## Protocol Section
### Identification Module
**NCT ID:** NCT06428565

**Brief Title:** Conventional Exercises Plan With or Without Laser Guided Feedback for Patients With Non-Specific Low Back Pain

**Official Title:** Conventional Exercises Plan With or Without Laser Guided Feedback for Patients With Non-Specific Low Back Pain

#### Organization Study ID Info
**ID:** MSRSW/Batch-Fall22/713
#### Organization
**Class:** OTHER
**Full Name:** Superior University
### Status Module
#### Completion Date
**Date:** 2024-09-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2024-04-29

**Type:** ACTUAL

#### Start Date
**Date:** 2023-11-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Superior University

#### Responsible Party

**Investigator Affiliation:** Superior University

**Investigator Full Name:** Muhammad Naveed Babur

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Low back pain (LBP) is a significant health issue. It impacts a significant portion of the adult population, reaching up to 80%, and results in substantial healthcare and socioeconomic expenses. To find out what changes occurred after the application of two exercise modalities \[Conventional Exercise (CE) and Laser-Guided Exercise (LGE)} and PNE on pain, pain pressure thresholds, disability, catastrophizing, kinesiophobia, and lumbar proprioception in subjects with NSCLBP.

### Conditions Module

**Conditions:**

- Low Back Pain

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 30

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** uses low-level lasers or light-emitting diodes to stimulate cellular function and improve healing. Physiotherapy, sports medicine, and rehabilitation use it as a non-invasive, painless complement or adjuvant therapy

**Intervention Names:**

- Diagnostic Test: Low-level laser therapy (LLLT) or cold laser therapy

**Label:** Low-level laser therapy (LLLT) or cold laser therapy

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Low-level laser therapy (LLLT) or cold laser therapy

**Description:** Low-level laser therapy (LLLT) or cold laser therapy

**Name:** Low-level laser therapy (LLLT) or cold laser therapy

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** it is a simple and widely used tool for measuring pain intensity. It consists of a horizontal line with 11 numbered points, ranging from 0 (no pain) to 10 (worst pain imaginable). Patients are asked to rate their pain by selecting the number that best describes their current pain intensity

**Measure:** The Numeric Pain Rating Scale (NRS)

**Time Frame:** 12 Months

**Description:** it is a patient-completed questionnaire used to measure the level of disability caused by low back pain. It is a widely used and validated tool in both research and clinical settings. Studies show high test-retest reliability of 0.90

**Measure:** The Oswestry Disability Index (ODI)

**Time Frame:** 12 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Both male and female ages between 18 and 45 years (11).
* Patients diagnosed with nonspecific low back pain (11).
* patients with pain intensity of "3" or greater on numeric pain rating scale

Exclusion Criteria:

* Patients with neurological symptoms.
* Patients diagnosed with fatigue syndrome
* Females having pregnancy
* History of low back surgery

**Maximum Age:** 45 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Lahore

**Country:** Pakistan

**Facility:** Hameed Latif Hospital Lahore

### 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

### Condition Browse Module - Browse Leaves

- ID: M4714

- Name: Back Pain

- Relevance: HIGH

- As Found: Back Pain

- 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

### Condition Browse Module - Meshes

- ID: D000001416

- Term: Back Pain

- ID: D000017116

- Term: Low Back Pain

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M6392

- Name: Complement System Proteins

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
