Effects of sling exercises on pain, function, and brain-muscle coordination in individuals with chronic low back pain
| ISRCTN | ISRCTN17254456 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17254456 |
- Submission date
- 17/05/2023
- Registration date
- 22/05/2023
- Last edited
- 22/05/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Chronic low back pain (CLBP) is a disabling condition that affects all populations. Exercise training has been proven to achieve promising outcomes for pain and function among patients with CLBP. Nevertheless, the mechanism that mediates pain reduction after exercise training is not well understood. Some studies have found deficits in neural connection and decreased trunk control in people with CLBP. Whether training-related symptom reduction is attributed to enhanced brain-trunk muscle control has not yet been explored. Therefore, this study aims to investigate whether improvement of back pain and function is attributed to a change in the link between brain and trunk muscle activities.
Who can participate?
Healthy volunteer control people and patients with chronic low back pain aged between 20-50 years old
What does the study involve?
All participants receive 40 minutes of sling exercises twice a week for 6 weeks. Selected exercises include chess press, hamstring curl, hip abduction in plank, and single-leg squat. All training is supervised by a licensed physical therapist. Exercise intensity and rest are adjusted according to each participant’s performance.
What are the possible benefits and risks of participating?
Participants with back pain may benefit from some extent of symptom relief. For healthy volunteers, they may experience the benefits of engaging in physical activities, and contribute to scientific understanding of the mechanism of exercise therapy on back pain. The risks involved in the intervention are similar to participating in daily exercises, where participants may experience soreness during or after exercises.
Where is the study run from?
Department of Physical Therapy and Assistive Technology, National Yang-Ming Chao Tung University (Taiwan), and Department of Rehabilitation Medicine, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation (Taiwan)
When is the study starting and how long is it expected to run for?
July 2014 to October 2016
Who is funding the study?
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation (Taiwan)
Who is the main contact?
Prof Li-Wei Chou, lwchou@nycu.edu.tw
Contact information
Principal Investigator
No. 155, Sec. 2, Linong Street
Beitou District
Taipei City
112
Taiwan
 ORCID ID |
0000-0002-2368-448X |
|---|---|
| Phone | +886 2 2826 7092 |
| lwchou@nycu.edu.tw |
Scientific
No. 155, Sec. 2 Linong Street
Beitou District
Taipei City
112
Taiwan
| Phone | +886228267092 |
|---|---|
| lwchou@nycu.edu.tw |
Study information
| Study design | Quasi-experimental design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Effects of sling exercises on pain, function, and corticomuscular functional connectivity in individuals with chronic low back pain - A preliminary study |
| Study objectives | Patients suffering from chronic low back pain can greatly benefit from performing sling exercises. The reason behind this improvement can be attributed to the enhancement of corticomuscular coherence. |
| Ethics approval(s) | 1. Approved 10/11/2014, Institutional Review Board of National Yang-Ming University (now National Yang Ming Chao Tung University) (No. 155, Sec. 2, Linong Street, Beitou Dist., Taipei City, 112, Taiwan; +886228239753; rec@nycu.edu.tw), ref: YM103090E 2. Approved 20/10/2014, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation (No. 289, Jianguo Rd., Xindian Dist., New Taipei City, 231405, Taiwan; +886266289779 ext. 1136; hrpc@tzuchi.com.tw), ref: 03-XD14-039 |
| Health condition(s) or problem(s) studied | Nonspecific chronic low back pain |
| Intervention | There are two study groups, namely a patient group with chronic low back pain and a healthy control group. Patients diagnosed with nonspecific chronic low back pain are screened by a physiatrist at the Department of Rehabilitation Medicine of Taipei Tzu Chi Hospital. The eligible patients are interviewed by a licensed physical therapist (Bo-Jhen Chen, one of the principal investigators). For healthy controls, asymptomatic adults (aged 20-50) are recruited at National Yang-Ming Chao Tung University (formerly called National Yang-Ming University). The principal investigator Professor Li-Wei Chou will explain the purpose and method of the study for candidates. Written informed consent is obtained from each participant before the commencement of assessment and training, which is conducted at the laboratory of the Department of Physical Therapy and Assistive Technology, National Yang-Ming Chao Tung University. Both the healthy control and patients receive 40 minutes of sling exercises twice a week for 6 weeks. Selected exercises include chess press, hamstring curl, hip abduction in plank, and single-leg squat. All training is supervised by a licensed physical therapist, who receives formal training in TRX (a sling exercise toolkit). Exercise intensity and rest are adjusted according to each participant’s performance. |
| Intervention type | Behavioural |
| Primary outcome measure | The following primary outcome measures are assessed at baseline and 6 weeks: 1. Pain measured using the Numeric Pain Rating Scale 2. Disability measured using the Oswestry Disability Index 3. Neuromuscular activity measured by calculating corticomuscular (electroencephalogram [EEG]–electromyography [EMG]) coherence |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/07/2014 |
| Completion date | 29/10/2016 |
Eligibility
| Participant type(s) | Healthy volunteer, Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 20 Years |
| Upper age limit | 50 Years |
| Sex | Both |
| Target number of participants | 30 |
| Total final enrolment | 23 |
| Key inclusion criteria | 1. Chronic low back pain for more than 3 months 2. Aged 20-50 years old |
| Key exclusion criteria | Patient: Spinal stenosis/fracture, radiculopathy, or history of surgery Healthy adults: 1. Aged outside of 20–50 years 2. Neurological diseases |
| Date of first enrolment | 23/11/2014 |
| Date of final enrolment | 19/10/2016 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
No. 289, Jianguo Rd.
Xindian Dist.
New Taipei City
231405
Taiwan
Sponsor information
Hospital/treatment centre
Buddhist Tzu Chi Medical Foundation
No. 289, Jianguo Rd
Xindian Dist.
New Taipei City
231405
Taiwan
| Phone | +886 2 6628 9779 - 1136 |
|---|---|
| hrpc@tzuchi.com.tw | |
| Website | https://taipei.tzuchi.com.tw/file_tp/IRB/index.htm |
"ROR" |
https://ror.org/00q017g63 |
Funders
Funder type
Hospital/treatment centre
Private sector organisation / Other non-profit organizations
- Location
- Taiwan
Results and Publications
| Intention to publish date | 01/07/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed international journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from the corresponding author Prof Li-Wei Chou, lwchou@nycu.edu.tw. The patient group is recruited from the Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Taiwan (R.O.C.), and their associated medical records are governed by the Personal Data Protection Act in Taiwan (R.O.C.). Prior to requesting access to these data from the corresponding author, please inform the Human Research Protection Center of Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Taiwan (R.O.C.) (hrpc@tzuchi.com.tw) in advance. Standardized written informed consent was obtained from each participant. All personal information will be de-identified. The demographic data (number of included subjects, age, body mass index, and symptom duration and severity) and the brain-muscle activities of the participants will be shared upon request. |
Editorial Notes
22/05/2023: Trial's existence confirmed by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation (Taiwan).
