Orthopedic Disorder of SpineTheEffectNCT05074576
The Effect of Mulligan Mobilization Technique
A study testing Mulligan group in people with Orthopedic Disorder of Spine and Manual Therapy, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effect of the Mulligan mobilization technique on pain intensity and range of motion individuals with neck pain. The patients were randomized into two groups. Group 1 is the Mulligan Mobilization group and the second group is the control group. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Orthopedic Disorder of Spine, Manual Therapy, Physical Therapy
- What is being tested?
- Mulligan group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2020to 15 Nov 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being between age of 25-65 years,
- having neck pain for at least 2 weeks,
- participants that were diagnosed with MNP by a doctor,
- having no contraindicated condition for manual treatment.
Who cannot join
- surgical indications and/ or surgery history for cervical region,
- history of trauma to the cervical region and those with systemic disease,
- participation of physical therapy and rehabilitation program in the last one year,
- fibromyalgia,
- presence of cardiac pacemaker,
- intra-articular steroid injection in neck joint in the last three months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Mulligan Mobilization Technique Application in Addition to Classical Therapies on Pain and Joint Range of Motion People With Neck Pain
The aim of this study is to investigate the effect of the Mulligan mobilization technique on pain intensity and range of motion individuals with neck pain. The patients were randomized into two groups. Group 1 is the Mulligan Mobilization group and the second group is the control group.
Read the detailed description
The study is designed as a single-center, parallel-group, randomized controlled clinical trial in Istanbul Medipol university hospital.
The study will be conducted on 40 volunteers with mechanical neck pain. The patients were randomized into two groups. Groups were determined by randomization method with closed box. A random paper was drawn for the participants included in the study.
Inclusion criterias are being between age of 25-65 years, having neck pain for at least 2 weeks, participants that were diagnosed with MNP by a doctor, having no contraindicated condition for manual treatment. Exclusion criterias were surgical indications and/ or surgery history for cervical region, history of trauma to the cervical region and those with systemic disease, participation of physical therapy and rehabilitation program in the last one year, fibromyalgia, presence of cardiac pacemaker, intra-articular steroid injection in neck joint in the last three months.
In the intervention; Mulligan mobilization technique, electroterapy and active range of motion and stretching exercises carried out in Mulligan group while only electrotherapy agents and exercises are applied as a classical treatment to the control group. Goniometer for the range of motion of the neck (ROM), Visual Analogue Scale (VAS), Neck Pain And Disability Scale (NPDS), Short Form Health Survey (SF-36) will be used for evaluation.
- Being tested
- Mulligan group, Control group
- Keywords
- Mulligan Mobilization, Mechanical Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mulligan groupOther
Ultrasound (8minutes, 1.5 w/cm2, pulsed), conventional transcutaneous electrical nerve stimulation (TENS) (20 minutes, 60-120 Hz frequency) and hot pack application (20 minutes) and interferential current (100 rpm) as electrotherapy agents. In addition to the conventional treatments, Sustained Natural Apophysial Gliding (SNAG) a type of Mulligan mobilization technique is applied. Mobilization is performed by giving 15-20 seconds rest between 3 sets of 4-5 repetations.
Patients were treated in a sitting position. SNAG technique was applied by the physiotherapist at each on spinal level. Active movement with using passive manual force in the direction of translation or rotation was applied to the cervical vertebrae. At the end range of the joint, overpressure was applied by the patient himself
Control groupOther
Electroterapy agents are applied in the same conditions with Mulligan Group. Active neck, shoulder and thoracic region exercises for correction postural misalignment are performed in both groups. All exercises were done in 3 sets of 10 repetitions. Stretching exercises of upper part of Trapezius, sternocleidomastoideus and pectoral muscles are done with 10 repetitions and for 15-30 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Mulligan group | Experimental | In addition to the conventional treatments, Sustained Natural Apophysial Gliding (SNAG) a type of Mulligan mobilization technique is applied. Receives: Other: Mulligan group |
| Control group | Other | Electroterapy agents are applied in the contro group Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of Motion
Universal goniometer is used to measure the joint position and joint range of motion measurements based on Kendall and American Association of Orthopedic Surgeons. The participant is in the sitting position and asked to perform active cervical region flexion, extension, right and left rotation, right and left lateral flexion of the neck movements and performed degrees are recorded.
Measured: 10 minutes
Pain status
Pain intensity is evaluated with visual analog scale (VAS) in two conditions during activity and resting time. This method, which is developed to determine the intensity of pain to indicate by numbers. It begins with the absence of pain (0) on numerical scale and ends the level of unbearable pain
Measured: 5 minutes
Life quality
Quality of life of the participants are evaluated by Short Form 36 (SF-36). It is a self-assessment scale developed by Rond Corporation in 1992. Short Form 36 (SF-36) is a personalized scale that assesses the general health status of the patients with 36 questions, 8 Sub-Items (Physical function, physical role weakness, body pain, general health, vitality, social function, emotional function, mental function). SF-36 scale is scored from 0 to 100 (0 = worst, 100 = best)
Measured: 15 minutes
Disability status
The items assess the severity of pain and the relationship between pain, occupational, social, recreational, emotional factors. It determines the effect of neck pain on disability, functionality and quality of life. Total score is the sum of the points in each item and ranges from 0 to 100. High scores indicate that more affected status
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start15 Aug 2020
- Primary completion15 Oct 2021 (estimated)
- Study completion15 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Orthopedic Disorder of SpineStudies of the same condition, open and under way.
- More trials run by Istanbul Medipol University HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ozluozge, Istanbul Medipol University Hospital
- Investigators
- OZGE OZLU, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05074576
- Sponsor's protocol ID
- ozluozge
- Acronym
- TheEffect
- Status last verified
- Sep 2021
- First submitted
- 29 Sep 2021
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: When I will publish this manuscript in a journal, I would share the results of individual participant data of this study with other researchers.
Publications
Ganesh GS, Mohanty P, Pattnaik M, Mishra C. Effectiveness of mobilization therapy and exercises in mechanical neck pain. Physiother Theory Pract. 2015 Feb;31(2):99-106. doi: 10.3109/09593985.2014.963904. Epub 2014 Sep 29.
PubMed 25264016Ozlu O, Sahin M. The effect of mulligan mobilization technique application in addition to conventional physiotherapy on pain and joint range of motion in people with neck pain. J Bodyw Mov Ther. 2024 Jul;39:225-230. doi: 10.1016/j.jbmt.2024.02.009. Epub 2024 Mar 5.
PubMed 38876630
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mulligan Mobilization Technique Application in Addition to Classical Therapies on Pain and Joint Range of Motion People With Neck Pain
- ClinicalTrials.gov ID
- NCT05074576
- Acronym / sponsor ID
- TheEffect / ozluozge
- Keywords
- Mulligan Mobilization, Mechanical Neck Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 15 Aug 2020 (actual)
- Primary completion
- 15 Oct 2021 (estimated)
- Study completion
- 15 Nov 2021 (estimated)
- First posted
- 12 Oct 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.
The aim of this study is to investigate the effect of the Mulligan mobilization technique on pain intensity and range of motion individuals with neck pain. The patients were randomized into two groups. Group 1 is the Mulligan Mobilization group and the second group is the control group.
Detailed description
The study is designed as a single-center, parallel-group, randomized controlled clinical trial in Istanbul Medipol university hospital.
The study will be conducted on 40 volunteers with mechanical neck pain. The patients were randomized into two groups. Groups were determined by randomization method with closed box. A random paper was drawn for the participants included in the study.
Inclusion criterias are being between age of 25-65 years, having neck pain for at least 2 weeks, participants that were diagnosed with MNP by a doctor, having no contraindicated condition for manual treatment. Exclusion criterias were surgical indications and/ or surgery history for cervical region, history of trauma to the cervical region and those with systemic disease, participation of physical therapy and rehabilitation program in the last one year, fibromyalgia, presence of cardiac pacemaker, intra-articular steroid injection in neck joint in the last three months.
In the intervention; Mulligan mobilization technique, electroterapy and active range of motion and stretching exercises carried out in Mulligan group while only electrotherapy agents and exercises are applied as a classical treatment to the control group. Goniometer for the range of motion of the neck (ROM), Visual Analogue Scale (VAS), Neck Pain And Disability Scale (NPDS), Short Form Health Survey (SF-36) will be used for evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mulligan group | Experimental | Other: Mulligan groupIn addition to the conventional treatments, Sustained Natural Apophysial Gliding (SNAG) a type of Mulligan mobilization technique is applied. |
| Control group | Other | Other: Control groupElectroterapy agents are applied in the contro group |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being between age of 25-65 years,
- having neck pain for at least 2 weeks,
- participants that were diagnosed with MNP by a doctor,
- having no contraindicated condition for manual treatment.
Key exclusion criteria (6 listed)
- surgical indications and/ or surgery history for cervical region,
- history of trauma to the cervical region and those with systemic disease,
- participation of physical therapy and rehabilitation program in the last one year,
- fibromyalgia,
- presence of cardiac pacemaker,
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 groupUltrasound (8minutes, 1.5 w/cm2, pulsed), conventional transcutaneous electrical nerve stimulation (TENS) (20 minutes, 60-120 Hz frequency) and hot pack application (20 minutes) and interferential current (100 rpm) as electrotherapy agents. In addition to the conventional treatments, Sustained Natural Apophysial Gliding (SNAG) a type of Mulligan mobilization technique is applied. Mobilization is performed by giving 15-20 seconds rest between 3 sets of 4-5 repetations. Patients were treated in a sitting position. SNAG technique was applied by the physiotherapist at each on spinal level. Active movement with using passive manual force in the direction of translation or rotation was applied to the cervical vertebrae. At the end range of the joint, overpressure was applied by the patient himself | Other | Mulligan group |
| Control groupElectroterapy agents are applied in the same conditions with Mulligan Group. Active neck, shoulder and thoracic region exercises for correction postural misalignment are performed in both groups. All exercises were done in 3 sets of 10 repetitions. Stretching exercises of upper part of Trapezius, sternocleidomastoideus and pectoral muscles are done with 10 repetitions and for 15-30 seconds. | Other | Control group |
Primary outcome
Range of Motion
Time frame: 10 minutes
Universal goniometer is used to measure the joint position and joint range of motion measurements based on Kendall and American Association of Orthopedic Surgeons. The participant is in the sitting position and asked to perform active cervical region flexion, extension, right and left rotation, right and left lateral flexion of the neck movements and performed degrees are recorded.
Pain status
Time frame: 5 minutes
Pain intensity is evaluated with visual analog scale (VAS) in two conditions during activity and resting time. This method, which is developed to determine the intensity of pain to indicate by numbers. It begins with the absence of pain (0) on numerical scale and ends the level of unbearable pain
Life quality
Time frame: 15 minutes
Quality of life of the participants are evaluated by Short Form 36 (SF-36). It is a self-assessment scale developed by Rond Corporation in 1992. Short Form 36 (SF-36) is a personalized scale that assesses the general health status of the patients with 36 questions, 8 Sub-Items (Physical function, physical role weakness, body pain, general health, vitality, social function, emotional function, mental function). SF-36 scale is scored from 0 to 100 (0 = worst, 100 = best)
Disability status
Time frame: 10 minutes
The items assess the severity of pain and the relationship between pain, occupational, social, recreational, emotional factors. It determines the effect of neck pain on disability, functionality and quality of life. Total score is the sum of the points in each item and ranges from 0 to 100. High scores indicate that more affected status
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- Results publication: PubMed 25264016Ganesh GS, Mohanty P, Pattnaik M, Mishra C. Effectiveness of mobilization therapy and exercises in mechanical neck pain. Physiother Theory Pract. 2015 Feb;31(2):99-106. doi: 10.3109/09593985.2014.963904. Epub 2014 Sep 29.
- Derived from this study: PubMed 38876630Ozlu O, Sahin M. The effect of mulligan mobilization technique application in addition to conventional physiotherapy on pain and joint range of motion in people with neck pain. J Bodyw Mov Ther. 2024 Jul;39:225-230. doi: 10.1016/j.jbmt.2024.02.009. Epub 2024 Mar 5.
- Individual participant dataSharing planned: No. When I will publish this manuscript in a journal, I would share the results of individual participant data of this study with other researchers.
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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.
OZGE OZLU principal investigator
Medipol 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 group in people with Orthopedic Disorder of Spine and Manual Therapy, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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 4 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: status not confirmed, as of the sponsor's last update on 12 Oct 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 Turkey (Türkiye). 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?
Range of Motion (time frame: 10 minutes). The study lists 4 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 NCT05074576, which also lists 2 linked publications.
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 12 Oct 2021.