Manual TherapyManualNCT05182346
Acupressure Versus Ischemic Release in Non-specific Neck Pain
A study testing Manual therapy in people with Manual Therapy and Neck Pain, run by Soheir Shehata RezkAllah Samaan at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Manual Therapy, Neck Pain
- What is being tested?
- Manual therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Oct 2020to 13 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Manual Therapy, Neck Pain
- Being tested
- Manual therapy
- Keywords
- Acupressure; Ischemic Compression Release; Neck Pain.
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual therapyProcedure or surgery
Also called Acupressure, Ischemic compression release
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Manual therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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").
Measured: 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.
Measured: 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
Measured: 4 successive weeks
Secondary outcomes (1)
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
Measured: 4 successive weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start20 Oct 2020
- Primary completion13 Jun 2021
- Study completion13 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Manual TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soheir Shehata RezkAllah Samaan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Soheir Shehata RezkAllah Samaan, Cairo University
- Investigators
- Soheir S RezkAllah, professor, Study chair, Professor of physical therapy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05182346
- Sponsor's protocol ID
- CURs
- Other IDs
- Reaserch promotion
- Acronym
- Manual
- Status last verified
- Feb 2022
- First submitted
- 10 Nov 2021
- Last updated
- 8 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33296258
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupressure of Acupoints Versus Ischemic Compression Release of Myofascial Trigger Points in Non-specific Neck Pain: Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05182346
- Acronym / sponsor ID
- Manual / CURs
- Conditions
- Manual Therapy, Neck Pain
- Keywords
- Acupressure; Ischemic Compression Release; Neck Pain.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Soheir Shehata RezkAllah SamaanUniversity, hospital or other
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 13 Jun 2021 (actual)
- Study completion
- 13 Jun 2021 (actual)
- First posted
- 10 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupressure of classical acupoints | Experimental | Procedure: Manual therapyAcupressure 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 release of myofascial trigger points | Experimental | Procedure: Manual therapyIschemic 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. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- Participants who met these criteria had been excluded:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual therapyAlso: Acupressure, Ischemic compression release* 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. | Procedure or surgery | Acupressure of classical acupoints, Ischemic compression release of myofascial trigger points |
Primary outcome
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").
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.
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
1 secondary outcome
Neck function
Time frame: 4 successive weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
- Results publication: PubMed 33296258Kim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Soheir S RezkAllah, professor study chair
Professor of physical therapy, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual therapy in people with Manual Therapy and Neck Pain, run by Soheir Shehata RezkAllah Samaan at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: 4 successive weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05182346, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2022.