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

NCT03534999 | Completed

• 1 other identifier: OJO/2018/002
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Fractures

Keywords

TENS,; VAS,; Oxford-Hip-score,; Hip-arthroplasthy,; Pain-intensity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Oxford hip score

  5 days

Study Arms (2)

TENS

EXPERIMENTAL

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.

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

Control

NO INTERVENTION

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.

Interventions

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

Also known as: TENS

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

Also known as: Control

TENS

Eligibility Criteria

• Age: 40 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who recently had hip arthroplasty were recruited for this study

You may not qualify if:

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

Sponsors & Collaborators

• Obafemi Awolowo University: lead

Study Sites (1)

Obafemi Awolowo University

Ile-Ife, Osun State, 220005, Nigeria

Location

Related 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(Suppl 1):S6. doi: 10.1186/ar2170.

  PMID: 17634145 BACKGROUND

• 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.

  PMID: 6970995 BACKGROUND

• 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.

  PMID: 15053950 BACKGROUND

MeSH Terms

Conditions

Hip Fractures; Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Adesola O Ojoawo, PhD

  Obafemi Awolowo University, Ile Ife

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients with Hip Arthroplasty, one group was on TENS other group was a control

Study Record Dates

• First Submitted: April 30, 2018
• First Posted: May 24, 2018
• Study Start: October 2, 2017
• Primary Completion: December 16, 2017
• Study Completion: February 16, 2018
• Last Updated: May 24, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

NG (1)