CervicalgiaNCT01774734
Effect of Combined Neck Strength Exerciser Plus Physiotherapy to Treatment Chronic Neck Pain
A study testing Physical therapy and Neck Strength Exerciser (NSE) in people with Cervicalgia, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.
Trial summary
1. Chronic neck pain is common in general population. High health care source expenditure Multiple therapeutic approaches available with limited evidence Previous studies showed active strengthening exercise improved pain (VAS) and functional performance (NDI) Muscle strengthening exercise with biofeedback technique… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cervicalgia
- What is being tested?
- Physical therapy and Neck Strength Exerciser (NSE)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2011to Sep 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult, ≧20 yr.
- Constantly or frequently occurring neck pain for more than 3 months in the last 1 year.
- Motivated and willing to participate in rehabilitation therapy
- Sign written informed consent.
Who cannot join
- Neck or shoulder surgery.
- Clinical evidence of cervical radiculopathy or myelopathy.
- History of disk disease, degenerative joint disease, fracture, or dislocation in the cervical vertebrae.
- Severe pathological change in the cervical vertebrae, including inflammatory rheumatic disease and tumor.
- History of poor diet, hypothyroidism, or other severe systemic disorders.
- Cognitive deficit and severe psychiatric illness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Combined Neck Strength Exerciser Plus Physiotherapy in Treatment of Patients With Chronic Neck Pain
- Chronic neck pain is common in general population.
- High health care source expenditure
- Multiple therapeutic approaches available with limited evidence
- Previous studies showed active strengthening exercise improved pain (VAS) and functional performance (NDI)
- Muscle strengthening exercise with biofeedback technique showed more long-lasting effect in patients with chronic neck pain
- The investigators hypothesize that daily use of the neck strength exerciser (NSE), combined biofeedback technique with muscle strengthening exercise posture adjustment, in addition to traditional physiotherapy, could have more long-lasting and prominent effect on pain and functional improvement in patients with chronic neck pain.
Read the detailed description
- A randomized single-blinded trial to compare the effect of combined home-based NSE with physiotherapy could be more effective to treat people with chronic neck pain
- The NSE is a simple equipment that is easy to learn and safe to apply as home-based program
- The NSE will apply to the patients in the NSE group for 6 weeks, and we will compare the target variables to see if it brings better improvement by correction of maladaptive habitual posture and daily postural muscle exercise
- Conditions
- Cervicalgia
- Being tested
- Physical therapy, Neck Strength Exerciser (NSE)
- Keywords
- Chronic neck pain, Neck strength exerciser, Biofeedback, Physiotherapy, Strengthening exercise, Randomized trials
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical therapyOther
Physical therapy
- Provided by 2 experienced physiotherapist
- Applied to every patients 3 times weekly
Neck Strength Exerciser (NSE)Device
- Neck strength exerciser use 10-20 minutes daily at home
- Plus traditional physical therapy three times weekly provided by two experienced physical therapist
| Study group | Role | What they receive |
|---|---|---|
| neck strength exerciser (NSE) group | Experimental | Traditional physiotherapy 30 minutes per session for three times weekly + home-based NSE training 20 minutes daily Receives: Other: Physical therapy; Device: Neck Strength Exerciser (NSE) |
| Physical therapy group | Placebo comparator | Traditional physiotherapy 30 minutes per session for three times weekly + home-based general neck exercise 20 minutes daily Receives: Other: Physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Visual analog scale (VAS) at three-month interval
a 10-point horizontal line with 0 represented the expressions "no pain at all, and 10 represented "the most intense pain imaginable"
Measured: day 0; day 42; 12 weeks
Secondary outcomes (6)
Cervical active ROM
including flexion, extension, side bending, and rotation was measured a special cervical goniometer (CROM)
Measured: day 0; day 42; 12 weeks
Patient global assessment (PGA)
The PGA questions will ask: "How has the neck pain been at the present time?" and will be scored on a Likert scale(very good＝1; good＝2; fair＝3; poor＝4; very poor＝5)
Measured: day 0; day 42; 12 weeks
Neck Disability Index (NDI)
The NDI was developed and validated by Vernon et al to measure neck pain and disability.[5] It is a 10-item self report instrument that evaluates perceived disability in 10 areas: pain intensity, self care, lifting, reading, headache, attention, working, driving, sleep and leisure activity. By using a 6-point Likert scale (1= no limitation; 6= severe limitation), the total maximal score was calculated. (appendix)
Measured: day 0; day 42; 12 weeks
Effect of the intervention on the neck pain
on a 6-point scale: 1 indicating more pain, and 6 indicating for completely relief from pain
Measured: day 42; 12 weeks
Amount of sick leave
Measured: day 42; 12 weeks
Amount of analgesics
Measured: day 42; 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2013 (estimated)
- Study startSep 2011
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CervicalgiaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lin-Fen Hsieh, M.D., Principal investigator, Shin Kong Wu Ho-Su Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01774734
- Sponsor's protocol ID
- 20110605R
- Status last verified
- Nov 2014
- First submitted
- 23 Jul 2012
- Last updated
- 26 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Combined Neck Strength Exerciser Plus Physiotherapy in Treatment of Patients With Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT01774734
- Acronym / sponsor ID
- 20110605R
- Conditions
- Cervicalgia
- Keywords
- Chronic neck pain, Neck strength exerciser, Biofeedback, Physiotherapy, Strengthening exercise, Randomized trials
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial HospitalUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 24 Jan 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.
- Chronic neck pain is common in general population.
- High health care source expenditure
- Multiple therapeutic approaches available with limited evidence
- Previous studies showed active strengthening exercise improved pain (VAS) and functional performance (NDI)
- Muscle strengthening exercise with biofeedback technique showed more long-lasting effect in patients with chronic neck pain
- The investigators hypothesize that daily use of the neck strength exerciser (NSE), combined biofeedback technique with muscle strengthening exercise posture adjustment, in addition to traditional physiotherapy, could have more long-lasting and prominent effect on pain and functional improvement in patients with chronic neck pain.
Detailed description
- A randomized single-blinded trial to compare the effect of combined home-based NSE with physiotherapy could be more effective to treat people with chronic neck pain
- The NSE is a simple equipment that is easy to learn and safe to apply as home-based program
- The NSE will apply to the patients in the NSE group for 6 weeks, and we will compare the target variables to see if it brings better improvement by correction of maladaptive habitual posture and daily postural muscle exercise
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| neck strength exerciser (NSE) group | Experimental | Other: Physical therapy, Device: Neck Strength Exerciser (NSE)Traditional physiotherapy 30 minutes per session for three times weekly + home-based NSE training 20 minutes daily |
| Physical therapy group | Placebo comparator | Other: Physical therapyTraditional physiotherapy 30 minutes per session for three times weekly + home-based general neck exercise 20 minutes daily |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult, ≧20 yr.
- Constantly or frequently occurring neck pain for more than 3 months in the last 1 year.
- Motivated and willing to participate in rehabilitation therapy
- Sign written informed consent.
Key exclusion criteria (6 listed)
- Neck or shoulder surgery.
- Clinical evidence of cervical radiculopathy or myelopathy.
- History of disk disease, degenerative joint disease, fracture, or dislocation in the cervical vertebrae.
- Severe pathological change in the cervical vertebrae, including inflammatory rheumatic disease and tumor.
- History of poor diet, hypothyroidism, or other severe systemic disorders.
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 |
|---|---|---|
| Physical therapyPhysical therapy * Provided by 2 experienced physiotherapist * Applied to every patients 3 times weekly | Other | Physical therapy group, neck strength exerciser (NSE) group |
| Neck Strength Exerciser (NSE)* Neck strength exerciser use 10-20 minutes daily at home * Plus traditional physical therapy three times weekly provided by two experienced physical therapist | Device | neck strength exerciser (NSE) group |
Primary outcome
Change from Baseline in Visual analog scale (VAS) at three-month interval
Time frame: day 0; day 42; 12 weeks
a 10-point horizontal line with 0 represented the expressions "no pain at all, and 10 represented "the most intense pain imaginable"
6 secondary outcomes
Cervical active ROM
Time frame: day 0; day 42; 12 weeks
Patient global assessment (PGA)
Time frame: day 0; day 42; 12 weeks
Neck Disability Index (NDI)
Time frame: day 0; day 42; 12 weeks
Effect of the intervention on the neck pain
Time frame: day 42; 12 weeks
Amount of sick leave
Time frame: day 42; 12 weeks
Amount of analgesics
Time frame: day 42; 12 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 26 Nov 2014.
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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.
Lin-Fen Hsieh, M.D. principal investigator
Shin Kong Wu Ho-Su Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical therapy and Neck Strength Exerciser (NSE) in people with Cervicalgia, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.
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: finished, as of the sponsor's last update on 26 Nov 2014. 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 Taiwan. 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. Some participants in this study may receive a placebo. 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?
Change from Baseline in Visual analog scale (VAS) at three-month interval (time frame: day 0; day 42; 12 weeks). 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 26 Nov 2014; AzTrials last refreshed its copy on 7 Nov 2026.