The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12612000839808
Ethics application status
Approved
Date submitted
4/08/2012
Date registered
9/08/2012
Date last updated
9/08/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pilot study: To determine the effect of physiotherapy on neck stiffness following radiotherapy for Nasopharyngeal Carcinoma
Scientific title
The effect of physiotherapy versus exercise on neck fibrosis for post-irradiated patients with Nasopharyngeal Carcinoma – A pilot randomised trial
Secondary ID [1] 280976 0
Nil
Universal Trial Number (UTN)
U1111-1133-2852
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
neck fibrosis post radiotherapy 287089 0
nasopharyngeal carcinoma 287090 0
Condition category
Condition code
Cancer 287418 287418 0 0
Head and neck
Musculoskeletal 287447 287447 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will receive a maximal of 3 months of weekly individual multimodal physiotherapy of 1 hour session composing of neck strengthening exercise, passive stretching and education.
Intervention code [1] 285422 0
Rehabilitation
Intervention code [2] 285447 0
Treatment: Other
Comparator / control treatment
Prior to self stretching exercise, the participants in the control group will be invited to attend a 1-hour education class. The education content covers neck strengthening and stretching exercises, functional care and daily coping skills. After that, they will have weekly 'physiotherapy' in which they are asked about their progress, functional concerns and will complete the self stretching exercise for 20-30 minutes under supervsision over the 3 month period. The subjects will be encouraged to perform stretching exercise at home as well.
Control group
Active

Outcomes
Primary outcome [1] 287684 0
Young's modulus of fibrotic neck muscles will be captured by an ultrasound probe connected to a computer algorithm
Timepoint [1] 287684 0
baseline, immediately post intervention, 1 month post intervention
Primary outcome [2] 287685 0
neck range of motions will be assessed by Hanoun multi-cerivcal rehabilitation unit
Timepoint [2] 287685 0
baseline, immediately post intervention, 1 month post intervention
Secondary outcome [1] 298624 0
global numeric subjective improvement score
Timepoint [1] 298624 0
baseline, immediately post intervention, 1 month post intervention

Eligibility
Key inclusion criteria
Patients who have: a) completed their course of radiotherapy more than three years ago; b) neck discomfort/pain, neck stiffness, and/or arm symptoms; and c) whose disease is in remission.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patietns will be excluded from the study if they a) have signs of active metastasis; b) have received surgical intervention for their NPC; c) are illiterate and unable to complete the questionnaire by themselves; d) have a recent (within one year) history of trauma to the neck; and e) have already been entered into another clinical trial.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be recruited once weekly from an Oncology Follow-up Clinic of the Prince of Wales Hospital. They will be first screened by an oncologist for eligibility for the study. A research assistant then invites all eligible patients to participate in the study during their waiting time at their regular oncology follow-up session. Eligible patients will be provided with an information sheet by the research assistant explaining the study details and informing them of the potential side effects of the 'intervention'. Consenting patients will be further screened by the research assistant for the nature and the extent of their musculoskeletal complications, and their time availability for the study. Concealed allocation will be done by central randomization using computer to assign patients to treatment groupings.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomly allocated into a multimodal physiotherapy treatment or a self management exercise group by using computer generated pseudo-random numbers to assign patients to these two groupings. The principal investigator will inform the participants about their 'treatment' allocation. Cervical radiography will be prescribed to each consenting patient in the multimodal treatment group to check for signs of cervical instability or other contraindications to physiotherapy before the 'intervention' will be provided. Orthopaedic consultation will be provided by an orthopaedic specialist as necessary.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
A prospective single blinded randomized controlled trial
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4461 0
Hong Kong
State/province [1] 4461 0

Funding & Sponsors
Funding source category [1] 285783 0
Self funded/Unfunded
Name [1] 285783 0
Wai Chi Lee, Edwin
Address [1] 285783 0
Physiotherapy Department
Prince of Wales Hospital
30-32 Ngan Shing Street
Shatin
Country [1] 285783 0
Hong Kong
Primary sponsor type
Hospital
Name
Prince of Wales Hospital
Address
30-32, Ngan Shing Street, Shatin, NT
Hong Kong
Country
Hong Kong
Secondary sponsor category [1] 284606 0
None
Name [1] 284606 0
Address [1] 284606 0
Country [1] 284606 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287770 0
Joint CUHK-NTEC Clinical Research Ethics Committee
Ethics committee address [1] 287770 0
Flat 3C, Blk B, Staff Quarters,
Prince of Wales Hospital
30-32 Ngan Shing Street,
Shatin
Ethics committee country [1] 287770 0
Hong Kong
Date submitted for ethics approval [1] 287770 0
30/04/2012
Approval date [1] 287770 0
30/05/2012
Ethics approval number [1] 287770 0
No

Summary
Brief summary
The study is the first trial investigating the effect of physiotherapy on neck muscle fibrosis for post irradiated patients with nasopharyngeal carcinoma, NPC. Exercise and education are commonly received by patients as a means of self empowerment. These treatments will be compared. Patients with NPC are studied because they are usually young and are the breadwiner of the family in a Chinese society. The study also bears significant meaning because musculoskeletal complications post radiotherapy are commonly neglected globally.
Trial website
nil
Trial related presentations / publications
nil
Public notes

Contacts
Principal investigator
Name 34540 0
Address 34540 0
Country 34540 0
Phone 34540 0
Fax 34540 0
Email 34540 0
Contact person for public queries
Name 17787 0
Edwin Lee
Address 17787 0
Physiotherapy Department
Prince of Wales Hospital
30-32, Ngan Shing Street
Shatin
NT
Country 17787 0
Hong Kong
Phone 17787 0
+852-26321415
Fax 17787 0
+852-26324536
Email 17787 0
edwinlee@cuhk.edu.hk
Contact person for scientific queries
Name 8715 0
Edwin Lee
Address 8715 0
Physiotherapy Department
Prince of Wales Hospital
30-32, Ngan Shing Street
Shatin
NT
Country 8715 0
Hong Kong
Phone 8715 0
+852-26321415
Fax 8715 0
+852-26324536
Email 8715 0
edwinlee@cuhk.edu.hk

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary