Trial Outcomes & Findings for Transcutaneous Electrical Nerve Stimulation After Total Hip Arthroplasty (NCT NCT03046212)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

baseline, 45 minutes

Results posted on

2017-11-09

Participant Flow

The study was carried out at the Hospital de Clínicas de Porto Alegre Hospital (HCPA), Rio Grande do Sul, Brazil. Evaluations and interventions occurred between May and August 2016.

Participant milestones

Participant milestones
Measure	Electrical Stimulation This group received application of transcutaneous electrical nerve stimulation (TENS) associated with conventional physical therapy (exercises).	Physical Therapy This group received only conventional physical therapy (exercises).
Overall Study STARTED	15	15
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Transcutaneous Electrical Nerve Stimulation After Total Hip Arthroplasty

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Electrical Stimulation n=15 Participants This group received application of transcutaneous electrical nerve stimulation (TENS) associated with conventional physical therapy (exercises).	Physical Therapy n=15 Participants This group received only conventional physical therapy (exercises).	Total n=30 Participants Total of all reporting groups
Age, Continuous	59.8 years STANDARD_DEVIATION 9.9 • n=5 Participants	66.9 years STANDARD_DEVIATION 12.8 • n=7 Participants	63.3 years STANDARD_DEVIATION 11.8 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Body mass index (BMI)	29.5 kg/m² STANDARD_DEVIATION 3.4 • n=5 Participants	28.6 kg/m² STANDARD_DEVIATION 5.9 • n=7 Participants	29.06 kg/m² STANDARD_DEVIATION 4.8 • n=5 Participants

PRIMARY outcome

Timeframe: baseline, 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.

Outcome measures

Outcome measures
Measure	Electrical Stimulation n=15 Participants This group received application of transcutaneous electrical nerve stimulation (TENS) associated with conventional physical therapy (exercises).	Physical Therapy n=15 Participants This group received only conventional physical therapy (exercises).
Change in Pain Level From Baseline to 45 Minutes	1.2 units on a scale Standard Deviation 1.9	3.7 units on a scale Standard Deviation 2.6

SECONDARY outcome

Timeframe: baseline, 45 minutes

Flexion and abduction movements were assessed by goniometry in the hip submitted to the surgery. Two evaluations were performed in each group, before and after the interventions.

Outcome measures

Outcome measures
Measure	Electrical Stimulation n=15 Participants This group received application of transcutaneous electrical nerve stimulation (TENS) associated with conventional physical therapy (exercises).	Physical Therapy n=15 Participants This group received only conventional physical therapy (exercises).
Change in Hip Range of Motion From Baseline to 45 Minutes	22.5 degrees Standard Deviation 5.8	20.5 degrees Standard Deviation 4.3

SECONDARY outcome

Timeframe: 24 hours

It was evaluated based on the information found in patients' electronic records, considering whether they received morphine during the 24 hours following the interventions or not.

Outcome measures

Outcome measures
Measure	Electrical Stimulation n=15 Participants This group received application of transcutaneous electrical nerve stimulation (TENS) associated with conventional physical therapy (exercises).	Physical Therapy n=15 Participants This group received only conventional physical therapy (exercises).
Number of Participants Who Received Morphine Within 24 Hours	6 participants	3 participants

Adverse Events

Electrical Stimulation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Physical Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Graciele Sbruzzi

Hospital de Clínicas de Porto Alegre

Phone: 55 51 9423-9420

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place