Neck PainNCT06858124
Mulligan vs Maitland With Home-Based Exercise for Non-Specific Neck Pain
A study testing Mulligan+TE and Maitland+TE in people with Neck Pain, run by International Hellenic University at 1 site in Greece.
Trial summary
Non-specific neck pain (NSNP) is a prevalent musculoskeletal condition with multiple contributing factors. The aim of this clinical study is to investigate the short-term effects of Mulligan in comparison to Maitland mobilization techniques in conjunction with a home-based therapeutic exercise program. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Mulligan+TE and Maitland+TE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteGreece
- Study dates
- 27 Feb 2025to 5 Apr 2025
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Acute-subacute-chronic neck pain
- Women - Men
- Age range between 18 and 30 years
- NPRS score >2
- Written consent to participate in the study
Who cannot join
- • Previous cervical/thoracic surgery
- Recent whiplash (≤6 months)
- Upper cervical pathology
- Osteoporosis
- Pregnancy
- Cancer
Show all 9Show fewer
- Systemic diseases or spinal disorders
- Neurological symptoms
- Severe medical conditions, positive red flags (Spurling test, Hoffmann's sign, Babinski reflex, clonus)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Mulligan and Maitland Mobilization Techniques Combined With Home-Based Exercise for Non-Specific Neck Pain: A Randomized Controlled Trial
Non-specific neck pain (NSNP) is a prevalent musculoskeletal condition with multiple contributing factors. The aim of this clinical study is to investigate the short-term effects of Mulligan in comparison to Maitland mobilization techniques in conjunction with a home-based therapeutic exercise program. 43 adults with non-specific neck pain will be randomly divided into three groups of 14,14 and 15 participants each. In the participants of the first group, a therapeutic protocol of Mulligan mobilizations in the cervical region will be applied and a protocol of exercises will be performed. To the participants of the second group, a therapeutic protocol od Maitland mobilizations in the cervical region will be applied and the same exercise program with the first group will be performed. The third group participants will perform only the same exercise protocol as the other groups. The first two groups will receive four mobilization treatments over two weeks. All three groups will perform the home-based exercise protocol daily for two weeks. Pain in the last 24 hours with the Numeric Pain Rating Scale (NPRS), Pressure Pain Threshold (PPT) in the cervical region with an algometer, functional ability with the Neck Disability Index (NDI), Range of Motion (ROM) with a digital goniometer, pain catastrophizing with the Pain Catastrophizing Scale (PCS) and kinesiophobia with the Tampa Scale of Kinesiophobia (TSK) will be evaluated before and after the intervention. For the statistical analysis of the results, a two-way repeated measures analysis of variance (ANOVA) will be applied using SPSS program, while the statistical significance index will be set at p < .05.
Read the detailed description
Background: Non-specific neck pain (NSNP) is a prevalent musculoskeletal condition with multiple contributing factors. Various manual therapy approaches, such as Mulligan and Maitland mobilizations, are commonly applied to alleviate pain and enhance function.
Aim: The purpose of this clinical study is to investigate the short-term effects of Mulligan in comparison to Maitland mobilization techniques in conjunction with a home-based therapeutic exercise (TE) program.
Method: 43 participants with non-specific neck pain will be randomly assigned to three groups of 14, 14 and 15 participants each. In the participants of the first group, a therapeutic protocol of mulligan mobilizations will be applied to the cervical region. In addition, the participants will perform a home-based therapeutic exercise program. To the participants of the second group, a therapeutic protocol of maitland mobilizations will be applied to the cervical region and they will perform the same home-based exercise protocol with the first group. The third group participants will perform only the same home-based exercise protocol with the other groups. The first two groups will receive four mobilization treatments over two weeks. All three groups will perform the home-based exercise protocol daily for two weeks. Pain in the last 24 hours with the Numeric Pain Rating Scale (NPRS), Pressure Pain Threshold (PPT) in the cervical region with an algometer, functional ability with the Neck Disability Index (NDI), Range of Motion (ROM) with a digital goniometer, pain catastrophizing with the Pain Catastrophizing Scale (PCS) and kinesiophobia with the Tampa Scale of Kinesiophobia (TSK) will be evaluated before and after the intervention. For the statistical analysis of the results, a two-way repeated measures analysis of variance (ANOVA) will be applied using SPSS program, while the statistical significance index will be set at p < .05. Expected results: The protocol proposed in this clinical study combines the benefits of applying manual therapy mobilizations with the beneficial effects of therapeutic exercise. Previous research shows Mulligan mobilizations may be slightly more beneficial in improving patients' symptoms with non-specific neck pain. For this reason, we expect that the combination of Mulligan mobilizations and home-based therapeutic exercise will be more effective than the combination of Maitland mobilizations and home-based therapeutic exercise only in improving the clinical symptoms of young adults with non-specific neck pain.
- Conditions
- Neck Pain
- Being tested
- Mulligan+TE, Maitland+TE, Control
- Keywords
- Non-Specific Neck Pain, Mulligan, Maitland
- 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+TEOther
Mulligan Mobilizations plus Home Therapeutic Exercise
The protocol will last 25 minutes (Mulligan protocol: 5 minutes and Home Therapeutic Exercise protocol: 20 minutes) and will include the application of the following mulligan techniques and home exercises:
- Mulligan sustained natural apophyseal glide SNAG mobilizations with overpressure with the patients in seated position.
- 4 home-based therapeutic exercises: isometric exercises for cervical regions, head retractions, thoracic spine rotation mobility exercise and diagonal cervical mobility exercise pattern.
Maitland+TEOther
The participants of this group will perform the same 4 home-based therapeutic exercises as the first group. In addition, they will receive a 5-minute maitland mobilization protocol.
Maitland mobilizations will include posterioranterior glides with oscillations with the patients in prone position.
ControlOther
Participants in this group will only perform the same 4 home-based therapeutic exercises as the first group.
| Study group | Role | What they receive |
|---|---|---|
| Mulligan+TE | Experimental | Participants allocated to this group will receive four sessions of Mulligan mobilizations and will perform a home-based therapeutic exercise program for two weeks. Receives: Other: Mulligan+TE |
| Maitland +TE | Experimental | Participants allocated to this group will receive four sessions of Maitland mobilizations and will perform a home-based therapeutic exercise program for two weeks. Receives: Other: Maitland+TE |
| Active Comparator: "TE group". | Active comparator | Participants in this group will only perform the same 4 home-based therapeutic exercises as the first group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in neck pain intensity with Numeric Pain Rating Scale (NPRS)
This tool is an 11-point scale from 0 ("no pain") to 10 ("worst imaginable pain"). Consequently, a higher value indicates more intense pain. The participant selects a number that best represents their pain intensity. The NPRS is a well-validated tool commonly used to measure pain intensity in clinical practice and research.
Measured: pre-treatment, week: 2
Changes in Pressure Pain Threshold (PPT) with pressure algometry
Pressure pain threshold (PPT) is defined as the minimal amount of pressure that produces pain. PPT will be assessed by a digital algometer and will be evaluated bilaterally in the upper trapezius muscle, between C7 and the acromion. The rubber tip of the algometer will be placed vertically on the site and the examiner will apply gradually increasing pressure in a rate of 1Kg/s.
Measured: pre-treatment, week: 2
Changes in cervical range of motion with digital goniometry
The cervical ROM of cervical flexion, extension, side bends and rotations will be assessed using a digital goniometer with the patient in the seated position. Each movement will be carried out once within the maximum pain-free range and will be documented by an independent physiotherapist
Measured: pre-treatment, week: 2
Changes in functional ability with Neck Disability Index (NDI)
The Neck Disability Index (NDI), validated for the Greek population, will be used to assess disability. It comprises 10 sections that evaluate pain intensity, functional restrictions, and daily activities, with a total score ranging from 0 (no disability) to 50 (severe disability).
Measured: pre-treatment, week: 2]
Changes in pain catastrophizing with Pain Catastrophizing Scale (PCS
The Pain Catastrophizing Scale (PCS) will be used to assess pain catastrophizing. It is a 13-item questionnaire designed to assess catastrophic thinking related to pain. Scores range from 0 to 52, with higher scores reflecting greater levels of catastrophizing across the subscales of rumination, magnification, and helplessness. The Greek version demonstrates high reliability (ICC = 0.85, Cronbach's α = 0.80).
Measured: pre-treatment, week: 2]
Changes in kinesiophobia with Tampa Scale of Kinesiophobia (TSK)
Kinesiophobia will be evaluated using the Tampa Scale of Kinesiophobia (TSK), a 17-item questionnaire that assesses fear of movement and anxiety related to injury. Scores range from 17 to 68, with ≤37 indicating low kinesiophobia and >37 representing high kinesiophobia. The Greek version has demonstrated good reliability (Cronbach's α = 0.74, ICC = 0.78).
Measured: pre-treatment, week: 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start27 Feb 2025
- Primary completion5 Apr 2025
- Study completion5 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Not applicable
- Intervention model
- Parallel groups
- Model description
- 43 participants with non-specific neck pain pain will be randomly assigned to three groups of 14, 14 and 15 participants each. The allocation of the sample to the groups will be performed using the randomization app Randomiser (Rob Sammons, Apple Store) by an independent researcher. In the first group, a mulligan mobilization protocol will be applied and the practitioners will follow a daily therapeutic exercise program at home, in the second group, a maitland mobilization protocol will be applied and the practitioners will follow a daily therapeutic exercise program at home, while the third group will follow only a daily therapeutic exercise program at home. Participants of the two intervention groups will follow a total of four treatments over a period of two weeks. The therapeutic home-based exercise program will be performed daily over the same period of two weeks.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Hellenic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dimitrios Lytras, International Hellenic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06858124
- Sponsor's protocol ID
- EC-5/2025
- Status last verified
- Apr 2025
- First submitted
- 27 Feb 2025
- Last updated
- 16 Apr 2025
- 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 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Mulligan and Maitland Mobilization Techniques Combined With Home-Based Exercise for Non-Specific Neck Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06858124
- Acronym / sponsor ID
- EC-5/2025
- Conditions
- Neck Pain
- Keywords
- Non-Specific Neck Pain, Mulligan, Maitland
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- International Hellenic UniversityUniversity, hospital or other
- Study start
- 27 Feb 2025 (actual)
- Primary completion
- 5 Apr 2025 (actual)
- Study completion
- 5 Apr 2025 (actual)
- First posted
- 5 Mar 2025 (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.
Non-specific neck pain (NSNP) is a prevalent musculoskeletal condition with multiple contributing factors. The aim of this clinical study is to investigate the short-term effects of Mulligan in comparison to Maitland mobilization techniques in conjunction with a home-based therapeutic exercise program. 43 adults with non-specific neck pain will be randomly divided into three groups of 14,14 and 15 participants each. In the participants of the first group, a therapeutic protocol of Mulligan mobilizations in the cervical region will be applied and a protocol of exercises will be performed. To the participants of the second group, a therapeutic protocol od Maitland mobilizations in the cervical region will be applied and the same exercise program with the first group will be performed. The third group participants will perform only the same exercise protocol as the other groups. The first two groups will receive four mobilization treatments over two weeks. All three groups will perform the home-based exercise protocol daily for two weeks. Pain in the last 24 hours with the Numeric Pain Rating Scale (NPRS), Pressure Pain Threshold (PPT) in the cervical region with an algometer, functional ability with the Neck Disability Index (NDI), Range of Motion (ROM) with a digital goniometer, pain catastrophizing with the Pain Catastrophizing Scale (PCS) and kinesiophobia with the Tampa Scale of Kinesiophobia (TSK) will be evaluated before and after the intervention. For the statistical analysis of the results, a two-way repeated measures analysis of variance (ANOVA) will be applied using SPSS program, while the statistical significance index will be set at p < .05.
Detailed description
Background: Non-specific neck pain (NSNP) is a prevalent musculoskeletal condition with multiple contributing factors. Various manual therapy approaches, such as Mulligan and Maitland mobilizations, are commonly applied to alleviate pain and enhance function.
Aim: The purpose of this clinical study is to investigate the short-term effects of Mulligan in comparison to Maitland mobilization techniques in conjunction with a home-based therapeutic exercise (TE) program.
Method: 43 participants with non-specific neck pain will be randomly assigned to three groups of 14, 14 and 15 participants each. In the participants of the first group, a therapeutic protocol of mulligan mobilizations will be applied to the cervical region. In addition, the participants will perform a home-based therapeutic exercise program. To the participants of the second group, a therapeutic protocol of maitland mobilizations will be applied to the cervical region and they will perform the same home-based exercise protocol with the first group. The third group participants will perform only the same home-based exercise protocol with the other groups. The first two groups will receive four mobilization treatments over two weeks. All three groups will perform the home-based exercise protocol daily for two weeks. Pain in the last 24 hours with the Numeric Pain Rating Scale (NPRS), Pressure Pain Threshold (PPT) in the cervical region with an algometer, functional ability with the Neck Disability Index (NDI), Range of Motion (ROM) with a digital goniometer, pain catastrophizing with the Pain Catastrophizing Scale (PCS) and kinesiophobia with the Tampa Scale of Kinesiophobia (TSK) will be evaluated before and after the intervention. For the statistical analysis of the results, a two-way repeated measures analysis of variance (ANOVA) will be applied using SPSS program, while the statistical significance index will be set at p < .05. Expected results: The protocol proposed in this clinical study combines the benefits of applying manual therapy mobilizations with the beneficial effects of therapeutic exercise. Previous research shows Mulligan mobilizations may be slightly more beneficial in improving patients' symptoms with non-specific neck pain. For this reason, we expect that the combination of Mulligan mobilizations and home-based therapeutic exercise will be more effective than the combination of Maitland mobilizations and home-based therapeutic exercise only in improving the clinical symptoms of young adults with non-specific neck pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
- Model description
- 43 participants with non-specific neck pain pain will be randomly assigned to three groups of 14, 14 and 15 participants each. The allocation of the sample to the groups will be performed using the randomization app Randomiser (Rob Sammons, Apple Store) by an independent researcher. In the first group, a mulligan mobilization protocol will be applied and the practitioners will follow a daily therapeutic exercise program at home, in the second group, a maitland mobilization protocol will be applied and the practitioners will follow a daily therapeutic exercise program at home, while the third group will follow only a daily therapeutic exercise program at home. Participants of the two intervention groups will follow a total of four treatments over a period of two weeks. The therapeutic home-based exercise program will be performed daily over the same period of two weeks.
| Arm | Type | Receives |
|---|---|---|
| Mulligan+TE | Experimental | Other: Mulligan+TEParticipants allocated to this group will receive four sessions of Mulligan mobilizations and will perform a home-based therapeutic exercise program for two weeks. |
| Maitland +TE | Experimental | Other: Maitland+TEParticipants allocated to this group will receive four sessions of Maitland mobilizations and will perform a home-based therapeutic exercise program for two weeks. |
| Active Comparator: "TE group". | Active comparator | –Participants in this group will only perform the same 4 home-based therapeutic exercises as the first group. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Acute-subacute-chronic neck pain
- Women - Men
- Age range between 18 and 30 years
- NPRS score >2
- Written consent to participate in the study
Key exclusion criteria (9 listed)
- • Previous cervical/thoracic surgery
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+TEMulligan Mobilizations plus Home Therapeutic Exercise The protocol will last 25 minutes (Mulligan protocol: 5 minutes and Home Therapeutic Exercise protocol: 20 minutes) and will include the application of the following mulligan techniques and home exercises: * Mulligan sustained natural apophyseal glide SNAG mobilizations with overpressure with the patients in seated position. * 4 home-based therapeutic exercises: isometric exercises for cervical regions, head retractions, thoracic spine rotation mobility exercise and diagonal cervical mobility exercise pattern. | Other | Mulligan+TE |
| Maitland+TEThe participants of this group will perform the same 4 home-based therapeutic exercises as the first group. In addition, they will receive a 5-minute maitland mobilization protocol. Maitland mobilizations will include posterioranterior glides with oscillations with the patients in prone position. | Other | Maitland +TE |
| ControlParticipants in this group will only perform the same 4 home-based therapeutic exercises as the first group. | Other | – |
Primary outcome
Changes in neck pain intensity with Numeric Pain Rating Scale (NPRS)
Time frame: pre-treatment, week: 2
This tool is an 11-point scale from 0 ("no pain") to 10 ("worst imaginable pain"). Consequently, a higher value indicates more intense pain. The participant selects a number that best represents their pain intensity. The NPRS is a well-validated tool commonly used to measure pain intensity in clinical practice and research.
Changes in Pressure Pain Threshold (PPT) with pressure algometry
Time frame: pre-treatment, week: 2
Pressure pain threshold (PPT) is defined as the minimal amount of pressure that produces pain. PPT will be assessed by a digital algometer and will be evaluated bilaterally in the upper trapezius muscle, between C7 and the acromion. The rubber tip of the algometer will be placed vertically on the site and the examiner will apply gradually increasing pressure in a rate of 1Kg/s.
Changes in cervical range of motion with digital goniometry
Time frame: pre-treatment, week: 2
The cervical ROM of cervical flexion, extension, side bends and rotations will be assessed using a digital goniometer with the patient in the seated position. Each movement will be carried out once within the maximum pain-free range and will be documented by an independent physiotherapist
Changes in functional ability with Neck Disability Index (NDI)
Time frame: pre-treatment, week: 2]
The Neck Disability Index (NDI), validated for the Greek population, will be used to assess disability. It comprises 10 sections that evaluate pain intensity, functional restrictions, and daily activities, with a total score ranging from 0 (no disability) to 50 (severe disability).
Changes in pain catastrophizing with Pain Catastrophizing Scale (PCS
Time frame: pre-treatment, week: 2]
The Pain Catastrophizing Scale (PCS) will be used to assess pain catastrophizing. It is a 13-item questionnaire designed to assess catastrophic thinking related to pain. Scores range from 0 to 52, with higher scores reflecting greater levels of catastrophizing across the subscales of rumination, magnification, and helplessness. The Greek version demonstrates high reliability (ICC = 0.85, Cronbach's α = 0.80).
Changes in kinesiophobia with Tampa Scale of Kinesiophobia (TSK)
Time frame: pre-treatment, week: 2
Kinesiophobia will be evaluated using the Tampa Scale of Kinesiophobia (TSK), a 17-item questionnaire that assesses fear of movement and anxiety related to injury. Scores range from 17 to 68, with ≤37 indicating low kinesiophobia and >37 representing high kinesiophobia. The Greek version has demonstrated good reliability (Cronbach's α = 0.74, ICC = 0.78).
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 16 Apr 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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+TE and Maitland+TE in people with Neck Pain, run by International Hellenic University at 1 site in Greece.
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 5 inclusion and 9 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 16 Apr 2025. 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 Greece. 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?
Changes in neck pain intensity with Numeric Pain Rating Scale (NPRS) (time frame: pre-treatment, week: 2). The study lists 6 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 16 Apr 2025.