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

Primary Purpose

Manual Therapy, Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Manual therapy
Sponsored by
Soheir Shehata RezkAllah Samaan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Manual Therapy focused on measuring Acupressure; Ischemic Compression Release; Neck Pain.

Eligibility Criteria

25 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Soheir

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Acupressure of classical acupoints

Ischemic compression release of myofascial trigger points

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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").
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.
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

Secondary Outcome Measures

Neck function
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

Full Information

First Posted
November 10, 2021
Last Updated
February 19, 2022
Sponsor
Soheir Shehata RezkAllah Samaan
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1. Study Identification

Unique Protocol Identification Number
NCT05182346
Brief Title
Acupressure Versus Ischemic Release in Non-specific Neck Pain
Acronym
Manual
Official Title
Acupressure of Acupoints Versus Ischemic Compression Release of Myofascial Trigger Points in Non-specific Neck Pain: Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
October 20, 2020 (Actual)
Primary Completion Date
June 13, 2021 (Actual)
Study Completion Date
June 13, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Soheir Shehata RezkAllah Samaan

4. Oversight

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

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Manual Therapy, Neck Pain
Keywords
Acupressure; Ischemic Compression Release; Neck Pain.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acupressure of classical acupoints
Arm Type
Experimental
Arm Description
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.
Arm Title
Ischemic compression release of myofascial trigger points
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Manual therapy
Other Intervention Name(s)
Acupressure, Ischemic compression release
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain intensity
Description
- 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").
Time Frame
4 successive weeks
Title
Pressure pain threshold
Description
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.
Time Frame
4 successive weeks
Title
Cervical range of motion
Description
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
Time Frame
4 successive weeks
Secondary Outcome Measure Information:
Title
Neck function
Description
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
Time Frame
4 successive weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soheir S RezkAllah, professor
Organizational Affiliation
Professor of physical therapy, Cairo University
Official's Role
Study Chair
Facility Information:
Facility Name
Soheir
City
Cairo
ZIP/Postal Code
11672
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33296258
Citation
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.
Results Reference
result

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Acupressure Versus Ischemic Release in Non-specific Neck Pain

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