Condition category
Injury, Occupational Diseases, Poisoning
Date applied
05/07/2018
Date assigned
30/07/2018
Last edited
20/07/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Transcutaneous electrical nerve stimulation (TENS) is a kind of therapy that uses low voltage electrical currents to treat pain. In this study, patients in hospital following surgery for a hip fracture will receive TENS therapy, to see if this results in less pain during the first few days after the surgery compared to patients who received the surgery but not TENS treatment. Additionally, we will be looking at the effects of TENS on mobility and walking.

Who can participate?
Men and women older than 50 years old, with a stable extracapsular intertrochanteric or subtrochanteric hip fracture, that was fixed with a Gamma nail. Patients must have been able to walk for at least ten minutes prior to their hip fracture, and be able to bear weight on the repaired leg.

What does the study involve?
Participants will be randomly allocated to one of two groups. One group will receive active TENS treatment; the other will receive sham TENS treatment (where the TENS device delivers no electric current). Both groups will receive the standard rehabilitation for hip fractures, beginning 24 hours after surgery for the five days they are in hospital. For all participants, electrodes will be taped to the skin on both sides of the surgical cut, through which the TENS treatment will be delivered. Each group will receive active TENS or sham TENS treatment for 30 minutes each day for 5 consecutive days. Active TENS devices will have their intensity adjusted so that the treatment will feel strong, but comfortable. Sham TENS devices will be switched on so that the participant will see a green light, but no current will be delivered.

What are the possible benefits and risks of participating?
The possible benefits are decreased pain after hip fracture surgery, and increased ability to walk and function. There are no known risks to participants taking part in this study.

Where is the study run from?
Galilee Medical Center
89 כביש
Nahariya
Israel
22100

When is the study starting and how long is it expected to run for?
The study will start in September 2014 and will run until September 2016.

Who is funding the study?
This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Who is the main contact?
Michal Elboim-Gabyzon
michal.elboim@gmail.com
moelboum-@staff.haifa.ac.il

Trial website

Contact information

Type

Scientific

Primary contact

Dr Michal Elboim

ORCID ID

http://orcid.org/0000-0002-7278-9421

Contact details

Balfour 9
Nahariya
224216
Israel

Additional identifiers

EudraCT number

No available

ClinicalTrials.gov number

No available

Protocol/serial number

0110-14-NHR

Study information

Scientific title

Effects of transcutaneous electrical nerve stimulation on acute postoperative pain intensity, ambulation and mobility after hip fracture: A double-blinded, randomized trial.

Acronym

TENS AND HIP

Study hypothesis

Incorporating TENS treatment during standard rehabilitation care in the acute post-operative phase following Gamma nail surgical fixation of extracapsular hip fracture will have a beneficial effect in terms of on pain intensity, ambulation and mobility.

Ethics approval

Helsinki committee of the Galilee Medical Center, 17/11/2014, 0110-14-NHR

Study design

Interventional double-blinded single-center randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Extracapsular proximal hip fracture stabilized with Gamma nail

Intervention

Eligible subjects will be randomly allocated to one of two groups (active TENS or sham TENS) using a computer algorithm. Each group will receive the TENS treatment (active or sham) each morning for 5 consecutive days for approximately 30 minutes. Four electrodes will be taped to the skin on both sides of the surgical cut for all participants, and the TENS treatment (active or sham) will be delivered by a portable clinical stimulator TENS device.
Active TENS units will deliver a biphasic symmetric waveform at a continuous frequency of 100 Hz and phase duration of 200 µsec. The participants in this group will be instructed that they should feel a strong but comfortable sensation.
Sham TENS units will be switched on so that the participant will see a green light; however, this device will deliver no current. The participants in this group will be informed that not everyone will necessarily feel stimulation from the device.
Participants in both groups will receive the standard interdisciplinary postoperative treatment, which was 30 minutes of physiotherapy each morning with a physical therapist. Each session involved transfer training, balance exercises, lower extremity exercises and ambulation training.

Intervention type

Device

Phase

Drug names

Primary outcome measure

Pain level at rest, at night and during ambulation, measured using a numeric rating scale (NRS) on days 1-5 before participants received TENS and physical therapy (PT) treatment
Ambulation status measured using a functional ambulation classification (FAC) instrument on days 2-5 at the end of the training session, after the participants received TENS and PT treatment
Physical performance tests - sit to stand (repeated five times) and two minute walk, assessed on the final day of treatment (day 5) after participants received TENS and PT treatment

Secondary outcome measures

N/A

Overall trial start date

01/12/2014

Overall trial end date

01/12/2015

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Over 50 years of age
2. Stable extracapsular proximal hip fraction (intertrochanteric or subtrochanteric)
3. Partial or full weight bearing instructions
4. Ability to ambulate independently for at least 10 m with or without an assistive device prior to the fracture
5. Ability to follow instructions
6. Mini mental state test score ≥ 20

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80

Participant exclusion criteria

1. Conditions that contraindicate electrical stimulation (i.e. pacemakers, significant sensory loss in lower extremities, local wound at the site of electrode placement)
2. History of cardiovascular, neurological or orthopedic problems with a mobility limitation of walking less than 100 m
3. Prior experience with TENS
4. Infection or systemic disease that may interfere with the rehabilitation process (i.e. lupus disease)

Recruitment start date

01/12/2014

Recruitment end date

01/12/2015

Locations

Countries of recruitment

Israel

Trial participating centre

Galilee Medical Center
89 כביש Nahariya
Nahariya
22100
Israel

Sponsor information

Organisation

Haifa university

Sponsor details

199 Aba Khoushy Ave.
Mt. Carmel
Haifa
Haifa
3498838
Israel

Sponsor type

University/education

Website

https://www.haifa.ac.il

Funders

Funder type

Not defined

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Publication in a scientific journal

Intention to publish date

01/09/2018

Participant level data

Available on request

Basic results (scientific)

Supplemental TENS to standard care physical therapy post-hip fracture repair for elderly patients resulted in significant pain reduction (difference between the fifth day and the second day) during walking in the active TENS group compared to the sham TENS (2.55±1.37 vs. 1.06± 1.11 respectively; p=0.0011). There was no additional effect of active TENS on "static pain" (pain at rest and at night).
Level of ambulation (measured by FAC) improved significantly in both groups. However, significantly greater improvement was seen in the active TENS group as compared to sham TENS. Active TENS participants demonstrated significantly greater increase in walking in walking distance compared to the sham TENS group. No effect was demonstrated on sit to stand (five times) test performance.

Publication list

Publication citations

Additional files

Editorial Notes