NCT05182346

Brief Summary

Chronic neck pain (CNP) attributed to myofascial pain syndrome (MFPS) which is one of the particularly common skeletal muscle disorder associated with the hyperirritable zone in the taut band of muscle. Myofascial trigger points (MTrP) are one of the most overlooked and ignored causes of musculoskeletal pain. This study aims to compare the clinical efficacy of acupressure of cervical acupoints versus ischemic compression release (ICR) of MTrPs in CNP.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 20, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 10, 2022

Completed
Last Updated

March 8, 2022

Status Verified

February 1, 2022

Enrollment Period

8 months

First QC Date

November 10, 2021

Last Update Submit

February 19, 2022

Conditions

Keywords

Acupressure; Ischemic Compression Release; Neck Pain.

Outcome Measures

Primary Outcomes (3)

  • Pain intensity

    \- The Visual Analog Scale (VAS) assessed the intensity of general pain and pain in the right and left upper trapezius. The scale consists of an unanchored horizontal line 10 centimeters in length, with one end corresponding to zero ("no pain") and the other to 10 ("maximum pain").

    4 successive weeks

  • Pressure pain threshold

    The palpated trigger points are marked with a skin marker. The patient is positioned accordingly and a dial type pressure algometer is placed on the site and a con¬stant vertical pressure was applied to the site. The subject is instructed to express pain by raising their hands when only slight pain was felt, until then the pressure is increased at a constant rate.

    4 successive weeks

  • Cervical range of motion

    It was aligned on the Nose Bridge and ears and was fastened to the head by a Velcro strap. It was imperative that the patient's chair be positioned such that the magnetic field would zero the dial meter for the rotation component. Prior to testing, Subjects were instructed to sit erect in the chair, with their low back against the chair, midback away from the chair, arms hanging at sides, and feet flat on the floor. Active right and left lateral flexion components of cervical spine motion were measured twice on each subject. During testing, all dials read zero before the desired component was measured. A horizontal line was placed on the wall for the purpose of tracking; subjects were instructed to follow this line when the lateral flexion component was measured

    4 successive weeks

Secondary Outcomes (1)

  • Neck function

    4 successive weeks

Study Arms (2)

Acupressure of classical acupoints

EXPERIMENTAL

Acupressure is applied on four acupoints: Pressure was applied to large intestine 10 (LI10) (large intestine meridians): It is located on the dorsal radial side of the forearm, 2 Cun below the transverse cubital crease. Hegu (large intestine meridians, LI 4): It is in the middle of the 2nd metacarpal bone on the radial side. TE5 (Triple energizer): It is located 2 cun proximal to the dorsal wrist crease between the radius and the ulna. SI3 (small intestine meridians): It is located at the ulnar end of the distal palmar crease proximal to the 5th metacarpal phalangeal joint. These acupoints are commonly used in the treatment of cervical myofascial pain syndrome.

Procedure: Manual therapy

Ischemic compression release of myofascial trigger points

EXPERIMENTAL

Ischemic compression was gradually applied pressure to the trigger point with your thumb. The patient will likely feel referred pain in a question mark pattern (along the back of the neck, around the side of the head, and then a focused pain right behind the eye). Keep in communication with the patient, checking to ensure that in staying within the limits of his pain tolerance. Hold this technique for approximately 20 seconds to 1 minute, patient tells you that pain has diminished, or until feels the muscle fibers begin to relax under your pressure. Once feel this release, gradually release pressure. All identified trigger points will be treated. Then apply a few effleurage strokes to flush out the area and follow up with a passive stretch to the muscle.

Procedure: Manual therapy

Interventions

* Acupressure of acupoints is manipulation of classic acupoints by pressure. * Ischemic compression release is applying pressure to the myofascial trigger points until release of these points.

Also known as: Acupressure, Ischemic compression release
Acupressure of classical acupointsIschemic compression release of myofascial trigger points

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • All participants have nonspecific NP for a period of \>3 months
  • All participants are presented with at least one active MTrP at the upper trapezius muscle, -
  • All participants had not used any medications or physiotherapy to alleviate pain were included in this study.

You may not qualify if:

  • Participants who met these criteria had been excluded:
  • NP due to trauma, whiplash, cervical disc prolapse, inflammation, malignant disease, or any other neurological and orthopedic conditions, which will affect the assessment.
  • Congenital malformation of the spine as it will alter the normal pattern of movements.
  • Had any invasive therapies in the past month.
  • Patients with sensory impairments, such as diabetic sensory neuropathy.
  • Mental disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soheir

Cairo, 11672, Egypt

Location

Related Publications (1)

  • Kim M, Kim J. Effects of Acupressure on Pain, Flexibility, and Substance P in Middle-Age Women with Chronic Neck Pain. J Altern Complement Med. 2021 Feb;27(2):160-167. doi: 10.1089/acm.2020.0413. Epub 2020 Dec 8.

MeSH Terms

Conditions

Neck Pain

Interventions

Musculoskeletal ManipulationsAcupressure

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationTherapy, Soft Tissue

Study Officials

  • Soheir S RezkAllah, professor

    Professor of physical therapy, Cairo University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 10, 2021

First Posted

January 10, 2022

Study Start

October 20, 2020

Primary Completion

June 13, 2021

Study Completion

June 13, 2021

Last Updated

March 8, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations