AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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.

Tunisia1 site
  • Charles Nicolle Hospital

    Tunis

Other trials in Tunisia

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.
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 groups in NCT06914362
Study groupRoleWhat they receive
control groupActive comparatorConventional 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 groupExperimentalGlobal 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.

  1. 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)
  1. 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).

  2. 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).

  3. 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).

  4. 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.

  1. First posted6 Apr 2025
  2. Study start1 Mar 2024
  3. Primary completion1 Sep 2024
  4. Study completion1 Sep 2024

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in