Chronic Neck PainMcKENICENCT04793763
Comparing the Effect of Deep Neck Flexors Versus MCkenice Exercises on Cervical Functions
A study testing traditional therapeutic exercises, traditional therapeutic exercises and McKenize technique and traditional therapeutic exercises and deep neck flexor exercises in people with Chronic Neck Pain, run by Cairo University at 1 site in Egypt.
Trial summary
Physical Therapy rehabilitation programs could involve Manual procedures, stretching, traction, massage, electrotherapy, thermal agents, ultrasound, education and general exercise..In the recovery of patients with neck pain, exercise is one of the most commonly used modalities to gain muscle strength, endurance, and… Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Chronic Neck Pain
- What is being tested?
- traditional therapeutic exercises, traditional therapeutic exercises and McKenize technique and traditional therapeutic exercises and deep neck flexor exercises
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Feb 2021to 30 Mar 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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age ranges from (30-50) years old with mean age,
- height ranges from (152-182) cm and their weight ranged from (55-90) kg
- Patients will be included if they have a localized chronic neck pain without any current arm pain or discomfort were included.
Who cannot join
- history of cervical spine injury or surgery, if neck pain is secondary to other conditions (including neoplasm, neurological diseases or vascular diseases),
- they have a radiculopathy presenting neurological deficit
- they had infection or inflammatory arthritis in the cervical spine,
- they have pain with any cause in or around the scapula, shoulder, upper extremities and lumbar spine that prevents stabilization of these structures.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculity of Physical Therapy
Giza, 12662
Reham H Diab, PH.D, reham.diab@yahoo.com
About this study
Official title: Comparing the Effect of Deep Neck Flexors and MCkenice Exercises on Cervical Mobility,Pain and Disability in Chronic Neck Pain Participants
Physical Therapy rehabilitation programs could involve Manual procedures, stretching, traction, massage, electrotherapy, thermal agents, ultrasound, education and general exercise..In the recovery of patients with neck pain, exercise is one of the most commonly used modalities to gain muscle strength, endurance, and flexibility in order to recover damaged muscles and to maintain regular life activities.. Neck pain management exercise programs vary in terms of length, training frequency, intensity, and mode of exercise. .
Read the detailed description
This study will be a randomized controlled trial that involved sixty patients of both gender with chronic neck pain with duration of at least six weeks that will be recruited into the study. They will be recruited from the out patient clinic of Faculty of Physical Therapy, Egypt ,their age ranged from (30-50) years old with mean age, their height ranged from (152-182) cm and their weight ranged from (55-90) kg , Patients will be included if they had a localized chronic neck pain without any current arm pain or discomfort were included.Groups:
A: twenty patients will receive traditional Physical Therapy agents, Group B: twenty patients will receive traditional Physical Therapy agents plus isometric, stretching, scapulothoracic exercises and deep neck flexors exercises; and Group C: twenty patients will receive traditional Physical Therapy agents plus isometric, stretching, scapulothoracic exercises and Mckenzie technique.
- Conditions
- Chronic Neck Pain
- Being tested
- traditional therapeutic exercises, traditional therapeutic exercises and McKenize technique, traditional therapeutic exercises and deep neck flexor exercises
- Keywords
- Mc Kenzie, chronic neck pain, deep neck flexor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
traditional therapeutic exercisesOther
group A will receive traditional exercises
traditional therapeutic exercises and McKenize techniqueOther
Group B will receive traditional therapeutic exercises and McKenize technique
traditional therapeutic exercises and deep neck flexor exercisesOther
Group C receive traditional therapeutic exercises and deep neck flexor exercises
| Study group | Role | What they receive |
|---|---|---|
| group A | Placebo comparator | placebo Comparator Group A
: twenty patients were received traditional Physical Therapy agents Receives: Other: traditional therapeutic exercises |
| group B | Experimental | experimental Group B Group B: twenty patients were received traditional Physical Therapy agents plus isometric, stretching, scapulothoracic exercises and deep neck flexors exercises; Receives: Other: traditional therapeutic exercises and McKenize technique |
| group C | Experimental | Experimental Group C
Group C: twenty patients were received traditional Physical Therapy agents plus isometric, stretching, scapulothoracic exercises and Mckenzie technique. Receives: Other: traditional therapeutic exercises and deep neck flexor exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
neck functional activity
The Copenhagen neck capacity inability scale
Measured: after 6 weeks
pain disability
VAS
Measured: after 6 weeks
cervical range of motion
use Myrin goniometer
Measured: after 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start27 Feb 2021
- Primary completion30 Mar 2021 (estimated)
- Study completion30 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Neck PainStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Diab, Cairo University
- Investigators
- Amr A Abd el aziem, professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04793763
- Sponsor's protocol ID
- P.T.REC/012/003053
- Acronym
- McKENICE
- Status last verified
- Feb 2021
- First submitted
- 19 Feb 2021
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effect of Deep Neck Flexors and MCkenice Exercises on Cervical Mobility,Pain and Disability in Chronic Neck Pain Participants
- ClinicalTrials.gov ID
- NCT04793763
- Acronym / sponsor ID
- McKENICE / P.T.REC/012/003053
- Conditions
- Chronic Neck Pain
- Keywords
- Mc Kenzie, chronic neck pain, deep neck flexor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 27 Feb 2021 (actual)
- Primary completion
- 30 Mar 2021 (estimated)
- Study completion
- 30 Mar 2021 (estimated)
- First posted
- 11 Mar 2021 (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.
Physical Therapy rehabilitation programs could involve Manual procedures, stretching, traction, massage, electrotherapy, thermal agents, ultrasound, education and general exercise..In the recovery of patients with neck pain, exercise is one of the most commonly used modalities to gain muscle strength, endurance, and flexibility in order to recover damaged muscles and to maintain regular life activities.. Neck pain management exercise programs vary in terms of length, training frequency, intensity, and mode of exercise. .
Detailed description
This study will be a randomized controlled trial that involved sixty patients of both gender with chronic neck pain with duration of at least six weeks that will be recruited into the study. They will be recruited from the out patient clinic of Faculty of Physical Therapy, Egypt ,their age ranged from (30-50) years old with mean age, their height ranged from (152-182) cm and their weight ranged from (55-90) kg , Patients will be included if they had a localized chronic neck pain without any current arm pain or discomfort were included.Groups:
A: twenty patients will receive traditional Physical Therapy agents, Group B: twenty patients will receive traditional Physical Therapy agents plus isometric, stretching, scapulothoracic exercises and deep neck flexors exercises; and Group C: twenty patients will receive traditional Physical Therapy agents plus isometric, stretching, scapulothoracic exercises and Mckenzie technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group A | Placebo comparator | Other: traditional therapeutic exercisesplacebo Comparator Group A : twenty patients were received traditional Physical Therapy agents |
| group B | Experimental | Other: traditional therapeutic exercises and McKenize techniqueexperimental Group B Group B: twenty patients were received traditional Physical Therapy agents plus isometric, stretching, scapulothoracic exercises and deep neck flexors exercises; |
| group C | Experimental | Other: traditional therapeutic exercises and deep neck flexor exercisesExperimental Group C Group C: twenty patients were received traditional Physical Therapy agents plus isometric, stretching, scapulothoracic exercises and Mckenzie technique. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age ranges from (30-50) years old with mean age,
- height ranges from (152-182) cm and their weight ranged from (55-90) kg
- Patients will be included if they have a localized chronic neck pain without any current arm pain or discomfort were included.
Key exclusion criteria (4 listed)
- history of cervical spine injury or surgery, if neck pain is secondary to other conditions (including neoplasm, neurological diseases or vascular diseases),
- they have a radiculopathy presenting neurological deficit
- they had infection or inflammatory arthritis in the cervical spine,
- they have pain with any cause in or around the scapula, shoulder, upper extremities and lumbar spine that prevents stabilization of these structures.
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 |
|---|---|---|
| traditional therapeutic exercisesgroup A will receive traditional exercises | Other | group A |
| traditional therapeutic exercises and McKenize techniqueGroup B will receive traditional therapeutic exercises and McKenize technique | Other | group B |
| traditional therapeutic exercises and deep neck flexor exercisesGroup C receive traditional therapeutic exercises and deep neck flexor exercises | Other | group C |
Primary outcome
neck functional activity
Time frame: after 6 weeks
The Copenhagen neck capacity inability scale
pain disability
Time frame: after 6 weeks
VAS
cervical range of motion
Time frame: after 6 weeks
use Myrin goniometer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- 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.
Amr A Abd el aziem, professor study director
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 traditional therapeutic exercises, traditional therapeutic exercises and McKenize technique and traditional therapeutic exercises and deep neck flexor exercises in people with Chronic Neck Pain, run by Cairo University 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 4 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: status not confirmed, as of the sponsor's last update on 11 Mar 2021. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Reham H Diab, profeessor (00201006195473, reham.diab@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neck functional activity (time frame: after 6 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?
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 11 Mar 2021.