Acupoint Focused Ultrasound Versus Laserpuncture In Mechanical Neck Pain (MNP)

Acupoint Focused Ultrasound Versus Laserpuncture In Chronic Mechanical Neck Pain

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

Study Overview

• Status: Not yet recruiting
• Conditions: Neck Pain
• Intervention / Treatment: Other: Acupoint focused ultrasound; Other: conventional treatment; Other: Laserpuncture

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.

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: conventional treatment; the patients will receive conventional treatment three times a week for four weeks	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)
Experimental: Acupoint focused ultrasound; the patients will receive Acupoint focused ultrasound therapy three times a week for four weeks	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; 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)
Experimental: Laserpuncture; the patients will receive Laserpuncture therapy three times a week for four weeks	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); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
cervical range of motion	The digital goniometer will be used for measuring cervical range of motion	up to four weeks

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 30, 2023
• Primary Completion (Anticipated): May 30, 2023
• Study Completion (Anticipated): May 30, 2023

Study Registration Dates

• First Submitted: March 11, 2023
• First Submitted That Met QC Criteria: March 11, 2023
• First Posted (Actual): March 23, 2023

Study Record Updates

• Last Update Posted (Actual): March 23, 2023
• Last Update Submitted That Met QC Criteria: March 11, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Chronic Mechanical Neck Pain; Acupoint Focused Ultrasound; Laserpuncture
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: P.T.REC/012/004126

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No