Chronic Low Back Pain (CLBP)GPR-LBPNCT06914362
Global Postural Reeducation in Nonspecific Chronic Low Back Pain
A study testing global postural reeducation and conventional rehabilitation in people with Chronic Low Back Pain (CLBP), run by Hopital Charles Nicolle at 1 site in Tunisia.
Trial summary
The aim of this study was to compare the effectiveness of GPR associated to conventional reeducation protocol to that of the conventional reeducation protocol alone on pain, mobility, function and psychological symptoms in patients with chronic non-specific LBP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low Back Pain (CLBP)
- What is being tested?
- global postural reeducation and conventional rehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Mar 2024to 1 Sep 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged 18 or older
- diagnosed with chronic (≥ 12 months) non-specific LBP
Who cannot join
- acute and sub-acute LBP
- neurological complications (motor impairment and cauda equina syndrome)
- specific causes of LBP (such as tumors, chronic rheumatic diseases infections and vertebral fracture)
- surgical spinal procedures within 6 months
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Global Postural Reeducation in Patients With Nonspecific Chronic Low Back Pain: A Randomized Controlled Study
The aim of this study was to compare the effectiveness of GPR associated to conventional reeducation protocol to that of the conventional reeducation protocol alone on pain, mobility, function and psychological symptoms in patients with chronic non-specific LBP.
A monocentric randomized controlled study was carried out, including patients with chronic non specific LBP, who were allocated to two groups: GPR group performed GPR associated to conventional reeducation and control group performed conventional reeducation alone. Two evaluations were performed for both groups: at baseline (T0) and at the end of the 4 weeks' sessions (T1), including pain (by Visual Analog Scale), mobility (by the Fingertip-to-floor test (FFT) and the Schober index), muscle endurance (by the Shirado and the Sorensen tests), function (by the Oswestry Disability index (ODI)) and anxiety-depressive symptoms (by the Hospital Anxiety and Depression (HAD)).
Read the detailed description
The aim of this study was to compare the effectiveness of GPR associated to conventional reeducation protocol to that of the conventional reeducation protocol alone on pain, mobility, function and psychological symptoms in patients with chronic non-specific LBP.
A monocentric randomized controlled trial was carried out between march and september 2024, in the department of physiotherapy and rheumatology of Charles Nicolle Hospital in Tunis, Tunisia.
The study population included patients aged 18 or older, diagnosed by a rheumatologist with chronic (≥ 12 months) non-specific LBP.
Exclusion criteria were acute and sub-acute LBP, neurological complications (motor impairment and cauda equina syndrome), specific causes of LBP (such as tumors, chronic rheumatic diseases infections and vertebral fracture) and pregnancy. Patients who had received other physiotherapeutic interventions or undergone surgical spinal procedures within 6 months prior to the baseline assessment were also excluded.
The included patients were allocated to two groups: GPR group performed GPR associated to conventional reeducation and control group performed conventional reeducation alone.
All patients gave their written consent before being included in the study. The study was approved by the local ethics committee of our hospital according to the number FWA00032745.
Two qualified physiotherapists, with at least 5-years' experience delivered the rehabilitation program either GPR or conventional reeducation according to group assignment.
For both groups, the programs started immediately after baseline evaluation. Both programs lasted 12 sessions over a period of 4 weeks, at a frequency of 3 times per week. Each session lasted 60 minutes. All sessions were performed in the morning and were undergone by the same physiotherapist who had experience with the GPR approach.
Conventional reeducation included manual therapy approaches such as spinal mobilization which aims to restore joint mobility and alleviate muscular tension.
It included also exercise therapy focusing on strengthening core muscles, improving lumbar flexibility, and enhancing posture to stabilize the spine and reduce strain on surrounding structures.
Modalities like heat therapy, cold therapy, and transcutaneous electrical nerve stimulation (TENS) were also used to manage pain and promote muscle relaxation. Additionally, education on ergonomic principles was part of the program to adopt healthy habits and prevent recurrence of pain.
Global postural reeducation included the following GPR postures according to the Souchard approach: lying on back with the legs extended and arms folded, lying on back with the legs flexed and arms folded, lying on back with the legs extended and arms open, lying on back with the legs flexed and arms open, sitting with legs extended and standing with the back against the wall.
Each posture was performed by the patient under the physiotherapist supervision and was held for 15 to 20 minutes.
Besides, each patient was asked to repeat the exercises daily at home. Two evaluations were performed for both groups: one at baseline (T0) and one at the end of the 4 weeks' sessions (T1).
Baseline assessment concerned sociodemographic characteristics (age, gender, body mass index (BMI), profession, physical activity) and disease characteristics (disease duration).
Outcome measurements at T0 and T1 included:
- Pain, which was evaluated using the visual analog scale (VAS) of pain
- Mobility of the lumbar spine, which was evaluated with the Fingertip-to-floor test (FFT) and the Schober index.
- Muscle endurance was evaluated using the Shirado and the Sorensen tests for abdominal and spinal musculature respectively.
- Function capacity, which was assessed by the Oswestry Disability index (ODI)
- Anxiety-depressive symptoms, which were assessed by the Hospital Anxiety and Depression (HAD) scale.
- Conditions
- Chronic Low Back Pain (CLBP)
- Being tested
- global postural reeducation, conventional rehabilitation
- Keywords
- low back pain, global postural reeducation, pain, mobility, function
- Medical subject headings
- Low Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
global postural reeducationProcedure or surgery
Global postural reeducation included the following GPR postures according to the Souchard approach [7]: lying on back with the legs extended and arms folded, lying on back with the legs flexed and arms folded, lying on back with the legs extended and arms open, lying on back with the legs flexed and arms open, sitting with legs extended and standing with the back against the wall.
Each posture was performed by the patient under the physiotherapist supervision and was held for 15 to 20 minutes.
Besides, each patient was asked to repeat the exercises daily at home.
conventional rehabilitationProcedure or surgery
Conventional reeducation included manual therapy approaches such as spinal mobilization which aims to restore joint mobility and alleviate muscular tension.
It included also exercise therapy focusing on strengthening core muscles, improving lumbar flexibility, and enhancing posture to stabilize the spine and reduce strain on surrounding structures.
Modalities like heat therapy, cold therapy, and transcutaneous electrical nerve stimulation (TENS) were also used to manage pain and promote muscle relaxation. Additionally, education on ergonomic principles was part of the program to adopt healthy habits and prevent recurrence of pain.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | Conventional reeducation included manual therapy approaches such as spinal mobilization which aims to restore joint mobility and alleviate muscular tension.
It included also exercise therapy focusing on strengthening core muscles, improving lumbar flexibility, and enhancing posture to stabilize the spine and reduce strain on surrounding structures.
Modalities like heat therapy, cold therapy, and transcutaneous electrical nerve stimulation (TENS) were also used to manage pain and promote muscle relaxation. Additionally, education on ergonomic principles was part of the program to adopt healthy habits and prevent recurrence of pain. Receives: Procedure: conventional rehabilitation |
| GPR group | Experimental | Global postural reeducation included the following GPR postures according to the Souchard approach: lying on back with the legs extended and arms folded, lying on back with the legs flexed and arms folded, lying on back with the legs extended and arms open, lying on back with the legs flexed and arms open, sitting with legs extended and standing with the back against the wall.
Each posture was performed by the patient under the physiotherapist supervision and was held for 15 to 20 minutes.
Besides, each patient was asked to repeat the exercises daily at home. Receives: Procedure: global postural reeducation; Procedure: conventional rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity
Pain, which was evaluated using the visual analog scale (VAS) of pain, ranging from 0 (painless) to 10 (severe pain)
Measured: Two evaluations were performed for both groups: one at baseline (T0) and one at the end of the 4 weeks' sessions (T1).
Secondary outcomes (4)
mobility
Mobility of the lumbar spine, which was evaluated the Schober index.
Measured: Two evaluations were performed for both groups: one at baseline (T0) and one at the end of the 4 weeks' sessions (T1).
muscle endurance
Muscle endurance was evaluated using the Shirado test for abdominal and spinal musculature respectively
Measured: Two evaluations were performed for both groups: one at baseline (T0) and one at the end of the 4 weeks' sessions (T1).
function
Function capacity, which was assessed by the Oswestry Disability index (ODI) in its Arabic version, which is structured in 10 sections aligning with various daily activities with each section scored on a six-point scale (0-5). Scores of 0-20% indicate minimal disability, 20-40% moderate disability, 40-60% severe disability, 60-80% significant impairment, 80-100% confinement to bed or potential exaggeration of symptoms.
Measured: Two evaluations were performed for both groups: one at baseline (T0) and one at the end of the 4 weeks' sessions (T1).
anxiety and depression
Anxiety-depressive symptoms, which were assessed by the Hospital Anxiety and Depression (HAD) scale in its Arabic version. The HAD questionnaire has seven items each for depression and anxiety subscales. Scoring for each item ranges from zero to three, with three denoting highest anxiety or depression level. A total subscale score of >8 points out of a possible 21 denotes considerable symptoms of anxiety or depression
Measured: Two evaluations were performed for both groups: one at baseline (T0) and one at the end of the 4 weeks' sessions (T1).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start1 Mar 2024
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back Pain (CLBP)Studies 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
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Charles Nicolle
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selma Bouden, Hopital Charles Nicolle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06914362
- Sponsor's protocol ID
- ECR-OMG-2024-007
- Other IDs
- ECR-OMG-2024-006
- Acronym
- GPR-LBP
- Status last verified
- Apr 2025
- First submitted
- 29 Mar 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Global Postural Reeducation in Patients With Nonspecific Chronic Low Back Pain: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06914362
- Acronym / sponsor ID
- GPR-LBP / ECR-OMG-2024-007
- Conditions
- Chronic Low Back Pain (CLBP)
- Keywords
- low back pain, global postural reeducation, pain, mobility, function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Hopital Charles NicolleUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 6 Apr 2025 (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 aim of this study was to compare the effectiveness of GPR associated to conventional reeducation protocol to that of the conventional reeducation protocol alone on pain, mobility, function and psychological symptoms in patients with chronic non-specific LBP.
A monocentric randomized controlled study was carried out, including patients with chronic non specific LBP, who were allocated to two groups: GPR group performed GPR associated to conventional reeducation and control group performed conventional reeducation alone. Two evaluations were performed for both groups: at baseline (T0) and at the end of the 4 weeks' sessions (T1), including pain (by Visual Analog Scale), mobility (by the Fingertip-to-floor test (FFT) and the Schober index), muscle endurance (by the Shirado and the Sorensen tests), function (by the Oswestry Disability index (ODI)) and anxiety-depressive symptoms (by the Hospital Anxiety and Depression (HAD)).
Detailed description
The aim of this study was to compare the effectiveness of GPR associated to conventional reeducation protocol to that of the conventional reeducation protocol alone on pain, mobility, function and psychological symptoms in patients with chronic non-specific LBP.
A monocentric randomized controlled trial was carried out between march and september 2024, in the department of physiotherapy and rheumatology of Charles Nicolle Hospital in Tunis, Tunisia.
The study population included patients aged 18 or older, diagnosed by a rheumatologist with chronic (≥ 12 months) non-specific LBP.
Exclusion criteria were acute and sub-acute LBP, neurological complications (motor impairment and cauda equina syndrome), specific causes of LBP (such as tumors, chronic rheumatic diseases infections and vertebral fracture) and pregnancy. Patients who had received other physiotherapeutic interventions or undergone surgical spinal procedures within 6 months prior to the baseline assessment were also excluded.
The included patients were allocated to two groups: GPR group performed GPR associated to conventional reeducation and control group performed conventional reeducation alone.
All patients gave their written consent before being included in the study. The study was approved by the local ethics committee of our hospital according to the number FWA00032745.
Two qualified physiotherapists, with at least 5-years' experience delivered the rehabilitation program either GPR or conventional reeducation according to group assignment.
For both groups, the programs started immediately after baseline evaluation. Both programs lasted 12 sessions over a period of 4 weeks, at a frequency of 3 times per week. Each session lasted 60 minutes. All sessions were performed in the morning and were undergone by the same physiotherapist who had experience with the GPR approach.
Conventional reeducation included manual therapy approaches such as spinal mobilization which aims to restore joint mobility and alleviate muscular tension.
It included also exercise therapy focusing on strengthening core muscles, improving lumbar flexibility, and enhancing posture to stabilize the spine and reduce strain on surrounding structures.
Modalities like heat therapy, cold therapy, and transcutaneous electrical nerve stimulation (TENS) were also used to manage pain and promote muscle relaxation. Additionally, education on ergonomic principles was part of the program to adopt healthy habits and prevent recurrence of pain.
Global postural reeducation included the following GPR postures according to the Souchard approach: lying on back with the legs extended and arms folded, lying on back with the legs flexed and arms folded, lying on back with the legs extended and arms open, lying on back with the legs flexed and arms open, sitting with legs extended and standing with the back against the wall.
Each posture was performed by the patient under the physiotherapist supervision and was held for 15 to 20 minutes.
Besides, each patient was asked to repeat the exercises daily at home. Two evaluations were performed for both groups: one at baseline (T0) and one at the end of the 4 weeks' sessions (T1).
Baseline assessment concerned sociodemographic characteristics (age, gender, body mass index (BMI), profession, physical activity) and disease characteristics (disease duration).
Outcome measurements at T0 and T1 included:
- Pain, which was evaluated using the visual analog scale (VAS) of pain
- Mobility of the lumbar spine, which was evaluated with the Fingertip-to-floor test (FFT) and the Schober index.
- Muscle endurance was evaluated using the Shirado and the Sorensen tests for abdominal and spinal musculature respectively.
- Function capacity, which was assessed by the Oswestry Disability index (ODI)
- Anxiety-depressive symptoms, which were assessed by the Hospital Anxiety and Depression (HAD) scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Procedure: conventional rehabilitationConventional reeducation included manual therapy approaches such as spinal mobilization which aims to restore joint mobility and alleviate muscular tension. It included also exercise therapy focusing on strengthening core muscles, improving lumbar flexibility, and enhancing posture to stabilize the spine and reduce strain on surrounding structures. Modalities like heat therapy, cold therapy, and transcutaneous electrical nerve stimulation (TENS) were also used to manage pain and promote muscle relaxation. Additionally, education on ergonomic principles was part of the program to adopt healthy habits and prevent recurrence of pain. |
| GPR group | Experimental | Procedure: global postural reeducation, Procedure: conventional rehabilitationGlobal postural reeducation included the following GPR postures according to the Souchard approach: lying on back with the legs extended and arms folded, lying on back with the legs flexed and arms folded, lying on back with the legs extended and arms open, lying on back with the legs flexed and arms open, sitting with legs extended and standing with the back against the wall. Each posture was performed by the patient under the physiotherapist supervision and was held for 15 to 20 minutes. Besides, each patient was asked to repeat the exercises daily at home. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients aged 18 or older
- diagnosed with chronic (≥ 12 months) non-specific LBP
Key exclusion criteria (5 listed)
- acute and sub-acute LBP
- neurological complications (motor impairment and cauda equina syndrome)
- specific causes of LBP (such as tumors, chronic rheumatic diseases infections and vertebral fracture)
- surgical spinal procedures within 6 months
- pregnancy
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 |
|---|---|---|
| global postural reeducationGlobal postural reeducation included the following GPR postures according to the Souchard approach [7]: lying on back with the legs extended and arms folded, lying on back with the legs flexed and arms folded, lying on back with the legs extended and arms open, lying on back with the legs flexed and arms open, sitting with legs extended and standing with the back against the wall. Each posture was performed by the patient under the physiotherapist supervision and was held for 15 to 20 minutes. Besides, each patient was asked to repeat the exercises daily at home. | Procedure or surgery | GPR group |
| conventional rehabilitationConventional reeducation included manual therapy approaches such as spinal mobilization which aims to restore joint mobility and alleviate muscular tension. It included also exercise therapy focusing on strengthening core muscles, improving lumbar flexibility, and enhancing posture to stabilize the spine and reduce strain on surrounding structures. Modalities like heat therapy, cold therapy, and transcutaneous electrical nerve stimulation (TENS) were also used to manage pain and promote muscle relaxation. Additionally, education on ergonomic principles was part of the program to adopt healthy habits and prevent recurrence of pain. | Procedure or surgery | GPR group, control group |
Primary outcome
pain intensity
Time frame: Two evaluations were performed for both groups: one at baseline (T0) and one at the end of the 4 weeks' sessions (T1).
Pain, which was evaluated using the visual analog scale (VAS) of pain, ranging from 0 (painless) to 10 (severe pain)
4 secondary outcomes
mobility
Time frame: Two evaluations were performed for both groups: one at baseline (T0) and one at the end of the 4 weeks' sessions (T1).
muscle endurance
Time frame: Two evaluations were performed for both groups: one at baseline (T0) and one at the end of the 4 weeks' sessions (T1).
function
Time frame: Two evaluations were performed for both groups: one at baseline (T0) and one at the end of the 4 weeks' sessions (T1).
anxiety and depression
Time frame: Two evaluations were performed for both groups: one at baseline (T0) and one at the end of the 4 weeks' sessions (T1).
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 6 Apr 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing global postural reeducation and conventional rehabilitation in people with Chronic Low Back Pain (CLBP), run by Hopital Charles Nicolle at 1 site in Tunisia.
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 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: finished, as of the sponsor's last update on 6 Apr 2025. 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 Tunisia. 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?
pain intensity (time frame: Two evaluations were performed for both groups: one at baseline (T0) and one at the end of the 4 weeks' sessions (T1).). 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 6 Apr 2025.