Effect of Instrument-Assisted Soft Tissue Mobilization on Proprioception and Disability in Patients With Cervicogenic Headache
IASTM
1 other identifier
interventional
80
0 countries
N/A
Brief Summary
This study will be conducted to investigate the effect of instrument assisted soft tissue mobilization technique In pain intensity, frequency of headache, medication Uptake, Suboccipital movement in flexion and extension, rounded shoulder, forward head posture and proprioception of cervical spine in cases of cervicogenic headache related to trigger points and myofascial restrictions when combined with conventional physical therapy modalities.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2022
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2022
CompletedFirst Posted
Study publicly available on registry
September 19, 2022
CompletedStudy Start
First participant enrolled
September 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2023
CompletedSeptember 19, 2022
September 1, 2022
6 months
September 14, 2022
September 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
joint position error
The Cervical Joint Position Error (JPE) Test is a measurement tool used to clinically assess an individual's cervicocephalic proprioception ability. Cervicocephalic proprioception describes one's sense of position of their head and neck in space. The Cervical JPE Test measures the ability of a blindfolded patient to accurately relocate their head position back to a predetermined neutral point after cervical joint movement. The test is most commonly performed with head movement in the transverse and sagittal planes by cervical range of motion device (CROM).
up to eight weeks
Secondary Outcomes (9)
disability
up to eight weeks
headache frequency
up to eight weeks
headache duration
up to eight weeks
medication intake
up to eight weeks
pain intensity
up to eight weeks
- +4 more secondary outcomes
Study Arms (2)
instrumented assisted soft tissue mobilization
EXPERIMENTALpatients will receive IASTM three times a week for eight weeks
traditional therapy
ACTIVE COMPARATORpatients will receive traditional therapy three times a week for eight weeks
Interventions
the appropriate Graston technique instrument will be selected to scan, and then treat the affected area for 30 to 60 seconds per treated area. The procedure will be applied to the superficial cervical fascia and invested the layers of deep cervical fascia that surround all the structures in the neck. Strokes will be applied on the sternocleidomastoids and upper fibers of trapezius muscles. The IASTM technique was applied at a 45° angle in a direction parallel to the treated muscle fibers for 20 seconds, following immediately by an additional 20-seconds application at a 45° angle in a perpendicular direction to the muscle fibers, resulting in a total treatment time of approximately 40 seconds.
The exercise program will be in the form of stretching exercises for the sternocleidomastoids (SCM), the scalenes, and upper fibers of trapezius; strengthening isometric exercises for the neck flexors, extensors, lateral flexors, and neck rotators; and postural correction and scapular stabilization exercises
Eligibility Criteria
You may qualify if:
- to 50 years old
- unilaterality of the head pain
- pain triggered by external pressure over the upper cervical joints (C1-C3)
- pain elicited by the neck movements, and/or sustained awkward positions, reduced neck ROM
- headache intensity pain score of at least 20mm on the Visual Analogue Scale,
- headache frequency of at least once a week for at least 3 months
- minimum neck disability index score of 10 points or greater.
You may not qualify if:
- migraine
- tension-type headache
- tumor
- osteoporosis
- fracture
- rheumatoid arthritis and metabolic diseases
- prolonged history of steroid use
- resting blood pressure greater than 140/90 mmHg
- cervical spinal stenosis
- diminished sensation
- central nervous system involvement
- previous head or neck surgery
- whiplash injury history within the last 6 weeks
- head or neck pain treatment within the last month from any practitioner and PT approach for head or neck pain within the last 3 months
- open wounds and psychiatric/cognitive disorders
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- opaque sealed envelop
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principle investigator
Study Record Dates
First Submitted
September 14, 2022
First Posted
September 19, 2022
Study Start
September 30, 2022
Primary Completion
March 30, 2023
Study Completion
March 30, 2023
Last Updated
September 19, 2022
Record last verified: 2022-09