Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00370

2 Trial Registration Date

2013-05-16

i Registration Status

Prospective

3 Secondary IDs

CRE-2012.554-T

4 Source(s) of Funding

Health and Medical Research Fund

5 Primary Sponsor

The Hong Kong Polytechnic University

6 Secondary Sponsor

The Chinese University

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Dr SZETO Pui Yuk Grace

ii Address

Dept of Rehab Sciences The Hong Kong Polytechnic University

iii Phone

85227666706

iv Email

grace.szeto@polyu.edu.hk

v Affiliation

The Hong Kong Polytechnic University

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Dr SZETO Pui Yuk Grace

ii Address

Dept of Rehab Sciences The Hong Kong Polytechnic University

iii Phone

85227666706

iv Email

grace.szeto@polyu.edu.hk

v Affiliation

The Hong Kong Polytechnic University

vi Country

9 Official Scientific Title of the Study

A study to compare the “Ergomotor” Intervention Program to conventional physiotherapy treatment in managing work-related neck-shoulder disorders: A randomized controlled trial

10 Public Title

A study to compare the “Ergomotor” Intervention Program to conventional physiotherapy treatment in managing work-related neck-shoulder disorders: A randomized controlled trial

i Public Title in Chinese 研究名稱

測試結合人體工學及運動控制的療法 - 對職業性頸肩痛症的影響

11 Short Title (Optional)

NA

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2013-04-05

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

work-related musculoskeletal disorders

15 Intervention

i Types of intervention

Other

Please specify

Physiotherapy

ii Description/ name of Intervention/article

The study investigates the effectiveness of a new approach combining motor control training and ergonomic interventions, in comparison to the conventional physiotherapy treatment which is more focused on symptom relief.

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

12 weeks for each group

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Ergomotor Intervention compared to conventional physiotherapy. Duration is 12 weeks for each type of intervention.

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

. Inclusion criteria involves a presence of chronic musculoskeletal pain of a “soft-tissue” nature for at least 1 month in the neck-shoulder region from initial onset, without any traumatic injury such as laceration or fracture.
Subject must affirm that the pain is related or aggravated by work activities. The level of pain must be more than 2/10 in a numerical rating scale of 0-10 with 10 being extreme pain.

ii Exclusion Criteria

There must be no or only slight degenerative changes demonstrated on x-rays and/or MRI, no serious pathology nor any known neurological deficits or dysfunctions

iii Age Minimum

18

iv Age Maximum

50

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Active

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2013-06-01

21 Target Sample Size

100

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

Primary outcome is measured pre- and post-intervention. They include:
1. Subjective measures - pain scores and functional outcome measure scores. Pain score is measured as Numerical Pain Rating Scale (NPRS) of 0-10.
2. Functional outcome measure -include the NDI and the DASH total scores.

24 Secondary Outcome

Seconary outcomes: 1. EMG amplitudes of neck muscles – amplitude ratios of muscles during functional tasks.
2. Work status and disability claims. The subject’s ability to perform his/her work on a full-time basis (at his/her pre-morbid capacity) is considered as the work status. 3. Cost-effectiveness is evaluated by comparing the healthcare costs of conventional physiotherapy treatment program to the cost of ergomotor training program.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2016-09-12

27 Primary Registry and Trial Identifying Number

ChiCTR-TCS-13003219

28 Date of Registration in Primary Registry

2013-05-16

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

not available yet

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Trial History Detail on 2014-05-17