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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05658627
Other study ID # P.T.REC/012/003916
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 2023
Est. completion date July 2023

Study information

Verified date April 2023
Source Cairo University
Contact Samar A Mohammed, Msc
Phone 01275298428
Email t_nona45@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

It has been suggested that the suboccipital muscles are a causative factor in both cervicogenic neck pain and headache. Hamstrings and sub-occipital muscles are connected by a neural system and sub-occipital muscles pass through the dura Mater. Increased tension and shortening of the hamstring's muscles can cause neck and shoulder pain. In addition, when the muscles around the neck are tensed, the muscles in the limbs are also tensed, so that if the tone of the hamstring muscles is decreased, SLR test score increased, and the tone of the sub-occipital muscles is reduced. Active release technique is found to have an effect on hamstring flexibility.


Description:

Cervicogenic Headache (CGH) is a secondary and often unilateral headache that is known by referring pain from soft or hard cervical structures to occipital, temporal and frontal regions. There are some fascial connections between suboccipital muscles with dura mater and C2 vertebra. Presumably, fascial restriction in one part of the body causes unusual stress in other parts of the body due to fascial continuity. It has demonstrated that increased tension and shortening of the hamstring's muscles can cause neck and shoulder pain. This occurs because the superficial fascial back line of the myofascial chain connects from the neck to the lower extremity, and the soft tissue in the cervical spine links the dura and suboccipital muscle fascia. Therefore, it is probable that if the tone of the hamstring muscles is decreased (passively, with a fascial treatment or with active movements), the tone of the knee flexors (hamstring muscles) is reduced and the amplitude of hip flexion is increased, thereby increasing the straight leg raise (SLR) test score. Active release technique (ART) is a type of manual therapy used for treating soft tissue injuries. Problems with muscles, tendons, ligaments, fascia and nerves are successfully treated with it and is found to have an effect on hamstring flexibility.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date July 2023
Est. primary completion date June 2023
Accepts healthy volunteers No
Gender All
Age group 25 Years to 45 Years
Eligibility Inclusion Criteria: - Unilateral headache (in the same side) related by pain, movement and sustaining position of neck started from the occiput spread to the tempro-frontal region for more than 3 months. - Pain and tenderness at the upper cervical segment's palpation. - Movement restriction in cervical region, especially in the upper cervical rotation. - Positive SLR test for hamstring muscle less than 80?. Exclusion Criteria: - Malignancy. - Other types of headaches, including migraine, tension type, other serious headaches. - History of head and neck trauma or surgery. - Pregnancy. - Physiotherapy for headache in the last 3 months.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
active release technique
Hamstring active release technique-
conventional therapy
ultrasound therapy - stretching Exercise - Strengthening Exercise -

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

References & Publications (1)

Cho SH, Kim SH, Park DJ. The comparison of the immediate effects of application of the suboccipital muscle inhibition and self-myofascial release techniques in the suboccipital region on short hamstring. J Phys Ther Sci. 2015 Jan;27(1):195-7. doi: 10.1589/jpts.27.195. Epub 2015 Jan 9. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Assess the change in pain intensity level The visual analogue scale (VAS) is a widely utilized pain intensity level assessment instrument in rehabilitation.VAS is typically composed of a 100 mm horizontal line attached with two opposed labels, the left end marked "no pain" and the right end "severe intolerable pain".Patients will mark a score on the scale by a vertical line. Before treatment and after 4 weeks treatment
Primary Assess the change in headache severity The headache impact test (HIT-6) : is a tool that subjectively evaluates the frequency of a patient's headache. The lowest score is 36, and the highest score is 78 for six items.Usually, if the score is over 59, it means the patient's daily life is severely affected by the headache. Before treatment and after 4 weeks treatment
Primary Assess the change in pressure pain threshold Pressure algometry will be used to evaluate the (PPT) for suboccipital and hamstring muscles.In the prone position, the physician will apply 1 kg/s of pressure directly to suboccipital and hamstring muscles, the participant will speak up at the point where the pressure evoke a painful sensation, and the instantaneous value will be recorded as the PPT. Before treatment and after 4 weeks treatment
Secondary Assess the change in Cervical flexion rotation test By the cervical range of motion (CROM) instrument placed on the head.The evaluator will perform maximum flexion of the cervical spine followed by a rotation to each side.Each measurement will be repeated 3 times at 30 s intervals. The mean value obtained from the 3 trials will be used for data analysis. The reported normal range of rotation during the CFRT is 44° to each side. A test will be reported as positive when individuals demonstrate a reduction of movement of 10? compared to the normal range of motion (<34?). Before treatment and after 4 weeks treatment
Secondary Assess the change in Hamstrings flexibility By Straight leg raising test (SLR) to assess Hamstrings flexibility.The participant will be placed in a supine position, his calcaneus will be held with one hand and the leg will be lifted, and the other hand will be fixed so that the patient's knee is not flexed. Before treatment and after 4 weeks treatment
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