Clinical trial NCT03534999: Transcutaneous Electrical Nerve Stimulation on Pain Intensity of Patients With Hip Arthroplasty
Official title: Effect of Transcutaneous Electrical Nerve Stimulation on Pain Intensity of Patients With Hip Arthroplasty: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Fractures
Keywords: TENS,
VAS,
Oxford-Hip-score,
Hip-arthroplasthy,
Pain-intensity
Lead sponsor: Obafemi Awolowo University
Sponsor class: OTHER
First posted: 2018-05-24
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with Hip Arthroplasty, one group was on TENS other group was a control
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: VAS. Visual Analogue Scale
timeFrame: 5 days
Secondary outcomes:
measure: Oxford hip score
timeFrame: 5 days
Other outcomes:
Locations:
city: Ile Ife
country: Nigeria
facility: Obafemi Awolowo University
state: Osun
Study officials:
affiliation: Obafemi Awolowo University, Ile Ife
name: Adesola O Ojoawo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Ali J, Yaffe CS, Serrette C. The effect of transcutaneous electric nerve stimulation on postoperative pain and pulmonary function. Surgery. 1981 Apr;89(4):507-12.
citation: Almeida TF, Roizenblatt S, Tufik S. Afferent pain pathways: a neuroanatomical review. Brain Res. 2004 Mar 12;1000(1-2):40-56. doi: 10.1016/j.brainres.2003.10.073.