Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00549

2 Trial Registration Date

2017-02-27

i Registration Status

Prospective

3 Secondary IDs

N/A

4 Source(s) of Funding

N/A

5 Primary Sponsor

N/A

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

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

i Name

Dr. Billy So

ii Address

Room ST520, 5/F, Ng Wing Hong Building,
The Hong Kong Polytechnic University
Hung Hom, Hong Kong

iii Phone

852 27664377

iv Email

billy.so@polyu.edu.hk

v Affiliation

The Hong Kong Polytechnic University

vi Country

Hong Kong

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

i Name

Billy So

ii Address

Room ST520, 5/F, Ng Wing Hong Building,
The Hong Kong Polytechnic University
Hung Hom, Hong Kong

iii Phone

27664377

iv Email

billy.so@polyu.edu.hk

v Affiliation

Department of Rehabilitation Sciences, The Hong Kong Polytechnic University

vi Country

Hong Kong

9 Official Scientific Title of the Study

The Evaluation of Two Aquatic Physiotherapy Approaches (Ai Chi and Bad Ragaz Ring Method) on Adults with Chronic Low Back Pain in a Community Setting

10 Public Title

The Evaluation of Two Aquatic Physiotherapy Approaches (Ai Chi and Bad Ragaz Ring Method) on Adults with Chronic Low Back Pain in a Community Setting

i Public Title in Chinese 研究名稱

針對慢性腰背痛症的兩種社區水中物理治療法(水中太極及拉格斯圈法) 之成效比較

11 Short Title (Optional)

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?

2017-02-24

iii Full Name of IRB/IEC

Other

Please specify

Ethics Committee of the Department of Research Committee, Department of RS, PolyU

iv IRB/IEC approval reference number

HSEARS20170106006

14 Medical Condition Being Studied

Chronic Non Specific Low Back Pain

15 Intervention

i Types of intervention

Other

Please specify

Two Aquatic Physiotherapy Approaches

ii Description/ name of Intervention/article

Ai Chi aquatic physiotherapy approach

iii Dosage form of the intervention

4-week

iv Dosage of the intervention

60 minutes per session

v Duration of the intervention

60 minutes per session

vi Frequency of the intervention

Two sessions per week

16 Comparative Treatments

i Description/ name of comparative treatments

Bad Ragaz Ring Method aquatic physiotherapy approach

ii Dosage form of the comparative treatments

4-week

iii Dosage of the comparative treatments

60 minutes per session

iv Duration of the comparative treatments

60 minutes per session

v Frequency of the comparative treatments

Two sessions per week

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Adults aged 45-65 years old

Non-specific CLBP (3 months or more)

ii Exclusion Criteria

Unable to communicate in Cantonese

Symptoms or signs of serious medical illness

Presence of severe cardiovascular disease

Major rheumatologic, neurologic or neoplastic conditions that may prevent participation in the intervention

Previous spinal surgery

Inflammatory, infectious or malignant diseases of vertebra

Presence of severe psychiatric disorder

Pregnancy or recent childbirth

iii Age Minimum

45

iv Age Maximum

65

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Non-randomized

Please specify

ii Nature of control

Active

iii Degree of masking

Not Applicable

If Single-blind, who will be masked?

iv Group Assignment

Not Applicable

v Study Phase

Other

Please specify

N/A

vi Study Objectives (Optional)

20 Anticipated trial start date

2017-03-15

21 Target Sample Size

50

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

Pain intensity:

ii The metric or method of measurement used

Visual Analogue Scale

iii The timepoint(s) of primary interest

Pre- & Post- Intervention

Primary Outcome

i The Name of the outcome

Physical disability:

ii The metric or method of measurement used

Roland-Morris Disability Questionnaire – Hong Kong

iii The timepoint(s) of primary interest

Pre- & Post- Intervention

24 Secondary Outcome

i The Name of the outcome

Postural stability:

ii The metric or method of measurement used

Single-leg stand test

iii The timepoint(s) of primary interest

Pre- & Post- Intervention

Secondary Outcome

i The Name of the outcome

Global core muscle endurance

ii The metric or method of measurement used

Prone and supine bridge manoeuvres

iii The timepoint(s) of primary interest

Pre- & Post- Intervention

Secondary Outcome

i The Name of the outcome

Trunk flexibility:

ii The metric or method of measurement used

Modified-modified Schober test

iii The timepoint(s) of primary interest

Pre- & Post- Intervention

Secondary Outcome

i The Name of the outcome

Transverse abdominis muscle thickness:

ii The metric or method of measurement used

Rehabilitative ultrasound imaging

iii The timepoint(s) of primary interest

Pre- & Post- Intervention

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2019-08-05

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

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Trial History Detail on 2017-02-27