Chronic Non-specific Low-Back PainNCT03097497
Physiotherapy Re-education of Pre-activation of the Transverse Abdominis in Patients With Chronic Low Back Pain
A study testing Physiotherapy re-education program and Conventional treatment by GP in people with Chronic Non-specific Low-Back Pain, run by Universitat de Lleida at 1 site in Spain.
Trial summary
Hypothesis: The hypothesis of the study is that the physiotherapeutic re-education of the pre-activation of the transverse abdominal muscle decreases pain intensity in patients with chronic non-specific low-back pain by at least 30% and is more effective than conventional treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Non-specific Low-Back Pain
- What is being tested?
- Physiotherapy re-education program and Conventional treatment by GP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSpain
- Study dates
- 30 Apr 2017to 30 Nov 2018
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being diagnosed of non-specific chronic low back pain of 3 or more months duration.
- Patients between 18-65 years old.
- To accept and sign the informed consent.
Who cannot join
- Patients with diagnosed of cognitive problems that prevent understanding the procedure or participation in the study.
- Any red flag condition:
- Age of pain onset <20 or >55
- Recent history of trauma
- Pain not associated with movement and not relieved by lying down
- Thoracic pain
Show all 13Show fewer
- Past history of malignancy, recurrent of prolonged use of corticosteroids, immunosuppression/HIV
- Being systematically unwell
- Unexplained weight loss
- Neurological symptoms such as weakness of the limbs
- Structural deformity of the spine
- Women on pregnancy or postpartum less than three months.
- Difficulty understanding and/or speaking Spanish or Catalan
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of a Physiotherapeutic Re-education Based on the Pre-activation of the Transverse Abdominis in Patients With Non-specific Chronic Low Back Pain in Primary Care.
Hypothesis: The hypothesis of the study is that the physiotherapeutic re-education of the pre-activation of the transverse abdominal muscle decreases pain intensity in patients with chronic non-specific low-back pain by at least 30% and is more effective than conventional treatment.
Aims: the principal aim is to determine the effectiveness of a physiotherapeutic re-education program based on the pre-activation of the transverse abdominal muscle on pain intensity in adult patients diagnosed with chronic non-specific low-back pain compared to conventional treatment in a primary care setting. The secondary aims of the study are to assess the effects of a physiotherapeutic re-education program based on the pre-activation of the transverse abdominal muscle on: (1) disability and limitations for the development of the activities of daily living associated with LBP, (2) transverse abdominal muscle muscle contraction, (3) to assess whether the resistance training parameters applied to older adults are valid for young adults and (4) to determine whether the training protocols used for the cervical spine could be extrapolated to the lumbar spine.
Read the detailed description
This study will be a parallel randomized controlled trial. Participants between 18-65 years old, diagnosed with chronic nonspecific low-back pain, who will sign the informed consent, will be included in the study. Participants will be excluded if they are diagnosed with cognitive impairments, if the presence of any "Red Flag" is identified, women on pregnancy or postpartum less than three months and participants with difficulties understanding and/or speaking Spanish or Catalan.
Based upon the results of a systematic review about the effectiveness of physical therapy based treatment for low back pain, a reduction in 15 points of pain intensity assessed through Visual Analogue Scale will be considered for sample size calculation. Therefore, accepting an alfa risk of 0.05, a beta risk less than 0.2 and assuming a 15% of withdrawals a sample size of 108 participants has been estimated for this study.
Participants will be recruited from Primary Care Centers of the city of Lleida (Catalonia, Spain). They will be first contacted by telephone and the suitability of each participant will be assessed trough a brief interview. After participant selection via telephone, those who meet the inclusion criteria will be invited to have a personal interview with the researchers in order to solve any doubt and to read and sign the written informed consent. To ensure all participants understand the study, they will simply be asked about general study information (i.e. objectives, treatment and control conditions, etc.).
The included participants will be assigned either to the experimental or the control group using a simple randomization method. The allocation will be concealed to both, the physiotherapists who will make the assessments (pre- and post-treatment and follows-up) of the participants and the researcher who will manage the results data.
Participants in the experimental group will receive an individualized physiotherapeutic re-education program based on the pre-activation of the transverse abdominal muscle. The intervention will last 4-weeks and will consist on two weekly sessions of 30-35 minutes each. Each session will be divided into two main parts (1) warm-up and (2) re-education of the pre-activation of the transverse abdominal muscle.
- . Warm-up (5 minutes): lumbopelvic dissociation exercises, increasing difficulty each week.
- . Re-education of the pre-activation of the transverse abdominal muscle (25-30 minutes) First session: participants will learn how to contract appropriately the transverse abdominal muscle through basic and easy exercises. In order to facilitate the contraction, one physiotherapist will monitor the lumbopelvic motion by placing a Pressure Biofeedback Unit under the participants' lumbar spine.
The authors will calculate the 75% of one-rep max (1RM) and the seconds that each participant can maintain the 75% 1RM contraction. This will allow to establish individualized times for carrying out the exercises during the following sessions.
Following sessions: 16 re-educational exercises have been design. In each session, the participants will perform four different exercises, increasing each week the difficulty and the degree of loading. The participants will perform the exercises based on their 75% 1RM calculation, completing 3 series of 9 repetitions, holding each repetition a maximum of 6 seconds. It will be a pause of 4 sec. between each exercise and a pause of 60 seconds between each series. The 75% 1RM will be calculated in each session.
Participants in the control group will follow the conventional treatment prescribe by their general practitioner in primary care.
Participants in both groups will be assessed pre- and post-treatment with a follow-up at 3, 6 and 12 months.
All statistical analyses will be carried out using the statistical program 'PASW 20'. An intention to treat analysis will be performed.
Expected outcomes: the authors expect that patients in the experimental group will achieve a greater (1) reduction in pain intensity, (2) improvement of disability associated with CLBP, (3) improvement in the development of activities of daily living, and (4) contraction of the transvers abdominal muscle, compared to patients in the control group.
- Conditions
- Chronic Non-specific Low-Back Pain
- Being tested
- Physiotherapy re-education program, Conventional treatment by GP
- Keywords
- Chronic Non-specific Low-Back Pain, Chronic Low-Back Pain, Physiotherapy, Therapeutic Exercise, Primary Care, Transverse Abdominal Muscle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy re-education programOther
Physiotherapy Program based on the Re-education of Pre-activation of the Transverse Abdominal Muscle
Conventional treatment by GPOther
Patients will follow the general practitioner's advice including medication if needed
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy re-education program | Experimental | Physiotherapy re-education program based on the pre-activation of the transverse abdominal muscle, performed with progressive difficulty and supervised at all times by an expert physiotherapist. The intervention will last 4 weeks, with two weekly sessions of 30-35 minutes each. Sessions will be held individually. Receives: Other: Physiotherapy re-education program |
| Conventional treatment by GP | Active comparator | Will follow conventional treatment prescribed by the general practitioner in a primary care consultation. This conventional treatment is based on the clinical guidlines of the "Institut Català de la Salut"
http://www.gencat.cat/ics/professionals/guies/docs/guia_lumbalgies.pdf Receives: Other: Conventional treatment by GP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity (from baseline)
The Visual Analogue Scale (VAS) is an unidimensional scale developed to measure pain intensity. This scale consists on a line of 100-mm with a description on both extremes. "No pain" appears on the left side, representing a value of 0, and "worst pain ever" appears on the right side of the scale, representing a value of 100. A higher score on the scale will be indicative of greater pain intensity. Although no normative values are available in regard of the distribution of VAS scores, the following cut-off scores have been recommended: no pain (0-4mm), slight pain (5-44mm), moderate pain (45-74mm) and severe pain (75-100mm)
Measured: 4 weeks, 3 months, 6 months, 12 months
Secondary outcomes (4)
Oswestry Disability Index
The Oswestry Disability Index (ODI) was created by John O'Brien (1976). It is a self-administered questionnaire that allows assessing the degree of disability and the limitations in activities of daily living related to low back pain.
The ODI contains ten main topics regarding pain intensity, lifting, self-care ability, sleep quality, social life, ability to sit, stand and walk, ability to travel and sexual function. This index consists of 10 questions with six potential responses scored from 0 to 5.
The measurement percentages are:
- 0-19%: minimal disability
- 20-39%: moderate disability
- 40-59%: intense disability
- 60-79%: severe disability
- 80-100%: maximal disability
Measured: 4 weeks, 3 months, 6 months, 12 months
Roland-Morris Scale
The Roland-Morris Scale (RMS) determines the degree of physical disability derived from nonspecific low back pain. It especially detects cases in which the degree of disability is exaggeratedly high or persistent. In order to establish the degree of disability, the numbers of items selected by each patient are counted, with the score ranging from 0 (absence of disability) to 24 (maximum degree of disability). A total score below 4 points is categorized as mild impairment. In monitoring patients' progress, a change of 2 points or more is considered as relevant.
Measured: 4 weeks, 3 months, 6 months, 12 months
Transverse abdominal muscle contraction with Pressure Biofeedback Unit
The Pressure Biofeedback Unit (PBU) is a simple pressure transducer consisting of a pressure cushion with three air filled chambers and connected to a sphygmomanometer. The pressure bag is 17.7 x 24 cm size and is made of inelastic material. The scale measured with the sphygmomanometer goes from 0mmHg to 200mmHg. The PBU registers the pressure caused by movement or change of position and is used to obtain information on the effect of a muscle contraction. Research on PBU indicates that it is a valid tool for measuring transverse abdominal muscle activity in people with non-specific chronic low back pain and has an intra- and inter-examiner agreement of a 95%.
Measured: 4 weeks, 3 months, 6 months, 12 months
Surface Electromyography
Surface electromyography is a method of recording the electrical-physiological activity generated after a muscle contraction. It is, therefore, a method of quantitative and non-invasive assessment that allows capturing the action potentials produced by the muscles of the explored zone. The electrical signal is captured by one or more electrodes placed strategically on the surface of the skin and sent to a receiving device for its processing. Thus, obtaining a frequency and intensity that allow us to interpret what is happening at the muscular level in different situations.
The electrodes used have a diameter of 10mm and should be placed in the cutaneous zone adjacent to the assessed musculature. Frequencies range from 20 to 500 Hz.
The most important parameters that can be extracted are timing and intensity of muscle activation as well as muscle fatigue.
Measured: 4 weeks, 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study start30 Apr 2017
- Primary completion30 Aug 2017
- Study completion30 Nov 2018
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 Chronic Non-specific 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
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat de Lleida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesc Josep Rubi Carnacea, Universitat de Lleida
- Investigators
- Francesc J Rubí Carnacea, PhDc, Principal investigator, Universitat de LleidaJorge Soler González, GP, Study director, Universitat de Lleida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03097497
- Sponsor's protocol ID
- P14/089
- Status last verified
- Nov 2022
- First submitted
- 18 Mar 2017
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rubi-Carnacea F, Masbernat-Almenara M, Climent-Sanz C, Soler-Gonzalez J, Garcia-Escudero M, Martinez-Navarro O, Valenzuela-Pascual F. Effectiveness of an exercise intervention based on preactivation of the abdominal transverse muscle in patients with chronic nonspecific low back pain in primary care: a randomized control trial. BMC Prim Care. 2023 Sep 6;24(1):180. doi: 10.1186/s12875-023-02140-3.
PubMed 37674205
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Physiotherapeutic Re-education Based on the Pre-activation of the Transverse Abdominis in Patients With Non-specific Chronic Low Back Pain in Primary Care.
- ClinicalTrials.gov ID
- NCT03097497
- Acronym / sponsor ID
- P14/089
- Conditions
- Chronic Non-specific Low-Back Pain
- Keywords
- Chronic Non-specific Low-Back Pain, Chronic Low-Back Pain, Physiotherapy, Therapeutic Exercise, Primary Care, Transverse Abdominal Muscle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Universitat de LleidaUniversity, hospital or other
- Study start
- 30 Apr 2017 (actual)
- Primary completion
- 30 Aug 2017 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 31 Mar 2017 (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.
Hypothesis: The hypothesis of the study is that the physiotherapeutic re-education of the pre-activation of the transverse abdominal muscle decreases pain intensity in patients with chronic non-specific low-back pain by at least 30% and is more effective than conventional treatment.
Aims: the principal aim is to determine the effectiveness of a physiotherapeutic re-education program based on the pre-activation of the transverse abdominal muscle on pain intensity in adult patients diagnosed with chronic non-specific low-back pain compared to conventional treatment in a primary care setting. The secondary aims of the study are to assess the effects of a physiotherapeutic re-education program based on the pre-activation of the transverse abdominal muscle on: (1) disability and limitations for the development of the activities of daily living associated with LBP, (2) transverse abdominal muscle muscle contraction, (3) to assess whether the resistance training parameters applied to older adults are valid for young adults and (4) to determine whether the training protocols used for the cervical spine could be extrapolated to the lumbar spine.
Detailed description
This study will be a parallel randomized controlled trial. Participants between 18-65 years old, diagnosed with chronic nonspecific low-back pain, who will sign the informed consent, will be included in the study. Participants will be excluded if they are diagnosed with cognitive impairments, if the presence of any "Red Flag" is identified, women on pregnancy or postpartum less than three months and participants with difficulties understanding and/or speaking Spanish or Catalan.
Based upon the results of a systematic review about the effectiveness of physical therapy based treatment for low back pain, a reduction in 15 points of pain intensity assessed through Visual Analogue Scale will be considered for sample size calculation. Therefore, accepting an alfa risk of 0.05, a beta risk less than 0.2 and assuming a 15% of withdrawals a sample size of 108 participants has been estimated for this study.
Participants will be recruited from Primary Care Centers of the city of Lleida (Catalonia, Spain). They will be first contacted by telephone and the suitability of each participant will be assessed trough a brief interview. After participant selection via telephone, those who meet the inclusion criteria will be invited to have a personal interview with the researchers in order to solve any doubt and to read and sign the written informed consent. To ensure all participants understand the study, they will simply be asked about general study information (i.e. objectives, treatment and control conditions, etc.).
The included participants will be assigned either to the experimental or the control group using a simple randomization method. The allocation will be concealed to both, the physiotherapists who will make the assessments (pre- and post-treatment and follows-up) of the participants and the researcher who will manage the results data.
Participants in the experimental group will receive an individualized physiotherapeutic re-education program based on the pre-activation of the transverse abdominal muscle. The intervention will last 4-weeks and will consist on two weekly sessions of 30-35 minutes each. Each session will be divided into two main parts (1) warm-up and (2) re-education of the pre-activation of the transverse abdominal muscle.
- . Warm-up (5 minutes): lumbopelvic dissociation exercises, increasing difficulty each week.
- . Re-education of the pre-activation of the transverse abdominal muscle (25-30 minutes) First session: participants will learn how to contract appropriately the transverse abdominal muscle through basic and easy exercises. In order to facilitate the contraction, one physiotherapist will monitor the lumbopelvic motion by placing a Pressure Biofeedback Unit under the participants' lumbar spine.
The authors will calculate the 75% of one-rep max (1RM) and the seconds that each participant can maintain the 75% 1RM contraction. This will allow to establish individualized times for carrying out the exercises during the following sessions.
Following sessions: 16 re-educational exercises have been design. In each session, the participants will perform four different exercises, increasing each week the difficulty and the degree of loading. The participants will perform the exercises based on their 75% 1RM calculation, completing 3 series of 9 repetitions, holding each repetition a maximum of 6 seconds. It will be a pause of 4 sec. between each exercise and a pause of 60 seconds between each series. The 75% 1RM will be calculated in each session.
Participants in the control group will follow the conventional treatment prescribe by their general practitioner in primary care.
Participants in both groups will be assessed pre- and post-treatment with a follow-up at 3, 6 and 12 months.
All statistical analyses will be carried out using the statistical program 'PASW 20'. An intention to treat analysis will be performed.
Expected outcomes: the authors expect that patients in the experimental group will achieve a greater (1) reduction in pain intensity, (2) improvement of disability associated with CLBP, (3) improvement in the development of activities of daily living, and (4) contraction of the transvers abdominal muscle, compared to patients in the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy re-education program | Experimental | Other: Physiotherapy re-education programPhysiotherapy re-education program based on the pre-activation of the transverse abdominal muscle, performed with progressive difficulty and supervised at all times by an expert physiotherapist. The intervention will last 4 weeks, with two weekly sessions of 30-35 minutes each. Sessions will be held individually. |
| Conventional treatment by GP | Active comparator | Other: Conventional treatment by GPWill follow conventional treatment prescribed by the general practitioner in a primary care consultation. This conventional treatment is based on the clinical guidlines of the "Institut Català de la Salut" http://www.gencat.cat/ics/professionals/guies/docs/guia_lumbalgies.pdf |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being diagnosed of non-specific chronic low back pain of 3 or more months duration.
- Patients between 18-65 years old.
- To accept and sign the informed consent.
Key exclusion criteria (13 listed)
- Patients with diagnosed of cognitive problems that prevent understanding the procedure or participation in the study.
- Any red flag condition:
- Women on pregnancy or postpartum less than three months.
- Difficulty understanding and/or speaking Spanish or Catalan
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 |
|---|---|---|
| Physiotherapy re-education programPhysiotherapy Program based on the Re-education of Pre-activation of the Transverse Abdominal Muscle | Other | Physiotherapy re-education program |
| Conventional treatment by GPPatients will follow the general practitioner's advice including medication if needed | Other | Conventional treatment by GP |
Primary outcome
Change in pain intensity (from baseline)
Time frame: 4 weeks, 3 months, 6 months, 12 months
The Visual Analogue Scale (VAS) is an unidimensional scale developed to measure pain intensity. This scale consists on a line of 100-mm with a description on both extremes. "No pain" appears on the left side, representing a value of 0, and "worst pain ever" appears on the right side of the scale, representing a value of 100. A higher score on the scale will be indicative of greater pain intensity. Although no normative values are available in regard of the distribution of VAS scores, the following cut-off scores have been recommended: no pain (0-4mm), slight pain (5-44mm), moderate pain (45-74mm) and severe pain (75-100mm)
4 secondary outcomes
Oswestry Disability Index
Time frame: 4 weeks, 3 months, 6 months, 12 months
Roland-Morris Scale
Time frame: 4 weeks, 3 months, 6 months, 12 months
Transverse abdominal muscle contraction with Pressure Biofeedback Unit
Time frame: 4 weeks, 3 months, 6 months, 12 months
Surface Electromyography
Time frame: 4 weeks, 3 months, 6 months, 12 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 8 Nov 2022.
- Derived from this study: PubMed 37674205Rubi-Carnacea F, Masbernat-Almenara M, Climent-Sanz C, Soler-Gonzalez J, Garcia-Escudero M, Martinez-Navarro O, Valenzuela-Pascual F. Effectiveness of an exercise intervention based on preactivation of the abdominal transverse muscle in patients with chronic nonspecific low back pain in primary care: a randomized control trial. BMC Prim Care. 2023 Sep 6;24(1):180. doi: 10.1186/s12875-023-02140-3.
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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.
Francesc J Rubí Carnacea, PhDc principal investigator
Universitat de Lleida
Jorge Soler González, GP study director
Universitat de Lleida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy re-education program and Conventional treatment by GP in people with Chronic Non-specific Low-Back Pain, run by Universitat de Lleida 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 3 inclusion and 13 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 8 Nov 2022. 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?
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?
Change in pain intensity (from baseline) (time frame: 4 weeks, 3 months, 6 months, 12 months). 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 NCT03097497, 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 8 Nov 2022.