NCT05782621

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 23, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

March 30, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
Last Updated

March 23, 2023

Status Verified

March 1, 2023

Enrollment Period

2 months

First QC Date

March 11, 2023

Last Update Submit

March 11, 2023

Conditions

Keywords

Acupoint Focused UltrasoundLaserpunctureChronic Mechanical Neck Pain

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • cervical range of motion

    up to four weeks

Study Arms (3)

Acupoint focused ultrasound

EXPERIMENTAL

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

Other: Acupoint focused ultrasoundOther: conventional treatment

Laserpuncture

EXPERIMENTAL

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

Other: LaserpunctureOther: conventional treatment

conventional treatment

ACTIVE COMPARATOR

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

Other: conventional treatment

Interventions

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

Acupoint focused ultrasound

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

Laserpuncture

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)

Acupoint focused ultrasoundLaserpunctureconventional treatment

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
opaque sealed envelop
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Acupoint Focused Ultrasound and Laserpuncture
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator Dina Ahmed Ahmed Asr

Study Record Dates

First Submitted

March 11, 2023

First Posted

March 23, 2023

Study Start

March 30, 2023

Primary Completion

May 30, 2023

Study Completion

May 30, 2023

Last Updated

March 23, 2023

Record last verified: 2023-03