Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05782621
Other study ID # P.T.REC/012/004126
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 30, 2023
Est. completion date May 30, 2023

Study information

Verified date March 2023
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

this study will be conducted to compare the effect of Acupoint focused ultrasound and Laser puncture on pain intensity level, neck range of motion, and neck function in patient with chronic mechanical neck pain


Description:

Neck pain is a musculoskeletal condition with a high prevalence that may affect the physical, social, and psychological aspects of the individual, contributing to the increase in costs in society and business. Neck pain was significantly associated with repetitive movement, activities that require lifting and moving loads, and being in sitting and leaning positions.Non specific neck pain is a multifactorial and very common condition in adult individuals, traditional acupuncture (TA) and laser puncture (LP) may be treatment options for certain individuals in such a condition. The laser will be placed at the specific acupuncture points: Tianzhu, Fengchi, Jianjing, and Jianzhongshu . Because ultrasound can deliver vibration energy to soft tissues noninvasively, ultrasound has been applied to diagnostic imaging and therapeutic applications. To use ultrasound for acupoint stimulation, a stimulation device was developed using focused ultrasound. The application of an ultrasound stimulus to the acupuncture meridian system has been found safe and effective in many common clinical entities. The Sonicator head is applied to the chosen location as in standard ultrasound therapy, with a gentle circular motion. forty five patients will be assigned randomly to three groups; experimental group 1 will receive acupoint focused ultrasound, experimental group 2 will receive laserpuncture and the control group will receive conventional treatment three times a week for four weeks.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 45
Est. completion date May 30, 2023
Est. primary completion date May 30, 2023
Accepts healthy volunteers No
Gender All
Age group 30 Years to 60 Years
Eligibility Inclusion Criteria: All subjects will be referred by the orthopedist. Cervical pain is episodic chronic, having occurred and recurred over regular or irregular intervals of time over at least the last 3 months. The subject is willing and able to refrain from non-study procedure therapies for the management of neck pain throughout study participation. Age ranged from 30-60 years BMI ranged from (25-30kg/m2) Exclusion Criteria: Cervical pain is undiagnosed or has been diagnosed as being other than of benign musculoskeletal origin. Tension myositis syndrome. Osteoporosis with compression fractures. Congenital deformity of spine. Current active chronic pain disease. Cancer or cancer treatment in the past 6 months. Use of the following analgesics within 7 days of study onset - paracetamol, acetominophen, non-steroidal anti-inflammatory drugs (NSAIDs), compound analgesics, topical analgesics. Use of the following muscle relaxants within the prior 30 days of study onset - cyclobenzaprine, diazepam, meprobamate.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Acupoint focused ultrasound
An ultrasound beam is normally pulsed in the ratio of 1:5. For perfect transmission of power from the treatment head to the body, the head will be applied perpendicularly to the skin surface. A stationary technique pulsed ultrasound (1 w/cm2) will be used. The application will be two minutes for each acupuncture point and the head will be glided to the next point in the same side; then to the other side for no more than 10 points, then the device will be turned off
Laserpuncture
The laser tip (0.03 cm2 of beam area) will be positioned with the "probe" head directly on the acupuncture point, in a perpendicular position and in direct contact with the skin, and every point will be treated for 2 min, totaling 16 min of treatment, plus 4 min of rest, to standardize with the traditional acupuncture time, which is 20 min
conventional treatment
the patients will receive selective neck strengthening ex for (extension, flexion, sidebending, lateral rotation) and selective neck stretching ex for (extension, flexion, sidebending, lateral rotation)

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Outcome

Type Measure Description Time frame Safety issue
Primary pain intensity pain will be measured by visual analogue scale. It is a vertical or horizontal 100 mm line graduated by different levels of pain, starting from 0 (no pain) till 100 (worst pain) up to four weeks
Primary Disability The Copenhagen Neck Functional Disability Scale will be used to evaluate the disability experienced by patients with neck pain. it consists of 15 items. These items are individually answered by either 'yes', 'occasionally' or 'no'. For questions one till five, a 'yes' indicates a good function. For questions six till fifteen, a 'no' indicates a good function. A good function receives a score of zero, a poor function receives a score of two and the answer 'occasionally' always receives a score of one. Afterwards, we add up all the scores of the questions to form the total score. This total score ranges from 0 to 30.The total score determines the level of functional disability, in which higher numbers represent a higher level of disability. A score of 0 indicates that there are no neck complaints present whereas 30 indicates that the patient is extremely disabled as a result of the neck complaints up to four weeks
Secondary cervical range of motion The digital goniometer will be used for measuring cervical range of motion up to four weeks
See also
  Status Clinical Trial Phase
Completed NCT05293847 - Postural Based Telerehabilitation in Mechanic Neck Pain N/A
Completed NCT04060004 - The Effects of Dry Needling on the Superficial Neck Musculature N/A
Recruiting NCT06204627 - TDCS* and Laterality Trainnning in Patients With Chronic Neck Pain N/A
Active, not recruiting NCT05870371 - The Effect of the Feldenkrais Method on Pain and Function in Patients With Chronic Neck Pain N/A
Completed NCT06049316 - Scapular Stabilization vs Functional Exercises on Chronic Neck Pain N/A
Recruiting NCT05944354 - Wearable Spine Health System for Military Readiness
Completed NCT02882061 - Examination of Cervical Thoracic Differentiation Testing in Individuals With Neck Pain N/A
Completed NCT02731014 - Dry Needling for Patients With Neck Pain N/A
Completed NCT02904668 - Self-management Program in Chronic Neck Pain N/A
Completed NCT03147508 - Investigating Clinical Indicators of Spine Related Dysfunction Patterns. A Clinical Study on Neck Pain Patients.
Completed NCT02638987 - EMG Activity Before, During and After Dry Needling N/A
Active, not recruiting NCT02843269 - Multiple-component Workplace FRamed Intervention to Decrease Occupational Muscle Pain - FRIDOM N/A
Enrolling by invitation NCT02485795 - Observational Study of the Impact of Genetic Testing on Healthcare Decisions and Care in Interventional Pain Management N/A
Completed NCT02235207 - Effectiveness of Fustra—Exercise Program in Neck and Low Back Pain N/A
Completed NCT02245425 - Comparison of Two Thoracic Manipulation Techniques to Improve Neck Pain N/A
Completed NCT02225873 - The Effectiveness of Exercises Protocol in Management of Neck Pain N/A
Completed NCT02190890 - Dry Needling Dosage in the Treatment of Myofascial Neck Pain N/A
Completed NCT02051478 - Thoracic Manipulation and Mobilization for Neck Pain N/A
Completed NCT01938209 - A Comparison of Seated Thoracic Manipulation and Targeted Supine Thoracic Manipulation on Cervical Flexion Motion and Pain N/A
Completed NCT01233180 - Effects of Gua Sha and Thermotherapy on Chronic Neck Pain N/A