The Use of NMES With Pelvic Fracture Rehabilitation

NCT03298425 | Completed

• 1 other identifier: BartsLondonNHS
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Fractures, Closed

Outcome Measures

Primary Outcomes (1)

• Muscle strength in peak torque between treatment and placebo group

  HUMAC isokinetic machine

  10 weeks

Secondary Outcomes (2)

• Gait analysis

  10 weeks

• EQ5D questionnarrie

  10 weeks

Study Arms (2)

Treatment NMES

ACTIVE COMPARATOR

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

Placebo NMES

PLACEBO COMPARATOR

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

Interventions

Treatment NMES DEVICE

Muscle stimulation to reproduce an active muscle contraction. CE marked used for intended purpose.

Treatment NMES

Placebo NMES DEVICE

TENS machine to mimic an active muscle contraction. CE marked used for intended purpose.

Placebo NMES

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Barts & The London NHS Trust: lead

MeSH Terms

Conditions

Fractures, Closed

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Study Officials

• Jessica A Rich, MRes

  Barts Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2015
• First Posted: October 2, 2017
• Study Start: February 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: October 2, 2017

Record last verified: 2017-06