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

Primary Purpose

Cervicalgia

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Physical therapy
Neck Strength Exerciser (NSE)
Sponsored by
Shin Kong Wu Ho-Su Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervicalgia focused on measuring Chronic neck pain, Neck strength exerciser, Biofeedback, Physiotherapy, Strengthening exercise, Randomized trials

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shin Kong Wu Ho-Su Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

neck strength exerciser (NSE) group

Physical therapy group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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"

Secondary Outcome Measures

Cervical active ROM
including flexion, extension, side bending, and rotation was measured a special cervical goniometer (CROM)
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)
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)
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
Amount of sick leave
Amount of analgesics

Full Information

First Posted
July 23, 2012
Last Updated
November 24, 2014
Sponsor
Shin Kong Wu Ho-Su Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01774734
Brief Title
Effect of Combined Neck Strength Exerciser Plus Physiotherapy to Treatment Chronic Neck Pain
Official Title
Effect of Combined Neck Strength Exerciser Plus Physiotherapy in Treatment of Patients With Chronic Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shin Kong Wu Ho-Su Memorial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervicalgia
Keywords
Chronic neck pain, Neck strength exerciser, Biofeedback, Physiotherapy, Strengthening exercise, Randomized trials

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
neck strength exerciser (NSE) group
Arm Type
Experimental
Arm Description
Traditional physiotherapy 30 minutes per session for three times weekly + home-based NSE training 20 minutes daily
Arm Title
Physical therapy group
Arm Type
Placebo Comparator
Arm Description
Traditional physiotherapy 30 minutes per session for three times weekly + home-based general neck exercise 20 minutes daily
Intervention Type
Other
Intervention Name(s)
Physical therapy
Intervention Description
Physical therapy Provided by 2 experienced physiotherapist Applied to every patients 3 times weekly
Intervention Type
Device
Intervention Name(s)
Neck Strength Exerciser (NSE)
Intervention Description
Neck strength exerciser use 10-20 minutes daily at home Plus traditional physical therapy three times weekly provided by two experienced physical therapist
Primary Outcome Measure Information:
Title
Change from Baseline in Visual analog scale (VAS) at three-month interval
Description
a 10-point horizontal line with 0 represented the expressions "no pain at all, and 10 represented "the most intense pain imaginable"
Time Frame
day 0; day 42; 12 weeks
Secondary Outcome Measure Information:
Title
Cervical active ROM
Description
including flexion, extension, side bending, and rotation was measured a special cervical goniometer (CROM)
Time Frame
day 0; day 42; 12 weeks
Title
Patient global assessment (PGA)
Description
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)
Time Frame
day 0; day 42; 12 weeks
Title
Neck Disability Index (NDI)
Description
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)
Time Frame
day 0; day 42; 12 weeks
Title
Effect of the intervention on the neck pain
Description
on a 6-point scale: 1 indicating more pain, and 6 indicating for completely relief from pain
Time Frame
day 42; 12 weeks
Title
Amount of sick leave
Time Frame
day 42; 12 weeks
Title
Amount of analgesics
Time Frame
day 42; 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin-Fen Hsieh, M.D.
Organizational Affiliation
Shin Kong Wu Ho-Su Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shin Kong Wu Ho-Su Memorial Hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

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

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