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Chronic neck pain is common in general population.
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.
1. 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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| neck strength exerciser (NSE) group | Experimental | Traditional physiotherapy 30 minutes per session for three times weekly + home-based NSE training 20 minutes daily |
|
| Physical therapy group | Placebo Comparator | Traditional physiotherapy 30 minutes per session for three times weekly + home-based general neck exercise 20 minutes daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical therapy | Other | Physical therapy
|
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| Measure | Description | Time Frame |
|---|---|---|
| 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" | day 0; day 42; 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cervical active ROM | including flexion, extension, side bending, and rotation was measured a special cervical goniometer (CROM) | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lin-Fen Hsieh, M.D. | Shin Kong Wu Ho-Su Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shin Kong Wu Ho-Su Memorial Hospital | Taipei | Taiwan |
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| ID | Term |
|---|---|
| D019547 | Neck Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| Neck Strength Exerciser (NSE) | Device |
|
|
| 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) | 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 | day 42; 12 weeks |
| Amount of sick leave | day 42; 12 weeks |
| Amount of analgesics | day 42; 12 weeks |