- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07373912
Impact of Adding Instrument-assisted Soft Tissue Mobilization to Mulligan Therapy in Patients With Cervicogenic Headache (CGH)
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: doaa youssef, master
- Phone Number: 01113279369
- Email: Doaa10997youssef@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
-Unilateral CGH presentation
- Age group above 18 years' old
- History of chronic CGH (>3 months)
- CGH owing to cervical spine (neck) dysfunction
- Reduced cervical motion
- Neck stiffness and movement restriction
Exclusion Criteria:
- Participants with other types of headache (migraine headache)
- Headache owing to other causes (sinus, tumor, neural, and tempero-mandibular joint issues)
- Any contraindications to manual and manipulative therapy (fracture, instability, osteoporosis and neural symptoms)
- Taking analgesics or corticosteroids and migraine-specific medications, such as triptans
- Metastasis
- Cardiac conditions (stroke and syncope)
- Neurological conditions (radiculopathy, myelopathy)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: instrumeted assissted soft tissue mobilization and mulligan therapy
twenty patients will receive IASTM, mulligan therapy and postural correction exercises three times per week for 6 weeks.
|
the patients will receive IASTM tools over the length of targeted muscles (descending fiber of trapezius, suboccipitalis muscles ) for 5 minutes.
also, SNAG technique; Each patient will be asked to sit comfortably, and the treating therapist will stand beside the patient.
The patient's head will be free and cradled between the therapist's right forearm and body, and the therapist stand at the patient's right side.
The therapist then will place his right index, middle, and ring fingers at the base of the occiput and kept his right little finger over the spinous process of C2.
Next, with the lateral border of his left thenar eminence, gentle pressure will be applied in a ventral and upward direction(45 degrees) over the right little finger.
finally postural correction execises
SNAG technique; Each patient will be asked to sit comfortably, and the treating therapist will stand beside the patient.
The patient's head will be free and cradled between the therapist's right forearm and body, and the therapist stand at the patient's right side.
The therapist then will place his right index, middle, and ring fingers at the base of the occiput and kept his right little finger over the spinous process of C2.
Next, with the lateral border of his left thenar eminence, gentle pressure will be applied in a ventral and upward direction(45 degrees) over the right little finger.
Finally, postural correction exercises will be addedd
the exercises will incluse, Stretching exercises for the sternocleidomastoids,the Scalenes,upper fibers of trapezius and strengthening exercises for cervical muscles
|
|
Experimental: mulligan therapy
Twenty patients will receive Mulligan therapy and postural correction exercises three times per week for 6 weeks.
|
SNAG technique; Each patient will be asked to sit comfortably, and the treating therapist will stand beside the patient.
The patient's head will be free and cradled between the therapist's right forearm and body, and the therapist stand at the patient's right side.
The therapist then will place his right index, middle, and ring fingers at the base of the occiput and kept his right little finger over the spinous process of C2.
Next, with the lateral border of his left thenar eminence, gentle pressure will be applied in a ventral and upward direction(45 degrees) over the right little finger.
Finally, postural correction exercises will be addedd
the exercises will incluse, Stretching exercises for the sternocleidomastoids,the Scalenes,upper fibers of trapezius and strengthening exercises for cervical muscles
|
|
Active Comparator: postural correction exercises
Twenty patients will receive postural correction exercises three times per week for 6 weeks.
|
the exercises will incluse, Stretching exercises for the sternocleidomastoids,the Scalenes,upper fibers of trapezius and strengthening exercises for cervical muscles
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
neck disability
Time Frame: up to 6 weeks
|
Assessment of neck function was performed by Arabic neck disability index.
It is a valid and reliable tool in the assessment of neck function.
It contains ten category/classes.
Each category contains six choices (zero-five).Score from zero to four no disability, from five to 15 this is mild, From 15 to 24 this is moderate, from 25 to 34 this is severe, more than 34 this is a complete disability
|
up to 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pain intensity
Time Frame: up to 6 weeks
|
The scale will be used is the VAS, which consists of a line, usually 10 cm long, ranging from no pain or discomfort (zero) , to the worst pain that could possibly feel (10)
|
up to 6 weeks
|
|
cervical range of motion
Time Frame: up to six weeks
|
The CROM device will be used to assess cervical range of motion.
it is headmounted equipment consists of a plastic frame placed on the head over the nose and the ears, secured by a Velcro strap.
Two independent inclinometers, 1 in the sagittal plane and 1 in the frontal plane, are attached to the frame and indicate the position of the head with respect to the line of gravity.
A third inclinometer is positioned in the horizontal plane and indicates the position of the head in rotation, with respect to a reference position
|
up to six weeks
|
|
muscle stiffness
Time Frame: up to six weeks
|
The MyotonPRO (Myoton AS, Tallinn, Estonia) is a recently introduced device that can objectively measure the mechanical properties of muscles including analyzing muccsle stiffness (N/m). The measurement procedure involved pressing the device against the skin, with a force of 0.18 N and instantly applying an impulse of 0.4 N for duration of 15 ms. The skin surface oscillation induced by the\ MyotonPRO was measured |
up to six weeks
|
|
headache frequency
Time Frame: up to six weeks
|
the number of days the subjects experienced headaches (frequency)
|
up to six weeks
|
|
headache duration
Time Frame: up to six weeks
|
the total number of hours they experienced headaches (duration)
|
up to six weeks
|
|
medication intake
Time Frame: up to 6 weeks
|
The frequency with which they used painkillers (medication intake) for their headaches were also noted
|
up to 6 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/006193
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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