Cervicalgia
Conditions
Keywords
Chronic neck pain, Neck strength exerciser, Biofeedback, Physiotherapy, Strengthening exercise, Randomized trials
Brief 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 showed more long-lasting effect in patients with chronic neck pain 2. 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
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 * 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
Interventions
OTHERPhysical therapy
Physical therapy * Provided by 2 experienced physiotherapist * Applied to every patients 3 times weekly
DEVICENeck 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
Sponsors
Shin Kong Wu Ho-Su Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Visual analog scale (VAS) at three-month interval | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient global assessment (PGA) | day 0; day 42; 12 weeks | 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) |
| Neck Disability Index (NDI) | day 0; day 42; 12 weeks | 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) |
| Cervical active ROM | day 0; day 42; 12 weeks | including flexion, extension, side bending, and rotation was measured a special cervical goniometer (CROM) |
| Amount of sick leave | day 42; 12 weeks | — |
| Amount of analgesics | day 42; 12 weeks | — |
| Effect of the intervention on the neck pain | day 42; 12 weeks | on a 6-point scale: 1 indicating more pain, and 6 indicating for completely relief from pain |
Countries
Taiwan
Outcome results
None listed