NCT06914362

Brief 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. 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)).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 6, 2025

Completed
Last Updated

April 6, 2025

Status Verified

April 1, 2025

Enrollment Period

6 months

First QC Date

March 29, 2025

Last Update Submit

April 4, 2025

Conditions

Keywords

low back painglobal postural reeducationpainmobilityfunction

Outcome Measures

Primary Outcomes (1)

  • pain intensity

    Pain, which was evaluated using the visual analog scale (VAS) of pain, ranging from 0 (painless) to 10 (severe pain)

    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

    Two evaluations were performed for both groups: one at baseline (T0) and one at the end of the 4 weeks' sessions (T1).

  • muscle endurance

    Two evaluations were performed for both groups: one at baseline (T0) and one at the end of the 4 weeks' sessions (T1).

  • function

    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

    Two evaluations were performed for both groups: one at baseline (T0) and one at the end of the 4 weeks' sessions (T1).

Study Arms (2)

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.

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.

Procedure: global postural reeducationProcedure: conventional rehabilitation

Interventions

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.

GPR group

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.

GPR groupcontrol group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients aged 18 or older
  • diagnosed with chronic (≥ 12 months) non-specific LBP

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charles Nicolle Hospital

Tunis, Tunisia

Location

MeSH Terms

Conditions

Low Back PainPain

Condition Hierarchy (Ancestors)

Back PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant doctor

Study Record Dates

First Submitted

March 29, 2025

First Posted

April 6, 2025

Study Start

March 1, 2024

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

April 6, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations