Skip to main content
OpenTrials
Completed

NCT Number: NCT03534999

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

40 year–68 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Obafemi Awolowo University

Ile-Ife, Osun State, 220005, Nigeria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Experimental. This was the group that received TENS

Device

Patients that were on TENS . They were treated twice daily for 5 days. VAS and Hip Score scale were used to assess the pain intensity and disability level

Other names: TENS

No intervention

Other

Patients in this group were on their drugs only. There was no physiotherapy intervention for the patient. VAS and Hip Score scale were used to ascertain the pain intensity and hip disability at the before the treatment and after the treatment

Other names: Control

Primary outcomes

  1. VAS. Visual Analogue Scale

    Time frame: 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 outcomes

  1. Oxford hip score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Obafemi Awolowo University

Other

Registry information

Official study title

Effect of Transcutaneous Electrical Nerve Stimulation on Pain Intensity of Patients With Hip Arthroplasty: A Randomized Control Trial

Acronym: TENSHIParth

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
May 24, 2018
Registry last updated
May 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.