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

Primary Purpose

Hip Fractures

Status
Completed
Phase
Not Applicable
Locations
Nigeria
Study Type
Interventional
Intervention
Experimental. This was the group that received TENS
No intervention
Sponsored by
Obafemi Awolowo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fractures focused on measuring TENS,, VAS,, Oxford-Hip-score,, Hip-arthroplasthy,, Pain-intensity

Eligibility Criteria

40 Years - 68 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Obafemi Awolowo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

TENS

Control

Arm Description

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.

This was the group with no intervention. Subjects were on their normal analgesic and antibiotic medication for the period of research. The VAS and Oxford hip score were administered on the first day 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 assess any change in the pain intensity and hip disability level.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
April 30, 2018
Last Updated
May 11, 2018
Sponsor
Obafemi Awolowo University
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1. Study Identification

Unique Protocol Identification Number
NCT03534999
Brief Title
Transcutaneous Electrical Nerve Stimulation on Pain Intensity of Patients With Hip Arthroplasty
Acronym
TENSHIParth
Official Title
Effect of Transcutaneous Electrical Nerve Stimulation on Pain Intensity of Patients With Hip Arthroplasty: A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
October 2, 2017 (Actual)
Primary Completion Date
December 16, 2017 (Actual)
Study Completion Date
February 16, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Obafemi Awolowo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures
Keywords
TENS,, VAS,, Oxford-Hip-score,, Hip-arthroplasthy,, Pain-intensity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients with Hip Arthroplasty, one group was on TENS other group was a control
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TENS
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
This was the group with no intervention. Subjects were on their normal analgesic and antibiotic medication for the period of research. The VAS and Oxford hip score were administered on the first day 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 assess any change in the pain intensity and hip disability level.
Intervention Type
Device
Intervention Name(s)
Experimental. This was the group that received TENS
Other Intervention Name(s)
TENS
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
No intervention
Other Intervention Name(s)
Control
Intervention Description
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
Primary Outcome Measure Information:
Title
VAS. Visual Analogue Scale
Description
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
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Oxford hip score
Description
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.
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
68 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adesola O Ojoawo, PhD
Organizational Affiliation
Obafemi Awolowo University, Ile Ife
Official's Role
Principal Investigator
Facility Information:
Facility Name
Obafemi Awolowo University
City
Ile Ife
State/Province
Osun
ZIP/Postal Code
220005
Country
Nigeria

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual data will not be shared with other researchers outside the study because data of patients should be kept confidential for ethical reaseons
Citations:
PubMed Identifier
17634145
Citation
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(Suppl 1):S6. doi: 10.1186/ar2170.
Results Reference
background
PubMed Identifier
6970995
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.
Results Reference
background
PubMed Identifier
15053950
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.
Results Reference
background

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

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