Low Back PainECOLUMNCT02103036
Valuation of the Low Back Pain Treated With Different Types of Active Exercises in Women
A study testing Core Stability Exercises (CSE), Traditional Back School and TENS in people with Low Back Pain, run by University Rovira i Virgili at 1 site in Spain.
Trial summary
The purpose of the study is determine whether the Core Stability Exercise is more effective than the traditional Back School for low back pain (LBP) in women. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Core Stability Exercises (CSE), Traditional Back School and TENS
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2014to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women aged 18 to 70 years.
- Diagnosis of back pain from a trauma.
- Untreated pain (except acetaminophen).
- Informed consent.
Who cannot join
- Algic process in the lumbar spine of infectious, neoplastic, metastasis, osteoporosis, inflammatory arthritis or fractures.
- Cognitive impairment of any etiology.
- Exercise intolerance for any reason.
- Patients who have completed physical therapy in the last 3 months.
- Patients who have received infiltration injections in the last 6 weeks.
Trial locations and contacts
1 site in 1 country.
Eduard Minobes, PT contact
Spain1 site, 1 recruiting
- Recruiting
Faculty of Medicine and Health Sciences
Reus, Tarragona, 43201
Rosa Nogués, PhD, +34977759355, mariarosa.nogues@urv.cat
Eduard Minobes, PT
About this study
The purpose of the study is determine whether the Core Stability Exercise is more effective than the traditional Back School for low back pain (LBP) in women.
Read the detailed description
The aim of this study is to check what kind of exercises are the best to treat LBP with regard to clinical improvements. The secondary objectives are: to determine which treatment is more effective in improving pain in the fewest sessions possible, to determine the involvement of inflammatory biomarkers in the development of pain and revalue the results after one month of having finishing treatment.
The project is a longitudinal, single-blind and randomized study with two treatment groups:
GROUP 1: Infrared light+ Transcutaneous Electrical Nerve Stimulation (TENS) + Core Stability Exercises.
GROUP 2: Infrared light + Transcutaneous Electrical Nerve Stimulation (TENS) + Traditional Back School.
Duration of treatment: 4 weeks. The participants will performe the exercises in 20 daily sessions (Monday to Friday) guided by a physiotherapist. Following treatment with the physiotherapist, the participants should perform the exercises at home for 4 weeks at a rate of three times per week.
- Conditions
- Low Back Pain
- Being tested
- Core Stability Exercises (CSE), Traditional Back School, TENS, Infra-red
- Keywords
- Low Back Pain, Core stability exercise, Back school, TENS, Infra- red light
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core Stability Exercises (CSE)Procedure or surgery
Also called Motor control exercises, Specific spinal stabilitation exercises
The increase in intra-abdominal pressure stiffens and strengthens the relevant structural support around the spine, compacts the arthrogenic structures and in combination with abdominal contraction, it can encourage a rigid cylinder and stiffness to occur around the spine. The relevant anatomy in these type of exercises are deep muscles like transversus abdominous, multifidus or pelvic floor. The participants will have to do 10 different exercises. They will have to perform from 8 to 10 repetitions of every exercise, guided by a physical therapist. They will be recommended about making some series more at home, three days a week, when the treatment was finished.
Traditional Back SchoolProcedure or surgery
The back school exercises are based in the traditional activity used for improve the back pain symptoms using the breathing with the stretching of the trunk muscles, the erector spinae reinforcement, the abdominal reinforcement or the postural movements. The participants will have to do 10 different exercises. They will have to perform from 8 to 10 repetitions of every exercise, guided by a physical therapist. They will be recommended about making some series more at home, three days a week, when the treatment was finished.
TENSDevice
Also called Transcutaneous Electrical Nerve Stimulation
Used equipment: MEGASONIC 313 P4 (Carin). Application program number 15: analgesic TENS with stimulation of afferent fibers.
Type of current: two-phase TNS. Width of the impulse: 70µs. Frequency of the impulse: 100Hz. Train: Not. Pause / pause activates: Not. Time of treatment: 20 minutes.
Infra-redDevice
Also called Infrared light
Used equipment: INFRA - 2000 (Enraf Nonius) with the following parameters: 230 V / 50-60 Hz / 1.2 A
| Study group | Role | What they receive |
|---|---|---|
| Core Stability Exercises | Experimental | Core Stability Exercises:
20 sessions, distributed daily, from Monday to Friday. The first 5 sessions are common in all patients in the study, and involves the application of infrared light (IR) (10 minutes) and TENS (20 minutes) to treat acute pain. From session number 6 to session 20, the patients will receive IR + TENS 2 days a week, and the other 3 days IR+TENS+Core Stability Exercises (25-30 minutes). Receives: Procedure: Core Stability Exercises (CSE); Device: TENS; Device: Infra-red |
| Traditional Back School | Experimental | Traditional Back School:
20 sessions, distributed daily, from Monday to Friday. The first 5 sessions are common in all patients in the study, and involves the application of infrared light (IR) (10 minutes) and TENS (20 minutes) to treat acute pain. From session number 6 to session 20, the patients will receive IR + TENS 2 days a week, and the other 3 days IR+TENS+Traditional Back School (25-30 minutes). Receives: Procedure: Traditional Back School; Device: TENS; Device: Infra-red |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Visual Scale Analogue (VAS)
The VAS scale represents the pain intensity on a line of 10 cm, and one end there are the words "no pain" and the other end "the worst imaginable pain" written the distance in centimetres from the "no pain" point to the place marked by the patient represents the intensity of pain.
Measured: Pain was measured at the beginning of the study (session 0), and changes are evaluated again at sessions 10, 20, and 1 month later.
Secondary outcomes (1)
Changes in the Roland- Morris Disability Questionnaire
It consists of 24 items, which reflect limitation in different activities of daily living attributed by the patient to LBP. The patient must mark each item that applies to her current status. Scoring is also simple and fast; each checked item receives a score of 1, so scores range between 0 (no disability caused by LBP) and 24 (the maximum possible disability).
Measured: Disability was measured at the beginning of the study (session 0), and changes are evaluated again at sessions 10, 20, and 1 month later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionMar 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Rovira i Virgili
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitari Sant Joan de Reus
- Responsible party
- Principal investigator, M. Rosa Nogués, University Rovira i Virgili
- Investigators
- Rosa Nogués, Pharm.D., Study director, Faculty of Medicine and Health Sciences. Rovira i Virgili University. Spain.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02103036
- Sponsor's protocol ID
- ECOLUM
- Acronym
- ECOLUM
- Status last verified
- Dec 2014
- First submitted
- 19 Mar 2014
- Last updated
- 5 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Minobes-Molina E, Nogues MR, Giralt M, Casajuana C, de Souza DLB, Jerez-Roig J, Romeu M. Effectiveness of specific stabilization exercise compared with traditional trunk exercise in women with non-specific low back pain: a pilot randomized controlled trial. PeerJ. 2020 Nov 27;8:e10304. doi: 10.7717/peerj.10304. eCollection 2020.
PubMed 33312766
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Valuation of the Low Back Pain Treated With Different Types of Active Exercises in Women
- ClinicalTrials.gov ID
- NCT02103036
- Acronym / sponsor ID
- ECOLUM / ECOLUM
- Conditions
- Low Back Pain
- Keywords
- Low Back Pain, Core stability exercise, Back school, TENS, Infra- red light
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Rovira i VirgiliUniversity, hospital or other
- Collaborators
- Hospital Universitari Sant Joan de Reus
- Study start
- Mar 2014
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 3 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is determine whether the Core Stability Exercise is more effective than the traditional Back School for low back pain (LBP) in women.
Detailed description
The aim of this study is to check what kind of exercises are the best to treat LBP with regard to clinical improvements. The secondary objectives are: to determine which treatment is more effective in improving pain in the fewest sessions possible, to determine the involvement of inflammatory biomarkers in the development of pain and revalue the results after one month of having finishing treatment.
The project is a longitudinal, single-blind and randomized study with two treatment groups:
GROUP 1: Infrared light+ Transcutaneous Electrical Nerve Stimulation (TENS) + Core Stability Exercises.
GROUP 2: Infrared light + Transcutaneous Electrical Nerve Stimulation (TENS) + Traditional Back School.
Duration of treatment: 4 weeks. The participants will performe the exercises in 20 daily sessions (Monday to Friday) guided by a physiotherapist. Following treatment with the physiotherapist, the participants should perform the exercises at home for 4 weeks at a rate of three times per week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Core Stability Exercises | Experimental | Procedure: Core Stability Exercises (CSE), Device: TENS, Device: Infra-redCore Stability Exercises: 20 sessions, distributed daily, from Monday to Friday. The first 5 sessions are common in all patients in the study, and involves the application of infrared light (IR) (10 minutes) and TENS (20 minutes) to treat acute pain. From session number 6 to session 20, the patients will receive IR + TENS 2 days a week, and the other 3 days IR+TENS+Core Stability Exercises (25-30 minutes). |
| Traditional Back School | Experimental | Procedure: Traditional Back School, Device: TENS, Device: Infra-redTraditional Back School: 20 sessions, distributed daily, from Monday to Friday. The first 5 sessions are common in all patients in the study, and involves the application of infrared light (IR) (10 minutes) and TENS (20 minutes) to treat acute pain. From session number 6 to session 20, the patients will receive IR + TENS 2 days a week, and the other 3 days IR+TENS+Traditional Back School (25-30 minutes). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women aged 18 to 70 years.
- Diagnosis of back pain from a trauma.
- Untreated pain (except acetaminophen).
- Informed consent.
Key exclusion criteria (5 listed)
- Algic process in the lumbar spine of infectious, neoplastic, metastasis, osteoporosis, inflammatory arthritis or fractures.
- Cognitive impairment of any etiology.
- Exercise intolerance for any reason.
- Patients who have completed physical therapy in the last 3 months.
- Patients who have received infiltration injections in the last 6 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Core Stability Exercises (CSE)Also: Motor control exercises, Specific spinal stabilitation exercisesThe increase in intra-abdominal pressure stiffens and strengthens the relevant structural support around the spine, compacts the arthrogenic structures and in combination with abdominal contraction, it can encourage a rigid cylinder and stiffness to occur around the spine. The relevant anatomy in these type of exercises are deep muscles like transversus abdominous, multifidus or pelvic floor. The participants will have to do 10 different exercises. They will have to perform from 8 to 10 repetitions of every exercise, guided by a physical therapist. They will be recommended about making some series more at home, three days a week, when the treatment was finished. | Procedure or surgery | Core Stability Exercises |
| Traditional Back SchoolThe back school exercises are based in the traditional activity used for improve the back pain symptoms using the breathing with the stretching of the trunk muscles, the erector spinae reinforcement, the abdominal reinforcement or the postural movements. The participants will have to do 10 different exercises. They will have to perform from 8 to 10 repetitions of every exercise, guided by a physical therapist. They will be recommended about making some series more at home, three days a week, when the treatment was finished. | Procedure or surgery | Traditional Back School |
| TENSAlso: Transcutaneous Electrical Nerve StimulationUsed equipment: MEGASONIC 313 P4 (Carin). Application program number 15: analgesic TENS with stimulation of afferent fibers. Type of current: two-phase TNS. Width of the impulse: 70µs. Frequency of the impulse: 100Hz. Train: Not. Pause / pause activates: Not. Time of treatment: 20 minutes. | Device | Core Stability Exercises, Traditional Back School |
| Infra-redAlso: Infrared lightUsed equipment: INFRA - 2000 (Enraf Nonius) with the following parameters: 230 V / 50-60 Hz / 1.2 A | Device | Core Stability Exercises, Traditional Back School |
Primary outcome
Changes in Visual Scale Analogue (VAS)
Time frame: Pain was measured at the beginning of the study (session 0), and changes are evaluated again at sessions 10, 20, and 1 month later.
The VAS scale represents the pain intensity on a line of 10 cm, and one end there are the words "no pain" and the other end "the worst imaginable pain" written the distance in centimetres from the "no pain" point to the place marked by the patient represents the intensity of pain.
1 secondary outcome
Changes in the Roland- Morris Disability Questionnaire
Time frame: Disability was measured at the beginning of the study (session 0), and changes are evaluated again at sessions 10, 20, and 1 month later.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2014.
- Derived from this study: PubMed 33312766Minobes-Molina E, Nogues MR, Giralt M, Casajuana C, de Souza DLB, Jerez-Roig J, Romeu M. Effectiveness of specific stabilization exercise compared with traditional trunk exercise in women with non-specific low back pain: a pilot randomized controlled trial. PeerJ. 2020 Nov 27;8:e10304. doi: 10.7717/peerj.10304. eCollection 2020.
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Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduard Minobes, PT contact
Rosa Nogués, Pharm.D. study director
Faculty of Medicine and Health Sciences. Rovira i Virgili University. Spain.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core Stability Exercises (CSE), Traditional Back School and TENS in people with Low Back Pain, run by University Rovira i Virgili at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rosa Nogués, Ph D. (+34977759355, mariarosa.nogues@urv.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Visual Scale Analogue (VAS) (time frame: Pain was measured at the beginning of the study (session 0), and changes are evaluated again at sessions 10, 20, and 1 month later.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02103036, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2014; AzTrials last refreshed its copy on 7 Nov 2026.