Transcutaneous Electrical Nerve Stimulation on Pain Intensity of Patients With Hip Arthroplasty

Not Applicable

Completed

• Conditions: Hip Fractures
• Interventions: Device: Experimental. This was the group that received TENS; Other: No intervention

• Registration Number: NCT03534999
• Lead Sponsor: Obafemi Awolowo University

Brief Summary

Fifty patients with hip arthroplasty were purposively recruited for the study. They were allocated into two groups randomly with equal number. One group had TEN, other served as control. Pain intensity was measured every day of the treatment.

Detailed Description

Subjects that participated were post-surgical patients with hip arthroplasty receiving treatment at Orthopedic Ward of Obafemi Awolowo University Teaching Hospitals Complex (OAUTHC), Ile-Ife. Excluded from the study were subjects who had surgery but have infected wound, those with deep vein thrombosis, and those with thrombophlebitis post-surgery. The subjects were allocated randomly into 2 groups; one group of 25 patients was on TENS (experimental group) and the other group of 25 patients was on their normal drugs without TENS (control group). Before the start of intervention, the procedure of the intervention and the way the subject would feel during the course of the intervention was explained to the subject and the consent of the patient was obtained. The procedure was as follows:The Visual Analogue Scale and Oxford hip score was administered prior to the treatment to ascertain their pain level and hip disability before the treatment. The site of intervention (5cm away from incision site) was cleaned properly with cotton wool soaked in methylated spirit in an outward motion. Before the self-adhesive, pre gelled electrodes was placed on the cleansed sites. The TENS unit was switched on and the parameters was adjusted to the required. For this study, parameters used are: 100µs pulse duration, 100Hz frequency and an intensity comfortable for the patient for a duration of 15 minutes.

At the expiration of treatment, the electrodes were removed. The treatment was carried out twice a day for three days in addition to the normal analgesic and antibiotics drugs taken by the patient. After the last treatment session, VAS and Oxford hip score was re-administered to ascertain their pain intensity and hip disability level.

For the group with no intervention The VAS and Oxford hip score was administered on the first day of contact to ascertain pain intensity and hip disability level . The subject continued on the normal analgesics only till the third day and VAS and Oxford hip score was re-administered to ascertain their pain intensity and hip disability level.

Study Timeline

• Study Start: 2017-10-02
• Primary Completion: 2017-12-16
• Study Completion: 2018-02-16
• Study First Submitted: 2018-04-30
• Status Verified: 2018-05
• Study First Submitted QC: 2018-05-11
• Last Update Submitted: 2018-05-11
• Study First Posted: 2018-05-24
• Last Update Posted: 2018-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Patients who recently had hip arthroplasty were recruited for this study

Exclusion Criteria

• Subjects who had surgery but have infected wounds.
• Patients who had deep vein thrombosis post-surgery.
• Patients who had thrombophlebitis post-surgery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TENS	No intervention	This is intervention Group. Patients in this group received Transcutaneous Electrical Nerve Stimulation (TENS). The VAS and Oxford hip score was administered prior to the treatment to ascertain their pain intensity and hip disability level. The site of intervention (5cm away from incision site) was cleaned properly with cotton wool soaked in methylated spirit in an outward motion. Before the self-adhesive, pre gelled electrodes was placed on the cleansed sites.The TENS unit was switched on and the parameters was adjusted to the required level. For this study, parameters used are: 100µs pulse duration, 100Hz frequency and an intensity comfortable for the patient for a duration of 15 minutes.
TENS	Experimental. This was the group that received TENS	This is intervention Group. Patients in this group received Transcutaneous Electrical Nerve Stimulation (TENS). The VAS and Oxford hip score was administered prior to the treatment to ascertain their pain intensity and hip disability level. The site of intervention (5cm away from incision site) was cleaned properly with cotton wool soaked in methylated spirit in an outward motion. Before the self-adhesive, pre gelled electrodes was placed on the cleansed sites.The TENS unit was switched on and the parameters was adjusted to the required level. For this study, parameters used are: 100µs pulse duration, 100Hz frequency and an intensity comfortable for the patient for a duration of 15 minutes.

Primary Outcome Measures

Name	Time	Method
VAS. Visual Analogue Scale	5 days	a horizontal 100mm scale made of plastic calibrated from left (no pain) to the right (severe pain). Ratings greater 70mm indicates severe pain, 45 -74 indicates moderate pain, 5-54 indicates mild pain and 0 -5 indicates no pain

Secondary Outcome Measures

Name	Time	Method
Oxford hip score	5 days	it is a 12-item patient-reported outcome measure designed to assess disability after surgery to the hip. Each item was scored between 0 and 4, with 4 been the best outcome per question producing overall scores running from 0 to 48(48 being the best outcome); \> 41 is excellent, 34 - 41 is good,27 -33 as fair, and \<27 is poor.

Trial Locations

Locations (1)

Obafemi Awolowo University; 🇳🇬 Ile Ife, Osun, Nigeria