Clinical trial NCT01774734: Effect of Combined Neck Strength Exerciser Plus Physiotherapy to Treatment Chronic Neck Pain
Official title: Effect of Combined Neck Strength Exerciser Plus Physiotherapy in Treatment of Patients With Chronic Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervicalgia
Keywords: Chronic neck pain
Neck strength exerciser
Biofeedback
Physiotherapy
Strengthening exercise
Randomized trials
Lead sponsor: Shin Kong Wu Ho-Su Memorial Hospital
Sponsor class: OTHER
First posted: 2013-01-24
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline in Visual analog scale (VAS) at three-month interval
timeFrame: day 0; day 42; 12 weeks
Secondary outcomes:
measure: Cervical active ROM
timeFrame: day 0; day 42; 12 weeks
measure: Patient global assessment (PGA)
timeFrame: day 0; day 42; 12 weeks
measure: Neck Disability Index (NDI)
timeFrame: day 0; day 42; 12 weeks
measure: Effect of the intervention on the neck pain
timeFrame: day 42; 12 weeks
measure: Amount of sick leave
timeFrame: day 42; 12 weeks
measure: Amount of analgesics
timeFrame: day 42; 12 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Shin Kong Wu Ho-Su Memorial Hospital
Study officials:
affiliation: Shin Kong Wu Ho-Su Memorial Hospital
name: Lin-Fen Hsieh, M.D.
role: PRINCIPAL_INVESTIGATOR
References: