TENS for Relief of Postoperative Pain in Orthopedic Patients

NCT05678101 | Active Not Recruiting FDA Device

• 1 other identifier: 2023-ORTHTENS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 as well as reduce opioid consumption.

Conditions

Orthopedic Disorder; Post Operative Pain; Hip Fractures; Arthroplasty, Replacement, Hip; Internal Fixation

Keywords

transcutaneous electrical nerve stimulation; Patient Global Impression of Change; numeric pain rating scale; TENS; PGIC; NRS; Post Operative Pain; Hip Fractures

Outcome Measures

Primary Outcomes (3)

• 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

  During intervention. Mesaured twice per round: First before mobility testing and TENS-session 'a' and a second time during the last 5 minutes of the TENS-session 'a' during inactivity.

• 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.

  During intervention. Measured twice per round after both TENS-session 'a' and 'b' respectively.

• 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)

  During intervention. Measured twice per round: First after mobility testing and before TENS-session 'a' and a second time in the last 5 minutes of TENS-session 'b'.

Secondary Outcomes (4)

• Mobility testing (Walking test)

  During intervention. Performed and measured twice per round: once before TENS-session 'a' and a second time during the last 5 minutes of TENS-session 'b'.

• Analgesic consumption

  During intervention. The information will be logged at the end of each day of intervention.

• Mobility testing (Put on pants time)

  During intervention. Measured once per day: Before the first pain assessment during rest and before TENS-session 'a' of the first round.

• Patients-reported impression of TENS (Qualitative assessment)

  Immediately after intervention

Study Arms (2)

TENS

ACTIVE COMPARATOR

The Chattanooga Physio TENS (DJO Global, Vista, CA) will be applied with mixed burst / TENS alternated, which is a 30-minute long program where the stimulation frequencies of alternate in 3 second intervals, producing a combined stimulation of 80 Hz and 2 Hz. Two programs/sessions ('a' and 'b') will be applied in succession for a total of 60-minutes (one round). In total, each day will have 3 rounds. The energy intensity level will firstly be adjusted for 80 Hz (TENS) until a tingling sensation is felt but no discomfort, and then the procedure will be repeat for 2 Hz. The patient will use a pair of pants with integrated stimulation electrodes, to which the CE-marked TENS device (Chattanooga Physio, DJO Nordic, Malmö, Sweden) will be connected and used to provide pain relief, in addition to usual postoperative care. The TENS device will be connected to the textile electrodes of the pants which are located 5cm in front and behind the hip incision dressing respectively.

Device: transcutaneous electrical nerve stimulation (TENS)

Control

SHAM COMPARATOR

The control group will also receive the TENS-pants described above with integrated stimulation electrodes, connected to TENS treatment. However, the TENS treatment to the control group will be set such that no electricity will be applied to the patient. In all other regards, the control group will follow the same protocol as the intervention group.

Device: Sham transcutaneous electrical nerve stimulation (TENS)

Interventions

transcutaneous electrical nerve stimulation (TENS) DEVICE

Chattanooga Physio TENS (DJO Global, Vista, CA)

Also known as: electrical nerve stimulation

TENS

Sham transcutaneous electrical nerve stimulation (TENS) DEVICE

Sham treatment with Chattanooga Physio TENS (DJO Global, Vista, CA)

Control

Eligibility Criteria

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

You may qualify if:

• Patients 18 years and above.
• Patient has undergone hip fracture surgery.
• Must be cognitively adequate.
• Must be without terminal illness.

You may not qualify if:

• Pregnancy
• Skin wounds
• Pacemaker
• Intracardiac defibrillator
• Ongoing thrombolysis or thromboprophylaxis.
• Class 3 and 4 heart disease
• Difficulties to understand the Swedish language
• Drug and narcotic abuses
• Postoperative delirium syndrome
• Epidural catheter.

Sponsors & Collaborators

• Karolinska University Hospital: lead

Study Sites (1)

Karolinska university Hospital

Stockholm, 17176, Sweden

Location

Related Publications (1)

• Opolka Y, Sundberg C, Juthberg R, Olesen A, Guo L, Persson NK, Ackermann PW. Transcutaneous Electrical Nerve Stimulation Integrated into Pants for the Relief of Postoperative Pain in Hip Surgery Patients: A Randomized Trial. Pain Res Manag. 2024 Jun 27;2024:6866549. doi: 10.1155/2024/6866549. eCollection 2024.

  PMID: 39145150 DERIVED

MeSH Terms

Conditions

Musculoskeletal Diseases; Pain, Postoperative; Hip Fractures

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

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

Study Officials

• Paul W Ackermann, MD, PhD

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Fifteen of the patients will be randomized to the intervention and 15 will receive placebo (non-active TENS treatment).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD

Model Details: This study will be a prospective, randomized, single-blinded, placebo-controlled repeated measures design.

Study Record Dates

• First Submitted: January 3, 2023
• First Posted: January 10, 2023
• Study Start: November 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 30, 2025
• Last Updated: October 22, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: During 2025.
• Access Criteria: On reasonable request

Locations

SE (1)