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.: PACTR202402720946459 Date of Approval: 02/02/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Adding Scapulothoracic Stabilization Exercises to Dorsal Scapular Nerve Blockade in Patients with Nerve Entrapment Syndrome.
Official scientific title Effect of Adding Scapulothoracic Stabilization Exercises to Dorsal Scapular Nerve Blockade in Patients with Nerve Entrapment Syndrome: A single-blinded randomized controlled trial
Brief summary describing the background and objectives of the trial BACKGROUND: Entrapment neuropathy of the dorsal scapular nerve (DSN) is known to be one of the common causes of pain in the inter-scapular region. Motor weakness in shoulder abduction and winged scapula have also been described as symptoms of this entrapment. Selective blockades have been conventionally used for diagnosing and treating DSN entrapment neuropathy. Scapulothoracic stabilization exercises are an effective rehabilitation intervention that can reduce symptoms and pain and improve function and disability secondary to dorsal scapular pain syndrome. PURPOSE: The purpose of this study is to evaluate the effectiveness of adding an exercise therapy in the form of scapulothoracic stabilization exercises to blockade injection of dorsal scapular nerve using the anterolateral approach within the middle scalene muscle through the posterior triangle of the neck in people with DSN entrapment syndrome.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 01/05/2023
Actual trial start date 14/05/2023
Anticipated date of last follow up 29/02/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants) 60
Recruitment status Completed
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
Control Group Dorsal Scapular Nerve Blockade Injection One time injection Assessment after four weeks from the day of injection Patients in this group will receive a blockade injection of the dorsal scapular nerve, by the anterolateral approach within the middle scalene muscle through the posterior triangle of the neck. The injection will be composed of Epirelefan (triamcinolone acetonide 40 mg) + 2 ml lidocaine 2% diluted to 10 ml volume with saline. 30 Active-Treatment of Control Group
Experimental Group Additional Scapulothoracic stabilization exercises to the dorsal scapular nerve blockade injection The exercise program will be 3 days a week. Each exercise session should be 40-45 min Four weeks Patients in the experimental group after receiving the nerve blockade injection, will perform an additional Scapulothoracic stabilization exercise program. The exercise program will be 3 days a week for four weeks by an experienced physical therapist. Each exercise session should be 40-45 min, composed of 10-minute warm-up exercises, 25-minute stabilization exercises, and 5-10 minutes cool-down. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- patients ranging in age from 20 to 60 years old. - All patients must have had chronic pain in the interscapular region and/or radiating to the neck or shoulder region, and the pain should be for at least 3 months duration. - The pain intensity should be at least 5/10 on a 10-point Numeric Rating Scale (NRS) (where 0 means no pain and 10 is the worst pain imaginable) and have failed medical treatment. - Patients with motor symptoms secondary to the DSC entrapment, such as winged scapula, weak scapular adductors, and scapula dyskinesis, could be included. - Patients with a history of coagulopathy or other bleeding disorders. - Patients with a history of neuromuscular disorders, and cervical radiculopathy. - Patients having a history of allergy to local anesthetics, and administration of any sedatives. - Patients with a history of trauma, surgery, or structural pathology in the target region. - Patients with preexisting mental illness, psychological or emotional problems, infection at the injection site, or refusal to participate in the trial were excluded. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 60 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 08/10/2023 Research Ethical Committee Faculty of Physical Therapy Cairo University
Ethics Committee Address
Street address City Postal code Country
7 Ahmed El Zayyat St., DOKKI, GIZA Giza 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain, using the Numeric Pain Rating Scale. Before intervention and after the intervention period which will be four weeks.
Primary Outcome The Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire. It is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. It is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5-point Likert scale. Before and after intervention period which will be 4 weeks.
Secondary Outcome Motor Distal Latency for the involved Dorsal Scapular Nerve. Before and after the intervention period which will be four weeks
Secondary Outcome The Fatigue Assessment Scale. It is a 10-item scale evaluating symptoms of chronic fatigue. Before and after the intervention period which will be for four weeks.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Medicine and Clinical Neurophysiology Department in Assiut university Hospitals Assiut university Hospitals Assiut Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Self Funded Assuit university Hospitals, Assuit University, Egypt. Assuit Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Bassam El Nassag 177 Gisr El Sweiz St., Heliopolis Cairo 11757 Egypt Individual
Primary Sponsor Shaymaa Salem Regional service road, New Assiut. Assiut Governorate. 71515 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Bassam El Nassag bassamesmail79@gmail.com +97450121527 177 Gisr El Sweiz St., Heliopolis
City Postal code Country Position/Affiliation
Cairo 11757 Egypt Faculty of Physical Therapy Cairo University.
Role Name Email Phone Street address
Public Enquiries Shaymaa Salem Drshymaasalem@yahoo.com +201005228820 Regional service zone, New Assuit
City Postal code Country Position/Affiliation
Assuit 71511 Egypt Sphinx university Egypt
Role Name Email Phone Street address
Scientific Enquiries Bassam El Nassag Bassamesmail79@gmail.com +97450121527 177 Gisr El Sweiz St., Heliopolis
City Postal code Country Position/Affiliation
Cairo 11757 Egypt Faculty of Physical Therapy Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Statistical Analysis Plan,Study Protocol Beginning 9 months and ending 36 months the following article publication. - Access to data shall be permitted to: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. - Data analysis permitted: To achieve aims in the approved proposal. - Mechanism by which data will be available: The proposal should be directed to xxx@yyy. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third-party website (Link to be included).
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