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IRCT20231009059664N1 IRCT 2026-10-06 Shahid Beheshti University of Medical Sciences The effect of suboccipital muscles release, using Instrument Assisted Soft Tissue Mobilization technique, in cervicogenic headache subjects The effect of suboccipital muscles release, using Instrument Assisted Soft Tissue Mobilization technique on pain, range of motion of the upper cervical region, function of the deep flexor muscles of the neck, sense of force, balance and neck disability index in cervicogenic headache subjects 2026-10-12 anticipated 20 Recruiting https://irct.ir/trial/73444 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Following confirmation of the patient's eligibility (based on the inclusion criteria) and obtaining informed consent, baseline assessments including age and BMI will be performed to determine the relevant stratum. The block randomization list (with blocks of 4, comprising six possible sequences: AABB, ABAB, ABBA, BBAA, BABA, BAAB) will be generated in advance, separately for each stratum, by an independent individual who has no role in the visits, treatment, or assessment of patients. (A represents the first group and B represents the second group.) The result of this pre-determined allocation is placed in opaque, sealed envelopes, numbered sequentially in order of enrollment. When each eligible patient enters the study, the enrolling researcher (who has no knowledge of the content of the randomization list) opens the next envelope corresponding to that patient's stratum, in order, and the patient is assigned to the IASTM or Sham IASTM group according to the code inside the envelope. In this way, patients enter the randomization list sequentially, with no possibility of predicting the assigned group before the envelope is opened, and the process of sequence generation (by the independent individual) is kept completely separate from the process of allocation implementation (by the enrolling researcher), Blinding description: All study measurements are performed by a blind examiner who is unaware of the conditions of the subjects, during the study, patients will remain unaware of which specific intervention (real or sham) they are receiving. N/A Cervicogenic headache. Intervention 1: Intervention group: Release of suboccipital muscles,using Instrument Assisted Soft Tissue Mobilization technique and routine physiotherapy.in this group, in addition to routine physical therapy, steel tools are used to mobilize soft tissue and release of suboccipital muscles.The instrument is placed on the muscle at an angle of 45 degrees and small strokes are performed for 30 seconds to one minute by the beveled edge by applying pressure along the entire length of the suboccipital muscles.routine physical therapy includes TENS and exercise therapy. The intervention is carried out for 4 weeks and 2 sessions per week. Intervention 2: Control group: Sham Instrument Assisted Soft Tissue Mobilization technique of suboccipital muscles and routine physiotherapy.In this group, in addition to routine physiotherapy, steel tools are used as a sham.Small strokes are performed on the entire length of the suboccipital muscles superficially, without applying pressure , for 30 seconds to one minute by the beveled edge.routine physical therapy includes TENS and exercise therapy. The intervention is carried out for 4 weeks and 2 sessions per week. 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 There is no further information
public shideh badeleh
No 148,zanbagh block ,behineh 3 condominium,Paknezhad Blvd,Sa'adat abad
Tehran Iran (Islamic Republic of) 1981877388 +98 21 2214 4882 badeleh.sh@gmail.com Shahid Beheshti University of Medical Sciences scientific shideh badeleh
No 148,zanbagh block ,behineh 3 condominium,Paknezhad Blvd,Sa'adat abad
Tehran Iran (Islamic Republic of) 1981877388 00 21 2214 4882 badeleh.sh@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Having diagnostic criteria approved by a neurologist Headache severity in VAS ≥ 3 Neck Disability Index score ≥ 10 Exacerbation of headache by external pressure on the suboccipital muscles 18 years 65 years Both Physiotherapy treatment for headache in the last 6 months History of neck and shoulder surgery History of diagnosis of primary headaches Taking drugs that cause dizziness and balance disorder Vision, vestibular and orthopedic problems affecting balance Cognitive and memory problems Contraindications for using the muscle release tool G44.8 Other specified headache syndromes Rehabilitation Rehabilitation Intervention group: Release of suboccipital muscles,using Instrument Assisted Soft Tissue Mobilization technique and routine physiotherapy.in this group, in addition to routine physical therapy, steel tools are used to mobilize soft tissue and release of suboccipital muscles.The instrument is placed on the muscle at an angle of 45 degrees and small strokes are performed for 30 seconds to one minute by the beveled edge by applying pressure along the entire length of the suboccipital muscles.routine physical therapy includes TENS and exercise therapy. The intervention is carried out for 4 weeks and 2 sessions per week Control group: Sham Instrument Assisted Soft Tissue Mobilization technique of suboccipital muscles and routine physiotherapy.In this group, in addition to routine physiotherapy, steel tools are used as a sham.Small strokes are performed on the entire length of the suboccipital muscles superficially, without applying pressure , for 30 seconds to one minute by the beveled edge.routine physical therapy includes TENS and exercise therapy. The intervention is carried out for 4 weeks and 2 sessions per week Intensity of pain. Timepoint: before the start of the intervention and immediately after 4 weeks of the intervention. Method of measurement: Visual Analogue Scale. Neck disability index. Timepoint: before the start of the intervention and immediately after 4 weeks of the intervention. Method of measurement: Neck disability index questionnaire. Headache frequency. Timepoint: before the start of the intervention and immediately after 4 weeks of the intervention. Method of measurement: by questionnaire. Headache duration. Timepoint: before the start of the intervention and immediately after 4 weeks of the intervention. Method of measurement: by questionnaire. Range of motion of the upper cervical region. Timepoint: before the start of the intervention and immediately after 4 weeks of the intervention. Method of measurement: IMU sensor. Function of the deep flexor muscles of the neck. Timepoint: before the start of the intervention and immediately after 4 weeks of the intervention. Method of measurement: Dynamometer and pressure biofeedback. Balance. Timepoint: before the start of the intervention and immediately after 4 weeks of the intervention. Method of measurement: forceplate. Sense of force. Timepoint: before the start of the intervention and immediately after 4 weeks of the intervention. Method of measurement: Dynamometer. Shahid Beheshti University of Medical Sciences Approved 2023-09-12 Ethics Committee of Shahid Beheshti University of Medical Sciences 6th floor,Shahid Beheshti University of Medical Sciences and Healthcare Services, Arabi Street,Shahid Chamran Highway,Tehran Tehran Tehran Iran (Islamic Republic of)