Immediate effect of thoracic mobilization on trunk motion, pain sensation and lumbar spine muscle activity in patients with chronic low back pain
| ISRCTN | ISRCTN75190733 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75190733 |
- Submission date
- 18/10/2021
- Registration date
- 22/10/2021
- Last edited
- 28/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English Summary
Background and study aims
Low back pain in older people is a common degenerative disease that mainly involves the structures of the lumbar spine such as the intervertebral discs, facet joints, and ligaments leading to lumbar instability. Conservative management is recommended as first-line therapy for mild to moderate low back pain. A combination of clinical treatments shows beneficial effects to chronic low back pain (CLBP) patients. Thoracic mobilization is a common manual technique in clinical practice. However, the effects of thoracic mobilization on pain sensation and muscle function in individuals with CLBP have not been explored. The aim of this study is to investigate the immediate effects of thoracic mobilization and soft tissue release technique on trunk movement, pain sensation, and muscle activity in CLBP patients.
Who can participate?
Low back pain patients aged 40-70 years with mild degenerated lumbar spondylolisthesis
What does the study involve?
Participants are randomly allocated into two groups: the thoracic mobilization group and the soft tissue release group. The treatment is performed in a single session. Trunk motion, tissue hardness, pressure pain threshold, and trunk muscle activity during a lifting task are measured before and immediately after the treatment.
What are the possible benefits and risks of participating?
Both interventions would increase trunk range of motion and pressure pain threshold, as well as reduce tissue hardness and muscle activation. However, this study might have some minor risks such as feeling uncomfortable lying prone or muscle soreness after the interventions.
Where does the study run from?
National Cheng Kung University (Taiwan)
When is the study starting and how long is it expected to run for?
July 2015 to July 2016
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Associate Professor Cheng-Feng Lin
connie@mail.ncku.edu.tw
Contact information
Scientific
Institute of Allied Health Sciences
College of Medicine
National Cheng Kung University
Tainan
70101
Taiwan
 ORCID ID |
0000-0003-4110-6867 |
|---|---|
| Phone | +886 (0)971652242 |
| hospital@mail.hosp.ncku.edu.tw |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Immediate effect of thoracic mobilization on trunk motion, pain sensation and lumbar spine muscle activity in patients with chronic low back pain |
| Study hypothesis | It is hypothesized that thoracic mobilization and soft tissue release intervention would improve the outcome variables and the mobilization technique might lead to superior effects than the soft tissue release. |
| Ethics approval(s) | Approved 10/11/2015, Institutional Review Board of National Cheng Kung University Hospital (No.138, Sheng Li Road, Tainan, Taiwan 704, R.O.C.; +886 (0)6 2353535; hospital@mail.hosp.ncku.edu.tw), ref: A-ER-104-192 |
| Condition | Mild degenerated lumbar spondylolisthesis (chronic low back pain) |
| Intervention | Participants are randomly allocated into two groups: the thoracic mobilization group and the soft tissue release group. The randomization is performed by the primary investigator using the block randomization method. The first participant is randomly drawn using sealed envelopes and assigned to group A. Then, the other participants are assigned into groups B, A, B, A, B etc. The mobilization technique is performed in the posteroanterior direction (PA technique) at the spinous process at least Grade III to grade IV described by Maitland concept. The experienced physiotherapist performs the mobilization along the middle (T5-9) and lower (T10-12) thoracic spine. The pressure is applied on the joint with hypomobility. The technique is carried out by oscillating pressure on the spinous process from posterior to anterior direction, produced by the movement of the trunk given by body weight and transmitted through the arms and to the thumb. The soft tissue release technique is carried out by the same experienced physiotherapist. The thoracolumbar fascial release and Swedish massage technique were chosen in this study. The technique is bilaterally applied along the superficial backline from the sciatic notch to the thoracolumbar junction. The Swedish application is also performed at the same location with the light effleurage technique. The treatment is performed in a single session. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Measured before (pre-intervention) and immediately after the interventions (post-intervention): 1. Trunk range of motion measured in three movement planes using a goniometer and a measuring tape 2. Tissue hardness measured using the algometer combo equipment (OE-220) at the bilaterally lumbar muscle in a relaxed state 3. Pressure pain threshold measured using the algometer combo equipment (OE-220) at the bilaterally lumbar muscle in a relaxed state. A switch of the algometer is connected to the machine and the participants are requested to press the switch immediately if their feeling changes from pressure to pain sensation. 4. Lumbar muscle activity measured by surface electromyography to detect the signal of the thoracic erector spinae muscle and the lumbar erector spinae muscle. The muscle activity test is recorded during performing the ascending and descending phases of the lifting task. |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/07/2015 |
| Overall study end date | 31/07/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 40 Years |
| Upper age limit | 70 Years |
| Sex | Both |
| Target number of participants | The sample size was calculated based on pilot data. The calculated effect size is 0.8, at least 24 participants were required |
| Total final enrolment | 28 |
| Participant inclusion criteria | 1. Patients with mild degenerated lumbar spondylolisthesis aged 40-70 years old 2. Experiencing chronic low back pain for at least 6 months 3. Visual analog scale (VAS) ≥30, ranging from 0 to 100 4. Spondylolisthesis clinically diagnosed by orthopedic surgeons confirmed with lateral view radiographic of the lumbar spine 5. Grade I spondylolisthesis was included based on the Meyerding grade classification from the lateral view radiographs |
| Participant exclusion criteria | 1. Patients with neurological signs, cardiovascular and respiratory diseases 2. Severe conditions that inhibit lifting a heavy object |
| Recruitment start date | 28/12/2015 |
| Recruitment end date | 03/06/2016 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
College of Medicine
No.1 University Road
Tainan
70101
Taiwan
Sponsor information
Hospital/treatment centre
No.138, Sheng Li Road
Tainan
704
Taiwan
| Phone | +886 (0)6 2353535 |
|---|---|
| hospital@mail.hosp.ncku.edu.tw | |
"ROR" |
https://ror.org/04zx3rq17 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 25/10/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in the Brazilian Journal of Physical Therapy. No additional documents or protocol will be available after the publication of the study. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Associated Professor Cheng-Feng Lin (connie@mail.ncku.edu.tw). The datasets will be provided in an Excel format after the study is published. The datasets will be provided to someone who wants to use the data for further analysis such as a meta-analysis. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 26/09/2024 | 28/11/2024 | Yes | No |
Editorial Notes
28/11/2024: Publication reference added.
21/10/2021: Trial's existence confirmed by the Institutional Review Board of National Cheng Kung University Hospital.
