Condition category
Musculoskeletal Diseases
Date applied
15/05/2018
Date assigned
16/05/2018
Last edited
16/05/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Shao jun Li

ORCID ID

Contact details

Gong nong Rd. No.1478
Changchun
130022
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

20180510ABAM

Study information

Scientific title

The efficacy of acupotomy combined with muscle activation for patients with myofascial chronic neck pain

Acronym

Study hypothesis

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

Institutional review board of affiliated hospital to Changchun university of Chinese medicine, 15/11/2017, ref: CCZYFYLL 2017 approval - 057

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

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/10/2016

Overall trial end date

10/05/2018

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant 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

Recruitment start date

02/10/2016

Recruitment end date

10/05/2018

Locations

Countries of recruitment

China

Trial participating centre

The affiliated hospital to Changchun university of Chinese medicine
130022
China

Sponsor information

Organisation

The affiliated hospital to Changchun university of Chinese medicine

Sponsor details

Gong nong Rd. No.1478
Changchun
-
China

Sponsor type

Not defined

Website

Funders

Funder type

Government

Funder name

Jilin Provincial Science and Technology Plan of China

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be submitted to BMC Musculoskeletal Disorders.

IPD sharing statement
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.

Intention to publish date

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes