Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202101475345034 Date of Registration: 28/01/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Efficacy of Electrical Stimulation versus Dry Needling on Spasticity in Stroke Patient
Official scientific title The Neurophysiological Effect of Electrical Stimulation versus Dry Needling on Post-Stroke Spasticity
Brief summary describing the background and objectives of the trial Stroke is the damage of brain cells due to abruption of blood supply to the brain. According to World Health Organization (WHO), 70% of strokes and 87% of both stroke-related deaths and disability-adjusted life occur in low and middle-income countries. This disability is mainly due to the development of spasticity. Indeed, lower limb spasticity limits normal standing, walking and interferes with many of activities of daily living leading to high level of dependency and disability. Spasticity can be treated with pharmacological or non-pharmacological interventions. Pharmacological interventions such as: Intramuscular botulinum injections, baclofen, etc. are considered very expensive therapies and these interventions may induce systematic effects and unwanted side effects such as: weakness, fatigability, etc. In addition Spastic muscle may not respond to the pharmacological therapies because of the biomechanical changes in it. the facts that, he cost of treating stroke survivor with spasticity increased four-fold than treating stroke survivor without spasticity and the lack of high-quality physical rehabilitation studies in low and middle- income countries led to the need of global response and more researches in the area of controlling neurological and biomechanical aspects of spasticity with an effective and lower cost therapy. So we aimed to study and compare the effects and combination of TENS and dry needling, two modalities that are intensively practiced in physical therapy and they can have both biomechanical and neurological mechanisms on spasticity. The objectives of this study will be: 1- To determine the immediate neurophysiological effect of dry needling on post-stroke spasticity. 2-To determine the immediate neurophysiological effect of electrical stimulation via dry needles on post-stroke spasticity. 3- To compare the immediate effect of electrical stimulation via dry needles, TENS and dry needling alone over agonist muscle on post stroke spasticity
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 18/01/2021
Actual trial start date
Anticipated date of last follow up 29/01/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group electrical stimulation via dry needlies Single session trial 30 minutes The patients will lay prone and a single-use sterile dry needles of 0.30 mm diameter and 40 mm length will be used. Two needles will be inserted in the lateral trigger points of soleus muscle and directed toward the fibula after disinfection of the skin with 90% alcohol. When first local twitch response will be obtained, the alligator clips of the TENS device will be attached to the handle of the needles and an electrical stimulation will be applied with frequency of 100 Hz, pulse width of 250 μs and the intensity will be increased to the patient’s two to three times sensory threshold for 30 minutes. 30
Experimental Group Dry Needling single session trial 25-30 seconds on each point or until no more twitch response will be elicited in each point . Two single-use sterile dry needles of 0.30 mm diameter and 40 mm length will be inserted into the lateral taught bands of spastic soleus muscle after disinfection of the skin with 90% alcohol. Once the trigger points were located fast in and fast out technique with rotation will be applied. When first local twitch response will be elicited, the needle will be moved up and down at approximately 1 Hz for 1 minute. Precaution must be taken, however no nerve or major artery passed in this area. 30
Control Group Transcutaneous Electrical Nerve Stimulation single session trial 30 min. TENS unite will be used with frequency of 100 Hz, pulse width of 250 μs and the intensity increased to the patient’s sensory threshold for 30 minutes while the patient in prone position. A pair of 5x5 cm. Electrodes will be placed over the lateral side of back of leg after disinfection of the skin with 90% alcohol. If accommodation occurs, the intensity will be adjusted as needed. 30 Active-Treatment of Control Group
Experimental Group electrical stimulation via needle electrodes single session trial 30 minutes Two needle electrodes (0.30 mm diameter and 40 mm length) will be inserted into the tibialis anterior muscle (L5 dermatome) and directed slightly medially toward the tibia after disinfection of the skin with 90% alcohol. The stimulation parameters will be as follow: frequency of 100 Hz, pulse width of 250 μs and the intensity increased to the patient’s sensory threshold for 30 minutes while the patient in supine position. If accommodation occurs, the intensity will be adjusted as needed. 30
Experimental Group Transcutaneous Electrical Nerve Stimulation over Tibialis Anterior single session trial 30 minutes TENS unite will be used with frequency of 100 Hz, pulse width of 250 μs and the intensity will be increased to the patient’s sensory threshold for 30 minutes while the patient in supine position. A pair of 5x5 Electrodes will be placed over L5 dermatome after disinfection of the skin with 90% alcohol. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Hemiplegia due to stroke 30 days after stroke onset willing to participate in this study Baseline MAS ≥1. any patient with spasticity due to other neurological disease as SCI or MS Any contraindication of dry needling like needle phobia or pregnancy any contraindication of electrical stimulation like metallic implants; treatment with botulinum toxin and nerve blocks in the past 6 months Baseline MAS =0 the presence of any musculoskeletal injury in the ankle. 80 and over: 80+ Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 60 Year(s) 85 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 09/09/2020 Faculty of physical therapy cairo university
Ethics Committee Address
Street address City Postal code Country
El-Tahrir st. - in front of Ben El- Sarayat Traffic - , Giza District, 11432, Egypt Dokki - Giza 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Electromyography (EMG) test at the beginning of the study and at the end of the study
Secondary Outcome Modified Ashworth Scale MAS at the beginning of the study and at the end of the study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Multirehablitation centers in Beirut Tariq Al Jadidah Beirut Lebanon
FUNDING SOURCES
Name of source Street address City Postal code Country
Ranim Al Amin Hareit Hreik - Abdelnour steet- Al-Moutassem Building - 4th Floor Beirut Lebanon
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ahmad Ali Aysha Bakkar -Knio street- Bakdash building- second floor Beirut Lebanon Individual
COLLABORATORS
Name Street address City Postal code Country
Ibtissam Saab Al-Mazraa, Cola Square, Shams BeirutBuilding,Bloc B, 12thfloor. Beirut Lebanon
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rami Abbas r.abbas@bau.edu.lb +9613942067 Cola Roundabout, Shams Beirut Building, Bloc B, 12th Floor
City Postal code Country Position/Affiliation
Beirut Lebanon Associate professor of physical therapy at Beirut Arab University
Role Name Email Phone Street address
Public Enquiries Ahmad Ali dr.shawky_2011@hotmail.com +96170627568 Aysha Bakkar -Knio street- Bakdash building- second floor
City Postal code Country Position/Affiliation
Beirut Lebanon Assistant professor of physical therapy at faculty of health sciences BAU
Role Name Email Phone Street address
Scientific Enquiries Ranim Al Amin ranim.alamin33@hotmail.com +96178826808 Hareit Hreik - Abdelnour steet- Al-Moutassem Building - 4th Floor
City Postal code Country Position/Affiliation
Beirut Lebanon Physical therapy student at Beirut Arab University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results of the study after de identification as texts and tables Statistical Analysis Plan One year after publication Controlled access through authors mail
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information