The Effectiveness of Transcutaneous Electrical Nerve Stimulation After Thoracic Surgery

NCT ID: NCT04879108

Last Updated: 2021-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-20
• Study Completion Date: 2011-09-05

Brief Summary

The purpose of this randomised and controlled study is to investigate the effects of transcutaneous electrical nerve stimulation combined with physiotherapy and rehabilitation program on pulmonary function and functional exercise capacity.

Detailed Description

Post-thoracotomy pain is one of the most severe types of post-surgical pain. When pain after thoracotomy is not treated effectively, it causes decrease in pulmonary compliance, inability to cough and deep breathing. Increased secretion leads to atelectasis and pneumonia. After surgery, early mobilization, providing airway cleaning (humidification, aspiration, forced expiration, assisted coughing), oxygen therapy, controlled breathing exercises, the use of incentive spirometry and such selected exercises, including posture and general exercises physiotherapy and rehabilitation approaches can prevent complications. A carefully planned pre and postoperative chest physiotherapy and rehabilitation program minimizes postoperative complications; it will restore normal function in these patients. Post-surgical physiotherapy applications should be combined with pain therapy for effective participation of the patient.

Local anesthetics, opioids and different special analgesia techniques including intercostal, paravertebral, interpleural and epidural blocks are used to relieve pain after thoracotomy. However, these techniques have serious side effects such as nausea, vomiting, respiratory depression, and sleepiness. It has been reported that the use of Transcutaneous Electrical Nerve Stimulation (TENS), in addition to traditional analgesia methods, may reduce the use of analgesics, side effects, and postoperative recovery period, and is useful for pain control. After cardiac surgery, TENS has been found useful in the treatment of postoperative incision pain. It has been reported that TENS therapy after thoracotomy as effective as patient-controlled analgesia.

Therefore, this study planned to investigate the effects of transcutaneous electrical nerve stimulation combined with physiotherapy and rehabilitation program on pulmonary function and functional exercise capacity in patients undergoing thoracic surgery.

Conditions

Thoracic; Surgery; Pain; Pulmonary Function; Functional Capacity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Physiotherapy rehabilitation and Transcutaneous Electrical Nerve Stimulation (TENS) group

Physiotherapy rehabilitation and Transcutaneous Electrical Nerve Stimulation (TENS) group received TENS therapy in addition to physiotherapy rehabilitation approaches after thoracic surgery.

Physiotherapy and rehabilitation program was started after surgery and it was performed for 30 min, twice a day, 5 day a week. The program was included respiratory and posture exercises, coughing, enhancing mobility.

TENS therapy was performed with the a 2-channel portable TENS device and using disposable electrodes. TENS applied on both sides of the incision line. After surgery, TENS was performed before the Physiotherapy rehabilitation for 30 min, twice a day, 5 day a week.

Patients were evaluated before the surgery and the end of postoperative 5th day.

Group Type: EXPERIMENTAL

Physiotherapy rehabilitation and Transcutaneous Electrical Nerve Stimulation

Intervention Type: OTHER

Physiotherapy rehabilitation and Transcutaneous Electrical Nerve Stimulation (TENS) group received TENS therapy in addition to physiotherapy rehabilitation after thoracic surgery.

Physiotherapy and rehabilitation program was started after surgery and it was performed for 30 min, twice a day, 5 day a week. The program was included respiratory and posture exercises, coughing, enhancing mobility.

Transcutaneous Electrical Nerve Stimulation was performed with the a 2-channel portable TENS device and using disposable electrodes. TENS applied on both sides of the incision line. After surgery, TENS was performed before the Physiotherapy and Rehabilitation for 30 min, twice a day, 5 day a week.

Patients were evaluated before the surgery and the end of postoperative 5th day.

Physiotherapy rehabilitation Group

This group was enrolled only physiotherapy and rehabilitation program after thoracic surgery.

Physiotherapy and rehabilitation program was started after surgery and it was performed for 30 min, twice a day, 5 day a week. The program was included respiratory and posture exercises, coughing, enhancing mobility.

Patients were evaluated before the surgery and the end of postoperative 5th day.

Group Type: ACTIVE_COMPARATOR

Physiotherapy Rehabilitation

Intervention Type: OTHER

Physiotherapy and Rehabilitation was performed for 5 days after surgery, twice a day, for 30 min, 5 day a week after thoracic surgery. The program was included respiratory and posture exercises, coughing, enhancing mobility.

Patients were evaluated before the surgery and the end of postoperative 5th day.

Interventions

Physiotherapy rehabilitation and Transcutaneous Electrical Nerve Stimulation

Physiotherapy rehabilitation and Transcutaneous Electrical Nerve Stimulation (TENS) group received TENS therapy in addition to physiotherapy rehabilitation after thoracic surgery.

Physiotherapy and rehabilitation program was started after surgery and it was performed for 30 min, twice a day, 5 day a week. The program was included respiratory and posture exercises, coughing, enhancing mobility.

Transcutaneous Electrical Nerve Stimulation was performed with the a 2-channel portable TENS device and using disposable electrodes. TENS applied on both sides of the incision line. After surgery, TENS was performed before the Physiotherapy and Rehabilitation for 30 min, twice a day, 5 day a week.

Patients were evaluated before the surgery and the end of postoperative 5th day.

Intervention Type: OTHER

Physiotherapy Rehabilitation

Physiotherapy and Rehabilitation was performed for 5 days after surgery, twice a day, for 30 min, 5 day a week after thoracic surgery. The program was included respiratory and posture exercises, coughing, enhancing mobility.

Patients were evaluated before the surgery and the end of postoperative 5th day.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients undergoing lobectomy for lung cancer

Exclusion Criteria

• Patients undergoing pneumonectomy.
• Patients undergoing smaller resection than lobectomy.
• Presence of serious arrhythmia, pacemaker, severe cardiac failure,
• Patients with cooperation disorder
• Presence of neurological or orthopedic problems affecting the extremities.
• Patients with severe psychiatric disorders

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marmara University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aysel Yildiz Ozer, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Marmara University

Nilgun Gurses, Prof

Role: STUDY_DIRECTOR

Bezmialem Vakif University

Alper Toker, Prof

Role: STUDY_CHAIR

Istanbul University

References

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Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: RESULT

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Freynet A, Falcoz PE. Is transcutaneous electrical nerve stimulation effective in relieving postoperative pain after thoracotomy? Interact Cardiovasc Thorac Surg. 2010 Feb;10(2):283-8. doi: 10.1510/icvts.2009.219576. Epub 2009 Nov 12.

Reference Type: RESULT

PMID: 19910359 (View on PubMed)

Other Identifiers

5563

Identifier Type: -

Identifier Source: org_study_id