Condition category
Musculoskeletal Diseases
Date applied
27/12/2018
Date assigned
10/01/2019
Last edited
11/01/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
People with neck pain often also have, neck disability and limited neck range of movement. Exercises are widely recommended for the improvement of pain in adults with persistent neck pain, but it is not agreed what the most effective exercises are. This study aimed to investigate whether shoulder and neck exercises can improving the neck disability of middle-aged and older adults with persistent neck pain.

Who can participate?
Men and women aged over 45 years with neck pain.

What does the study involve?
Participants were randomly allocated to one of two groups. All participants received interferential current therapy (a type of electrical stimulation therapy) for 15 minutes, intermittent (on and off) neck traction (pulling/stretching) for 17 minutes per time and heat pack for 15 minutes, 3 times a week for 6 weeks. Participants in the intervention group were also asked to participate in a 6-week training program of shoulder and neck exercises performed with supervision 3 times a week.

What are the possible benefits ?
Participants might experience improvement in pain, disability and range of motion. They might find some of the treatments uncomfortable or time-consuming.

Where is the study run from?
Wan-Fang Hospital (Taiwan)

When is the study starting and how long is it expected to run for?
December 2015 to September 2016

Who is funding the study?
Wan Fang Medical Center (Taiwan)

Who is the main contact?
I-Hsien Lin, 88262@w.tmu.edu.tw

Trial website

Contact information

Type

Scientific

Primary contact

Ms I-Hsien Lin

ORCID ID

http://orcid.org/0000-0002-3753-1070

Contact details

No.111
Sec. 3
Xinglong Rd
Wenshan District
Taipei City
116
Taiwan

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N201508012

Study information

Scientific title

Effect of shoulder and neck exercises on improving neck disability of middle-aged and older adults with chronic neck pain.

Acronym

shoulder and neck exercises on improving neck disability.

Study hypothesis

This study explored the effectiveness of 6-week shoulder and neck exercises on improving the neck disability of middle-aged and older adults with chronic neck pain.

Ethics approval

The Institutional Review Board of Taipei Medical University, 18/12/2015, ref: N201508012

Study design

Randomized controlled assessor-blinded trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Chronic neck pain

Intervention

All participants attended physical therapy for 6 weeks. The therapy was composed of interferential current therapy (a type of electrical stimulation therapy) for 15 minutes, intermittent cervical traction for 17 minutes per time and heat pack for 15 minutes, 3 times per week for 6 weeks.
Participants in the intervention group also received a shoulder and neck exercises program consisting of craniocervical flexion exercises and progressive elastic-band resistance exercises. They performed these exercises with one-on-one supervision performed 3 times per week for 6 consecutive weeks.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Pain measured using a visual analogue scale (VAS) before and after the 6-week intervention.

Secondary outcome measures

1. Neck disability measured using a neck disability index (NDI) before and after the 6-week intervention.
2. Neck flexibility measured using cervical range of motion (CROM) instrument (CROM Deluxe, Performance Attainment Associates, Lindstrom, MN) before and after the 6-week intervention. The participants were seated on a chair with back support and were asked to perform the maximum angles of flexion, extension, and side bending and rotation until they felt pain. In each direction, the mean CROM derived from the 3 angles was obtained.

Overall trial start date

18/12/2015

Overall trial end date

04/11/2016

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 45 years or older
2. Have experienced neck pain for more than 3 months
3. Neck pain exceeding 30 mm on a visual analogue scale (VAS)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

72

Participant exclusion criteria

1. Aged younger than 45 years
2. History of spine surgery
3. Major cardiovascular diseases
4. Rheumatoid arthritis
5. Pregnancy
6. Shoulder impingement syndrome
7. Spinal tumor
8 Participated in a neck exercise program in past 12 months.

Recruitment start date

20/12/2015

Recruitment end date

17/09/2016

Locations

Countries of recruitment

Taiwan

Trial participating centre

Wan-Fang Hospital
111 Hsing-Long Road, Section 3
Taipei
116
Taiwan

Sponsor information

Organisation

Wan Fang Medical Center

Sponsor details

No.111
Sec. 3
Xinglong Rd
Wenshan District
Taipei City
Taipei
116
Taiwan

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Wan Fang Medical Center

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication of study results in a peer reviewed journal.

IPD Sharing plan:
The data sets generated and/or analysed during the current study during this study will be included in the subsequent results publication

Intention to publish date

31/12/2019

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

11/01/2019: Internal review.