The efficacy of acupotomy combined with muscle activation for patients with myofascial chronic neck pain
| ISRCTN | ISRCTN64518034 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN64518034 |
| Secondary identifying numbers | 20180510ABAM |
- Submission date
- 15/05/2018
- Registration date
- 16/05/2018
- Last edited
- 16/05/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Neck pain is the fourth leading cause of disability in middle age. Several factors are linked to the etiology (cause) of neck pain, and myofascial trigger points (sensitive spots in soft tissue) are the most common reason for chronic neck pain. The aim of this study is to investigate the effects of acupotomy (a minimally invasive surgery of traditional Chinese medicine) combined with muscle activation in patients with myofascial chronic neck pain.
Who can participate?
Patients aged 18 to 75 with neck pain
What does the study involve?
All patients undergo acupotomy treatment once every two days , and then the muscles surrounding the cervical spine are strengthened or stretched twice a day. Disability, pain and cervical range of motion are assessed before the first treatment, immediately after the treatment and in the follow-up (1 week, 4 and 8 weeks after the last treatment).
What are the possible benefits and risks of participating?
The acupotomy operation may quickly relieve pain and functional limitations in patients with myofascial chronic neck pain. Selective muscle activation may provide a long-lasting healing effect by preventing the occurrence of fascial trigger points. The risk of manipulation is bleeding, pain and infection.
Where is the study run from?
The affiliated hospital to Changchun university of Chinese medicine (China)
When is the study starting and how long is it expected to run for?
October 2016 to May 2018
Who is funding the study?
Jilin Provincial Science and Technology Plan of China
Who is the main contact?
Dr Shao jun Li
Contact information
Scientific
Gong nong Rd. No.1478
Changchun
130022
China
Study information
| Study design | The clinical data of patients with chronic fascial neck pain was studied retrospectively |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | The efficacy of acupotomy combined with muscle activation for patients with myofascial chronic neck pain |
| Study objectives | The trialists hypothesize that acupotomy combined with muscle activation can provide long-lasting and stable efficacy for the patients with chronic myofascial neck pain. |
| Ethics approval(s) | Institutional review board of affiliated hospital to Changchun university of Chinese medicine, 15/11/2017, ref: CCZYFYLL 2017 approval - 057 |
| Health condition(s) or problem(s) studied | Neck pain is the fourth leading cause of disability in middle age. Several factors link to the etiology of neck pain, and myofascial trigger points is the common reason for chronic neck pain. |
| Intervention | The clinical data of patients with chronic fascial neck pain was studied retrospectively. All the patients underwent the treatment of acupotomy, and then the muscles surrounding the cervical spine were strengthened or stretched. The acupotomy operation was performed once every two days. Muscle activation training was practiced twice a day. The duration of follow-up was 8 weeks. Neck Disability Index (NDI) was used to assess psychological and disability variables. NDI consists of 10 items that evaluate different functional activities. Each item is divided into six levels: from 0 (no disability) to 5 (completely disabled). The total score is obtained by adding the score of each item and multiplying it by 2. Higher scores indicate more severe pain and dysfunction. All the patients who were included in the study had to complete all these questionnaires before the first treatment, immediately after the treatment and in the follow-up. The duration of follow-up was 1 week, 4 and 8 weeks after the last intervention. Visual Analogue Scale (VAS) was utilized in assessment of the degree of cervical pain. It was scored 0-10 (0 being no pain and 10 being unbearable pain). The cervical range of motion (ROM) was used to evaluate cervical range motion. As with NDI, the assessment was performed before, immediately after treatment and during the follow-up period. |
| Intervention type | Other |
| Primary outcome measure | 1. Degree of cervical pain, assessed using the visual analogue scale before the first treatment, immediately after the treatment and in the follow-up (1 week, 4 and 8 weeks after the last intervention) 2. Cervical range of motion, assessed before the first treatment, immediately after the treatment and in the follow-up (1 week, 4 and 8 weeks after the last intervention) |
| Secondary outcome measures | Psychological and disability variables, assessed using the Neck Disability Index (NDI) before the first treatment, immediately after the treatment and in the follow-up (1 week, 4 and 8 weeks after the last intervention) |
| Overall study start date | 01/10/2016 |
| Completion date | 10/05/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 30 |
| Key inclusion criteria | 1. Subjects with neck pain 2. Suffering from neck pain for at least 3 months 3. The pain intensity was higher than 2 on a visual analogue scale (VAS) 4. Neck pain could be provoked by either neck postures or neck movement 5. Restricted cervical range of movements (flexion, extension, rotation, and side-bending) 6. Males or females aged 18 to 75 years |
| Key exclusion criteria | 1. Orofacial pain and temporomandibular disorders 2. A history of traumatic injuries (e.g., contusion, fracture, and whiplash injury) 3. Systemic diseases such as fibromyalgia, systemic erythematous lupus, and psoriatic arthritis 4. Neurologic disorders 5. Concomitant medical diagnosis of any primary headache (tension type or migraine) 6. Patients who had coagulopathy, abnormal findings on their ECG 7. Cervical spine surgery 8. Clinical diagnosis of cervical radiculopathy or myelopathy 9. Needle phobia |
| Date of first enrolment | 02/10/2016 |
| Date of final enrolment | 10/05/2018 |
Locations
Countries of recruitment
- China
Study participating centre
China
Sponsor information
Not defined
Gong nong Rd. No.1478
Changchun
-
China
"ROR" |
https://ror.org/035cyhw15 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | To be submitted to BMC Musculoskeletal Disorders. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a publically available repository (https://figshare.com). The data of VAS, NDI, and ROM will be shared and the pictures will be shared too. The data will become available after the paper is published, and will be available to everyone permanently. |
