Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Use of NMES With Pelvic Fracture Rehabilitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03298425
Recruitment Status : Completed
First Posted : October 2, 2017
Last Update Posted : October 2, 2017
Sponsor:
Information provided by (Responsible Party):
Barts & The London NHS Trust

Brief Summary:

The purpose of the study is to investigate if using an electrical stimulation machine to see if it can help strengthen the muscles around the hip during the first three months post pelvic fracture will help with the early stages of rehabilitation. Electrical stimulation is a treatment machine that uses an electrical current to cause a single muscle or a group of muscles to contract. This contraction helps strengthen injured muscles and helps with the healing process. It can also help with pain relief by blocking pain signals from the brain.

After a pelvic fracture they are surgically fixed and will be advised not to put any weight on the operated leg for 10 weeks. During this time hip muscles become very weak as they will not be used as much as normal. Bed exercises can help keep muscle strength but this study would like to try using electrical stimulation machines alongside bed exercises to see if it can improve muscle strength even more. Electrical stimulation machines are already used by rehabilitation. Electrical stimulation is a treatment machine that uses an electrical current to cause a single muscle or a group of muscles to contract. This contraction helps strengthen injured muscles and helps with the healing process. It can also help with pain relief by blocking pain signals from the brain.

After a pelvic fracture they are surgically fixed and will be advised not to put any weight on the operated leg for 10 weeks. During this time hip muscles become very weak as they will not be used as much as normal. Bed exercises can help keep muscle strength but this study would like to try using electrical stimulation machines alongside bed exercises to see if it can improve muscle strength even more. Electrical stimulation machines are already used by patients to increase muscle strength.

Participants will be put into one of two groups, both groups will be given an electrical stimulation machine but one will be on a placebo setting. Participants will need to use the machine twice a day along with their bed exercises and will need to fill in a diary when and how many times the machine has been used for 10 weeks until their 12 week appointment with the orthopaedic consultant. The participants weight bearing status will change and they will be asked to perform a muscle strength test on both the operated and nonoperated leg. They will also have their walking quality assessed. The results will compare both groups for muscle strength and walking changes.


Condition or disease Intervention/treatment Phase
Fractures, Closed Device: Treatment NMES Device: Placebo NMES Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use of Neuromuscular Electrical Muscle Stimulation With Pelvic Fracture Rehabilitation: A Double Blind, Placebo Controlled, Randomised Control Trial
Actual Study Start Date : February 2015
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Treatment NMES
Patients allocated to the NMES group will be given an information booklet on NMES machines. The Cefar Compex three electrical stimulator will be used. Participants are expected to use the NMES machine for half an hour and complete bed exercises twice daily. Patients should relax during the NMES as completing both does not demonstrate better results, due to unsynchronised activation of the NMES (Gregory & Bickel, 2005). Using the machine once daily will allow for the recovery of the muscle. A voluntary contraction would normally be 20-30Hz but due to the high intensities of the NMES (35-75Hz) it can cause muscle fatigue (Maffiuletti, 2011).
Device: Treatment NMES
Muscle stimulation to reproduce an active muscle contraction. CE marked used for intended purpose.

Placebo Comparator: Placebo NMES
The placebo group will act as the control group. They will be expected to complete the same regime as previously described above, however these machines will be on TENS setting (80-100Hz) as even low Hz can trigger motor stimulation (Paillard 2008). This setting is designed as a sensory stimulus therefore will have no effects on muscle strength however the patient will feel a small twitch sensation. This setting is not painful and will have no effect on muscle fatigue. The patient will not be expected to complete the bed exercises and the TENS session together.
Device: Placebo NMES
TENS machine to mimic an active muscle contraction. CE marked used for intended purpose.




Primary Outcome Measures :
  1. Muscle strength in peak torque between treatment and placebo group [ Time Frame: 10 weeks ]
    HUMAC isokinetic machine


Secondary Outcome Measures :
  1. Gait analysis [ Time Frame: 10 weeks ]
    to assess participants gait analysis post intervention - Using gait analysis equipment at a gait analysis lab

  2. EQ5D questionnarrie [ Time Frame: 10 weeks ]
    pre and post intervention EQ5D scores



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients who can give written informed consent
  • Patients with surgically fixed pelvic fractures who are TTWB for up to 10-12 weeks
  • Patients with associated injuries considered for example fractured upper limb however their recovery must be within six weeks when they start the intervention.
  • Males and females between 18-70 years old
  • Patients able to comply and complete the electrical stimulation machine and complete both bed exercises and NMES twice daily.

Exclusion Criteria:

  • Patients with current or previous mental health, chronic pain or previous injury which may affect participation.
  • Any complex lower limb injury in either limb unless fixed and cleared six weeks post injury.
  • Severe kidney injuries which are ongoing will not considered following a case of rhabdomyolysis induced by excessive NMES (Guarascio et al, 2004).
  • Patients who may be pregnant
  • Patients who suffer from sensitivity problems for the skin
  • Patients who may have an abdominal or Inguinal hernia
  • Patients with arterial circulation disorders of the lower limb
  • Patients with pacemakers

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03298425


Sponsors and Collaborators
Barts & The London NHS Trust
Investigators
Layout table for investigator information
Principal Investigator: Jessica A Rich, MRes Barts Health
Layout table for additonal information
Responsible Party: Barts & The London NHS Trust
ClinicalTrials.gov Identifier: NCT03298425    
Other Study ID Numbers: BartsLondonNHS
First Posted: October 2, 2017    Key Record Dates
Last Update Posted: October 2, 2017
Last Verified: June 2017

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Fractures, Bone
Hip Fractures
Fractures, Closed
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries