Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00535

2 Trial Registration Date

2016-11-24

i Registration Status

Prospective

3 Secondary IDs

CRE.2016.486-T

4 Source(s) of Funding

Department of Anaesthesia & Intensive Care, Department of Occupational Therapy, PWH

5 Primary Sponsor

Department of Anaesthesia & Intensive care, PWH

6 Secondary Sponsor

Department of Occupational Therapy, PWH

Function

Form a group with the primary sponsor in which the responsibilities of sponsorship are allocated among the members of the group

Please specify

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

i Name

Winnie SAMY

ii Address

Department of Anaesthesia & Intensive Care, Prince of Wales Hospital, CUHK, Shatin

iii Phone

2632 2735

iv Email

wsamy@cuhk.edu.hk

v Affiliation

Department of Anaesthesia & Intensive Care, PWH

vi Country

Hong Kong

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

i Name

YING Chee Lun Aaron

ii Address

Department of Anaesthesia & Intensive Care, Prince of Wales Hospital, Shatin

iii Phone

55699271

iv Email

dr@claying.net

v Affiliation

Department of Anaesthesia & Intensive Care, PWH

vi Country

Hong Kong

9 Official Scientific Title of the Study

A Prospective Randomized Control Trial on the Effectiveness of Bowen Therapy for management of Myofascial Neck pain and Enhancement of Nurse Triage

10 Public Title

A Prospective Randomized Control Trial on the Effectiveness of Bowen Therapy for management of Myofascial Neck pain and Enhancement of Nurse Triage

i Public Title in Chinese 研究名稱

保雲療法在治療頸部肌筋膜疼痛成效之前瞻隨機性研究及改善由護士轉介的分流過程

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?

2016-10-28

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2016.486-T

14 Medical Condition Being Studied

Myofascial neck pain

15 Intervention

i Types of intervention

Other

Please specify

Bowen therapy - a kind of treatment modalities being practiced by Occupational Therapists

ii Description/ name of Intervention/article

Bowen therapy is a technique of fascial work, characterized as being an effective non-invasive, gentle approach to improve health and well-being and accomplishes holistic balance in the body efficiently. It is safe to use on almost anyone, from newborn to elderly as there are no vigorous manipulations employed in the treatment. In Hong Kong, Bowen therapy is one of the treatment modalities being adopted and practiced by Occupational therapists. Yet to date there is a lack of adequate clinical trials to validate the effectiveness of Bowen Therapy to different conditions that hinder clinicians in recommending this therapy to patients. This prospective randomized study evaluates the effectiveness of Bowen Therapy and we expect this non-invasive treatment is superior to the conventional treatment in the pain management of myofascial neck pain.

iii Dosage form of the intervention

not applicable

iv Dosage of the intervention

not applicable

v Duration of the intervention

A total of 8 sessions of Bowen therapy, each Bowen session will last fro 30 minutes to one hour.

vi Frequency of the intervention

once every week for the first 4 weeks and then once every two week for the remaining 4 sessions

16 Comparative Treatments

i Description/ name of comparative treatments

The control group will receive conventional treatment for myofascial neck pain.

ii Dosage form of the comparative treatments

not applicable

iii Dosage of the comparative treatments

not applicable

iv Duration of the comparative treatments

during study period (ie. 24 weeks)

v Frequency of the comparative treatments

no difference from usual conventional treatment

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Consenting adult (age 18-75) with subacute or chronic myofascial neck problem with at least 1 trigger point presents at the neck region, and agrees to discontinue other alternative treatments once giving consent to participate unless approved by the investigators.

ii Exclusion Criteria

Patient refusal, pregnancy, confirmed to be unsuitable to participate by pain specialists due to the presence of urgent or severe co-morbidities or conditions, known severe psychiatric illness, known malignancy, skin disease, infectious disease, severe cardiovascular disease, patients taking anti-coagulants, and patients who are being randomized to receive Bowen therapy (Group 2), receiving concurrent treatment or intervention for pain control such as alternative medicine, physiotherapy, chiropractor, but refuse to discontinue during study period will be excluded.

iii Age Minimum

18

iv Age Maximum

75

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

Randomized control trial

ii Nature of control

Active

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

Investigator/research team

iv Group Assignment

Parallel

v Study Phase

Other

Please specify

Long established practice

vi Study Objectives (Optional)

20 Anticipated trial start date

2016-12-01

21 Target Sample Size

90

22 Recruitment Status

Recruiting

23 Primary Outcome

i The Name of the outcome

The pressure pain threshold (PPT) in pounds/Newton measured by algometer at the pain sites of both groups of patients at 3 different time points [i.e. before the treatment (0 week), the end of the treatment (12th week) and the 24th weeks].

ii The metric or method of measurement used

Pressure pain threshold in pounds/ Newton

iii The timepoint(s) of primary interest

Before treatment (0 week), end of treatment (12th week), and the 24th week

24 Secondary Outcome

i The Name of the outcome

pain score, the wellness of patient (physical, mental , & functional status). process of nurse triage & referral process

ii The metric or method of measurement used

pain score in numeric rating scale (NRS), wellness of patient by questionnaires (GAD7, PHQ9, SF12, NDI) & measured neck range of movement. Research team will review the nurse triage process at the end of study

iii The timepoint(s) of primary interest

Before treatment (0 week), end of treatment (12th week), and the 24th week

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2021-01-26

27 Primary Registry and Trial Identifying Number

ChiCTR-INR-16010046

28 Date of Registration in Primary Registry

2016-11-24

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Trial History Detail on 2019-01-14