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Transcutaneous Electrical Nerve Stimulation After Total Hip Arthroplasty

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ClinicalTrials.gov Identifier: NCT03046212
Recruitment Status : Completed
First Posted : February 8, 2017
Results First Posted : November 9, 2017
Last Update Posted : November 9, 2017
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Transcutaneous Electric Nerve Stimulation
Pain
Interventions: Device: Transcutaneous electrical nerve stimulation
Other: Exercises

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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).

Participant Flow:   Overall Study
    Electrical Stimulation   Physical Therapy
STARTED   15   15 
COMPLETED   15   15 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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).
Total Total of all reporting groups

Baseline Measures
   Electrical Stimulation   Physical Therapy   Total 
Overall Participants Analyzed 
[Units: Participants]
 15   15   30 
Age 
[Units: Years]
Mean (Standard Deviation)
 59.8  (9.9)   66.9  (12.8)   63.3  (11.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      9  60.0%      10  66.7%      19  63.3% 
Male      6  40.0%      5  33.3%      11  36.7% 
Body mass index (BMI) 
[Units: Kg/m²]
Mean (Standard Deviation)
 29.5  (3.4)   28.6  (5.9)   29.06  (4.8) 


  Outcome Measures

1.  Primary:   Change in Pain Level From Baseline to 45 Minutes   [ Time Frame: baseline, 45 minutes ]

2.  Secondary:   Change in Hip Range of Motion From Baseline to 45 Minutes   [ Time Frame: baseline, 45 minutes ]

3.  Secondary:   Number of Participants Who Received Morphine Within 24 Hours   [ Time Frame: 24 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Graciele Sbruzzi
Organization: Hospital de Clínicas de Porto Alegre
phone: 55 51 9423-9420
e-mail: graciele.sbruzzi@ufrgs.br



Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT03046212     History of Changes
Other Study ID Numbers: 160105
First Submitted: November 29, 2016
First Posted: February 8, 2017
Results First Submitted: March 9, 2017
Results First Posted: November 9, 2017
Last Update Posted: November 9, 2017