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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06267755
Other study ID # P.T.REC/012/004884
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 20, 2024
Est. completion date August 30, 2024

Study information

Verified date February 2024
Source Cairo University
Contact Mahmoud Fouad, master
Phone 01227740639
Email mahmoud.adel27392@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

this study will be conducted to investigate the effect of Extracorporeal Shockwave Therapy on Ultrasonography Changes of Upper Trapezius Myofascial Trigger Points in Patients With Non Specific Neck Pain


Description:

Neck pain is one of the most commonly reported musculoskeletal disorders. The prevalence for neck pain varies between 16.7% and 75.1% in the general population. Up to 67% of world's population may present chronic non-specific neck pain at least once in their lives. The upper trapezius is probably the muscle most often beset by trigger points, it is indicated that the upper trapezius is the most sensitive of 8 different muscles (upper trapezius, pectoralis major, levator scapulae, teres major, supraspinatus, gluteus medius, infraspinatus, paraspinal) to the pressure of an algometer.Recently, the extracorporeal shock wave has been widely known to be an effective therapeutic modality in myofascial pain syndrome treatment and a systematic review provided promising insight into the effectiveness of ESWT in Myofascial pain syndrome treatment. sixty patients with non specific neck pain will be assigned randomly to two groups; first one will receive shock wave therapy and traditional therapy and the second one will receive traditional therapy only for six weeks.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date August 30, 2024
Est. primary completion date August 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Sixty patients receiving a diagnosis of non-specific neck pain with upper trapezius myofascial trigger points by an orthopaedist physician. - Body mass index of participants was normal less than (30 kg/m2)(Al-asadi, 2018). - Age over 18 years. - Presence of taught band. - Presence of hyper irritable spot in a taught band, and reproduction of the typical referred pain pattern of the myofascial trigger point in response to compression Exclusion Criteria: - Having signs and symptoms of neurological disorders that cause nerve root compression. - Headache as a consequence of specific headache diagnosis. - Having a history of specific signs of malignancy, or infection. - Having a history of trauma with or without proven structural disorders in the region of the neck, shoulder, and head (e.g. whiplash). - Having signs and symptoms of cerebrovascular insufficiency. - Having a severe chronic disease of the locomotor system (e.g. polyarthritis, muscular disease - Any participant with contraindications to shock wave therapy

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Extracorporeal Shockwave therapy
the patients will receive Extracorporeal Shockwave therapy sessions by 600 impulses with 1.6 bar pressure at a frequency of 8 Hz on site of the upper trapezius
Traditional physical therapy
the patients will receive Traditional physical therapy in the form of Integrated neuro-muscular inhibition technique + posture correction and scapular stabilization exercises.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Outcome

Type Measure Description Time frame Safety issue
Primary muscle thickness Ultrasonography device will be used to assess muscle thickness up to six weeks
Primary hypoechoic area intensity An ultrasonography device will be used to assess the hypoechoic area intensity up to six weeks
Secondary neck disability Arabic version of neck disability index will be used to measure neck disability. It consists of 10 questions: pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation. 5 Each item is scored from 0 (no disability) to 5 (total disability). The maximum possible score is 50. up to six weeks
Secondary pressure pain threshold Digital algometer will be used to measure pressure pain threshold up to six weeks
Secondary cervical range of motion The cervical range of motion (CROM) device will be used to measure cervical ROM up to six weeks
Secondary pain intensity The visual analog scale (VAS) will be used to measure pain intensity. it is a10 cm line, oriented vertically or horizontally, with one end representing "no pain" and the other end representing pain as bad as it can be up to six weeks
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