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

Hip Fractures Clinical Trial

— TENSHIParth  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03534999
• Other study ID #: OJO/2018/002
• Status: Completed
• Phase: N/A
• Start date: October 2, 2017
• Est. completion date: February 16, 2018

Study information

• Verified date: May 2018
• Source: Obafemi Awolowo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 16, 2018
• Est. primary completion date: December 16, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 68 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hip Fractures
• Pain

Intervention

Device:
• Experimental. This was the group that received TENS
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:
• No intervention
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

Locations

Country	Name	City	State
Nigeria	Obafemi Awolowo University	Ile Ife	Osun

Sponsors (1)

Lead Sponsor	Collaborator
Obafemi Awolowo University

Country where clinical trial is conducted

Nigeria, 

References & Publications (3)

Abu-Amer Y, Darwech I, Clohisy JC. Aseptic loosening of total joint replacements: mechanisms underlying osteolysis and potential therapies. Arthritis Res Ther. 2007;9 Suppl 1:S6. Review. — View 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. — View Citation

Almeida TF, Roizenblatt S, Tufik S. Afferent pain pathways: a neuroanatomical review. Brain Res. 2004 Mar 12;1000(1-2):40-56. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS. Visual Analogue Scale	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	5 days
Secondary	Oxford hip score	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.	5 days