Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001488897
Ethics application status
Approved
Date submitted
25/03/2021
Date registered
1/11/2021
Date last updated
1/11/2021
Date data sharing statement initially provided
1/11/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of neck specific exercise combined with breathing retraining in patients with chronic neck pain
Scientific title
The effects of neck specific exercise combined with breathing retraining on pain intensity, neck superficial muscles activity during craniocervical flexion test, cervical range of motion, thoracic mobility, chest expansion, respiratory muscles strength and disability in patients with chronic neck pain.
Secondary ID [1] 303792 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with chronic neck pain 321299 0
Condition category
Condition code
Physical Medicine / Rehabilitation 319083 319083 0 0
Physiotherapy
Musculoskeletal 320476 320476 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will receive 10 mins breathing retraining and 30 mins neck specific exercise in each session. The breathing retraining focuses on diaphragmatic breathing and pursed-lip breathing technique. The subjects will practice the breathing techniques under a slow and comfortable pace with hand guiding and verbal cuing from the physiotherapist. The subjects will practice the technique in different positions such as supine lying, prone baby pose, side lying, upright sitting and standing progressively. The neck specific exercise doing craniocervical flexion with pressure biofeedback unit under the suboccipital area will be taught immediately after the breathing retraining. The training will be separated into two phases to make the subjects do the movement more correctly. Phase 1: Re-education of the craniocervical flexion movement. Craniocervical flexion exercise will be performed in supine crooked lying position, targeting the deep neck flexor muscles, the longus capitus and colli. The subjects will be taught the nodding movement that slides the head in the cephalad direction as if saying “yes”, without moving the lower cervical spine or using the superficial neck muscles. The quality of movement will be confirmed and supervised by the same physiotherapist through verbal and hand cuing. It is expected that the subjects achieve the correct movement within 1-4 sessions. Once the correct craniocervical flexion motion is achieved, the physiotherapist will add phase 2 training program into the session progressively. Phase 2: Holding the increasing ranges of craniocervical flexion according to different pressure of the pressure biofeedback unit (PBU). In the beginning of this phase, a pressure biofeedback unit will be placed under the subjects’ upper cervical spine. As the subjects’ head positioned in the neutral position, the PBU will be inflated to 20mmHg. The PBU, as a movement detecting device, the pressure increases when the subjects’ craniocervical flexion range increase. Targeting 5 incremental stages from 20 to 30 mmHg progressively, the subjects will be instructed to do craniocervical flexion and hold in different ranges for 10 seconds according to their ability. The pressure will be shown to the subjects when they move so they can adjust the range of movement according to the pressure shown. Finally, when the subjects achieve the target pressure, they will be asked to close their eyes and to memorize the range they move. The range and the control of movement quality will be assigned as home program. The subjects have to practice both the breathing technique and the craniocervical flexion exercise 10 times a set, 2 sets a day under good movement quality with self-palpation. A Google sheet which reports the tasks they do has to be filled after the practice for monitoring adherence of the intervention. It is expected that the subjects achieve the goal to hold in all stages of pressure for 10 times and for 10 seconds after the total of 12 sessions training.
Intervention code [1] 320097 0
Treatment: Other
Intervention code [2] 320098 0
Rehabilitation
Comparator / control treatment
The control group receives the same neck specific exercise as the intervention group. The neck specific exercise includes two phases of craniocervical flexion exercise training. In the first phase, the subjects will be taught to do the correct craniocervical flexion movement under physiotherapist’s instruction. As the subjects succeed in doing the correct movement, the PBU will be placed under their suboccipital area for monitoring in the second phase. Targeting 5 incremental stages from 20 to 30 mmHg progressively, the subjects will be instructed to do craniocervical flexion and hold in different ranges for 10 seconds with PBU according to their ability. They also have to practice the movement at home and fill the Google sheet after the program accomplished everyday. The session of the control group includes only the neck specific exercise training lasting for 40 minutes each session. The control group will not receive the breathing retraining in any session.
Control group
Active

Outcomes
Primary outcome [1] 326974 0
Bilateral sternocleidomastoid muscle electromyogram during craniocervical flexion test assessed by surface electromyography.
Timepoint [1] 326974 0
Baseline and at 6 weeks after intervention commencement.
Primary outcome [2] 326975 0
Bilateral anterior scalene muscle electromyogram during craniocervical flexion test assessed by surface electromyography.
Timepoint [2] 326975 0
Baseline and at 6 weeks after intervention commencement.
Primary outcome [3] 328402 0
Pain intensity assessed by numeric rating scale (NRS).
Timepoint [3] 328402 0
Baseline and at 6 weeks after intervention commencement.
Secondary outcome [1] 393325 0
Cervical active range of motion assessed by cervical-range-of-motion measurement device.
Timepoint [1] 393325 0
Baseline and at 6 weeks after intervention commencement.
Secondary outcome [2] 393326 0
Thoracic mobility assessed by gravity inclinometer.
Timepoint [2] 393326 0
Baseline and at 6 weeks after intervention commencement
Secondary outcome [3] 393327 0
Chest expansion with a tape measure at the axillary and xiphoid levels.
Timepoint [3] 393327 0
Baseline and at 6 weeks after intervention commencement.
Secondary outcome [4] 393328 0
Disability assessed by Neck Disability Index (NDI).
Timepoint [4] 393328 0
Baseline and at 6 weeks after intervention commencement.
Secondary outcome [5] 393340 0
Maximal inspiratory pressure assessed by spirometer.
Timepoint [5] 393340 0
Baseline and at 6 weeks after intervention commencement.
Secondary outcome [6] 398906 0
Maximal expiratory pressure assessed by spirometer.
Timepoint [6] 398906 0
Baseline and at 6 weeks after intervention commencement.

Eligibility
Key inclusion criteria
1. Patients aged above 20 with chronic neck and/or shoulder pain.
2. More than 12 months neck and/or shoulder pain history since first onset.
3. At least once a week neck and/or shoulder pain occurrence in the last 1 month, with pain intensity (numeric rating scale) >3.
Minimum age
20 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Traumatic cervical injury, whiplash injury, fracture of the spine.
2. Previous surgery of the spine or rib cage.
3. Neck pain with neurological signs in the upper limb.
4. Known cardiovascular, pulmonary disease and under medicine control currently.
5. Known psychological disease and under medicine control currently.
6. Medicine or alcohol addicted.
7. Smoking.
8. Pregnancy.

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
All subject will be randomized into either the control or the intervention group by drawing lots.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Independent-t test and Chi-squared test will be used to compare the basic data in the two groups. Two-way mixed ANOVA test will be used for the pre- and post- outcomes analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
27/01/2021
Date of last participant enrolment
Anticipated
31/12/2021
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
21
Final
Recruitment outside Australia
Country [1] 23567 0
Taiwan, Province Of China
State/province [1] 23567 0
Taipei City and New Taipei City

Funding & Sponsors
Funding source category [1] 308193 0
Self funded/Unfunded
Name [1] 308193 0
Nil.
Country [1] 308193 0
Primary sponsor type
Individual
Name
Yi-fen Shih
Address
No. 155, Li-Nong Street Section 2, Pei-Tou District,
National Yang-Ming-Chiao-Tung University Department of Physical Therapy and Assistive Technology Taipei, Taiwan 112.
Country
Taiwan, Province Of China
Secondary sponsor category [1] 308978 0
None
Name [1] 308978 0
Nil.
Address [1] 308978 0
Nil.
Country [1] 308978 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308176 0
Institutional Review Board (IRB) of National Yang-Ming University
Ethics committee address [1] 308176 0
Ethics committee country [1] 308176 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 308176 0
10/06/2020
Approval date [1] 308176 0
21/08/2020
Ethics approval number [1] 308176 0
YM109096F

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109810 0
Prof Yi-Fen Shih
Address 109810 0
No. 155, Li-Nong Street Section 2, Pei-Tou District, National Yang-Ming-Chiao-Tung University Department of Physical Therapy and Assistive Technology Taipei, Taiwan 112.
Country 109810 0
Taiwan, Province Of China
Phone 109810 0
+886 2 2826 7340
Fax 109810 0
Email 109810 0
[email protected]
Contact person for public queries
Name 109811 0
Yi-Fen Shih
Address 109811 0
No. 155, Li-Nong Street Section 2, Pei-Tou District, National Yang-Ming-Chiao-TungUniversity Department of Physical Therapy and Assistive Technology Taipei, Taiwan 112.
Country 109811 0
Taiwan, Province Of China
Phone 109811 0
+886 2 2826 7340
Fax 109811 0
Email 109811 0
[email protected]
Contact person for scientific queries
Name 109812 0
Yi-Fen Shih
Address 109812 0
No. 155, Li-Nong Street Section 2, Pei-Tou District, National Yang-Ming-Chiao-TungUniversity Department of Physical Therapy and Assistive Technology Taipei, Taiwan 112.
Country 109812 0
Taiwan, Province Of China
Phone 109812 0
+886 2 2826 7340
Fax 109812 0
Email 109812 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.