| CTRI Number |
CTRI/2022/06/043564 [Registered on: 29/06/2022] Trial Registered Prospectively |
| Last Modified On: |
27/06/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effects of nerve mobilisation and exercise on Diabetic Peripheral Neuropathy patients |
|
Scientific Title of Study
|
"Study on the effects of Neural Mobilisation and exercises on Neuromuscular properties in subjects with Diabetic Peripheral Neuropathy†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Majumi M Noohu PhD |
| Designation |
Associate Professor |
| Affiliation |
Jamia Millia Islamia (Central university), New Delhi, India. |
| Address |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia (Central University), New Delhi, India-110025
South
DELHI
110025
India |
| Phone |
|
| Fax |
|
| Email |
mnoohu@jmi.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Majumi M Noohu PhD |
| Designation |
Associate Professor |
| Affiliation |
Jamia Millia Islamia (Central university), New Delhi, India. |
| Address |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia (Central University), New Delhi, India-110025
DELHI
110025
India |
| Phone |
|
| Fax |
|
| Email |
mnoohu@jmi.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Majumi M Noohu PhD |
| Designation |
Associate Professor |
| Affiliation |
Jamia Millia Islamia (Central university), New Delhi, India. |
| Address |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia (Central University), New Delhi, India-110025
South
DELHI
110025
India |
| Phone |
|
| Fax |
|
| Email |
mnoohu@jmi.ac.in |
|
|
Source of Monetary or Material Support
|
| Centre for Physiotherapy and Rehabilitation Sciences Jamia Millia Islamia (Central university), New Delhi, India. |
|
|
Primary Sponsor
|
| Name |
Centre for Physiotherapy and Rehabilitation Sciences Jamia Millia Islamia Central university |
| Address |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia (Central university), New Delhi, India-110025 |
| Type of Sponsor |
Other [Central University] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Irshad Naqvi |
Dr. M.A, Ansari Health Centre, JMI |
OPD,Dr. M.A, Ansari Health Centre, Jamia Millia Islamia (Central University), Jamia Nagar, Okhla, New delhi, India-110025
South
DELHI |
09811082089
inaqvi@jmi.ac.in |
| Dr Majumi M Noohu PhD |
OPD, Centre for Physiotherapy and Rehabilitation Sciences, JMI |
OPD CPRS, Ground floor, Jamia Millia Islamia (Central University), New Delhi-110025
South
DELHI |
09868023378
mnoohu@jmi.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Jamia Millia Islamia |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E104||Type 1 diabetes mellitus with neurological complications, (2) ICD-10 Condition: E114||Type 2 diabetes mellitus with neurological complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Neural mobilization |
Neural mobilisation of the tibial and peroneal nerve of the lower limb in supine and side lying position will be given.
The interventions will be given 3 sessions/week. Each session will take around 40-50 mins for the intervention group.
Progressive strengthening exercise of the muscles of the lower limb will be given along with NM in one group. |
| Comparator Agent |
No interventions will be given in the Control group |
No intervention will be given in the control group. |
| Intervention |
Strengthening exercise |
In second group, only progressive strengthening exercise of the muscles of the lower limb will be given. Similar to NM, this will be given 3 sessions/week.
Each session will take around 30-45 mins. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects diagnosed with diabetes mellitus detected at least 5 years or before the enrolment.
2. MDNS score ≥ 6 will be included.
3. MMSE > 24
4. Ability to walk independently household distances without assistive device.
|
|
| ExclusionCriteria |
| Details |
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.
7.Unstable proliferative retinopathy.
8.Vascular complications (venous or arterial ulcers)
9.Receiving any physical therapy intervention.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Blood glucose level, Glycosylated haemoglobin (HbA1c),motor and sensory Nerve conduction velocity (tibial and sural nerve),Fatigue of lower limb muscles,TNF-α, NPRS |
At baseline (pre-intervention) and at 8 weeks (post-intervention) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NPRS, Quality of life, |
At baseline(pre-intervention) and at 8 weeks (post-intervention) |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Neural
Mobilization (NM) techniques are performed to reduce nerve mechano-sensitivity
and increase the compliance of nerve tissues by increasing neural flexibility
(Schmid et al., 2009). The
technique works by improving axonal transport and increasing blood flow by
reducing pressure within the nerves (Schmid et al., 2009). The NM techniques
are useful in restoring the normal physiological function through both the
intraneural and extra neural effect (Brown et al., 2011; Goyal et al., 2016). A
study conducted on normal population showed NM increase pain threshold and
improvement in biceps brachii muscle fatigue (M. K. Kim et al., 2016). Endurance is
reduced by as much as 45% in type 1 DM and is also related to lowered NCV
(Almeida et al., 2008). A
study conducted to check the feasibility
of NM in DM patients concluded it is safe without any adverse effects (Boyd,
Nee, & Smoot, 2017). Although this technique is safe in
DM patients, effects of NM as an intervention on various neuromuscular
properties like nerve function, sensorimotor functions and inflammatory
biomarkers in patients with DPN is a place to research. We, therefore, plan this study to
examine the effects of NM plus strengthening exercises in patients with DPN. In
this study we will screen the patients through MDNS scoring and randomized the
patients into control group, experimental group A and experimental group B. The
control 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. |