Text Size

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

This study is currently recruiting participants.
Verified January 2013 by Shin Kong Wu Ho-Su Memorial Hospital
Sponsor:
Information provided by (Responsible Party):
Shin Kong Wu Ho-Su Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01774734
First received: July 23, 2012
Last updated: January 21, 2013
Last verified: January 2013
History of Changes
  Purpose

  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.

Condition Intervention
Cervicalgia
 Other: Physical therapy
Device: Neck Strength Exerciser (NSE)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Combined Neck Strength Exerciser Plus Physiotherapy in Treatment of Patients With Chronic Neck Pain

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shin Kong Wu Ho-Su Memorial Hospital:

Primary Outcome Measures:
  • Change from Baseline in Visual analog scale (VAS) at three-month interval [ Time Frame: day 0; day 42; 12 weeks ] [ Designated as safety issue: No ]
    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:
  • Cervical active ROM [ Time Frame: day 0; day 42; 12 weeks ] [ Designated as safety issue: No ]
    including flexion, extension, side bending, and rotation was measured a special cervical goniometer (CROM)

  • Patient global assessment (PGA) [ Time Frame: day 0; day 42; 12 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: day 0; day 42; 12 weeks ] [ Designated as safety issue: No ]
    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)

  • Effect of the intervention on the neck pain [ Time Frame: day 42; 12 weeks ] [ Designated as safety issue: No ]
    on a 6-point scale: 1 indicating more pain, and 6 indicating for completely relief from pain

  • Amount of sick leave [ Time Frame: day 42; 12 weeks ] [ Designated as safety issue: No ]
  • Amount of analgesics [ Time Frame: day 42; 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: September 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: neck strength exerciser (NSE) group
Traditional physiotherapy 30 minutes per session for three times weekly + home-based NSE training 20 minutes daily
 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
Placebo Comparator: Physical therapy group
Traditional physiotherapy 30 minutes per session for three times weekly + home-based general neck exercise 20 minutes daily
 Other: Physical therapy

Physical therapy

  • Provided by 2 experienced physiotherapist
  • Applied to every patients 3 times weekly

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01774734

Contacts
Contact: Lin-Fen Hsieh, M.D. +886-28332211 ext 2538 M001026@ms.skh.org.tw

Locations
Taiwan
Shin Kong Wu Ho-Su Memorial Hospital Recruiting
Taipei, Taiwan
Contact: Lin-Fen Hsieh, M.D.     +886-28332211 ext 2538     M001026@ms.skh.org.tw    
Sponsors and Collaborators
Shin Kong Wu Ho-Su Memorial Hospital
Investigators
Principal Investigator: Lin-Fen Hsieh, M.D. Shin Kong Wu Ho-Su Memorial Hospital
  More Information

No publications provided

Responsible Party: Shin Kong Wu Ho-Su Memorial Hospital
ClinicalTrials.gov Identifier: NCT01774734     History of Changes
Other Study ID Numbers: 20110605R
Study First Received: July 23, 2012
Last Updated: January 21, 2013
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Shin Kong Wu Ho-Su Memorial Hospital:
Chronic neck pain
Neck strength exerciser
Biofeedback
 Physiotherapy
Strengthening exercise
Randomized trials

Additional relevant MeSH terms:
Neck Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013