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IRCT20180721040539N1 IRCT 2018-09-24 Babol University of Medical Sciences The effect of dry needling in cervicogenic headache- A randomized controlled clinical trial Comparison of effect of dry needling, physiotherapy, and sham dry needling in cervicogenic headache- A randomized controlled clinical trial 2018-07-23 anticipated 60 Complete https://irct.ir/trial/32790 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: At first, a physiotherapist with ten years of experience perform patient’s physical examination. If they meet the conditions for entry into the study, and don’t have exclusion criteria, a randomization into three groups (control and DN group, sham DN group) was performed by packed envelopes via blind independent researcher to aim of allocation concealment, Blinding description: In sham dry needling group, the patient will not be aware of the fact that he/she does not receive the actual dry needling. The assessor and therapist will two different individuals and assessor blind to intervention. Also , statistical analysis will be done by a person who is blind to grouping. N/A cervicogenic headache patients. Intervention 1: Intervention group 1: Routine physiotherapy and dry needle. Intervention 2: Intervention group2: Routine physiotherapy and placebo needle. Intervention 3: Intervention group 3: Routine physiotherapy. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is We have not yet decided on this.
public Khodabakhsh Javanshir
University of Medical Sciences , Ganjafrooz Street , Babol , Mazandaran ,Iran
Babol Iran (Islamic Republic of) 47176-47745 +98 32194641 kjavanshir@yahoo.com Babol University of Medical Sciences scientific Roghayeh Mousavi-khatir
School of Rehabilitation,University of Medical Sciences , Ganjafrooz Street , Babol , Mazandaran ,Iran
Babol Iran (Islamic Republic of) 47176-47745 +98 11 3219 4641 r-mousavi@mubabol.ac.ir Babol University of Medical Sciences Iran (Islamic Republic of) Unilateral pain Starting in the neck and radiating to the frontotemporal region Pain aggravated by neck movement Restricted cervical range of motion Joint tenderness in at least one of the joints of the upper cervical spine (C1-C3) Headache frequency of at least 1 per week over a period greater than 3 months Active trigger point in the suboccipital and upper trapezius and sternoclidomastoid muscles 19 years 60 years Both Cervical radiculopathy A history of spinal or shoulder trauma or spinal surgery History of physical therapy intervention in the neck and shoulder region within the previous 6 months Diagnosed primary headache Needle phobia G44.0 Other headache syndromes Rehabilitation Rehabilitation Rehabilitation Intervention group 1: Routine physiotherapy and dry needle Intervention group2: Routine physiotherapy and placebo needle Intervention group 3: Routine physiotherapy Intensity of the headache. Timepoint: Before treatment, immediately after treatment, one , three and six month later. Method of measurement: questionnaire. Headache frequency. Timepoint: Before treatment, immediately after treatment, one , three and six month later. Method of measurement: questionnaire. Neck range of motion. Timepoint: Before treatment, immediately after treatment, one , three and six month later. Method of measurement: Goniometry. Function of deep neck flexor muscles. Timepoint: Before treatment, immediately after treatment, one , three and six month later. Method of measurement: pressure biofeedback. Pressure pain threshold and tenderness at the trigger point of the muscles. Timepoint: Before treatment, immediately after treatment, one , three and six month later. Method of measurement: Algometer. Neck proprioception. Timepoint: Before treatment, immediately after treatment, one , three and six month later. Method of measurement: laser pointer and software. Quality of life. Timepoint: Before treatment, Immediately after treatment, One month later, Three months and Six month later. Method of measurement: Quality of life questionnaire. Functional rating index. Timepoint: Before treatment, Immediately after treatment, One month later, Three months and Six month later. Method of measurement: Functional rating index-questionnaire. Babol University of Medical Sciences Approved 2018-06-10 Ethics Committee of Babol University of Medical Sciences University of Medical Sciences , Ganjafrooz Street , Babol , Mazandaran ,Iran Babol Mazandaran Iran (Islamic Republic of)