## Protocol Section
### Identification Module
**NCT ID:** NCT06428123

**Brief Title:** Comparison of Efficacy of Mirror Therapy vs Mental Imagery in Reduction of Phantom Limb Pain in AKAP

**Official Title:** Comparison of Efficacy of Mirror Therapy vs Mental Imagery in Reduction of Phantom Limb Pain in Above Knee Amputee Patients: A Comparative Study

#### Organization Study ID Info
**ID:** MSRSW/Batch-Fall22/708
#### Organization
**Class:** OTHER
**Full Name:** Superior University
### Status Module
#### Completion Date
**Date:** 2024-10-01

**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:** 2024-04-01

**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:** Limb amputation results in many types of pain, including localized pain at the stump and projected pain experienced by the patient in the location where the amputated limb used to be, known as phantom limb pain (PLP). The aim of this study is to determine the relative benefits of mirror therapy vs mental imagery in reduction of phantom limb pain. Randomized clinical trial study design will be followed.

### Conditions Module

**Conditions:**

- Phantom Limb Pain

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 24

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Behavioral: Mirror Therapy on present Lower Limb

**Label:** Mirror Therapy

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Diagnostic Test: Mental Imagery on present Lower Limb

**Label:** Mental Imagery

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Mirror Therapy

**Description:** Patients will be seated close to a table on which a mirror will placed vertically. The normal (i.e., no amputated limb) will be placed in front of the mirror and made to perform movements of the different joints while the patient looking into the mirror.

**Name:** Mirror Therapy on present Lower Limb

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Mental Imagery

**Description:** Mental imagery technique in which patients will be instructed to concentrate on sensations from each area of the body, including the phantom limb. Patients will be advised to imagine comfortable, thorough movement and sensation in the phantom limb, such that they could "stretch away the pain," and finally to "allow the limb to rest in a comfortable position." The actual therapy of "moving" and "feeling" the limb will lasted for 5 minutes. Patients will be asked to perform 40 minutes of meditation and imagery exercises.

**Name:** Mental Imagery on present Lower Limb

**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 Rating (NRS)

**Time Frame:** 12 Months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Both male and female gender with ages from 12 to 75 years (17).
* Individuals with a unilateral above-knee amputation (AKA) at least 6 months prior to the study.
* Experiencing phantom limb pain at least 3 months (16).

Exclusion Criteria:

* History of neurological disorders affecting pain perception or motor function (e.g., stroke, spinal cord injury, brain injury).
* Uncontrolled diabetes or other medical conditions that could affect healing or participation in the study.
* Pregnancy or breastfeeding.

**Maximum Age:** 75 Years

**Minimum Age:** 12 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Lahore

**Country:** Pakistan

**Facility:** Azra Naheed Medical College, Superior University

**State:** Punjab

**Location 2:**

**City:** Lahore

**Country:** Pakistan

**Facility:** Ghurkee Hospital

**State:** Punjab

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010468

- Term: Perceptual Disorders

- ID: D000019954

- Term: Neurobehavioral Manifestations

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000010149

- Term: Pain, Postoperative

- ID: D000011183

- Term: Postoperative Complications

- ID: D000010335

- Term: Pathologic Processes

- ID: D000010146

- Term: Pain

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M13498

- Name: Phantom Limb

- Relevance: HIGH

- As Found: Phantom Limb

- ID: M13379

- Name: Perceptual Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M21826

- Name: Neurobehavioral Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M13069

- Name: Pain, Postoperative

- Relevance: LOW

- As Found: Unknown

- ID: M14065

- Name: Postoperative Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010591

- Term: Phantom Limb

### Misc Info Module

- Version Holder: 2024-05-31
