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
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