Transcutaneous Electrical Nerve Stimulation After Total Hip Arthroplasty

NCT03046212 | Completed Results

• 1 other identifier: 160105
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Transcutaneous electrical nerve stimulation (TENS) is characterized by the application of an electric pulsed current through electrodes positioned on the skin. It can be an alternative for pain management after surgery for total hip arthroplasty (THA), since it is a safe and cost-effective therapeutic tool, allowing the patient to move early due to pain relief. Therefore, the study aims to evaluate the acute effects of TENS associated with standard physical therapy compared with standard physical therapy on the intensity of pain, hip range of motion and morphine consumption in the rehabilitation of patients after THA.

Conditions

Transcutaneous Electric Nerve Stimulation; Pain

Outcome Measures

Primary Outcomes (1)

• Change in Pain Level From Baseline to 45 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 were performed in each group, before and after the interventions.

  baseline, 45 minutes

Secondary Outcomes (2)

• Change in Hip Range of Motion From Baseline to 45 Minutes

  baseline, 45 minutes

• Number of Participants Who Received Morphine Within 24 Hours

  24 hours

Study Arms (2)

Electrical stimulation

EXPERIMENTAL

This group received application of transcutaneous electrical nerve stimulation (TENS) associated with conventional physical therapy (exercises).

Device: Transcutaneous electrical nerve stimulation; Other: Exercises

Physical therapy

ACTIVE COMPARATOR

This group received only conventional physical therapy (exercises).

Other: Exercises

Interventions

Transcutaneous electrical nerve stimulation DEVICE

TENS: it was applied in the conventional mode, through four self-adhesive electrodes of size 5x9cm positioned about five centimeters from the edges of the surgical scar, with frequency of 100 Hz and pulse duration of 100μs, for 30 minutes. The intensity was adjusted according to the maximum tolerance of the patient and was it increased during the application time with their permission.

Also known as: TENS

Electrical stimulation

Exercises OTHER

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

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 THA surgery due to primary or secondary coxarthrosis; both sexes; age between 40 and 90 years.

You may not qualify if:

• patients who refused to participate of the study; THA indication for fractures and bone tumors; THA review surgery; postoperative infection; congenital anatomical alterations; neurological disorders; lack of understanding of commands; sensitivity alterations in the 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 analogic 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: August 1, 2016
• Study Completion: November 1, 2016
• Last Updated: November 9, 2017
• Results First Posted: November 9, 2017

Record last verified: 2017-02