NCT01774734

Brief Summary

  • 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2012

Completed
6 months until next milestone

First Posted

Study publicly available on registry

January 24, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

November 26, 2014

Status Verified

November 1, 2014

Enrollment Period

2 years

First QC Date

July 23, 2012

Last Update Submit

November 24, 2014

Conditions

Cervicalgia

Keywords

Chronic neck painNeck strength exerciserBiofeedbackPhysiotherapyStrengthening exerciseRandomized trials

Outcome Measures

Primary Outcomes (1)

  • 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"

    day 0; day 42; 12 weeks

Secondary Outcomes (6)

  • Cervical active ROM

    day 0; day 42; 12 weeks

  • Patient global assessment (PGA)

    day 0; day 42; 12 weeks

  • Neck Disability Index (NDI)

    day 0; day 42; 12 weeks

  • Effect of the intervention on the neck pain

    day 42; 12 weeks

  • Amount of sick leave

    day 42; 12 weeks

  • +1 more secondary outcomes

Study Arms (2)

neck strength exerciser (NSE) group

EXPERIMENTAL

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

Other: Physical therapyDevice: Neck Strength Exerciser (NSE)

Physical therapy group

PLACEBO COMPARATOR

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

Other: Physical therapy

Interventions

Physical therapyOTHER

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

Physical therapy groupneck strength exerciser (NSE) group
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

neck strength exerciser (NSE) group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Neck Pain

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Lin-Fen Hsieh, M.D.

    Shin Kong Wu Ho-Su Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2012

First Posted

January 24, 2013

Study Start

September 1, 2011

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

November 26, 2014

Record last verified: 2014-11

Locations

TW(1)