will be measured using a universal inclinometer at baseline (prior to surgery) then twice daily on days 1 - 4 post-operatively and after 3 months.

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Secondary

Measure	Time frame
1. Pulmonary function data, i.e. Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 second (FEV 1) will be collected using the Pony FX Spirometer (Cosmed®). All the participants will be tested the day before the surgery and at day 4 post-operatively and after 3 months. 2. CRP testing will be done through blood sample collection on the day before the surgery and from day 1 – day 4 post-operatively	—

Measure

Time frame

1. Pulmonary function data, i.e. Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 second (FEV 1) will be collected using the Pony FX Spirometer (Cosmed®). All the participants will be tested the day before the surgery and at day 4 post-operatively and after 3 months. 2. CRP testing will be done through blood sample collection on the day before the surgery and from day 1 – day 4 post-operatively

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Countries

Malta

Contacts

Public ContactClaire Martin

claire.martin.04@um.edu.mt+356 (0)2545 6600

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026