## Protocol Section
### Identification Module
**NCT ID:** NCT06430255

**Brief Title:** Effects of Global Postural Re-education Versus Laser-guided Exercise in Non-specific Chronic Low Back Pain

**Official Title:** Effects of Global Postural Re-education Versus Laser-guided Supervised Exercise in Individuals With Non-specific Chronic Low Back Pain: A Randomized Controlled Clinical Trial

#### Organization Study ID Info
**ID:** 24-1243
#### Organization
**Class:** OTHER
**Full Name:** Taif University
### Status Module
#### Completion Date
**Date:** 2024-06-25

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-06-25

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-16

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Taif University

#### Responsible Party

**Investigator Affiliation:** Taif University

**Investigator Full Name:** Alaa Saleh Baboor

**Investigator Title:** Physical Therapist

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** Effects of Global Postural Re-education Versus Laser-guided Supervised Exercise in Individuals With Non-specific Chronic Low Back Pain

**Detailed Description:** The objective of this study will be to investigate the effectiveness of GPR or LGE, in addition to PNE and home exercise program. The primary outcomes will be pain intensity, disability, and fingertip to floor test. The secondary outcomes will be pain catastrophizing, kinesiophobia and depression.

### Conditions Module

**Conditions:**

- Pain, Back

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 36

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** is a physical therapy method developed in France by Philippe-Emmanuel Souchard. This therapy method is founded on an integrated concept of the muscular system, which is composed of muscle chains. These muscle chains are susceptible to shortening as a result of constitutional, behavioral, and psychological factors, Patients allocated to this group will be having a GPR method course of 8 sessions, two sessions per week for a four-week period. Each session will consist of 3 therapeutic postures, lying, sitting, or standing, to be held for 15-20 minutes each. The postures used are considered the most effective in lengthening the posterior chain, which is usually shortened in patients with LBP.

**Intervention Names:**

- Other: Global Postural Re-education

**Label:** Global Postural Re-education

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Patients allocated to this group will be having a LGSE method course of 8 sessions, two sessions per week for a four-week period. Each session will consist of lumbar movement control exercises. The physiotherapist responsible for the intervention corrected each participant individually as required when performing the movement control exercises to ensure the correct technique. The exercises is progress from the supine position through to standing, 4-point kneeling. The program consists of 8 exercises first starting with abdominal-diaphragmatic breathing and isolated contraction of the transversus abdominis contractions of 10 seconds' duration 5 repetition, Abdominal preparation, Pelvic elevation with previous transversus abdominis contraction and neutral pelvis,

**Intervention Names:**

- Other: Laser-guided Supervised Exercise

**Label:** Laser-guided Supervised Exercise

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Global Postural Re-education

**Description:** Program for treatment

**Name:** Global Postural Re-education

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Laser-guided Supervised Exercise

**Description:** Program for treatment

**Name:** Laser-guided Supervised Exercise

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** assessed using the Numerical Pain Rating Scale which goes from 0 ("no pain at all") to 10 ("worst imaginable pain")

**Measure:** Pain intensity

**Time Frame:** One month

**Description:** modified Oswestry Low Back Pain Disability (ODI) questionnaire Each part has six statements rated from 0 (least difficult to accomplish action) to 5 (most difficult) The overall score goes from 0 to 50 (the greatest impairment) In individuals with LBP

**Measure:** Disability

**Time Frame:** 7 weeks

**Description:** excellent metric properties for LBP

**Measure:** Fingertip-to-floor test

**Time Frame:** 7 weeks

#### Secondary Outcomes

**Description:** will be used to measure pain catastrophizing. Scores range from 0 (never) to 4 (always) for each item (total score = 0-52). Higher ratings reflect more catastrophizing of pain

**Measure:** Pain catastrophizing

**Time Frame:** One month

**Description:** will be assessed using the 11 items that make up the TSK-11. The overall score is between 11 and 44 points. A higher score indicates a greater fear of discomfort, movement, and harm.

**Measure:** Kinesiophobia

**Time Frame:** One month

**Description:** Patient Health Questionnaire (PHQ-9), The PHQ-9 is a self-administered 9-item questionnaire with four statements ranging from 0 (not at all) to 3 (nearly every day) for each item. A higher total score (20-27) suggests that the patient is suffering from severe depression.

**Measure:** Depression

**Time Frame:** 4 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Aged between 18 and 45 years.
* Diagnosed with NSLBP.
* Experiencing NSCLBP for ≥ 3 months and score at least 3/10 on the Numerical Pain Rating Scale (NPRS).

Exclusion Criteria:

* Diagnosed with a condition that hinders their ability to engage in physical exercise (e.g., uncontrolled diabetes, cardiovascular disease, orthopedic impairments; balancing problems).
* Diagnosed with severe spine conditions (such as fractures, tumors, ankylosing spondylitis, or inflammatory disorders).
* Diagnosed with neurological problems (such as spine nerve problems or cauda equina syndrome)
* Diagnosed with mental illness or severe cognitive impairment that made it impossible to follow the PNE program.
* With a physical condition that made it impossible to complete the PNE program (the timed "up and go" test had to be completed in 10 seconds at a minimum).
* Receiving alternate therapy for related pathologies (myopathies and neurological diseases) that prevented them from completing the PNE program.

**Healthy Volunteers:** True

**Maximum Age:** 45 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** Alaa.s.baboor@hotmail.com

**Name:** Alaa Baboor

**Phone:** 966596628155

**Role:** CONTACT

**Contact 2:**

**Email:** Ibrahim.alkayshan@gmail.com

**Name:** Ibrahim Alkayshan

**Phone:** 966501272615

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Taif University

**Name:** Hosam Alzahrani, Dr

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M4714

- Name: Back Pain

- Relevance: HIGH

- As Found: Pain, Back

- ID: M19433

- Name: Low Back Pain

- Relevance: HIGH

- As Found: Low Back Pain

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001416

- Term: Back Pain

- ID: D000017116

- Term: Low Back Pain

### Misc Info Module

- Version Holder: 2024-05-31
