Neck PainNCT02695108
Scapular Stabilization Exercise on Neck Pain
A study testing classical approach for neck pain and scapular exercise on neck pain in people with Neck Pain, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Neck pain is a very common problem in the population. Most of the patients suffer from neck pain for long time and the problem becomes chronic. The investigators studied the effects of scapular stabilization exercise on mechanical neck pain. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- classical approach for neck pain and scapular exercise on neck pain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2016to 15 Mar 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- having neck pain at least 6 months
- having score of at least 10 points from Neck Disability Index
- having type-1, type-2 or type-3 scapula from Kibler's four types rating system
- no previous shoulder or neck surgery
- no accompanying shoulder problem
Who cannot join
- no complying to the rehabilitation
- if patient wants to finished and don't want to complete study, they were excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Scapular Stabilization Exercise on Mechanical Neck Pain: A Randomized Control
Neck pain is a very common problem in the population. Most of the patients suffer from neck pain for long time and the problem becomes chronic. The investigators studied the effects of scapular stabilization exercise on mechanical neck pain.
Read the detailed description
Neck is one of the most common musculoskeletal problem in the world. Yet the problem still haven't been understood and solved completely. Its incidence is also becoming higher and most people who have neck pain suffer from it for long time. Several problems have been related to neck pain. Hence, the investigators designed a study to see the effects of scapular stabilization exercise on neck pain.
- Conditions
- Neck Pain
- Being tested
- classical approach for neck pain, scapular exercise on neck pain
- Keywords
- Scapula, Neck, Pain, Therapy, Kinematic
- Medical subject headings
- Neck Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
classical approach for neck painOther
Patients with mechanical neck pain were instructed to do cervical exercise
scapular exercise on neck painOther
Patients with mechanical neck pain were instructed to do scapular stabilization and cervical exercise
| Study group | Role | What they receive |
|---|---|---|
| classical approach for neck pain | Experimental | patients in this arm received classical approaches for neck pain. Cervical manual therapy was performed on patients in this arm and they were also instructed to to perform cervical endurance, strength and stretching exercises. Rehabilitation period was lasted for 6 weeks. Pain, quality of life and scapular kinematics were assessed before and after rehabilitation program. Receives: Other: classical approach for neck pain |
| scapular exercise on neck pain | Experimental | patients in this arm received cervical manual therapy and cervical exercises too. Apart from cervical manual therapy and cervical exercises,patients also performed scapular stabilization exercise targeting trapezius, serratus anterior and rhomboid muscles. Rehabilitation period was lasted for 6 weeks. The same assessment parameters was conducted on this arm too. Receives: Other: scapular exercise on neck pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck pain measured with Visual Analog Scale
Patient's neck was measured with Visual Analog Scale
Measured: 6 weeks
Secondary outcomes (2)
Quality of Life measured with Neck Disability Index
Patient's quality of life was measured with Neck Disability Index
Measured: 6 weeks
Scapular Kinematics measured with 3-D motion monitor device
Patient's scapular kinematics was measured with 3-D motion monitor device
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2016 (estimated)
- Study start15 Feb 2016
- Primary completion15 Dec 2016
- Study completion15 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taha İbrahim Yıldız, Hacettepe University
- Investigators
- İrem Düzgün, Study director, supervisor of the study
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02695108
- Sponsor's protocol ID
- GO 14/498
- Status last verified
- Aug 2019
- First submitted
- 9 Feb 2016
- Last updated
- 8 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Helgadottir H, Kristjansson E, Mottram S, Karduna AR, Jonsson H Jr. Altered scapular orientation during arm elevation in patients with insidious onset neck pain and whiplash-associated disorder. J Orthop Sports Phys Ther. 2010 Dec;40(12):784-91. doi: 10.2519/jospt.2010.3405. Epub 2010 Oct 22.
PubMed 20972341Helgadottir H, Kristjansson E, Einarsson E, Karduna A, Jonsson H Jr. Altered activity of the serratus anterior during unilateral arm elevation in patients with cervical disorders. J Electromyogr Kinesiol. 2011 Dec;21(6):947-53. doi: 10.1016/j.jelekin.2011.07.007. Epub 2011 Sep 1.
PubMed 21889362Cagnie B, Struyf F, Cools A, Castelein B, Danneels L, O'leary S. The relevance of scapular dysfunction in neck pain: a brief commentary. J Orthop Sports Phys Ther. 2014 Jun;44(6):435-9. doi: 10.2519/jospt.2014.5038. Epub 2014 May 10.
PubMed 24816504
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scapular Stabilization Exercise on Mechanical Neck Pain: A Randomized Control
- ClinicalTrials.gov ID
- NCT02695108
- Acronym / sponsor ID
- GO 14/498
- Conditions
- Neck Pain
- Keywords
- Scapula, Neck, Pain, Therapy, Kinematic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 15 Feb 2016 (actual)
- Primary completion
- 15 Dec 2016 (actual)
- Study completion
- 15 Mar 2017 (actual)
- First posted
- 1 Mar 2016 (estimated)
- 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.
Neck pain is a very common problem in the population. Most of the patients suffer from neck pain for long time and the problem becomes chronic. The investigators studied the effects of scapular stabilization exercise on mechanical neck pain.
Detailed description
Neck is one of the most common musculoskeletal problem in the world. Yet the problem still haven't been understood and solved completely. Its incidence is also becoming higher and most people who have neck pain suffer from it for long time. Several problems have been related to neck pain. Hence, the investigators designed a study to see the effects of scapular stabilization exercise on neck pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| classical approach for neck pain | Experimental | Other: classical approach for neck painpatients in this arm received classical approaches for neck pain. Cervical manual therapy was performed on patients in this arm and they were also instructed to to perform cervical endurance, strength and stretching exercises. Rehabilitation period was lasted for 6 weeks. Pain, quality of life and scapular kinematics were assessed before and after rehabilitation program. |
| scapular exercise on neck pain | Experimental | Other: scapular exercise on neck painpatients in this arm received cervical manual therapy and cervical exercises too. Apart from cervical manual therapy and cervical exercises,patients also performed scapular stabilization exercise targeting trapezius, serratus anterior and rhomboid muscles. Rehabilitation period was lasted for 6 weeks. The same assessment parameters was conducted on this arm too. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- having neck pain at least 6 months
- having score of at least 10 points from Neck Disability Index
- having type-1, type-2 or type-3 scapula from Kibler's four types rating system
- no previous shoulder or neck surgery
- no accompanying shoulder problem
Key exclusion criteria (2 listed)
- no complying to the rehabilitation
- if patient wants to finished and don't want to complete study, they were excluded
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 |
|---|---|---|
| classical approach for neck painPatients with mechanical neck pain were instructed to do cervical exercise | Other | classical approach for neck pain |
| scapular exercise on neck painPatients with mechanical neck pain were instructed to do scapular stabilization and cervical exercise | Other | scapular exercise on neck pain |
Primary outcome
Neck pain measured with Visual Analog Scale
Time frame: 6 weeks
Patient's neck was measured with Visual Analog Scale
2 secondary outcomes
Quality of Life measured with Neck Disability Index
Time frame: 6 weeks
Scapular Kinematics measured with 3-D motion monitor device
Time frame: 6 weeks
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 8 Aug 2019.
- Results publication: PubMed 20972341Helgadottir H, Kristjansson E, Mottram S, Karduna AR, Jonsson H Jr. Altered scapular orientation during arm elevation in patients with insidious onset neck pain and whiplash-associated disorder. J Orthop Sports Phys Ther. 2010 Dec;40(12):784-91. doi: 10.2519/jospt.2010.3405. Epub 2010 Oct 22.
- Results publication: PubMed 21889362Helgadottir H, Kristjansson E, Einarsson E, Karduna A, Jonsson H Jr. Altered activity of the serratus anterior during unilateral arm elevation in patients with cervical disorders. J Electromyogr Kinesiol. 2011 Dec;21(6):947-53. doi: 10.1016/j.jelekin.2011.07.007. Epub 2011 Sep 1.
- Results publication: PubMed 24816504Cagnie B, Struyf F, Cools A, Castelein B, Danneels L, O'leary S. The relevance of scapular dysfunction in neck pain: a brief commentary. J Orthop Sports Phys Ther. 2014 Jun;44(6):435-9. doi: 10.2519/jospt.2014.5038. Epub 2014 May 10.
- Individual participant dataSharing planned: Yes
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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.
İrem Düzgün study director
supervisor of the study
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing classical approach for neck pain and scapular exercise on neck pain 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 5 inclusion and 2 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 8 Aug 2019. 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?
Neck pain measured with Visual Analog Scale (time frame: 6 weeks). 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 NCT02695108, which also lists 3 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 8 Aug 2019.