Acupressure Versus Ischemic Release in Non-specific Neck Pain (Manual)

February 19, 2022 updated by: Soheir Shehata RezkAllah Samaan

Acupressure of Acupoints Versus Ischemic Compression Release of Myofascial Trigger Points in Non-specific Neck Pain: Randomised Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Nonspecific neck pain (NSNP) is the commonest cause of neck symptoms and results from postural and mechanical causes.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.The objectives of this study is to compare the clinical efficacy of acupressure of cervical acupoints versus ischemic compression release (ICR) of MTrPs in CNP. This single blind randomized trial involves patients with NSNP were randomly assigned into three groups: the acupressure group (ACG), and the ischemic compression release group (ICRG) and the control group (CG). Patients in all groups received hot packs and post-isometric relaxation. Patients in ACG received acupressure at local acupuncture points, Gall bladder 21 (GB 21), small intestine 14 (SI 14) and SI 15, and the ICRG received pressure on MTrPs of trapezius muscle on both sides. VAS sores, pressure pain threshold (PPT), neck lateral flexion range of motion, and neck disability index (NDI) were assessed before and after 4 weeks of treatment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11672
        • Soheir

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Participants who met these criteria had been excluded:

    1. NP due to trauma, whiplash, cervical disc prolapse, inflammation, malignant disease, or any other neurological and orthopedic conditions, which will affect the assessment.
    2. Congenital malformation of the spine as it will alter the normal pattern of movements.
    3. Had any invasive therapies in the past month.
    4. Patients with sensory impairments, such as diabetic sensory neuropathy.
    5. Mental disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Acupressure of classical acupoints
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
  • 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.
Other Names:
  • Acupressure
  • Ischemic compression release
EXPERIMENTAL: Ischemic compression release of myofascial trigger points
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
  • 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.
Other Names:
  • Acupressure
  • Ischemic compression release

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: 4 successive weeks
- 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
Time Frame: 4 successive weeks
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
Time Frame: 4 successive weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Neck function
Time Frame: 4 successive weeks
The neck disability index is composed of ten descriptions which assess an individual's daily activities, pain and concentration in regards to their functional sta¬tus. Each question carries six responses on a scale of 0-5 (Howard, 1991). The maximum possible score is 50. Disability is cal¬culated using the NDI raw score as no disability (0-4), mild (5-14), moderate (15-24), severe (25-34) and complete (<34).The Neck Disability Index (NDI) is the most widely used instrument in neck pain
4 successive weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Soheir Shehata RezkAllah Samaan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Soheir S RezkAllah, professor, Professor of physical therapy, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 20, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 13, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 13, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 10, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 10, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 8, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CURs
  • Reaserch promotion (OTHER: Faculty of Physical Therapy)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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