An evaluation of therapy for postural neck-shoulder pain
| ISRCTN | ISRCTN61539024 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61539024 |
| Secondary identifying numbers | CRREC-105-011 |
- Submission date
- 01/07/2021
- Registration date
- 08/07/2021
- Last edited
- 01/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English Summary
Background and study aims
Good posture is referred to the proper musculoskeletal alignment of the body between postural extremes. There has been mounting evidence in recent years identifying the static neck and shoulder posture that frequently assumed by office workers, as a possible risk factor in work-related neck and upper limb disorders. There is evidence that sustained forward flexion of the cervical spine results in increased compressive loading in the cervical spine and a creep response in the soft tissues. Although many spinal patients demonstrated clinically meaningful improvements in pain relief and functional recovery following the muscular intervention, the associatively underlying intervertebral posture relationship needed to be concerned for a better understanding the possible mechanism. In order to provide additional insights into the cervical biomechanics concerning postural neck-shoulder pain, this research project investigated the muscular intervention and monitored their intervention effects by videofluoroscopy and pressure measurement system.
Who can participate?
Adults over 18 years, with and without neck pain.
What does the study involve?
Participants were recruited from Taichung Veterans General Hospital and HUNGKUANG University to enroll in the study. The intervention group receives a deep friction massage for 8-weeks and the control group receives no intervention.
What are the possible benefits and risks of participating?
Participants in the intervention group may benefit from relaxing the muscle tightness and correcting postural. There are no risks involved.
Where is the study run from?
HUNGKUANG University (Taiwan)
When is the study starting and how long is it expected to run for?
June 2016 to July 2021
Who is funding the study?
Ministry of Science and Technology, Taiwan
Who is the main contact?
Shyi-Kuen Wu, rickwu01@gmail.com
Contact information
Scientific
No. 1018
Sec. 6
Taiwan Boulevard
Shalu Dist.
Taichung City
43302
Taiwan
| Phone | +886-4-26318652 Ext.5581 or3309 |
|---|---|
| skwu@sunrise.hk.edu.tw |
Study information
| Study design | interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Postural neck-shoulder pain – therapeutic efficacy evaluation |
| Study hypothesis | There are no differences between healthy subjects and postural neck pain patients on intervertebral postural relationship and biomechanics |
| Ethics approval(s) | Approved 09/06/2016, Research Ethics Committee China Medical University & Hospital (2 Ynde had, Trircbg, 40447, Taiwan (R.O.C.); +886-4-22052121 ext: 1925; rrec@mail.cmu.edu.tw), ref: CRREC-105-011 |
| Condition | Therapeutic efficacy evaluation on patients with postural neck-shoulder pain |
| Intervention | Thirty healthy adult subjects (15 males and 15 females) without neck symptoms within recent 4 weeks and thirty adult subjects (15 males and 15 females) who are diagnosed with postural neck-shoulder pain will participate in the study. The randomization is by sealed envelope the experimental group and control group. The experimental group receives an 8-week deep friction massage intervention for the myofascial trigger points. The control group receives no intervention. |
| Intervention type | Behavioural |
| Primary outcome measure | The intervertebral postural alignment for the C2/3 to C6/7 segments measured at baseline, and eight weeks using a videofluoroscopy system to capture the cervical spine motion, and transform it into 900 videofluoroscopic posture image sequences |
| Secondary outcome measures | At baseline, and eight weeks: 1. Neck disability measured using the neck disability index 2. Pain pressure threshold measured using the Coretac Pressure System |
| Overall study start date | 09/06/2016 |
| Overall study end date | 31/07/2021 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 60 |
| Participant inclusion criteria | 1. Presence of a palpable taut band in a skeletal muscle 2. Presence of a hypersensible tender spot in the taut band 3. Local twitch response elicited by the snapping palpation of the taut band 4. Reproduction of the typical referred pain pattern of the trigger point in response to compression 5. Spontaneous presence of the typical referred pain pattern and/or patient recognition of the referred pain as familiar |
| Participant exclusion criteria | 1. History of cervical trauma or surgery 2. Bone pathology 3. Arthritic or other inflammatory disorders 4. Pregnancy 5. Restrictive muscle spasm |
| Recruitment start date | 02/08/2016 |
| Recruitment end date | 07/07/2020 |
Locations
Countries of recruitment
- Taiwan
Study participating centres
Taiwan Boulevard
Shalu Dist.
Taichung City
433
Taiwan
Taiwan Blvd.
Xitun Dist.
Taichung City
407219
Taiwan
Sponsor information
Government
106, Sec. 2
Heping E. Rd.
Taipei
10622
Taiwan
| Phone | +886 (02) 2737-7992 |
|---|---|
| misservice@most.gov.tw | |
| Website | https://www.most.gov.tw/ |
"ROR" |
https://ror.org/02kv4zf79 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Ministry of Science and Technology, R.O.C. (Taiwan), Ministry of Science and Technology of Taiwan, MOST
- Location
- Taiwan
Results and Publications
| Intention to publish date | 29/06/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 30/07/2022 | 01/08/2022 | Yes | No |
Editorial Notes
01/08/2022: Publication reference added.
09/07/2021: Internal review.
08/07/2021: Trial's existence confirmed by China Medical University and Hospital ethics committee.
