Low Back PainNCT05422079
Motor Control Exercises Versus a General Exercise Program in Patients With Nonspecific Chronic Low Back Pain
A study testing Non-specific lumbar exercise group in people with Low Back Pain, run by University of Alcala at 2 sites in Spain.
Trial summary
The prevalence of low back pain is approximately 49% to 90%, and that 25% of patients seeking treatment for low back pain have a recurrence within the first year. Chronic non-specific low back pain is the most common of all types of pain, not being attributed to a specific pathological cause and with a minimum pain… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Non-specific lumbar exercise group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 2 sitesSpain
- Study dates
- 20 Jun 2022to 15 Nov 2023
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with low back pain (pain located between the costal margin and the gluteal fold), of non-specific origin, of at least 3 months of evolution.
- Subjects who are not receiving other types of treatment or participating in parallel research.
Who cannot join
- Muscular diseases that contraindicate the performance of exercise.
- Tumour and/or bone diseases of the dorsolumbar spine.
- Diagnosis of lumbar radiculopathy.
- Women in the process of pregnancy or breastfeeding.
- Consumption of tobacco, alcohol or other substances.
- BMI > 30.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Centro Investigación Fisioterapia y Dolor
Alcalá de Henares, Madrid, 28805
Physioterapy and Pain center research
Alcalá de Henares, Madrid, 28805
About this study
Official title: Effects of a Motor Control Exercise Protocol Versus a General Exercise Program in Patients With Nonspecific Chronic Low Back Pain: Ultrasound Monitoring
The prevalence of low back pain is approximately 49% to 90%, and that 25% of patients seeking treatment for low back pain have a recurrence within the first year. Chronic non-specific low back pain is the most common of all types of pain, not being attributed to a specific pathological cause and with a minimum pain duration of 12 weeks. Forty percent of subjects with acute low back pain will develop chronic low back pain.
Exercise is recommended for the treatment of chronic low back pain because of significant improvements in pain and disability over other therapies, but the evidence is low in the treatment of subacute or acute pain, as exercise appears to be equally effective over rest. Motor control is based on the contraction of the deep and stabilising muscles of the lumbar spine (multifidus and transverse abdominis), performing simple voluntary contraction exercises and increasing (without losing this contraction) their difficulty and functionality. At the beginning, the patient must be able to maintain the isometric contraction of the deep muscles while breathing normally. On the other hand, there is great difficulty in voluntarily contracting the multifidus muscles, especially for subjects with chronic non-specific low back pain, where arthrogenic inhibition hinders their contraction. The application of ultrasound as feedback may help patients to correctly contract this musculature.
Read more
Our main objective in the study will be to measure and compare pain, disability, global impression of effect, in patients with non-specific mechanical chronic low back pain after applying a motor control exercise programme with and without ultrasound feedback.
In addition, the investigators will compared this type of exercise with a conventional exercise programme.
Read the detailed description
A study will be carried out to compare a conventional exercise protocol for the management of non-specific chronic low back pain, with another motor control exercise protocol with and without ultrasound feedback for its correct learning and execution.
For the ultrasound feedback, a video will be recorded where the participant will be able to see how the core muscles contract when each of the motor control exercises is performed.
The participants will be divided into three groups. The first group will perform a general exercise plan for the lower back. The second group will perform a plan of specific motor control exercises aimed at activating the lumbar multifidus and transversus abdominis muscles, and the third group will perform a plan of specific motor control exercises aimed at activating the lumbar multifidus and transversus abdominis muscles using ultrasound as a feedback method.
- Conditions
- Low Back Pain
- Being tested
- Non-specific lumbar exercise group, motor control lumbar exercises, motor control lumbar exercises with ultrasound echography feedack
- Keywords
- Low Back Pain, exercises, ultrasound echography
- Medical subject headings
- Low Back Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-specific lumbar exercise groupOther
Subjects perform a conventional lumbar exercise program twice a week.
motor control lumbar exercisesOther
Subjects perform a lumbar stabilization exercise program.
motor control lumbar exercises with ultrasound echography feedackOther
Subjects perform a lumbar stabilization exercise program in conjunction with a video where participants can see how the muscles contract.
| Study group | Role | What they receive |
|---|---|---|
| Non-specific lumbar exercise group | Experimental | Subjects perform a conventional lumbar exercise program twice a week for four weeks. Receives: Other: Non-specific lumbar exercise group |
| Group motor control lumbar exercises | Experimental | Subjects perform a lumbar stabilization exercise program twice a week for four weeks. Receives: Other: motor control lumbar exercises |
| Group motor control lumbar exercises with ultrasound echography feedack | Experimental | Subjects perform a lumbar stabilization exercise program in conjunction with a video where participants can see how the muscles contract. Receives: Other: motor control lumbar exercises with ultrasound echography feedack |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Pain Rating Scale
This scale assesses the level of pain on a range from 0 to 10, with 0 being no pain and 10 being the maximum possible pain. For a clinically relevant difference to exist, there has to be a difference between measurements of at least 2 points.
This scale has been shown to have good levels of reliability for pain measurement.
Measured: Change from baseline at 3 months
Secondary outcomes (3)
Roland-Morris Disability Questionnarie
This questionnaire assesses the degree of disability of the patient with low back pain (range 0-24, with 0 being no disability and 24 being total disability). Its Spanish version has been shown to be reliable. To obtain a clinically relevant difference, differences of 1-2 points would be necessary in those patients with low levels of disability, and 7-8 points in those with high levels of disability.
Measured: Change from baseline at 3 months
Tampa Scale for Kinesiphobia (TSK-11)
This questionnaire assesses fear of movement. A minimum detectable change in fear or avoidance behaviour requires 5.6 items. The total score of the scale range from 17- 68, where 17 means no kinesiophobia, 68 means severe kinesiophobia, and score ± 37 indicates there is kinesiophobia. This scale has been shown to have an acceptable internal consistency and to be valid.
Measured: Change from baseline at 3 months
Patient Global Impression of Change (PGIC)
The self-report measure Patient Global Impression of Change (PGIC) reflects a patient's belief about the efficacy of treatment. PGIC is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."The PGIC is commonly used in clinical studies assessing pain relief following treatment.
Measured: Change from baseline at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start20 Jun 2022
- Primary completion15 Oct 2023
- Study completion15 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Single-blind, randomised clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Daniel Pecos Martín, University of Alcala
- Investigators
- Daniel Pecos-Martin, PhD, Study chair, Alcala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05422079
- Sponsor's protocol ID
- CEIM/HU/2019/40
- Status last verified
- Dec 2023
- First submitted
- 13 Jun 2022
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Motor Control Exercise Protocol Versus a General Exercise Program in Patients With Nonspecific Chronic Low Back Pain: Ultrasound Monitoring
- ClinicalTrials.gov ID
- NCT05422079
- Acronym / sponsor ID
- CEIM/HU/2019/40
- Conditions
- Low Back Pain
- Keywords
- Low Back Pain, exercises, ultrasound echography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 15 Oct 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 16 Jun 2022 (actual)
- 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 prevalence of low back pain is approximately 49% to 90%, and that 25% of patients seeking treatment for low back pain have a recurrence within the first year. Chronic non-specific low back pain is the most common of all types of pain, not being attributed to a specific pathological cause and with a minimum pain duration of 12 weeks. Forty percent of subjects with acute low back pain will develop chronic low back pain.
Exercise is recommended for the treatment of chronic low back pain because of significant improvements in pain and disability over other therapies, but the evidence is low in the treatment of subacute or acute pain, as exercise appears to be equally effective over rest. Motor control is based on the contraction of the deep and stabilising muscles of the lumbar spine (multifidus and transverse abdominis), performing simple voluntary contraction exercises and increasing (without losing this contraction) their difficulty and functionality. At the beginning, the patient must be able to maintain the isometric contraction of the deep muscles while breathing normally. On the other hand, there is great difficulty in voluntarily contracting the multifidus muscles, especially for subjects with chronic non-specific low back pain, where arthrogenic inhibition hinders their contraction. The application of ultrasound as feedback may help patients to correctly contract this musculature.
Our main objective in the study will be to measure and compare pain, disability, global impression of effect, in patients with non-specific mechanical chronic low back pain after applying a motor control exercise programme with and without ultrasound feedback.
In addition, the investigators will compared this type of exercise with a conventional exercise programme.
Detailed description
A study will be carried out to compare a conventional exercise protocol for the management of non-specific chronic low back pain, with another motor control exercise protocol with and without ultrasound feedback for its correct learning and execution.
For the ultrasound feedback, a video will be recorded where the participant will be able to see how the core muscles contract when each of the motor control exercises is performed.
The participants will be divided into three groups. The first group will perform a general exercise plan for the lower back. The second group will perform a plan of specific motor control exercises aimed at activating the lumbar multifidus and transversus abdominis muscles, and the third group will perform a plan of specific motor control exercises aimed at activating the lumbar multifidus and transversus abdominis muscles using ultrasound as a feedback method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Single-blind, randomised clinical trial
| Arm | Type | Receives |
|---|---|---|
| Non-specific lumbar exercise group | Experimental | Other: Non-specific lumbar exercise groupSubjects perform a conventional lumbar exercise program twice a week for four weeks. |
| Group motor control lumbar exercises | Experimental | Other: motor control lumbar exercisesSubjects perform a lumbar stabilization exercise program twice a week for four weeks. |
| Group motor control lumbar exercises with ultrasound echography feedack | Experimental | Other: motor control lumbar exercises with ultrasound echography feedackSubjects perform a lumbar stabilization exercise program in conjunction with a video where participants can see how the muscles contract. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects with low back pain (pain located between the costal margin and the gluteal fold), of non-specific origin, of at least 3 months of evolution.
- Subjects who are not receiving other types of treatment or participating in parallel research.
Key exclusion criteria (6 listed)
- Muscular diseases that contraindicate the performance of exercise.
- Tumour and/or bone diseases of the dorsolumbar spine.
- Diagnosis of lumbar radiculopathy.
- Women in the process of pregnancy or breastfeeding.
- Consumption of tobacco, alcohol or other substances.
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 |
|---|---|---|
| Non-specific lumbar exercise groupSubjects perform a conventional lumbar exercise program twice a week. | Other | Non-specific lumbar exercise group |
| motor control lumbar exercisesSubjects perform a lumbar stabilization exercise program. | Other | Group motor control lumbar exercises |
| motor control lumbar exercises with ultrasound echography feedackSubjects perform a lumbar stabilization exercise program in conjunction with a video where participants can see how the muscles contract. | Other | Group motor control lumbar exercises with ultrasound echography feedack |
Primary outcome
Numerical Pain Rating Scale
Time frame: Change from baseline at 3 months
This scale assesses the level of pain on a range from 0 to 10, with 0 being no pain and 10 being the maximum possible pain. For a clinically relevant difference to exist, there has to be a difference between measurements of at least 2 points. This scale has been shown to have good levels of reliability for pain measurement.
3 secondary outcomes
Roland-Morris Disability Questionnarie
Time frame: Change from baseline at 3 months
Tampa Scale for Kinesiphobia (TSK-11)
Time frame: Change from baseline at 3 months
Patient Global Impression of Change (PGIC)
Time frame: Change from baseline at 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
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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.
Daniel Pecos-Martin, PhD study chair
Alcala University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-specific lumbar exercise group in people with Low Back Pain, run by University of Alcala at 2 sites 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Pain Rating Scale (time frame: Change from baseline at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Dec 2023.