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Trial registered on ANZCTR


Registration number
ACTRN12617001556336
Ethics application status
Approved
Date submitted
28/08/2017
Date registered
15/11/2017
Date last updated
29/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of cervical mobilization on decreasing pain, increasing shoulder strength and function in patients with non-specific shoulder/arm pain
Scientific title
Effectiveness of cervical mobilization versus conventional physical therapy on pain intensity, shoulder strength, function, and disability in patients with non-specific shoulder/arm pain
Secondary ID [1] 293039 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-specific shoulder/arm pain 304550 0
Condition category
Condition code
Musculoskeletal 303872 303872 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 303873 303873 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group 1 (anterior to posterior gapping and lateral glide cervical mobilization): Subjects in this group will receive cervical mobilization treatments including (1) anterior–posterior gapping of the facet joints, performed in supine for 30 repetitions for 3 sets; and (2) lateral to medial gliding movements of each cervical segment from C3 to C6, performed in supine for 30 repetitions for 3 sets. The intervention will be given by a physiotherapist.
The intervention group 2 (anterior to posterior gapping mobilization): Subjects in this group will receive cervical mobilization treatments including the anterior–posterior gapping of the facet joints, performed in supine for 30 repetitions for 3 sets. The intervention will be given by a physiotherapist.

The above two intervention groups will also receive modality intervention after mobilization. The modality intervention include the application of hot pack for 10 mins, ultrasound and/or interferential current therapy (frequency: 50-160Hz, 4bps; Intensity: 10-50mA) for 15 mins.

The approximate duration of each treatment session for each group will be 45 minutes.

The whole treatment program for the two intervention groups will be 6 sessions (2 sessions per week for 3 weeks).

The intervention adherence will be recorded using a log sheet by the study therapist. Subjects will be reminded to adhere their treatment schedule during each session.
Intervention code [1] 298995 0
Rehabilitation
Intervention code [2] 299262 0
Treatment: Other
Comparator / control treatment
Subjects in the control group will receive a placebo manual therapy with the physiotherapist applying stroking on the subject’s neck for 10 minutes.

The control group will also receive modality intervention after mobilization. The modality intervention include the application of hot pack for 10 mins, ultrasound and/or interferential current therapy (frequency: 50-160Hz, 4bps; Intensity: 10-50mA) for 15 mins.

The whole treatment program for the two intervention groups will be 6 sessions, 2 sessions per week for 3 weeks, or 3 sessions per week for 2 weeks.
Control group
Active

Outcomes
Primary outcome [1] 303229 0
The current pain intensity will be assessed by the numeric pain rating scale (NPRS) and will be rated by the study participants.
Timepoint [1] 303229 0
Baseline, immediately after each treatment session, upon completion of 6 treatment sessions, and at 4-week after completion of treatment program.
Primary outcome [2] 303230 0
The isometric strength of shoulder muscles (abductors and flexors) will be tested by a hand-held dynamometer (MicroFET2, Hoggan Industries, Utah, USA)
Timepoint [2] 303230 0
Baseline, immediately after each treatment session, upon completion of 6 treatment sessions, and at 4-week after completion of treatment program.
Primary outcome [3] 303231 0
Function will be assessed by the Patient Specific-Functional Scale (PSFS)
Timepoint [3] 303231 0
Baseline, immediately after each treatment session, upon completion of 6 treatment sessions, and at 4-week after completion of treatment program.
Secondary outcome [1] 338290 0
Pain-free cervical range of motion (flexion, extension, lateral flexion and rotation) will be assessed by the cervical-range-of-motion device (CROM, Performance Attainment Associates)
Timepoint [1] 338290 0
Baseline, immediately after each treatment session, upon completion of 6 treatment sessions, and at 4-week after completion of treatment program.
Secondary outcome [2] 338293 0
Functional disability will be assessed either by the Neck Disability Index (NDI) if the subject's main symptom is neck pain or the Disabilities of the Arm, Shoulder and Hand (DASH) if the subject's main symptom is shoulder pain .
Timepoint [2] 338293 0
Baseline, upon completion of 6 treatment sessions, and at 4-week after completion of treatment program.
Secondary outcome [3] 338294 0
Perceived improvement will be assessed by the Global Rating of Change Scale (GROC)
Timepoint [3] 338294 0
Baseline, immediately after each treatment session, upon completion of 6 treatment sessions, and at 4-week after completion of treatment program.
Secondary outcome [4] 338301 0
Pain-free shoulder range of motion (flexion and abduction) will be assessed by a universal goniometer.
Timepoint [4] 338301 0
Baseline, upon completion of 6 treatment sessions, and at 4-week after completion of treatment program.
Secondary outcome [5] 339729 0
Primary Outcome [4]: the 24-hr worst pain intensity will be assessed by the numeric pain rating scale (NPRS) and will be rated by the study participants.
Timepoint [5] 339729 0
Baseline, immediately after each treatment session, upon completion of 6 treatment sessions, and at 4-week after completion of treatment program.

Eligibility
Key inclusion criteria
1. Patients with non-specific shoulder/arm pain aged more than 20 years
2. Pain/symptoms or weakness with shoulder resisted strength testing (shoulder flexors and abductors)

Minimum age
20 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Shoulder tendinitis (palpable tenderness on the rotator cuff tendons or the biceps tendon)
2. Previous surgery of the neck or shoulder
3. Previous dislocation of the affected shoulder
3. Clinically definitive arthritis of the shoulder on X-ray
4. Had a cortisone injection for the current episode of shoulder pain
5. Had any neurological diseases

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)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/11/2017
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
78
Accrual to date
0
Final
Recruitment outside Australia
Country [1] 9173 0
Taiwan, Province Of China
State/province [1] 9173 0

Funding & Sponsors
Funding source category [1] 297394 0
University
Name [1] 297394 0
National Yang-Ming University
Country [1] 297394 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] 296672 0
None
Name [1] 296672 0
Address [1] 296672 0
Country [1] 296672 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298493 0
Chen-Hsin General Hospital Institutional Review Board (IRB)
Ethics committee address [1] 298493 0
Ethics committee country [1] 298493 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 298493 0
15/03/2017
Approval date [1] 298493 0
09/08/2017
Ethics approval number [1] 298493 0
(598)106-06

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

Contacts
Principal investigator
Name 77266 0
A/Prof Tzyy-Jiuan Wang
Address 77266 0
Department of Physical Therapy and Assistive Technology
National Yang-Ming University
No.155, Sec.2, Linong Street, Taipei 11221
Country 77266 0
Taiwan, Province Of China
Phone 77266 0
+886-2-2826-7091
Fax 77266 0
+886-2-2820-1841
Email 77266 0
tjwang@ym.edu.tw
Contact person for public queries
Name 77267 0
Tzyy-Jiuan Wang
Address 77267 0
Department of Physical Therapy and Assistive Technology
National Yang-Ming University
No.155, Sec.2, Linong Street, Taipei 11221
Country 77267 0
Taiwan, Province Of China
Phone 77267 0
+886-2-2826-7091
Fax 77267 0
+886-2-2820-1841
Email 77267 0
tjwang@ym.edu.tw
Contact person for scientific queries
Name 77268 0
Tzyy-Jiuan Wang
Address 77268 0
Department of Physical Therapy and Assistive Technology
National Yang-Ming University
No.155, Sec.2, Linong Street, Taipei 11221
Country 77268 0
Taiwan, Province Of China
Phone 77268 0
+886-2-2826-7091
Fax 77268 0
+886-2-2820-1841
Email 77268 0
tjwang@ym.edu.tw

No information has been provided regarding IPD availability


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
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