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

November 24, 2014 updated by: Shin Kong Wu Ho-Su Memorial Hospital

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Shin Kong Wu Ho-Su Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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"
day 0; day 42; 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
day 0; day 42; 12 weeks
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)
day 0; day 42; 12 weeks
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)
day 0; day 42; 12 weeks
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
day 42; 12 weeks
Amount of sick leave
Time Frame: day 42; 12 weeks
day 42; 12 weeks
Amount of analgesics
Time Frame: day 42; 12 weeks
day 42; 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shin Kong Wu Ho-Su Memorial Hospital

Investigators

  • Principal Investigator: Lin-Fen Hsieh, M.D., Shin Kong Wu Ho-Su Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

July 23, 2012

First Submitted That Met QC Criteria

January 21, 2013

First Posted (Estimate)

January 24, 2013

Study Record Updates

Last Update Posted (Estimate)

November 26, 2014

Last Update Submitted That Met QC Criteria

November 24, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20110605R

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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