The Effectiveness of Transcutaneous Electrical Nerve Stimulation After Thoracic Surgery

NCT04879108 | Completed

• 1 other identifier: 5563
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Thoracic; Surgery; Pain; Pulmonary Function; Functional Capacity

Keywords

transcutaneous electrical nerve stimulation; physiotherapy and rehabilitation; thoracic surgery; pain; pulmonary function; functional capacity

Outcome Measures

Primary Outcomes (5)

• 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.

• 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.

• 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.

• 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.

• 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 Outcomes (1)

• Evaluation of dyspnea

  Baseline and postoperative 5th days.

Study Arms (2)

Physiotherapy rehabilitation and Transcutaneous Electrical Nerve Stimulation (TENS) group

EXPERIMENTAL

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.

Other: Physiotherapy rehabilitation and Transcutaneous Electrical Nerve Stimulation

Physiotherapy rehabilitation Group

ACTIVE COMPARATOR

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.

Other: Physiotherapy Rehabilitation

Interventions

Physiotherapy rehabilitation and Transcutaneous Electrical Nerve Stimulation 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 and Transcutaneous Electrical Nerve Stimulation (TENS) group

Physiotherapy Rehabilitation 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.

Physiotherapy rehabilitation Group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing lobectomy for lung cancer

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Related Publications (7)

• 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. doi: 10.1007/s00268-005-7934-6.

  PMID: 16331341 RESULT

• 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. Lung Cancer. 2007 Aug;57(2):175-80. doi: 10.1016/j.lungcan.2007.02.017. Epub 2007 Apr 17.

  PMID: 17442449 RESULT

• 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. doi: 10.1007/s11748-007-0169-8. Epub 2007 Dec 11.

  PMID: 18066640 RESULT

• 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. doi: 10.1016/s0003-4975(96)01249-0.

  PMID: 9066400 RESULT

• Sancho J, Servera E, Diaz J, Marin 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. doi: 10.1097/01.phm.0000133431.70907.a2.

  PMID: 15277962 RESULT

• Meek PM. Measurement of dyspnea in chronic obstructive pulmonary disease: what is the tool telling you? Chron Respir Dis. 2004;1(1):29-37. doi: 10.1191/1479972304cd008ra.

  PMID: 16281665 RESULT

• 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.

  PMID: 19910359 RESULT

MeSH Terms

Conditions

Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Aysel Yildiz Ozer, PT, PhD

  Marmara University

  PRINCIPAL INVESTIGATOR

• Nilgun Gurses, Prof

  Bezmialem Vakif University

  STUDY DIRECTOR

• Alper Toker, Prof

  Istanbul University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes Assessor (pain, pulmonary function tests, 6 minute walking test, peak cough flow)
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Crossover Assignment Randomized controlled

Study Record Dates

• First Submitted: May 2, 2021
• First Posted: May 10, 2021
• Study Start: July 20, 2009
• Primary Completion: April 30, 2011
• Study Completion: September 5, 2011
• Last Updated: May 10, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share