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Trial registered on ANZCTR


Registration number
ACTRN12619000013167
Ethics application status
Approved
Date submitted
4/12/2018
Date registered
9/01/2019
Date last updated
9/01/2019
Date data sharing statement initially provided
9/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effects of Soft Tissue Release of Superficial Neck Muscles on the Motor Control Ability in Patients with Neck Pain
Scientific title
The Effects of Soft Tissue Release of Superficial Neck Muscles on the Motor Control Ability in Patients with Neck Pain
Secondary ID [1] 296740 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with neck pain 310613 0
Condition category
Condition code
Physical Medicine / Rehabilitation 309326 309326 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A physiotherapist will administer each aspect of the intervention.

The soft-tissue release group
First, patients will be positioned comfortably in supine lying with the knees bent and the position of the head will be standardized by placing the craniocervical and cervical spines in a mid-position. An air-filled pressure sensor (Pressure Biofeedback Unit, Chattanooga Group, Hixon, TN) will be placed suboccipitally behind the neck of the patient and inflated to a pressure of 20 mm Hg. Patients will be instructed in the action of craniocervical flexion and practiced progressive targeting of five incremental levels (increment, 2 mm Hg) between 22 and 30 mm Hg. Substitution strategies such as neck retraction will be identified visually and discouraged.

Recordings of EMG activity from the sternal head of sternocleidomastoid (SCM) and the anterior scalene muscles will be made bilaterally with Ag/AgCl surface electrodes following careful skin preparation and using previously published guidelines for electrode placement. EMG data will be collected for 10 seconds during a standardized maneuver for normalization of the EMG amplitude. The task will involve a combined movement of craniocervical and cervical flexion to lift the head up and hold up isometrically for 10 seconds.
Patients will perform the five incremental stages (22-24-26-28-30 mm Hg) of the craniocervical flexion test to the best of their abilities, maintaining the pressure steady on each target for 10 seconds. Thirty seconds rest will be allowed between trials.

After establishing the baseline EMG data, subjects in the soft-tissue release group will receive a session of kneading, rolling and transverse friction massage therapy for 15 minutes. The massage therapy/sham therapy will be applied to the bilateral sternocleidomastoid and anterior scalene muscles. Then, a posttest with the same testing procedure as the pretest will be conducted immediately after the treatment.

The sham therapy group
The pretest and posttest procedure will be the same as the soft-tissue release group. Subjects in the sham therapy group will receive a 15-minute session of superficial stroking massage with light pressure on the anterior neck muscles.

Two interventions will be applied to all subjects. The duration of the wash-out period will be 1 week between interventions.
Intervention code [1] 313048 0
Treatment: Other
Intervention code [2] 313051 0
Rehabilitation
Comparator / control treatment
This study is a prospective, randomized crossover trial. All subjects will receive two interventions, including soft-tissue release and sham therapy. The orders of two interventions will be randomly assigned.
Control group
Active

Outcomes
Primary outcome [1] 308287 0
Primary outcome1:
Craniocervical flexion test
Timepoint [1] 308287 0
Timepoint:
Baseline, after soft tissue release and after sham therapy.
Primary outcome [2] 308288 0
Primary Outcome 2:
Electromyography amplitude of the bilateral sternocleidomastoid muscles during the five stages of the CCFT.
Timepoint [2] 308288 0
Time point:
Baseline, after soft tissue release and after sham therapy.
Primary outcome [3] 308289 0
Primary outcome 3:
Electromyography amplitude of the bilateral anterior scalene muscles during the five stages of the CCFT.
Timepoint [3] 308289 0
Time point:
Baseline, after soft tissue release and after sham therapy.
Secondary outcome [1] 354542 0
Primary Outcome 4:
Pain intensity assessed by the numeric rating scale (NRS).
Timepoint [1] 354542 0
Time point:
Baseline, after soft tissue release and after sham therapy.
Secondary outcome [2] 354543 0
Secondary Outcome 1:
Muscle stiffness of the bilateral sternocleidomastoid muscles assessed by using the MyotonPRO.
Timepoint [2] 354543 0
Baseline, after soft tissue release and after sham therapy.
Secondary outcome [3] 365255 0
Secondary Outcome 2
Muscle stiffness of the bilateral anterior scalene muscles assessed by using the MyotonPRO.
Timepoint [3] 365255 0
Baseline, after soft tissue release and after sham therapy.
Secondary outcome [4] 365256 0
Secondary Outcome 3:
Perceived feeling of muscle tightness assessed by the numeric rating scale (NRS).
Timepoint [4] 365256 0
Baseline, after soft tissue release and after sham therapy.

Eligibility
Key inclusion criteria
1. Aged 20-65 patients, with histories of non-specific neck pain > 1 month
2. The outcome of CCFT < 26 mmHg
3. Pain intensity (NRS) > or = 3
Minimum age
20 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. A history of neck surgery or trauma
2. Neck pain with radiculopathy
3. Cognitive impairment
4. Pregnant women

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/01/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 21089 0
Taiwan, Province Of China
State/province [1] 21089 0

Funding & Sponsors
Funding source category [1] 301319 0
University
Name [1] 301319 0
National Yang-Ming University
Country [1] 301319 0
Taiwan, Province Of China
Primary sponsor type
University
Name
National Yang-Ming University
Address
No.155, Sec.2, Linong Street, Taipei, 112 Taiwan (ROC)
Country
Taiwan, Province Of China
Secondary sponsor category [1] 300985 0
Hospital
Name [1] 300985 0
Cheng Hsin General Hospital
Address [1] 300985 0
No.45,Cheng Hsin St.,Pai-Tou,Taipei (ROC)
Country [1] 300985 0
Taiwan, Province Of China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302062 0
Cheng Hsin General Hospital
Ethics committee address [1] 302062 0
Ethics committee country [1] 302062 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 302062 0
18/09/2018
Approval date [1] 302062 0
25/10/2018
Ethics approval number [1] 302062 0
(661)107-33

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

Contacts
Principal investigator
Name 88994 0
A/Prof Tzyy-Jiuan Wang
Address 88994 0
Department of Physical Therapy and Assistive Technology
National Yang-Ming University
No.155, Sec.2, Linong Street, Beitou District, Taipei, Taiwan
Country 88994 0
Taiwan, Province Of China
Phone 88994 0
+886-2-2826-7091
Fax 88994 0
+886-2-2820-1841
Email 88994 0
tjwang@ym.edu.tw
Contact person for public queries
Name 88995 0
Tzyy-Jiuan Wang
Address 88995 0
Department of Physical Therapy and Assistive Technology
National Yang-Ming University
No.155, Sec.2, Linong Street, Beitou District, Taipei, Taiwan
Country 88995 0
Taiwan, Province Of China
Phone 88995 0
+886-2-2826-7091
Fax 88995 0
+886-2-2820-1841
Email 88995 0
tjwang@ym.edu.tw
Contact person for scientific queries
Name 88996 0
Tzyy-Jiuan Wang
Address 88996 0
Department of Physical Therapy and Assistive Technology
National Yang-Ming University
No.155, Sec.2, Linong Street, Beitou District, Taipei, Taiwan
Country 88996 0
Taiwan, Province Of China
Phone 88996 0
+886-2-2826-7091
Fax 88996 0
+886-2-2820-1841
Email 88996 0
tjwang@ym.edu.tw

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


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.