Neck PainPhase 1NCT01310595

Manual Therapy on Head-repositioning Accuracy and Static Postural Balance in Neck Pain Patients

A Phase 1 study testing Manual mobilization on cervical spine and Infra-red therapy with self exercise pamphlet in people with Neck Pain, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Neck Pain
What is being tested?: Manual mobilization on cervical spine and Infra-red therapy with self exercise pamphlet
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 145 participants
Where: 1 siteHong Kong
Study dates: Jan 2010to Aug 2013
Phase: Phase 1
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Aged 18 to 65 years
Presented with a complaint of neck pain (defined as pain in the region from the upper thoracic spine to the occiput and the surrounding musculature) for more than 7 weeks.
Had not received neck pain treatment in the past 1 month

Who cannot join

Onset of presenting neck pain episode after trauma (eg, whiplash)
History of cervical injury of trauma since the onset of presenting neck pain episode
History of cervical injury or trauma
Neck pain due to fracture, tumor, infection, severe spondyloarthropathy, or other non-mechanical cause such as inflammatory arthritis;
Progressive neurological deficit, myelopathy, herniated nucleus pulpous, or severe incapacitating pain;
Being treated by electrical devices;

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Blood coagulation disorder or were using corticosteroids or anticoagulant medications;
History of stroke or transient ischemic attacks;
Vertebrobasilar artery insufficiency;
Neurologic disease (eg, multiple sclerosis, Parkinson's disease, syringomyelia);
Congenital anomalies involving the C-spine;
Systemic disease (eg, diabetes mellitus);
Pain involving third-party liability or Workers' Compensation.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

Physiotherapy Department, Prince of Wales Hospital
Stain

Other trials in Hong Kong

About this study

Official title: To Investigate the Effectiveness of Manual Therapy on Head-repositioning Accuracy and Static Postural Balance in Patients With Non-traumatic Chronic Mechanical Neck Pain.

To investigate the effect of cervical manual mobilization on head repositioning accuracy and postural balance in patients with chronic mechanical neck pain in a randomized controlled trial. Hypothesis: There is no difference between the intervention group (manual mobilization) and control group head repositioning accuracy and postural balance.

Read the detailed description

The aim of the study is to investigate the effectiveness of manual therapy to standing balance and head-neck proprioception sense in patients with chronic neck pain. The study will recruit 120 chronic neck pain patients and randomize the into 2 groups of 60. Group 1 will receive a course of manual therapy and infrared radiation for 15 minutes (twice weekly for 12 sessions). The other group (control) will receive infrared radiation therapy only. Manual therapy will be provided by experienced physiotherapists and assessed by a separate assessor. All outcome measures will be assessed at the beginning of study, upon completion of intervention, 3-month and 6-month after the completion of study. All measurements collected will be analysed by computerized statistical software in order to calculate the effectiveness of manual therapy and relationship among those outcome measurements.

Conditions: Neck Pain
Being tested: Manual mobilization on cervical spine, Infra-red therapy with self exercise pamphlet
Keywords: Musculoskeletal manipulations, Proprioception, Postural balance
Medical subject headings: Neck Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Manual mobilization on cervical spineProcedure or surgery
Manual mobilization provided on selected cervical spine in patients with chronic mechanical neck apin
Infra-red therapy with self exercise pamphletProcedure or surgery
Infra-red radiation therapy on cervical spine with self exercise pamphlet given to patients with chronic mechanical neck pain.

Study groups in NCT01310595
Study group	Role	What they receive
Manual mobilization on cervical spine	Experimental	Manual mobilization given on cervical spine with infra-red therapy and self exercise and advice pamphlet. Receives: Procedure: Manual mobilization on cervical spine
Infra-red radiation therapy	Active comparator	Infra-red radiation therapy with self exercise pamphlet given to patients with chronic mechanical neck pain. Receives: Procedure: Infra-red therapy with self exercise pamphlet

What is being measured

The primary outcome is the main question the study is designed to answer.

Head repositioning accuracy
Head re-positioning accuracy by using laser-pointer mounted in a cyclist helmet.
Measured: up to 6 month post intervention

Secondary outcomes (4)

Postural balance
Standing postural sway using computerized validated equipment.
Measured: up to 6 month post intervention
Northwick Park Questionnaire
Neck disability questionnaire
Measured: up to 6 month post intervention
Active neck range of motion
Active neck range of motion using 3-dimensional goniometer.
Measured: up to 6 month post intervention
Numeric Pain Rating Scale
Subjective numeric pain rating scale from 0 - 10.
Measured: up to 6 month post intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2010Aug 2013

First posted8 Mar 2011 (estimated)
Study startJan 2010
Primary completionJul 2013
Study completionAug 2013

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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 145 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01310595
Sponsor's protocol ID: HongKong PU
Status last verified: Aug 2013
First submitted: 7 Mar 2011
Last updated: 28 Aug 2013
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effects of the Timing of Vagus Nerve Stimulation Combined With Exercise in Chronic Neck Pain
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Comparative Effects of Exercises on Pain, Cervical Proprioception, Neck Disability and Visual Performance in Patients With Computer Vision Syndrome.
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The Clinical Efficacy and Multimodal Imaging Mechanism of the Knot-tying Technique in the Treatment of Chronic Neck Pain
Chronic Neck Pain
Not yet recruitingObservational study
Relationship of Forward Head Posture With Burnout and Quality of Life
Forward Head Posture
Not yet recruiting
Effects of Progressive Neck Motor Control Exercises With and Without Conventional Therapy in Text Neck Syndrome.(PNMCE-TNS)
Text Neck Syndrome

All Neck Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: To Investigate the Effectiveness of Manual Therapy on Head-repositioning Accuracy and Static Postural Balance in Patients With Non-traumatic Chronic Mechanical Neck Pain.
ClinicalTrials.gov ID: NCT01310595
Acronym / sponsor ID: HongKong PU
Conditions: Neck Pain
Keywords: Musculoskeletal manipulations, Proprioception, Postural balance
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 145 participants (actual)
Lead sponsor: The Hong Kong Polytechnic UniversityUniversity, hospital or other
Study start: Jan 2010
Primary completion: Jul 2013 (actual)
Study completion: Aug 2013 (actual)
First posted: 8 Mar 2011 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Manual mobilization on cervical spine	Experimental	Procedure: Manual mobilization on cervical spineManual mobilization given on cervical spine with infra-red therapy and self exercise and advice pamphlet.
Infra-red radiation therapy	Active comparator	Procedure: Infra-red therapy with self exercise pamphletInfra-red radiation therapy with self exercise pamphlet given to patients with chronic mechanical neck pain.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Aged 18 to 65 years
Presented with a complaint of neck pain (defined as pain in the region from the upper thoracic spine to the occiput and the surrounding musculature) for more than 7 weeks.
Had not received neck pain treatment in the past 1 month

Key exclusion criteria (13 listed)

Onset of presenting neck pain episode after trauma (eg, whiplash)
History of cervical injury of trauma since the onset of presenting neck pain episode
History of cervical injury or trauma
Neck pain due to fracture, tumor, infection, severe spondyloarthropathy, or other non-mechanical cause such as inflammatory arthritis;
Progressive neurological deficit, myelopathy, herniated nucleus pulpous, or severe incapacitating pain;

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
Manual mobilization on cervical spineManual mobilization provided on selected cervical spine in patients with chronic mechanical neck apin	Procedure or surgery	Manual mobilization on cervical spine
Infra-red therapy with self exercise pamphletInfra-red radiation therapy on cervical spine with self exercise pamphlet given to patients with chronic mechanical neck pain.	Procedure or surgery	Infra-red radiation therapy

Primary outcome

Head repositioning accuracy
Time frame: up to 6 month post intervention
Head re-positioning accuracy by using laser-pointer mounted in a cyclist helmet.

4 secondary outcomes

Postural balance
Time frame: up to 6 month post intervention
Northwick Park Questionnaire
Time frame: up to 6 month post intervention
Active neck range of motion
Time frame: up to 6 month post intervention
Numeric Pain Rating Scale
Time frame: up to 6 month post intervention

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 28 Aug 2013.

Related trials for Neck Pain

Not yet recruiting
Effects of the Timing of Vagus Nerve Stimulation Combined With Exercise in Chronic Neck Pain
Chronic Neck Pain
Not yet recruiting
Comparative Effects of Exercises on Pain, Cervical Proprioception, Neck Disability and Visual Performance in Patients With Computer Vision Syndrome.
Computer Vision Syndrome
Not yet recruiting
The Clinical Efficacy and Multimodal Imaging Mechanism of the Knot-tying Technique in the Treatment of Chronic Neck Pain
Chronic Neck Pain
Not yet recruitingObservational study
Relationship of Forward Head Posture With Burnout and Quality of Life
Forward Head Posture
Not yet recruiting
Effects of Progressive Neck Motor Control Exercises With and Without Conventional Therapy in Text Neck Syndrome.(PNMCE-TNS)
Text Neck Syndrome

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.

Siu H Kit, MSc principal investigator

The Hong Kong Polytechnic University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 13 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 28 Aug 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 Hong Kong. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 repositioning accuracy (time frame: up to 6 month post intervention). 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 NCT01310595.

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 28 Aug 2013.