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

Cervicalgia Clinical Trial

Official title:

Effect of Combined Neck Strength Exerciser Plus Physiotherapy in Treatment of Patients With Chronic Neck Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01774734
• Other study ID #: 20110605R
• Status: Completed
• Phase: N/A
• First received: July 23, 2012
• Last updated: November 24, 2014
• Start date: September 2011
• Est. completion date: September 2013

Study information

• Verified date: November 2014
• Source: Shin Kong Wu Ho-Su Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical 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 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervicalgia
• Neck Pain

Intervention

Other:
• Physical therapy
Physical therapy Provided by 2 experienced physiotherapist Applied to every patients 3 times weekly

Device:
• 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

Locations

Country	Name	City	State
Taiwan	Shin Kong Wu Ho-Su Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Shin Kong Wu Ho-Su Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Cervical active ROM	including flexion, extension, side bending, and rotation was measured a special cervical goniometer (CROM)	day 0; day 42; 12 weeks	No
Secondary	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)	day 0; day 42; 12 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	Amount of sick leave		day 42; 12 weeks	No
Secondary	Amount of analgesics		day 42; 12 weeks	No