Transcutaneous Electrical Nerve Stimulation After Total Knee Arthroplasty.

NCT03046225 | Completed Results

• 1 other identifier: 16-0104
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief Summary

Total knee arthroplasty (TKA) consists of a surgical replacement of this joint by a prosthesis, and it is mainly carried out in cases of knee osteoarthrosis. In the postoperative period of TKA, the pain is intense and limits the mobility of patients, so the analgesia is one of the goals of the physical therapy. One of the alternatives available for pain management is the transcutaneous electrical nerve stimulation (TENS), characterized by the application of an electric pulsed current through electrodes positioned on the skin. Therefore, the present study aims to evaluate the acute effects of TENS associated with conventional physical therapy compared with conventional physical therapy on the pain level, knee range of motion and administration of morphine in the rehabilitation of patients after TKA.

Conditions

Transcutaneous Electric Nerve Stimulation; Pain

Outcome Measures

Primary Outcomes (1)

• Change in Pain Level From Baseline to 90 Minutes

  It was measured by Visual Analogue Pain Scale (VAS), which has scores ranging from zero (which means "no pain") to 10 (which means "worst possible pain"). Two evaluations of the pain level were performed in each group, before and after the interventions.

  90 minutes

Secondary Outcomes (2)

• Number of Participants Who Received Morphine Within 24 Hours

  24 hours

• Change in Knee Range of Motion From Baseline to 30 Minutes

  30 minutes

Study Arms (2)

Electrical stimulation

EXPERIMENTAL

This group received application of transcutaneous electrical nerve stimulation (TENS) associated with conventional physical therapy (continuous passive movement device and exercises).

Device: Transcutaneous electrical nerve stimulation; Device: Continuous passive movement device; Other: Exercises

Physical therapy

ACTIVE COMPARATOR

This group received only conventional physical therapy (continuous passive movement device and exercises).

Device: Continuous passive movement device; Other: Exercises

Interventions

Transcutaneous electrical nerve stimulation DEVICE

TENS was applied in the conventional mode, through two self-adhesive electrodes of size 5x9cm positioned parallel to the lumbar spine, on the nerve roots of L3, L4 and L5, with frequency of 100 Hz and pulse duration of 100 μs, for 30 minutes. The intensity was adjusted according to the maximum tolerance of the patient and was gradually increased, with his permission, during the application time.

Also known as: TENS

Electrical stimulation

Continuous passive movement device DEVICE

CPM device was used for 30 minutes and realized continuous passive flexion and extension of the operated knee.

Also known as: CPM

Electrical stimulation; Physical therapy

Exercises OTHER

Active exercises of plantar flexion and dorsal flexion of the ankles, adduction and abduction of the hips and flexion and extension of the operated knees. All exercises were performed in 10 repetitions, with the patient positioned in the supine position in the bed.

Electrical stimulation; Physical therapy

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who underwent TKA surgery due to primary or secondary gonarthrosis; Both sexes; Age between 40 and 90 years.

You may not qualify if:

• Patients who refused to participate of the study; Indication of TKA for fractures and bone tumors; TKA review surgery; Infection during the postoperative period; Congenital anatomical alterations; Neurological disorders; Lack of understanding of commands; Sensitivity alterations in the lumbar spine or lower limbs; Decompensated heart disease or cardiac pacemaker use.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

MeSH Terms

Conditions

Pain

Interventions

Transcutaneous Electric Nerve Stimulation; Exercise

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; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

The subjects had difficulty to understand Visual Analogue Pain Scale, the sample was small, and there was not a TENS placebo group, which could allow other comparisons on the effectiveness of TENS in this population.

Results Point of Contact

• Title: Graciele Sbruzzi
• Organization: Hospital de Clínicas de Porto Alegre

graciele.sbruzzi@ufrgs.br

55 51 9423-9420

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2016
• First Posted: February 8, 2017
• Study Start: May 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: November 1, 2016
• Last Updated: March 22, 2018
• Results First Posted: March 22, 2018

Record last verified: 2017-02