The Effectiveness of Transcutaneous Electrical Nerve Stimulation After Thoracic Surgery

Pain Clinical Trial

Official title:

The Role of Transcutaneous Electrical Nerve Stimulation Combined With Physiotherapy and Rehabilitation Program on Pulmonary Function and Functional Exercise Capacity in Patients Undergoing Thoracic Surgery? A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04879108
• Other study ID #: 5563
• Status: Completed
• Phase: N/A
• Start date: July 20, 2009
• Est. completion date: September 5, 2011

Study information

• Verified date: May 2021
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 5, 2011
• Est. primary completion date: April 30, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm, Dissecting
• Functional Capacity
• Pain
• Pulmonary Function
• Surgery
• Thoracic

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

References & Publications (7)

Benedetti F, Amanzio M, Casadio C, Cavallo A, Cianci R, Giobbe R, Mancuso M, Ruffini E, Maggi G. Control of postoperative pain by transcutaneous electrical nerve stimulation after thoracic operations. Ann Thorac Surg. 1997 Mar;63(3):773-6. — View Citation

Cesario A, Ferri L, Galetta D, Pasqua F, Bonassi S, Clini E, Biscione G, Cardaci V, di Toro S, Zarzana A, Margaritora S, Piraino A, Russo P, Sterzi S, Granone P. Post-operative respiratory rehabilitation after lung resection for non-small cell lung cancer — View Citation

Erdogan M, Erdogan A, Erbil N, Karakaya HK, Demircan A. Prospective, Randomized, Placebo-controlled Study of the Effect of TENS on postthoracotomy pain and pulmonary function. World J Surg. 2005 Dec;29(12):1563-70. — View Citation

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. Review. — View Citation

Kaneda H, Saito Y, Okamoto M, Maniwa T, Minami K, Imamura H. Early postoperative mobilization with walking at 4 hours after lobectomy in lung cancer patients. Gen Thorac Cardiovasc Surg. 2007 Dec;55(12):493-8. Epub 2007 Dec 11. — View Citation

Meek PM. Measurement of dyspnea in chronic obstructive pulmonary disease: what is the tool telling you? Chron Respir Dis. 2004;1(1):29-37. Review. — View Citation

Sancho J, Servera E, Díaz J, Marín J. Comparison of peak cough flows measured by pneumotachograph and a portable peak flow meter. Am J Phys Med Rehabil. 2004 Aug;83(8):608-12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Exercise Capacity	Functional exercise capacity was measured with the 6 Minute Walk Test according to the American Thoracic Society guidelines. The 6 minutes walking distance was recorded in meters.	Change from Baseline Functional Exercise Capacity at postoperative 5th days.
Primary	Forced expiratory volume in one second Spirometric measurement	Forced expiratory volume in one second spirometric measurement was measured. Test was carried out according to American Thoracic Society / European Respiratory Society criteria.	Change from Baseline Functional Exercise Capacity at postoperative 5th days.
Primary	Forced Vital Capacity Spirometric measurement	Forced Vital Capacity spirometric measurement was measured. Test was carried out according to American Thoracic Society / European Respiratory Society criteria.	Change from Baseline Functional Exercise Capacity at postoperative 5th days.
Primary	Pain severity	Visual Analogue Scale that is an easy, reproducible, minimal tool-requiring, and understandable measurement tool for the assessment of pain intensity was used. This scale consists of a horizontal, straight line. There is a value of 0 at the beginning of the line and 10 at the end.	Baseline and postoperative 5th days.
Primary	Peak cough flow	It was evaluated with the peak flow meter device while the patient was sitting upright in a chair with a back. The test method is explained and a trial test is carried out. The nosepiece was attached to the nose and the mouthpiece of the device was wrapped tightly with the lips.; It was asked to take a deep breath and suddenly and quickly blow into the device fron the patient. The best out of three acceptable tests was recorded.	Change from Baseline Functional Exercise Capacity at postoperative 5th days.
Secondary	Evaluation of dyspnea	It was evaluated with a 0-10 point borg scale. Dyspnea was measured at rest and after exertion. An increase in score is interpreted as an increase in dyspnea.	Baseline and postoperative 5th days.