Neck PainNCT01806519
Motor_Control_Neck_SSED
A study of Neck Pain and Forward Head Posture, run by Luleå Tekniska Universitet at 1 site in Sweden.
Trial summary
Neck pain is a common problem in the western world. There is a group of people suffering from neck pain with a reduced ability to maintain an upright posture showing a forward head position and an altered muscle function. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Neck Pain, Forward Head Posture
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 3 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2009to Jan 2011
- 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
- 20 - 50 years of age with pain originating from the neck for at least three months.
- A visual forward head posture.
- Less than105 points on the Örebro musculoskeletal pain screening questionnaire
Who cannot join
- neurological dysfunction.
- former cervical surgery or compression fracture of the spine
- no mental retardation
- no physiotherapy treatment during the last 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Motor Control Intervention of Patients With Forward Head Posture and Persistent Neck Pain - A Single System Experimental Design With 12 Month Follow-up
Neck pain is a common problem in the western world. There is a group of people suffering from neck pain with a reduced ability to maintain an upright posture showing a forward head position and an altered muscle function.
The aim of the study was to evaluate a motor control intervention for patients with persistent neck pain and a forward head posture.
This pilot study used a Single System Experimental Design (SSED) with an A-B-A-design and multiple baselines.
The tailored motor control intervention addressed the faulty postural alignment and the deep muscles of the cervical spine.
- Conditions
- Neck Pain, Forward Head Posture
- Being tested
- Motor control intervention of head posture
- Keywords
- neck pain, motor control, intervention, forward head posture
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor control intervention of head postureBehavioural
The tailored motor control intervention used for motor learning-procedure described by Fitts and Posner, further developed and adapted to rehabilitation of the spine by O´Sullivan.
The stages involved in the process was the Cognitive stage, Associative stage and the Autonomous stage
What is being measured
The primary outcome is the main question the study is designed to answer.
Head posture
The craniovertebral (CV) -angle was used to estimate the cervical curvature and head posture in relation to the thorax being measured with the Head Posture Spinal Curvature Instrument
Measured: Effect from baseline to 8 weeks and being maintained to 12 month
Muscle function of the deep cervical flexors
The Cranio-Cervical Flexion Test (C-CFT) was used to assess the tonic holding abilities of the deep cervical muscles by using a Pressure biofeedback unit.
Measured: Effect from baseline to 8 weeks and being maintained to 12 month
Secondary outcomes (2)
Disability
The Neck Disability Index (NDI) is a self-reported questionnaire with 10 categories where each question estimates the current status, from no disability (0) to full disability within that category used to assess disability.
Measured: Effect from baseline to 8 weeks and being maintained to 12 month
Pain intensity
The pain intensity was evaluated using the 100 mm Visual Analogue Scale (VAS) with the anchors "no pain" and "worst pain imaginable" that assessed the average pain intensity in the neck over the last seven days.
Measured: Effect from baseline to 8 weeks and being maintained to 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2013 (estimated)
- Study startSep 2009
- Primary completionJan 2011
- Study completionJan 2011
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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luleå Tekniska Universitet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Michaelson, Luleå Tekniska Universitet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01806519
- Sponsor's protocol ID
- LTU_SG_5
- Status last verified
- Mar 2013
- First submitted
- 4 Mar 2013
- Last updated
- 7 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Motor Control Intervention of Patients With Forward Head Posture and Persistent Neck Pain - A Single System Experimental Design With 12 Month Follow-up
- ClinicalTrials.gov ID
- NCT01806519
- Acronym / sponsor ID
- LTU_SG_5
- Conditions
- Neck Pain, Forward Head Posture
- Keywords
- neck pain, motor control, intervention, forward head posture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Luleå Tekniska UniversitetUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 7 Mar 2013 (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 common problem in the western world. There is a group of people suffering from neck pain with a reduced ability to maintain an upright posture showing a forward head position and an altered muscle function.
The aim of the study was to evaluate a motor control intervention for patients with persistent neck pain and a forward head posture.
This pilot study used a Single System Experimental Design (SSED) with an A-B-A-design and multiple baselines.
The tailored motor control intervention addressed the faulty postural alignment and the deep muscles of the cervical spine.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 20 - 50 years of age with pain originating from the neck for at least three months.
- A visual forward head posture.
- Less than105 points on the Örebro musculoskeletal pain screening questionnaire
Key exclusion criteria (4 listed)
- neurological dysfunction.
- former cervical surgery or compression fracture of the spine
- no mental retardation
- no physiotherapy treatment during the last 6 months.
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 |
|---|---|---|
| Motor control intervention of head postureThe tailored motor control intervention used for motor learning-procedure described by Fitts and Posner, further developed and adapted to rehabilitation of the spine by O´Sullivan. The stages involved in the process was the Cognitive stage, Associative stage and the Autonomous stage | Behavioural | – |
Primary outcome
Head posture
Time frame: Effect from baseline to 8 weeks and being maintained to 12 month
The craniovertebral (CV) -angle was used to estimate the cervical curvature and head posture in relation to the thorax being measured with the Head Posture Spinal Curvature Instrument
Muscle function of the deep cervical flexors
Time frame: Effect from baseline to 8 weeks and being maintained to 12 month
The Cranio-Cervical Flexion Test (C-CFT) was used to assess the tonic holding abilities of the deep cervical muscles by using a Pressure biofeedback unit.
2 secondary outcomes
Disability
Time frame: Effect from baseline to 8 weeks and being maintained to 12 month
Pain intensity
Time frame: Effect from baseline to 8 weeks and being maintained to 12 month
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 7 Mar 2013.
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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 of Neck Pain and Forward Head Posture, run by Luleå Tekniska Universitet at 1 site in Sweden.
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 4 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 7 Mar 2013. 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 Sweden. 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?
Head posture (time frame: Effect from baseline to 8 weeks and being maintained to 12 month). 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 7 Mar 2013.