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

NCT ID: NCT01774734

Last Updated: 2014-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-09-30

Brief Summary

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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

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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

Conditions

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Cervicalgia

Keywords

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Chronic neck pain Neck strength exerciser Biofeedback Physiotherapy Strengthening exercise Randomized trials

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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neck strength exerciser (NSE) group

Traditional physiotherapy 30 minutes per session for three times weekly + home-based NSE training 20 minutes daily

Group Type EXPERIMENTAL

Physical therapy

Intervention Type OTHER

Physical therapy

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

Neck Strength Exerciser (NSE)

Intervention Type DEVICE

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

Physical therapy group

Traditional physiotherapy 30 minutes per session for three times weekly + home-based general neck exercise 20 minutes daily

Group Type PLACEBO_COMPARATOR

Physical therapy

Intervention Type OTHER

Physical therapy

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

Interventions

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Physical therapy

Physical therapy

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

Intervention Type OTHER

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shin Kong Wu Ho-Su Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lin-Fen Hsieh, M.D.

Role: PRINCIPAL_INVESTIGATOR

Shin Kong Wu Ho-Su Memorial Hospital

Locations

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Shin Kong Wu Ho-Su Memorial Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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20110605R

Identifier Type: -

Identifier Source: org_study_id