TENS for Relief of Postoperative Pain in Orthopedic Patients

Hip Fractures Clinical Trial

Official title:

Transcutaneous Electrical Nerve Stimulation (TENS) Integrated Into Pants for Relief of Postoperative Pain in Orthopedic Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05678101
• Other study ID #: 2023-ORTHTENS
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: November 1, 2022
• Est. completion date: December 30, 2025

Study information

• Verified date: March 2024
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To ensure early mobilization, minimize suffering, and to prevent postoperative complications postoperative pain, should be reduced as soon and as effectively as possible. A non-pharmacological post-operative intervention in terms of the application of transcutaneous electrical nerve stimulation (TENS), could have the potential to accelerate early mobilization and reduce the use of opioids.

The overall aim is to demonstrate that the addition of TENS to standard postoperative pain management of orthopedic patients can alleviate pain during mobilization and at rest

Description:

Annually, more than 200 million people undergo surgery worldwide and the number is increasing.To ensure early mobilization, minimize suffering, and to prevent postoperative complications and subsequent mortality, postoperative pain, should be reduced as soon and as effectively as possible.

Acute complications include impaired mobility, respiratory difficulties, pneumonia, protracted healing processes, thromboembolic events like deep vein thrombosis or pulmonary embolism, and prolonged need for care . Acute postoperative pain also has several negative long-term effects gas, risk of residual pain, higher mortality risk and worsened patient outcome at 6 months especially in hip fractures of older individuals.

A non-pharmacological post-operative intervention in terms of the application of transcutaneous electrical nerve stimulation (TENS), could have the potential to accelerate early mobilization and reduce the use of opioids .TENS is a non-invasive method that delivers electrical impulses through electrodes placed on the skin and has been shown to be an effective supplement that can decrease postoperative pain after thoracic and abdominal surgery . However, it is yet unclear whether TENS after orthopedic hip prosthesis surgery can reduce post-operative pain to improve early mobilization, decrease opioid consumption and shorten hospitalization time.

The overall aim is to demonstrate that the addition of TENS to standard postoperative pain management of orthopedic patients can alleviate pain during mobilization and at rest. The primary aim of this feasibility study using a CE-marked TENS device with applied textile electrodes in a pair of pants is to reduce postoperative pain during mobilization following hip prosthesis surgery.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 30, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients 18 years and above.

• Diagnosis of hip prosthesis surgery or hip fracture surgery.

• Must be cognitively adequate.

• Must be without terminal illness.

Exclusion Criteria:

• Pregnancy

• Skin wounds

• Pacemaker

• Intracardiac defibrillator

• Ongoing thrombolysis or thromboprophylaxis treatment

• Class 3 and 4 heart disease

• Difficulties to understand the Swedish language

• Drug and narcotic abuses

• Postoperative delirium syndrome

• Epidural catheter.

Related Conditions & MeSH terms

• Hip Fractures
• Hip Osteoarthritis
• Musculoskeletal Diseases
• Orthopedic Disorder
• Osteoarthritis, Hip
• Pain, Postoperative
• Post Operative Pain

Intervention

Device:
• transcutaneous electrical nerve stimulation (TENS)
Chattanooga Physio TENS (DJO Global, Vista, CA)
• Sham transcutaneous electrical nerve stimulation (TENS)
Sham treatment with Chattanooga Physio TENS (DJO Global, Vista, CA)

Locations

Country	Name	City	State
Sweden	Karolinska university Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain estimation during rest	A 11-point numeric pain rating scale (Minimum 0, Maximum 10, higher score means worse outcome, i.e more pain) assessment will be performed during inactivity	Immediately after 30-minute TENS application during inactivity
Primary	Pain estimation during activity	A 11-point numeric pain rating scale (Minimum 0, Maximum 10, higher score means worse outcome, i.e more pain) assessment will be performed during activity after the Standardized three-meter Walking test (WALK3m)	Immediately after 30-minute TENS application during activity
Primary	Patient Global Impression of Change (PGIC)	The patient's belief about the efficacy of treatment, which ranged from 1 (minimum, "no change") to 7 (maximum, "a great deal better") will be assessed by PGIC.	Immediately after 30-minute TENS application
Secondary	Mobility testing	The Standardized three-meter Walking test (WALK3m). With a stopwatch, the patient will be instructed to walk a 3 meters distance beginning from a marked position, in comfortable steps, to a stop position, turn around and walk back to the marked position where he or she started. The timing will begin when the patient starts on the word go, and the timing will end when the patient stopped at the marked position where they started.	Immediately after 30-minute TENS application
Secondary	Analgesic consumption	Extra analgesic consumption during the entire intervention will be documented. Under the intervention period, which is the first two times 30-minute TENS stimulation intervention, a 30-minute inactive interval, and there after another two times 30-minute stimulation intervention, all supplementary analgesics consumed will be documented to assess and evaluate the effect of the intervention.	During intervention
Secondary	Patients-reported impression of TENS	A short follow-up will be performed before discharge 24 hours after the surgery. The patient in both active and placebo groups will be a asked the following questions: Was TENS therapy comfortable for you?; Would you like to use TENS again if you would undergo another surgery in the future?; Were the TENS trousers comfortable to wear for you?; The NRS will also be used to measure patient's satisfaction of the TENS- treatment (from 0, no satisfaction, to 10, major satisfaction with the treatment)	Within 3 hours after the intervention.