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

ISRCTN ISRCTN51622393
DOI https://doi.org/10.1186/ISRCTN51622393
Secondary identifying numbers N201508012
Submission date
27/12/2018
Registration date
10/01/2019
Last edited
11/01/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Ms I-Hsien Lin
Scientific

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

ORCiD logoORCID ID 0000-0002-3753-1070

Study information

Study designRandomized controlled assessor-blinded trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet No participant information sheet available
Scientific titleEffect of shoulder and neck exercises on improving neck disability of middle-aged and older adults with chronic neck pain.
Study acronymshoulder and neck exercises on improving neck disability.
Study objectivesThis 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(s)The Institutional Review Board of Taipei Medical University, 18/12/2015, ref: N201508012
Health condition(s) or problem(s) studiedChronic neck pain
InterventionAll 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 typeOther
Primary outcome measurePain measured using a visual analogue scale (VAS) before and after the 6-week intervention.
Secondary outcome measures1. 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 study start date18/12/2015
Completion date04/11/2016

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants72
Key inclusion criteria1. 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)
Key exclusion criteria1. 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.
Date of first enrolment20/12/2015
Date of final enrolment17/09/2016

Locations

Countries of recruitment

  • Taiwan

Study participating centre

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

Sponsor information

Wan Fang Medical Center
Hospital/treatment centre

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

ROR logo "ROR" https://ror.org/058y0nn10

Funders

Funder type

Hospital/treatment centre

Wan Fang Medical Center

No information available

Results and Publications

Intention to publish date31/12/2019
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryOther
Publication and dissemination planPlanned publication of study results in a peer reviewed journal.
IPD sharing planThe data sets generated and/or analysed during the current study during this study will be included in the subsequent results publication

Editorial Notes

11/01/2019: Internal review.