Skip to main content
OpenTrials
Completed

NCT Number: NCT01774734

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cervicalgia Neck Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taiwan

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physical Therapy

Other

Physical therapy

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

Neck Strength Exerciser (NSE)

Device
  • Neck strength exerciser use 10-20 minutes daily at home
  • Plus traditional physical therapy three times weekly provided by two experienced physical therapist

Primary outcomes

  1. Change from Baseline in Visual analog scale (VAS) at three-month interval

    Time frame: 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 outcomes

  1. Cervical active ROM

    Time frame: day 0; day 42; 12 weeks

    including flexion, extension, side bending, and rotation was measured a special cervical goniometer (CROM)

  2. Patient global assessment (PGA)

    Time frame: 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)

  3. Neck Disability Index (NDI)

    Time frame: 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)

  4. Effect of the intervention on the neck pain

    Time frame: day 42; 12 weeks

    on a 6-point scale: 1 indicating more pain, and 6 indicating for completely relief from pain

  5. Amount of sick leave

    Time frame: day 42; 12 weeks

  6. Amount of analgesics

    Time frame: day 42; 12 weeks

Sponsors and collaborators

Lead sponsor

Shin Kong Wu Ho-Su Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 24, 2013
Registry last updated
Nov 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.