TraumaNCT03278834
NMES and Pelvic Fracture Rehabilitation
A study testing Neuromuscular muscle stimulation machine- Strength Setting and Neuromuscular muscle stimulation machine - TENS Setting in people with Trauma and Rehabilitation, run by Barts & The London NHS Trust.
Trial summary
Objectives: The acute care of pelvic fractures has improved recently however there are no formal guidelines for rehabilitation of these types of fractures. Patients have long periods of non-weight bearing causing muscle wastage. Neuromuscular electrical stimulation (NMES) has proven to minimise muscle loss. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Trauma, Rehabilitation
- What is being tested?
- Neuromuscular muscle stimulation machine- Strength Setting and Neuromuscular muscle stimulation machine - TENS Setting
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 1 Jun 2014
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Inclusion criteria were any patient with a pelvic fracture that was surgically fixed with no associated injuries and able to give written informed consent.
- Pelvic fractures including acetabular and pelvic ring fracture that were fixed using open reduction internal fixation (ORIF) were considered.
Who cannot join
- Exclusion criteria were patients who could not comply with the NMES or who had previous mental health diagnosis.
- Patients who may be pregnant, have severe kidney injury or have a pacemaker were excluded.
About this study
Official title: The Use of Neuromuscular Electrical Stimulation With Pelvic Fracture Rehabilitation: A Randomised, Double Blind, Pilot Study
Objectives: The acute care of pelvic fractures has improved recently however there are no formal guidelines for rehabilitation of these types of fractures. Patients have long periods of non-weight bearing causing muscle wastage. Neuromuscular electrical stimulation (NMES) has proven to minimise muscle loss. However, this has not previously been investigated within this patient population.
Design: Double blind, randomised, feasibility study.
Read more
Setting: NHS trust hospital setting.
Participants: Nine patients with surgically fixed pelvic fractures were randomly allocated at six weeks post fracture.
Interventions: The intervention group completed six weeks of NMES. The placebo group used transcutaneous electrical nerve stimulation (TENS).
Main outcome measures: Peak torque (Nm) was calculated in the operated limb at 12 weeks using the non-operated limb as a baseline. Compliance and intensity levels were recorded. Feasibility of NMES was evaluated using a feasibility questionnaire. Pain was measured at six and 12 weeks using a visual analogue scale (VAS).
- Conditions
- Trauma, Rehabilitation
- Being tested
- Neuromuscular muscle stimulation machine- Strength Setting, Neuromuscular muscle stimulation machine - TENS Setting
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular muscle stimulation machine- Strength SettingDevice
Muscle stimulation to strength skeletal muscle
Neuromuscular muscle stimulation machine - TENS SettingDevice
Muscle stimulation to mimic the intervention but without the strength gains.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Neuromuscular muscle stimulation machine - Muscle stimulation machine to be used on glutes and abductors on disuse atrophy setting.
Twice per day for 45 minutes.
Exercise - Home exercises programme once per day with 10 exercises. Receives: Device: Neuromuscular muscle stimulation machine- Strength Setting |
| Placebo Group | Placebo comparator | Neuromuscular muscle stimulation- Muscle stimulation machine to be used on glutes and abductors on TENS setting. Twice per day for 45 minutes.
Exercise - Home exercises programme once per day with 10 exercises. Receives: Device: Neuromuscular muscle stimulation machine - TENS Setting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Strength
Peak Torque muscle strength
Measured: 12 weeks post operation
Secondary outcomes (1)
Feasibility questionnaire
questionnaire of 10 questions
Measured: 12 weeks post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start1 Jan 2014
- Primary completion1 Jun 2014
- Study completion1 Jun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies 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
- Factorial
- Model description
- Treatment and intervention group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03278834
- Sponsor's protocol ID
- NMES Pilot Study
- Status last verified
- Jul 2017
- First submitted
- 13 Jul 2017
- Last updated
- 12 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Neuromuscular Electrical Stimulation With Pelvic Fracture Rehabilitation: A Randomised, Double Blind, Pilot Study
- ClinicalTrials.gov ID
- NCT03278834
- Acronym / sponsor ID
- NMES Pilot Study
- Conditions
- Trauma, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 Jun 2014 (actual)
- Study completion
- 1 Jun 2014 (actual)
- First posted
- 12 Sep 2017 (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.
Objectives: The acute care of pelvic fractures has improved recently however there are no formal guidelines for rehabilitation of these types of fractures. Patients have long periods of non-weight bearing causing muscle wastage. Neuromuscular electrical stimulation (NMES) has proven to minimise muscle loss. However, this has not previously been investigated within this patient population.
Design: Double blind, randomised, feasibility study.
Setting: NHS trust hospital setting.
Participants: Nine patients with surgically fixed pelvic fractures were randomly allocated at six weeks post fracture.
Interventions: The intervention group completed six weeks of NMES. The placebo group used transcutaneous electrical nerve stimulation (TENS).
Main outcome measures: Peak torque (Nm) was calculated in the operated limb at 12 weeks using the non-operated limb as a baseline. Compliance and intensity levels were recorded. Feasibility of NMES was evaluated using a feasibility questionnaire. Pain was measured at six and 12 weeks using a visual analogue scale (VAS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Treatment and intervention group
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: Neuromuscular muscle stimulation machine- Strength SettingNeuromuscular muscle stimulation machine - Muscle stimulation machine to be used on glutes and abductors on disuse atrophy setting. Twice per day for 45 minutes. Exercise - Home exercises programme once per day with 10 exercises. |
| Placebo Group | Placebo comparator | Device: Neuromuscular muscle stimulation machine - TENS SettingNeuromuscular muscle stimulation- Muscle stimulation machine to be used on glutes and abductors on TENS setting. Twice per day for 45 minutes. Exercise - Home exercises programme once per day with 10 exercises. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Inclusion criteria were any patient with a pelvic fracture that was surgically fixed with no associated injuries and able to give written informed consent.
- Pelvic fractures including acetabular and pelvic ring fracture that were fixed using open reduction internal fixation (ORIF) were considered.
Key exclusion criteria (2 listed)
- Exclusion criteria were patients who could not comply with the NMES or who had previous mental health diagnosis.
- Patients who may be pregnant, have severe kidney injury or have a pacemaker were excluded.
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 |
|---|---|---|
| Neuromuscular muscle stimulation machine- Strength SettingMuscle stimulation to strength skeletal muscle | Device | Intervention Group |
| Neuromuscular muscle stimulation machine - TENS SettingMuscle stimulation to mimic the intervention but without the strength gains. | Device | Placebo Group |
Primary outcome
Muscle Strength
Time frame: 12 weeks post operation
Peak Torque muscle strength
1 secondary outcome
Feasibility questionnaire
Time frame: 12 weeks post operation
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 12 Sep 2017.
Related trials for Trauma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
Safety Study of Microlyte DualGuard
Wound Closure, Wound Care
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular muscle stimulation machine- Strength Setting and Neuromuscular muscle stimulation machine - TENS Setting in people with Trauma and Rehabilitation, run by Barts & The London NHS Trust.
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 2 inclusion and 2 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 12 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Muscle Strength (time frame: 12 weeks post operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Sep 2017.