"Study on the effects of Neural Mobilisation and exercises on Neuromuscular properties in subjects with Diabetic Peripheral Neuropathyâ€
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 84
- Locations
- 2
- Primary Endpoint
- Blood glucose level, Glycosylated haemoglobin (HbA1c),motor and sensory Nerve conduction velocity (tibial and sural nerve),Fatigue of lower limb muscles,TNF-α, NPRS
Study Overview
Brief Summary
NeuralMobilization (NM) techniques are performed to reduce nerve mechano-sensitivityand increase the compliance of nerve tissues by increasing neural flexibility(Schmid et al., 2009). Thetechnique works by improving axonal transport and increasing blood flow byreducing pressure within the nerves (Schmid et al., 2009). The NM techniquesare useful in restoring the normal physiological function through both theintraneural and extra neural effect (Brown et al., 2011; Goyal et al., 2016). Astudy conducted on normal population showed NM increase pain threshold andimprovement in biceps brachii muscle fatigue (M. K. Kim et al., 2016). Endurance isreduced by as much as 45% in type 1 DM and is also related to lowered NCV(Almeida et al., 2008). Astudy conducted to check the feasibilityof NM in DM patients concluded it is safe without any adverse effects (Boyd,Nee, & Smoot, 2017). Although this technique is safe inDM patients, effects of NM as an intervention on various neuromuscularproperties like nerve function, sensorimotor functions and inflammatorybiomarkers in patients with DPN is a place to research. We, therefore, plan this study toexamine the effects of NM plus strengthening exercises in patients with DPN. Inthis study we will screen the patients through MDNS scoring and randomized thepatients into control group, experimental group A and experimental group B. Thecontrol group will receive consultation for usual care and dietary advice. The duration of intervention is 8 weeks. A sample size of 84 will be randomized into the 3 groups. The outcomes measures are Blood glucose level, Glycosylated haemoglobin (HbA1c), motor and sensory Nerve conduction velocity (tibial and sural nerve),Fatigue of lower limb muscles, TNF-α, NPRS.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 40.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Subjects diagnosed with diabetes mellitus detected at least 5 years or before the enrolment.
- •MDNS score ≥ 6 will be included.
- •Ability to walk independently household distances without assistive device.
Exclusion Criteria
- •1.History of neurological symptoms other than that of diabetic peripheral neuropathy (i.e., hemiparesis, myelopathy, cerebellar ataxia, etc.) 2.History of cardiovascular disease (angina, breathlessness, uncontrolled hypertension).
- •3.Significant musculoskeletal deformity (amputation, scoliosis, severe osteoarthritis).
- •4.Lower extremity arthritis that limits standing or weight bearing position.
- •5.Symptomatic postural hypotension (standing up to 5 min).
- •6.Evidence of vestibular dysfunction.
- •8.Vascular complications (venous or arterial ulcers) 9.Receiving any physical therapy intervention.
Outcomes
Primary Outcomes
Blood glucose level, Glycosylated haemoglobin (HbA1c),motor and sensory Nerve conduction velocity (tibial and sural nerve),Fatigue of lower limb muscles,TNF-α, NPRS
Time Frame: At baseline (pre-intervention) and at 8 weeks (post-intervention)
Secondary Outcomes
- NPRS, Quality of life,(At baseline(pre-intervention) and at 8 weeks (post-intervention))