Physical therapy for non-specific chronic low back pain derived from occupational risk
| ISRCTN | ISRCTN79081718 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79081718 |
| Secondary identifying numbers | CSUVM042020 |
- Submission date
- 18/03/2021
- Registration date
- 25/03/2021
- Last edited
- 26/03/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aim
Non-specific chronic low back pain (NSCLBP) is one of the most prevalent musculoskeletal disorder (13-15%) in the Mexican working population. This affection produces disability and impairs the quality of life of patients who suffer from this condition. Recently, the international guidelines for the management and treatment of low back pain suggest that physical therapy, as a non-pharmacologic treatment, is an effective therapeutic option for patients with NSCLBP. On the other hand, non-treated NSCLBP in the working population produces a high economic impact for the company and the public and private health systems. Hence, the early detection of occupation risk and concomitantly, the diagnoses and treatment of affected workers with back pain, is one of the gold objectives in the field of occupational health. The aim of this study was to determinate the effects of physical therapy as a treatment approach in NSCLBP derived from occupational risk. Also, this physical intervention tries to impact the overall quality of life in the workers.
Who can participate?
Patients in a range of age between 18 - 55 years of both genders, who presented chronic low back pain condition during the last 12 months.
What does the study involve?
The included participants undergo a physical therapy rehabilitation intervention which includes: 1) Core exercises 2) manual therapy and 3) pain neurological education, applied for 4 weeks. Participants complete questionaries and assessments at the beginning of physical therapy and at the end.
What are the possible benefits and risks of participating?
The benefits of this physical therapy intervention are directly measured as a improvement in pain and quality of life in patients. It is important to highlight that this alternative treatment doesn't represent a risk for enrolling patients. The main risk of manual therapy is a musculoskeletal lesion; however, this therapy involves a light manipulation free of pain or damage. The intensity of core exercise is increased gradually each week. Participants will be able to abandon the study if they consider that have not improved after the first week, or if the painful condition gets worse.
Where is the study run from?
The study is being run by National Autonomous University of Mexico, including Medicine School and Chemistry School, and the University of the Vallely of Mexico and takes place Queretaro bottling industry IEQSA, whom we acknowledgment for allowing the development of this protocol in their facilities.
When is the study starting and how long is it expected to run for?
July 2020 to December 2020
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Geovanna Nallely Quiñonez-Bastidas, PhD., Geovanna_quinonez@quimica.unam.mx
Contact information
Scientific
Ciudad Universitaria, Coyoacán
Ciudad de Mexico
04360
Mexico
 ORCID ID |
0000-0002-8006-3022 |
|---|---|
| Phone | +52 (0)5556225329 |
| geovanna_quinonez@quimica.unam.mx |
Study information
| Study design | Clinical interventional longitudinal and prospective pilot trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Pre-clinical and post-clinical evaluation of physical therapy rehabilitation on non-specific chronic low back pain derived from occupational risk: a pilot study with an intervention of 4-week follow-up |
| Study objectives | The physical therapy rehabilitation intervention decreases non-specific chronic low back pain derived from occupational risk. |
| Ethics approval(s) | Approved 25/09/2020, University of the Valley of México Research and Ethics Committee (Naranjos Punta Juriquilla 1000, 76230 Santiago de Querétaro, México; +52 (0)442 2111900; belzabeth.tovar@uvmnet.edu), ref: CSUVM042020 |
| Health condition(s) or problem(s) studied | Non-specific chronic low back pain derived from occupational risk |
| Intervention | Participants are recruited by an internal call for low back pain during the last 12 months. All participants were diagnosed with non-specific chronic low back pain derived from occupational risk. The participants undergo a physical therapy rehabilitation intervention which includes core exercises (basic, intermediate and advanced), manual therapy (myofascial release, McKenzie exercises and diaphragmatic breathing) and pain re-education, in a scheme of 30 minutes per session, two times a week, for 4 weeks. |
| Intervention type | Behavioural |
| Primary outcome measure | Pain measured using a visual analogue scale (VAS) at baseline (pre-treatment) and after 4 weeks (post-treatment) |
| Secondary outcome measures | 1. Kinesophobia measured using the Tampa scale of Kinesophobia at baseline (pre-treatment) and after 4 weeks (post-treatment) 2. Disability measured using the Oswestry Questionnaire at baseline (pre-treatment) and after 4 weeks (post-treatment) 3. Sleep quality measured using the Pittsburgh Questionnaire at baseline (pre-treatment) and after 4 weeks (post-treatment) 4. Quality of life measured using the short form 36 questionnaire (SF-36) at baseline (pre-treatment) and after 4 weeks (post-treatment) |
| Overall study start date | 08/07/2020 |
| Completion date | 08/12/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 457 |
| Total final enrolment | 14 |
| Key inclusion criteria | 1. Worker with localized chronic low back pain (≥ 6 months) presenting mild, mild-moderate and/or moderate pain, according to the VAS scale 2. Pain associated with an occupational risk 3. Constant and collaborative patient 4. Not receiving pharmacological treatment 5. Without aggravating family history 6. Aged 20 to 55 years 7. Actively working in the company |
| Key exclusion criteria | 1. Workers who are receiving pharmacological treatment prior to or during the study 2. Non-cooperative worker 3. Neoplastic process 4. Neurological disorders 5. Pregnancy 6. Previous or current trauma 7. Obesity |
| Date of first enrolment | 08/10/2020 |
| Date of final enrolment | 01/11/2020 |
Locations
Countries of recruitment
- Mexico
Study participating centre
Santiago de Querétaro
76130
Mexico
Sponsor information
University/education
Ciudad Universitaria
Coyoacán
Mexico City
04510
Mexico
| Phone | +52 (0)5556225329 |
|---|---|
| Omarf.carrasco@facmed.unam.mx | |
| Website | http://www.unam.mx |
"ROR" |
https://ror.org/01tmp8f25 |
University/education
Naranjos Punta Juriquilla 1000 Santa Rosa Jáuregui
Santiago Queretaro
76230
Mexico
| Phone | +52 (0)800 000 0886 |
|---|---|
| Diana.espinoma@my.uvm.edu.mx | |
| Website | https://uvm.mx/ |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/10/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to confidentiality |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 26/03/2021 | No | No |
Additional files
- ISRCTN79081718_PROTOCOL.pdf
- uploaded 26/03/2021
Editorial Notes
26/03/2021: Uploaded protocol (not peer-reviewed) as an additional file. Version n/a, no date provided.
22/03/2021: Trial's existence confirmed by University of the Valley of México
