Hip FracturesTENSHIParthNCT03534999
Transcutaneous Electrical Nerve Stimulation on Pain Intensity of Patients With Hip Arthroplasty
A study testing Experimental. This was the group that received TENS in people with Hip Fractures, run by Obafemi Awolowo University at 1 site in Nigeria.
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. Read more about this study
- Who is it for?
- Ages 40 to 68 years
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Experimental. This was the group that received TENS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteNigeria
- Study dates
- 2 Oct 2017to 16 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who recently had hip arthroplasty were recruited for this study
Who cannot join
- Subjects who had surgery but have infected wounds.
- Patients who had deep vein thrombosis post-surgery.
- Patients who had thrombophlebitis post-surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Transcutaneous Electrical Nerve Stimulation on Pain Intensity of Patients With Hip Arthroplasty: A Randomized Control Trial
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.
Read the 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.
- Conditions
- Hip Fractures
- Being tested
- Experimental. This was the group that received TENS, No intervention
- Keywords
- TENS,, VAS,, Oxford-Hip-score,, Hip-arthroplasthy,, Pain-intensity
- Medical subject headings
- Hip Fractures, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental. This was the group that received TENSDevice
Also called 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
No interventionOther
Also called Control
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 days
Secondary outcomes (1)
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.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start2 Oct 2017
- Primary completion16 Dec 2017
- Study completion16 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients with Hip Arthroplasty, one group was on TENS other group was a control
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Obafemi Awolowo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adesola Ojo Ojoawo, Obafemi Awolowo University
- Investigators
- Adesola O Ojoawo, PhD, Principal investigator, Obafemi Awolowo University, Ile Ife
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03534999
- Sponsor's protocol ID
- OJO/2018/002
- Acronym
- TENSHIParth
- Status last verified
- May 2018
- First submitted
- 30 Apr 2018
- Last updated
- 24 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual data will not be shared with other researchers outside the study because data of patients should be kept confidential for ethical reaseons
Publications
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.
PubMed 17634145Ali 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.
PubMed 6970995Almeida 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.
PubMed 15053950
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcutaneous Electrical Nerve Stimulation on Pain Intensity of Patients With Hip Arthroplasty: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03534999
- Acronym / sponsor ID
- TENSHIParth / OJO/2018/002
- Conditions
- Hip Fractures
- Keywords
- TENS,, VAS,, Oxford-Hip-score,, Hip-arthroplasthy,, Pain-intensity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Obafemi Awolowo UniversityUniversity, hospital or other
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 16 Dec 2017 (actual)
- Study completion
- 16 Feb 2018 (actual)
- First posted
- 24 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients with Hip Arthroplasty, one group was on TENS other group was a control
| Arm | Type | Receives |
|---|---|---|
| TENS | Experimental | Device: Experimental. This was the group that received TENS, Other: No interventionThis 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. |
| 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. |
Who may qualify
- Ages
- 40 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who recently had hip arthroplasty were recruited for this study
Key exclusion criteria (3 listed)
- Subjects who had surgery but have infected wounds.
- Patients who had deep vein thrombosis post-surgery.
- Patients who had thrombophlebitis post-surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental. This was the group that received TENSAlso: TENSPatients 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 | Device | TENS |
| No interventionAlso: ControlPatients 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 | TENS |
Primary outcome
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
1 secondary outcome
Oxford hip score
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2018.
- Background: PubMed 17634145Abu-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.
- Background: PubMed 6970995Ali 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.
- Background: PubMed 15053950Almeida 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.
- Individual participant dataSharing planned: No. Individual data will not be shared with other researchers outside the study because data of patients should be kept confidential for ethical reaseons
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adesola O Ojoawo, PhD principal investigator
Obafemi Awolowo University, Ile Ife
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental. This was the group that received TENS in people with Hip Fractures, run by Obafemi Awolowo University at 1 site in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS. Visual Analogue Scale (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03534999, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2018.