- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05182346
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
45
Phase
- 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
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Cairo, Egypt, 11672
- Soheir
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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
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:
- 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.
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 |
Intervention / Treatment |
|---|---|
|
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.
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Other Names:
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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.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pain intensity
Time Frame: 4 successive weeks
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- 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").
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4 successive weeks
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Pressure pain threshold
Time Frame: 4 successive weeks
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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.
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4 successive weeks
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Cervical range of motion
Time Frame: 4 successive weeks
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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
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4 successive weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Neck function
Time Frame: 4 successive weeks
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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
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4 successive weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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.
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)
October 20, 2020
Primary Completion (ACTUAL)
June 13, 2021
Study Completion (ACTUAL)
June 13, 2021
Study Registration Dates
First Submitted
November 10, 2021
First Submitted That Met QC Criteria
December 20, 2021
First Posted (ACTUAL)
January 10, 2022
Study Record Updates
Last Update Posted (ACTUAL)
March 8, 2022
Last Update Submitted That Met QC Criteria
February 19, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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