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IRCT20220401054379N1 IRCT 2022-10-13 Iran University of Medical Sciences The effectiveness of neurodynamic techniques in diabetic peripheral neuropathy. The effectiveness of neurodynamic techniques on neuropathy severity, tibial nerve’s conduction parameters, quality of life, straight leg raising range of motion in patients with diabetic peripheral neuropathy. 2022-10-23 anticipated 40 Complete https://irct.ir/trial/62695 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: DPN participants will be randomized to a real NDT group or a sham NDT group with a ratio of 1:1. Block-balanced randomization technique will be used for randomization with 4 character blocks containing letters A and B. Allocation instruction will be written and will be placed in sequentially numbered, opaque, sealed envelopes. The allocation sequence will be conducted by https://www.randomizer.org/. DPN participants will be blinded to allocation schedule until the end of the study. The procedure will be performed by the impartial secretary of the Baghiyatallah physical medicine and rehabilitation clinic who will not be involved with participant assessment, allocation, or treatment. The randomization schedule is known only to the first author (MA) who is the therapist of this study. Participants will receive numbered, opaque, and sealed envelopes. The therapist who is not responsible for outcomes assessment will open these sealed envelopes and realize the participant’s treatment condition. Research team members who are responsible for data collection (SEH) and data analysis (MRP) will not be permitted to be aware of group allocation, Blinding description: This is a double-blinded trial. Participants, outcome assessor, and data analysts are all blinded regarding allocation throughout the duration of the study. Therapist will be asked not to reveal participants’ allocation status during the trial. N/A Diabetic peripheral neuropathy. Intervention 1: 1. Experimental group a) Real tibial nerve’s distal slider technique: This technique will be performed in the side-lying position on the intended side. Enough pillows will support the patient’s head and neck in a comfortable and neutral position and will also assure that the thoracolumbar spine is in neutral alignment. In this position, the therapist will flex the patient’s hip to 80°, and keep the knee in full extension. Therapist will move the ankle into dorsiflexion, eversion combined with toes extension, and ask the patient to extend his or her head and neck simultaneously. b) Real tibial nerve’s proximal slider technique:This technique will be performed in the same position as explained for tibial nerve distal slider technique. In this position, the therapist will move the ankle toward plantarflexion, inversion combined with toes flexion and ask the patient to flex the head and neck simultaneously. These techniques will be performed with 10 repetition in 5 sets. Standard basic treatment: Participants will receive TENS for 20 minutes. On of the electrodes will be placed over the popliteal fossa and the other one will be placed at the medial tarsal tunnel level. On the other hand participants will receive nerve massage for tibial nerve in transverse and longitudinal order at popliteal fossa and medial tarsal tunnel for 4 minutes. Intervention 2: 2. Control group: a) Sham tibial nerve’s distal slider technique: Patient will be asked to be in side-lying position as described for real slider techniques , but the therapist will move the patient’s hip toward abduction, flex the hip to 20°, and keep the knee in extended position. The sequence of sham tibial neurodynamic distal slider technique will be the same as the sequence of real tibial neurodynamic distal slider technique . b) Sham tibial nerve’s proximal slider technique: Participants’ starting position will be as same as the initial position of sham tibial nerve distal slider technique. The sequence of this technique will be the same as real tibial proximal slider technique. These techniques will be performed with 10 repetition in 5 sets. Standard basic treatment: Participants will receive TENS for 20 minutes. On of the electrodes will be placed over the popliteal fossa and the other one will be placed at the medial tarsal tunnel level. On the other hand participants will receive nerve massage for tibial nerve in transverse and longitudinal order at popliteal fossa and medial tarsal tunnel for 4 minutes. Yes - There is a plan to make this available What will be shared: If it is necessary, raw data of the results of the present study will be accessible for applicants. When: 6 months after the publication date of the original article. To whom: Researchers, scientists, and clinicians who are interested in this field. Conditions: The raw data of the results of this study will be appropriate for secondary analysis in review articles, and also, can be utilized by scientists in neurodynamic or diabetic peripheral neuropathy field. Where to obtain: If data access was required, the individual-level dataset would be available by sending a reasonable e-mail to the first corresponding author (MRP) (pourahmadipt@gmail.com). How to obtain: If the request is acceptable, data will be sent by an email in one week. Request email have to sent to the first corresponding author(MRP) (pourahmadipt@gmail.com). Comments:
public Seyed Ebrahim Hashemi
Physical medicine and rehabilitation clinic, second floor, Baqiyatallah al-Azam Hospital
Tehran Iran (Islamic Republic of) 1435915371 +98 21 81261 drhashemi.pmr@gmail.com Bagheiat-allah University of Medical Sciences scientific Mohammadreza Pourahmadi
School of rehabilitation sciences Department of Physical Therapy Iran university of Medical Sciences Madadkaran All., Shahnazari St., Madar Sq., Mirdamad Blvd. Tehran, Islamic Republic of Iran
Tehran Iran (Islamic Republic of) 1545913487 +98 21 2222 7124 pourahmadipt@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) 1. Adults (18-70 years) diagnosed with T2DM by an expert endocrinologist based on their most recent test (within the past 3 months). 2. Patients diagnosed with diabetic peripheral neuropathy based on electrodiagnostic study that was taken by an expert physiatrist. 3. Included patients must have at least 90° hip flexion, full knee extension, and 0° dorsiflexion to 30° plantarflexion 18 years 70 years Both 1. Lasting low back pain, neck pain, and sciatalgia (at least for 3 days) in the last 6 months 2. History of chemotherapy or spinal surgery in the last year 3. History of peripheral nerves' injury or surgery 4. Alcohol or chemical addiction 5. Pregnancy 6. Syphilis, Guillain barre syndrome, rheumatoid arthritis 7. Infection or open wound in the lower limbs 8. Amputation proximal to the metatarsophalangeal joint 9. Complex regional pain syndrome 10. Tarsal tunnel syndrome 11. Severe diabetic peripheral neuropathy (30<MDNS<46) 12. Personal reluctance to paticipate in the present study G63.2 Polyneuropathy in diseases classified elsewhere Rehabilitation Placebo 1. Experimental group a) Real tibial nerve’s distal slider technique: This technique will be performed in the side-lying position on the intended side. Enough pillows will support the patient’s head and neck in a comfortable and neutral position and will also assure that the thoracolumbar spine is in neutral alignment. In this position, the therapist will flex the patient’s hip to 80°, and keep the knee in full extension. Therapist will move the ankle into dorsiflexion, eversion combined with toes extension, and ask the patient to extend his or her head and neck simultaneously. b) Real tibial nerve’s proximal slider technique:This technique will be performed in the same position as explained for tibial nerve distal slider technique. In this position, the therapist will move the ankle toward plantarflexion, inversion combined with toes flexion and ask the patient to flex the head and neck simultaneously. These techniques will be performed with 10 repetition in 5 sets. Standard basic treatment: Participants will receive TENS for 20 minutes. On of the electrodes will be placed over the popliteal fossa and the other one will be placed at the medial tarsal tunnel level. On the other hand participants will receive nerve massage for tibial nerve in transverse and longitudinal order at popliteal fossa and medial tarsal tunnel for 4 minutes. 2. Control group: a) Sham tibial nerve’s distal slider technique: Patient will be asked to be in side-lying position as described for real slider techniques , but the therapist will move the patient’s hip toward abduction, flex the hip to 20°, and keep the knee in extended position. The sequence of sham tibial neurodynamic distal slider technique will be the same as the sequence of real tibial neurodynamic distal slider technique . b) Sham tibial nerve’s proximal slider technique: Participants’ starting position will be as same as the initial position of sham tibial nerve distal slider technique. The sequence of this technique will be the same as real tibial proximal slider technique. These techniques will be performed with 10 repetition in 5 sets. Standard basic treatment: Participants will receive TENS for 20 minutes. On of the electrodes will be placed over the popliteal fossa and the other one will be placed at the medial tarsal tunnel level. On the other hand participants will receive nerve massage for tibial nerve in transverse and longitudinal order at popliteal fossa and medial tarsal tunnel for 4 minutes. The Michigan Diabetic Neuropathy Score(MDNS). Timepoint: MDNS as the primary outcome of the present study will be evaluated before the study and at the last session. Method of measurement: The Michigan Diabetic Neuropathy Score(MDNS). Tibial nerve conduction velocity. Timepoint: Before the study and at the last session. Method of measurement: Nerve condyution study unit (Neuropack®, s1 MEB-9400, Nihon Kohden, Japan). Tibial nerve's distal latency. Timepoint: Before the study and at the last session. Method of measurement: Nerve condyution study unit (Neuropack®, s1 MEB-9400, Nihon Kohden, Japan) . Amplitude of motor nerve action potential. Timepoint: Before the study and at the last session. Method of measurement: Nerve condyution study unit (Neuropack®, s1 MEB-9400, Nihon Kohden, Japan) . Quality of life. Timepoint: Before the study and at the last session. Method of measurement: Persian localized version of Neuro QoL questionnaire. Straight leg raising range of motion. Timepoint: Before the study and at the last session. Method of measurement: Manual goniometer. F-wave latency. Timepoint: Before the study and at the last session. Method of measurement: Nerve condyution study unit (Neuropack®, s1 MEB-9400, Nihon Kohden, Japan) . Iran University of Medical Sciences Approved 2022-07-10 Research Ethics Committees of Iran University of Medical Sciences No. 5, Farhang Street, West Sadooghi, Ashrafiesfahani street. Tehran Tehran Iran (Islamic Republic of)