Nonspecific Neck PainNCT03089021
Maitland Mobilization Versus Mulligan Mobilization in Sub-Acute and Chronic Non-Specific Neck Pain
A study testing mulligan mobilization and maitland mobilization in people with Nonspecific Neck Pain, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
Trial summary
This study investigate the short term effect of Maitland in comparison to Mulligan mobilization with sub-acute and chronic non specific neck pain to improve neck pain, pain pressure threshold, rang of motion, joint position sense, disability, and to evaluate the interaction with psychological factors. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Nonspecific Neck Pain
- What is being tested?
- mulligan mobilization and maitland mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 20 Dec 2016to 28 Dec 2017
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • Patients aged between 20 to 50 years.
- Neck pain more than one week without radicular symptoms.
- Pain on posterior neck from superior nuchal line to first thoracic vertebra.
Who cannot join
- • Patient contraindicate to mobilization (pregnancy, whiplash injury, tumor, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis and resting blood pressure higher than 140/90 mmHg).
- Cervical radiculopathy.
- Fibromyalgia pain syndrome.
- Previous neck surgery.
- Neck pain associate with vertigo caused by vertebrobasilar insufficiency or chronic headache.
- Patient received physical therapy treatment in the previous three months.
- Psychiatric disorders.
- Vestibular system deficits.
Trial locations and contacts
1 site in 1 country.
About this study
This study investigate the short term effect of Maitland in comparison to Mulligan mobilization with sub-acute and chronic non specific neck pain to improve neck pain, pain pressure threshold, rang of motion, joint position sense, disability, and to evaluate the interaction with psychological factors.
Study design: experimental study
Read the detailed description
44 patients with sub-acute or chronic neck pain will be randomized into Maitland group: 22 patients receive central postro anterior or unilateral postero anterior. Mulligan group: 22 patients receive sustain natural apophyseal glides. The treatment will be 2 times /week for three weeks. Measurement will be taken pre intervention and after three weeks for neck pain, pain pressure threshold, range of motion, joint position sense, and disability using a numeric pain rating scale, pain pressure threshold test, cervical range of motion device, and neck disability index, depression, anxiety, fear avoidance believe and pain catestrophizing respectively.
- Conditions
- Nonspecific Neck Pain
- Being tested
- mulligan mobilization, maitland mobilization
- Keywords
- 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.
mulligan mobilizationOther
mobilization with movement for spinous process or facet joint.
maitland mobilizationOther
posterioanterior of spinous process or facet joint.
| Study group | Role | What they receive |
|---|---|---|
| mulligan mobilization | Experimental | mobilization for spinous process or facet with neck movement 10 repetetions for 3 times. Receives: Other: mulligan mobilization |
| maitland mobilization | Experimental | maitland mobilization for spinous process or facet joint for 2 min and repeated 3 times. Receives: Other: maitland mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain pressure threshold
It will be measured with an electronic algometer (Somedic AB, Farsta, Sweden) with a circular probe of 1 cm2. The PPT will be measured over the following site: (1) area of maximum tenderness over the cervical spine as identify by palpation, (2) tibialis anterior muscle (upper one-third of the muscle belly) bilateral. Tibialis anterior sites will be as remote lower limb sites to investigate any widespread changes in sensitivity. The pressure will be applied perpendicular over the identified sites at a rate of 40 KPa/s until the individual verbally states that the pressure is starting to change to a pain sensation. Then, the pressure will be stopped. The test will be repeated three times for each site within 30 second between measurements. An average of three measurements will be calculated
Measured: 3 weeks
pain intensity
: numeric pain rating scale (NPRS) will be used to evaluate the intensity of pain perceived by patient. Pain is rated on 11 point scale from (0) no pain to (10) sever pain. The patients will be asked to point out the number that describes their pain level.
Measured: 3 weeks
Secondary outcomes (3)
cervical range of motion
it will be measured by cervical range of motion (CROM) device. It consists of three gravitational inclinometers system for flexion, extension and lateral flexion, and magnetic inclinometer for rotation.
Measured: 3 weeks
joint position sense
it will be measured by using the (CROM) device
Measured: 3 weeks
neck disability index
This questioner is used to report disability results from neck pain and it is a self-report based outcome. In addition, it contains ten sections with total score of 50 points
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start20 Dec 2016
- Primary completion1 Nov 2017 (estimated)
- Study completion28 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonspecific Neck PainStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imam Abdulrahman Bin Faisal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Mohammed Alansari, Imam Abdulrahman Bin Faisal University
- Investigators
- samar alansari, master, Principal investigator, Imam Abdulrahman Bin Faisal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03089021
- Sponsor's protocol ID
- IRB -PGS-2016-03-143
- Status last verified
- Sep 2017
- First submitted
- 20 Mar 2017
- Last updated
- 20 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: only coded data (describtive)
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maitland Mobilization Versus Mulligan Mobilization in Sub-Acute and Chronic Non-Specific Neck Pain
- ClinicalTrials.gov ID
- NCT03089021
- Acronym / sponsor ID
- IRB -PGS-2016-03-143
- Conditions
- Nonspecific Neck Pain
- Keywords
- neck pain,
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Imam Abdulrahman Bin Faisal UniversityUniversity, hospital or other
- Study start
- 20 Dec 2016 (actual)
- Primary completion
- 1 Nov 2017 (estimated)
- Study completion
- 28 Dec 2017 (estimated)
- First posted
- 24 Mar 2017 (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.
This study investigate the short term effect of Maitland in comparison to Mulligan mobilization with sub-acute and chronic non specific neck pain to improve neck pain, pain pressure threshold, rang of motion, joint position sense, disability, and to evaluate the interaction with psychological factors.
Study design: experimental study
Detailed description
44 patients with sub-acute or chronic neck pain will be randomized into Maitland group: 22 patients receive central postro anterior or unilateral postero anterior. Mulligan group: 22 patients receive sustain natural apophyseal glides. The treatment will be 2 times /week for three weeks. Measurement will be taken pre intervention and after three weeks for neck pain, pain pressure threshold, range of motion, joint position sense, and disability using a numeric pain rating scale, pain pressure threshold test, cervical range of motion device, and neck disability index, depression, anxiety, fear avoidance believe and pain catestrophizing respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mulligan mobilization | Experimental | Other: mulligan mobilizationmobilization for spinous process or facet with neck movement 10 repetetions for 3 times. |
| maitland mobilization | Experimental | Other: maitland mobilizationmaitland mobilization for spinous process or facet joint for 2 min and repeated 3 times. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- • Patients aged between 20 to 50 years.
Key exclusion criteria (8 listed)
- • Patient contraindicate to mobilization (pregnancy, whiplash injury, tumor, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis and resting blood pressure higher than 140/90 mmHg).
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 |
|---|---|---|
| mulligan mobilizationmobilization with movement for spinous process or facet joint. | Other | mulligan mobilization |
| maitland mobilizationposterioanterior of spinous process or facet joint. | Other | maitland mobilization |
Primary outcome
pain pressure threshold
Time frame: 3 weeks
It will be measured with an electronic algometer (Somedic AB, Farsta, Sweden) with a circular probe of 1 cm2. The PPT will be measured over the following site: (1) area of maximum tenderness over the cervical spine as identify by palpation, (2) tibialis anterior muscle (upper one-third of the muscle belly) bilateral. Tibialis anterior sites will be as remote lower limb sites to investigate any widespread changes in sensitivity. The pressure will be applied perpendicular over the identified sites at a rate of 40 KPa/s until the individual verbally states that the pressure is starting to change to a pain sensation. Then, the pressure will be stopped. The test will be repeated three times for each site within 30 second between measurements. An average of three measurements will be calculated
pain intensity
Time frame: 3 weeks
: numeric pain rating scale (NPRS) will be used to evaluate the intensity of pain perceived by patient. Pain is rated on 11 point scale from (0) no pain to (10) sever pain. The patients will be asked to point out the number that describes their pain level.
3 secondary outcomes
cervical range of motion
Time frame: 3 weeks
joint position sense
Time frame: 3 weeks
neck disability index
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2017.
- Individual participant dataSharing planned: Undecided. only coded data (describtive)
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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.
samar alansari, master principal investigator
Imam Abdulrahman Bin Faisal 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 mulligan mobilization and maitland mobilization in people with Nonspecific Neck Pain, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
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 8 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 20 Sep 2017. 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 Saudi Arabia. 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?
Results are not available in the source record.
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 pressure threshold (time frame: 3 weeks). The study lists 2 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 20 Sep 2017.