Acupoint Focused Ultrasound Versus Laserpuncture In Mechanical Neck Pain

NCT ID: NCT05782621

Last Updated: 2023-03-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-30
• Study Completion Date: 2023-05-30

Brief 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

Detailed 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.

Conditions

Neck Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Acupoint focused ultrasound

the patients will receive Acupoint focused ultrasound therapy three times a week for four weeks

Group Type: EXPERIMENTAL

Acupoint focused ultrasound

Intervention Type: OTHER

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

conventional treatment

Intervention Type: OTHER

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)

Laserpuncture

the patients will receive Laserpuncture therapy three times a week for four weeks

Group Type: EXPERIMENTAL

Laserpuncture

Intervention Type: OTHER

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

Intervention Type: OTHER

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)

conventional treatment

the patients will receive conventional treatment three times a week for four weeks

Group Type: ACTIVE_COMPARATOR

conventional treatment

Intervention Type: OTHER

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)

Interventions

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

Intervention Type: OTHER

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

Intervention Type: OTHER

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)

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Dina Ahmed Ahmed Asr

principle investigator Dina Ahmed Ahmed Asr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

P.T.REC/012/004126

Identifier Type: -

Identifier Source: org_study_id