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IRCT20240315061292N1 IRCT 2024-05-05 Tehran University of Medical Sciences Evaluation the effect of exercise therapy and perineural electrical dry needling on the severity, frequency and disability of patients with cervicogenic headache: a randomized clinical trial. Evaluation the effect of exercise therapy and perineural electrical dry needling on the severity, frequency and disability of patients with cervicogenic headache: a randomized clinical trial. 2024-06-21 anticipated 26 Complete https://irct.ir/trial/76184 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: After meeting the inclusion criteria for entering the study, the patients will be randomly placed in one of two groups A or B using the block randomization method using a sealed envelope. Consecutive but equal times, they enter the intervention and control group, Blinding description: In this study, the patients in both the control and intervention groups are not aware of the type of intervention that will be performed for them, and all study steps for these two groups are conducted in separate sessions. Also, the evaluator is not aware of the intervention on the two groups. N/A Cervicogenic headache. Intervention 1: Intervention group: The intended intervention consists of 8 sessions of 20-30 minutes of dry needling with perineural electrical stimulation with a frequency of 50 Hz and home exercises during 6 weeks. These exercises in both groups include neck and periscapular exercises. The exercises are performed 5 days a week, 3 times a day and at home. The patients are instructed to stop the exercises and inform the researcher if the symptoms worsen and the pain worsens more than 3.10 NPRS. In addition to the exercises, the intervention group is treated with dry needling with perineural electrical stimulation. Acupuncture is performed on the trigger points that are performed by the doctor during the initial examination. These points can be located in the occipital, paraspinal, periscapular and trapezius muscle areas. Acupuncture sessions are done 2 days a week with an at least one day between two sessions. After each session, the patient is asked about the regular exercise, and if necessary, retraining and correction of movements is done. All patients are trained about sports exercises in person, and in order to prevent forgetting and perform them correctly, exercises are presented to patients in the form of a logbook with pictures and explanations. Intervention 2: Control group: In the control group, exercises are prescribed. These exercises are performed at least 5 days a week, 3 times a day and at home. Patients in the control group are regularly followed up by phone once every two weeks, in order to motivate and check the performance of exercises. Explanations and pictures related to sports exercises are attached in the form of a training logbook. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals. When: The access period starts 3 months after the results are published. To whom: The data will be available to researchers working in academic and scientific institutions or people who are also engaged in industry and can apply to receive them. Conditions: The use of data for other scientific researches is permitted by mentioning the source. Where to obtain: m.m.z.of7sky@gmail.com How to obtain: At first, the researcher sends an e-mail stating the request to the mentioned e-mail address, and then after a maximum of 1 month, the investigation is done and the documents are sent to the e-mail address of the researcher. Comments:
public Marzieh Mahmoudi Zarandi
Sports Medicine Department, Sina Hospital, Hassan Abad Square, Imam Khomeini Street
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6634 8500 m-mahmoudiz@razi.tums.ac.ir Tehran University of Medical Sciences scientific Maryam Abolhasani
Sports Medicine Department, Sina Hospital, Hassan Abad Square, Imam Khomeini Street
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6634 8500 dr_m_abolhasani@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) The presence of laboratory, clinical and/or imaging evidence of a neck disorder, known to be able to cause headache. A headache that has at least 2 of the following 4 criteria: A) Headache in the temporal region that is related to the presence of neck disorders. B) Headache that improves in parallel with the improvement of the neck disorder. C) Cervical range of motion Is reduced and headache made worse by provocative manoeuvres. D) Headache is abolished following cervical diagnostic anaesthetic blockade. There is no other diagnosis for headache. Definitive diagnosis of cervicogenic headache by a neurologist based on HIS criteria. Absence of orthopedic disorders and diseases such as cervical discopathy that prevent exercises. The patient has not participated in a regular exercise program or physical therapy during the last 4 weeks. The patient has not been treated with corticosteroids (injection or oral) in the last 2 weeks. no limit no limit Both The patient suffers an injury or any disorder during the study that prevents him or her from performing and continuing exercises and acupuncture. The patient is unable to complete acupuncture sessions. The patient's unwillingness to complete the exercise program and acupuncture sessions. Follow-up through the logbook has missed 30% of the exercises. A history of bleeding disorders or the use of anticoagulant drugs Suffering from psychiatric disorders G44.8 Headache associated with sexual activity Treatment - Other Treatment - Other Intervention group: The intended intervention consists of 8 sessions of 20-30 minutes of dry needling with perineural electrical stimulation with a frequency of 50 Hz and home exercises during 6 weeks. These exercises in both groups include neck and periscapular exercises. The exercises are performed 5 days a week, 3 times a day and at home. The patients are instructed to stop the exercises and inform the researcher if the symptoms worsen and the pain worsens more than 3.10 NPRS. In addition to the exercises, the intervention group is treated with dry needling with perineural electrical stimulation. Acupuncture is performed on the trigger points that are performed by the doctor during the initial examination. These points can be located in the occipital, paraspinal, periscapular and trapezius muscle areas. Acupuncture sessions are done 2 days a week with an at least one day between two sessions. After each session, the patient is asked about the regular exercise, and if necessary, retraining and correction of movements is done. All patients are trained about sports exercises in person, and in order to prevent forgetting and perform them correctly, exercises are presented to patients in the form of a logbook with pictures and explanations. Control group: In the control group, exercises are prescribed. These exercises are performed at least 5 days a week, 3 times a day and at home. Patients in the control group are regularly followed up by phone once every two weeks, in order to motivate and check the performance of exercises. Explanations and pictures related to sports exercises are attached in the form of a training logbook. Pain intensity based on the Numerical Pain Rating Scale (NPRS). Timepoint: At the beginning of the study and after 6 weeks. Method of measurement: The Numerical Pain Rating Scale (NPRS). Patient's disability. Timepoint: At the beginning of the study and after 6 weeks. Method of measurement: The Neck Disability Index (NDI). Pain intensity. Timepoint: At the beginning of the study and after 6 weeks. Method of measurement: Headache Impact Test (HIT-6): This test consists of 6 questions and shows the impact of headache on the patient's life. For each question, a score between 6 and 13 is considered. The Global Rating of Change Score (GROC). Timepoint: At the beginning of the study and after 6 weeks. Method of measurement: This questionnaire measures the overall changes in recovery and can include values from negative 7 to positive 7. Tehran University of Medical Sciences Approved 2023-05-06 Research Ethics Committee of Sina Hospital - Tehran University of Medical Sciences Sports Medicine Department, Sina Hospital, Hassan Abad Square, Imam Khomeini Street Tehran Tehran Iran (Islamic Republic of)