| CTRI Number |
CTRI/2023/01/049324 [Registered on: 31/01/2023] Trial Registered Prospectively |
| Last Modified On: |
31/01/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Therapeutic taping in patients with diabetic peripheral neuropathy |
|
Scientific Title of Study
|
Effectiveness of Neuromuscular Taping on Balance, Proprioception, Pain and
Nerve Conduction parameters in patients 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 |
Prof Dr Manu Goyal |
| Designation |
Principal and Professor |
| Affiliation |
MAHARISHI MARKANDESHWAR INSTITUTE OF PHYSIOTHERAPY AND REHABILITATION, MM (DU) |
| Address |
MAHARISHI MARKANDESHWAR INSTITUTE OF PHYSIOTHERAPY AND REHABILITATION, MAHARISHI MARKANDESHWAR (DEEMED TO BE) UNIVERSITY, MULLANA- AMBALA, HARYANA
Ambala
HARYANA
133207
India |
| Phone |
|
| Fax |
|
| Email |
manugoyal1111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Manu Goyal |
| Designation |
Principal and Professor |
| Affiliation |
MAHARISHI MARKANDESHWAR INSTITUTE OF PHYSIOTHERAPY AND REHABILITATION, MM (DU) |
| Address |
MAHARISHI MARKANDESHWAR INSTITUTE OF PHYSIOTHERAPY AND REHABILITATION, MAHARISHI MARKANDESHWAR (DEEMED TO BE) UNIVERSITY, MULLANA- AMBALA, HARYANA
Ambala
HARYANA
133207
India |
| Phone |
|
| Fax |
|
| Email |
manugoyal1111@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Manu Goyal |
| Designation |
Principal and Professor |
| Affiliation |
MAHARISHI MARKANDESHWAR INSTITUTE OF PHYSIOTHERAPY AND REHABILITATION, MM (DU) |
| Address |
MAHARISHI MARKANDESHWAR INSTITUTE OF PHYSIOTHERAPY AND REHABILITATION, MAHARISHI MARKANDESHWAR (DEEMED TO BE) UNIVERSITY, MULLANA- AMBALA, HARYANA
Ambala
HARYANA
133207
India |
| Phone |
|
| Fax |
|
| Email |
manugoyal1111@gmail.com |
|
|
Source of Monetary or Material Support
|
| NEUROLOGICAL PHYSIOTHERAPY OPD, MAHARISHI MARKANDESHWAR INSTITUTE OF PHYSIOTHERAPY AND REHABILITATION, MAHARISHI MARKANDESHWAR (DEEMED TO BE) UNIVERSITY, MULLANA, AMBALA- HARYANA- 133207 |
|
|
Primary Sponsor
|
| Name |
KANIKA |
| Address |
MAHARISHI MARKANDESHWAR INSTITUTE OF PHYSIOTHERAPY AND REHABILITATION, MAHARISHI MARKANDESHWAR (DEEMED TO BE) UNIVERSITY, MULLANA, AMBALA- HARYANA- 133207 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Prof Dr MANU GOYAL |
MAHARISHI MARKANDESHWAR INSTITUTE OF PHYSIOTHERAPY AND REHABILITATION, MAHARISHI MARKANDESHWAR (DEEMED TO BE) UNIVERSITY, MULLANA, AMBALA- HARYANA- 133207 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| kanika |
Neurological OPD, Department of Physiotherapy |
MAHARISHI MARKANDESHWAR (DEEMED TO BE UNIVERSITY) MULLANA, AMBALA- HARYANA- 133207
Ambala
HARYANA |
8826903418
kanika.k160@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Maharishi Markandeshwar Institute of Medical Sciences and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
Control group will receive sham Neuromuscular Taping (Sham NMT) and TENS with same parameters as experimental group but sham taping will be done without any tension in tape. |
| Intervention |
EXPERIMENTAL GROUP |
Experimental group will receive Neuromuscular Taping (NMT) and
Transcutaneous Electrical Nerve Stimulation (TENS). given 3 times a week for 8 weeks (24 sessions).NMT will be done at first day and will
be replaced at 3rd day of every week. NMT will be done at tibialis posterior,
tibialis anterior, peroneus longus muscles and medial arch of foot. TENS will be applied at distribution of tibial nerve and peroneal nerve.
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Referred cases of Type 1 & Type 2 diabetes mellitus induced diabetic
peripheral neuropathy of lower limbs diagnosed by physician and score more than 2/13 on MNSI physical appearance section and scored greater than 1/10 on physical examination of Michigan neuropathy screening instrument (MNSI)
2. Diabetes duration: ≥5 years
3. Age between 40 to 70 years
4.Chronic symmetric sensorimotor involvement of bilateral lower limb
after excluding all other causes of peripheral neuropathies
5. Leeds Assessment of Neuropathic Symptoms Scale (LANSS) score > 12
6.Berg Balance Scale (BBS)<45
7. HbA1C report ≥6% not older than 3 months
8. Willing to participate
9. BMI <30kg/m2 (According to Asian criterion) |
|
| ExclusionCriteria |
| Details |
1. Allergic to tape
2. Any other diagnosed neuromuscular disease
3. Vestibular system dysfunction in the last one year (complaint of dizziness, vertigo, nausea and loss of balance)
4.Diabetic foot ulcers, neuropathic joint, charcot joint
5. . History of any recent injury (soft tissue and bony) in lower limb six months prior to participation in study
6. Patients with rheumatoid arthritis
7. Patients with varicose veins
8. Any other cause of balance and gait disturbance
9. Deformities of lower limb
10. Patients with leg length discrepancy
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Berg Balance Scale (BBS)
2. Pedalo®-Sensamove Balance Test Pro with Miniboard
3. Leeds Assessment of Neuropathic Symptoms and Signs(LANSS)Pain Scale
4.Nerve Conduction Velocity (NCV)
5. Michigan Neuropathy Screening Instrument |
1. Berg Balance Scale (BBS)
2. Pedalo®-Sensamove Balance Test Pro with Miniboard
3. Leeds Assessment of Neuropathic Symptoms and Signs(LANSS)Pain Scale
4.Nerve Conduction Velocity (NCV)
5. Michigan Neuropathy Screening Instrument |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
06/02/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
06/02/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
No publication is done till date regarding this trial. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Diabetic Peripheral Neuropathy (DPN) is defined as “the presence of symptoms or signs of peripheral nerve dysfunction in people with diabetes after exclusion of other causes. 60-70% of diabetic population experience mild to severe damage to nervous system which leads to DPN which usually involves distal body parts and is characterised as distal symmetrical sensorimotor neuropathy which is progressive in nature and follows a "glove and stocking pattern". DPN is found to be more associated with Type 1 diabetes mellitus (DM) (90-95%) compared to Type 1 DM. Interaction of metabolic and vascular factors are responsible for peripheral neuropathy. Physiotherapy has been an option for the management of DPN. There is plenty of literature available in treating DPN using various physiotherapeutic approach but there is scarcity of literature stating the effects of Neuromuscular Taping (NMT) for the management of DPN. NMT has emerged as an effective approach to treat musculoskeletal and neurological conditions but this concept has never been explored to treat balance, proprioception, pain and nerve conduction parameters in patients with DPN, thereby, making it the real need of time to explore. |