Neck PainNCT03507907
The Effects of Mulligan Mobilization Technique in Older Adults With Neck Pain
A study testing Mulligan Mobilization for Study Group in people with Neck Pain, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
When the literature is examined, there is study investigating the effect of mulligan mobilization technique on older adults with neck pain. This study aims to investigate the effect of mulligan mobilization technique on pain, range of motion, functional level, kinesiophobia, fear of movement, depression and quality of… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Neck Pain
- What is being tested?
- Mulligan Mobilization for Study Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 May 2017to 14 Oct 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Ongoing neck pain for at least 3 months,
- Having no neurological, rheumatological or musculoskeletal problems
- Having not taken any analgesic medication for neck pain for the last 3 months.
Who cannot join
- Neck pain originating from various pathologies
- Presence of cord compression,
- Vertebrobasilar artery insufficiency,
- Severe radiculopathy,
- Osteoporosis or osteopenia (t score>-1),
- Long-term use of anticoagulant or corticosteroid drugs,
- Patients who had received any treatment for their neck pain.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Mulligan Mobilization Technique in Older Adults With Neck Pain: A Randomized Controlled, Double-Blind Study
When the literature is examined, there is study investigating the effect of mulligan mobilization technique on older adults with neck pain. This study aims to investigate the effect of mulligan mobilization technique on pain, range of motion, functional level, kinesiophobia, fear of movement, depression and quality of life in older adults with neck pain.
Read the detailed description
Neck pain is common in older adults. There are a lot of approaches for treatment of neck pain such as soft tıssue mobilizations, electirical stimulations etc. Mulligan proposes mobilization with movement (MWM) technique for various musculoskeletal disorders. But there is no study related MWM for older adults with neck pain. The purpose of this study is to examine the effect of mulligan mobilization technique on pain, range of motion (ROM), functional level, kinesiophobia, depression and quality of life (QoL) in older adults with neck pain. The hypothesis of our study is MWM can be effective on ROM, kinesiophobia, depression and QoL in older adults with neck pain.
- Conditions
- Neck Pain
- Being tested
- Mulligan Mobilization for Study Group, Conventional therapy for Control Group
- Keywords
- neck pain, older adults, mobilization
- 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 Mobilization for Study GroupOther
Mulligan Mobilization techniques were applied to the older adults who included in study group.
Conventional therapy for Control GroupOther
Conventional therapy was applied to the older adults who included in control group.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Mulligan mobilization techniques were applied to the older adults. Receives: Other: Mulligan Mobilization for Study Group |
| Control Group | Other | Conventional physiotherapy programs were applied to the older adults who included in control group. Receives: Other: Conventional therapy for Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
The severity of pain at rest and during activity was assessed by Visual Analogue Scale (VAS). Participants were questioned about their average pain over the last 4 weeks. They were asked to mark the severity of their pain on a 10-cm-long line where 0 represented no pain, and 10 stood for vicious pain
Measured: 5 months
Secondary outcomes (5)
Neck Disability Index
This scale was used to evaluate how the participants' daily life was influenced by their neck pain. Total score of the scale ranges from 0 to 35 and higher scores indicate higher levels of disability
Measured: 5 months
Tampa Scale of Kinesiophobia
This scale was used to assess the patients' fear of pain or re-injury due to movement. It consists of 17 items and assesses various factors of fear/avoidance and injury/re-injury in several activities. Total score of the scale varies between 17 and 68 and higher scores represent higher levels of kinesiophobia.
Measured: 5 months
Universal goniometer
A universal goniometer was used to assess the range of motion (ROM) of the cervical vertebrae. Cervical flexion, extension, right and left lateral flexion and right and left rotation movements were measured 3 times in active manner while the patients were in a comfortable sitting position. The average value of the measurements was recorded as ROM.
Measured: 5 months
Beck Depression Inventory
Participants' level of depression was assessed using this scale that consists of 21 categories with 4 options in each. Each item has a score between 0 and 3 and total score varies from 0 to 63. Score ranges are interpreted as: 0-9 points = Minor depression, 10-16 points = Mild depression, 17-29 points = Moderate depression, and 30-63 points = Severe depression
Measured: 5 months
Short Form-36
This form was used to assess the quality of life (QoL) of the participants. This questionnaire is consisted of 36 questions that are categorized into 8 groups as following: physical role functioning, emotional role functioning, bodily pain, energy, social role functioning, mental health, and general health perception. Each category is scored on a 0-100 range, and higher scores indicate better QoL
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study start20 May 2017
- Primary completion15 Sep 2017
- Study completion14 Oct 2017
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 Neck PainStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caner Karartı, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03507907
- Sponsor's protocol ID
- 2018300
- Status last verified
- Apr 2018
- First submitted
- 10 Apr 2018
- Last updated
- 25 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Buyukturan O, Buyukturan B, Sas S, Kararti C, Ceylan I. The Effect of Mulligan Mobilization Technique in Older Adults with Neck Pain: A Randomized Controlled, Double-Blind Study. Pain Res Manag. 2018 May 15;2018:2856375. doi: 10.1155/2018/2856375. eCollection 2018.
PubMed 29861800
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Mulligan Mobilization Technique in Older Adults With Neck Pain: A Randomized Controlled, Double-Blind Study
- ClinicalTrials.gov ID
- NCT03507907
- Acronym / sponsor ID
- 2018300
- Conditions
- Neck Pain
- Keywords
- neck pain, older adults, mobilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 20 May 2017 (actual)
- Primary completion
- 15 Sep 2017 (actual)
- Study completion
- 14 Oct 2017 (actual)
- First posted
- 25 Apr 2018 (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.
When the literature is examined, there is study investigating the effect of mulligan mobilization technique on older adults with neck pain. This study aims to investigate the effect of mulligan mobilization technique on pain, range of motion, functional level, kinesiophobia, fear of movement, depression and quality of life in older adults with neck pain.
Detailed description
Neck pain is common in older adults. There are a lot of approaches for treatment of neck pain such as soft tıssue mobilizations, electirical stimulations etc. Mulligan proposes mobilization with movement (MWM) technique for various musculoskeletal disorders. But there is no study related MWM for older adults with neck pain. The purpose of this study is to examine the effect of mulligan mobilization technique on pain, range of motion (ROM), functional level, kinesiophobia, depression and quality of life (QoL) in older adults with neck pain. The hypothesis of our study is MWM can be effective on ROM, kinesiophobia, depression and QoL in older adults with neck pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Other: Mulligan Mobilization for Study GroupMulligan mobilization techniques were applied to the older adults. |
| Control Group | Other | Other: Conventional therapy for Control GroupConventional physiotherapy programs were applied to the older adults who included in control group. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Ongoing neck pain for at least 3 months,
- Having no neurological, rheumatological or musculoskeletal problems
- Having not taken any analgesic medication for neck pain for the last 3 months.
Key exclusion criteria (7 listed)
- Neck pain originating from various pathologies
- Presence of cord compression,
- Vertebrobasilar artery insufficiency,
- Severe radiculopathy,
- Osteoporosis or osteopenia (t score>-1),
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 Mobilization for Study GroupMulligan Mobilization techniques were applied to the older adults who included in study group. | Other | Study Group |
| Conventional therapy for Control GroupConventional therapy was applied to the older adults who included in control group. | Other | Control Group |
Primary outcome
Visual Analogue Scale
Time frame: 5 months
The severity of pain at rest and during activity was assessed by Visual Analogue Scale (VAS). Participants were questioned about their average pain over the last 4 weeks. They were asked to mark the severity of their pain on a 10-cm-long line where 0 represented no pain, and 10 stood for vicious pain
5 secondary outcomes
Neck Disability Index
Time frame: 5 months
Tampa Scale of Kinesiophobia
Time frame: 5 months
Universal goniometer
Time frame: 5 months
Beck Depression Inventory
Time frame: 5 months
Short Form-36
Time frame: 5 months
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 25 Apr 2018.
- Derived from this study: PubMed 29861800Buyukturan O, Buyukturan B, Sas S, Kararti C, Ceylan I. The Effect of Mulligan Mobilization Technique in Older Adults with Neck Pain: A Randomized Controlled, Double-Blind Study. Pain Res Manag. 2018 May 15;2018:2856375. doi: 10.1155/2018/2856375. eCollection 2018.
- Individual participant dataSharing planned: Undecided
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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 Mobilization for Study Group in people with Neck Pain, run by Hacettepe University 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 3 inclusion and 7 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 25 Apr 2018. 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?
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?
Visual Analogue Scale (time frame: 5 months). 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 NCT03507907, 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 25 Apr 2018.