Effect of Combined Neck Strength Exerciser Plus Physiotherapy to Treatment Chronic Neck Pain

Not Applicable

Completed

• Conditions: Cervicalgia
• Interventions: Other: Physical therapy; Device: Neck Strength Exerciser (NSE)

• Registration Number: NCT01774734
• Lead Sponsor: Shin Kong Wu Ho-Su Memorial Hospital

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

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-07-23
• Study First Submitted QC: 2013-01-21
• Study First Posted: 2013-01-24
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-24
• Last Update Posted: 2014-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physical therapy group	Physical therapy	Traditional physiotherapy 30 minutes per session for three times weekly + home-based general neck exercise 20 minutes daily
neck strength exerciser (NSE) group	Physical therapy	Traditional physiotherapy 30 minutes per session for three times weekly + home-based NSE training 20 minutes daily
neck strength exerciser (NSE) group	Neck Strength Exerciser (NSE)	Traditional physiotherapy 30 minutes per session for three times weekly + home-based NSE training 20 minutes daily

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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)
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
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)
Amount of analgesics	day 42; 12 weeks

Trial Locations

Locations (1)

Shin Kong Wu Ho-Su Memorial Hospital; 🇨🇳 Taipei, Taiwan