Comparison of Efficacy of Mirror Therapy vs Mental Imagery in Reduction of Phantom Limb Pain in AKAP

NCT06428123 | Active Not Recruiting DMC

• 1 other identifier: MSRSW/Batch-Fall22/708
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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

Phantom Limb Pain

Outcome Measures

Primary Outcomes (1)

• The Numeric Rating (NRS)

  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

  12 Months

Study Arms (2)

Mirror Therapy

EXPERIMENTAL

Behavioral: Mirror Therapy on present Lower Limb

Mental Imagery

OTHER

Diagnostic Test: Mental Imagery on present Lower Limb

Interventions

Mirror Therapy on present Lower Limb BEHAVIORAL

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.

Mirror Therapy

Mental Imagery on present Lower Limb DIAGNOSTIC_TEST

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.

Mental Imagery

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Superior University: lead

Study Sites (2)

Azra Naheed Medical College, Superior University

Lahore, Punjab Province, Pakistan

Location

Ghurkee Hospital

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Phantom Limb

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: May 24, 2024
• Study Start: November 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: October 1, 2024
• Last Updated: May 24, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)