- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06428123
Comparison of Efficacy of Mirror Therapy vs Mental Imagery in Reduction of Phantom Limb Pain in AKAP
May 20, 2024 updated by: Muhammad Naveed Babur, Superior University
Comparison of Efficacy of Mirror Therapy vs Mental Imagery in Reduction of Phantom Limb Pain in Above Knee Amputee Patients: A Comparative Study
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan
- Azra Naheed Medical College, Superior University
-
Lahore, Punjab, Pakistan
- Ghurkee Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mirror Therapy
|
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.
|
Other: Mental Imagery
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Numeric Rating (NRS)
Time Frame: 12 Months
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2023
Primary Completion (Actual)
April 1, 2024
Study Completion (Estimated)
October 1, 2024
Study Registration Dates
First Submitted
May 20, 2024
First Submitted That Met QC Criteria
May 20, 2024
First Posted (Actual)
May 24, 2024
Study Record Updates
Last Update Posted (Actual)
May 24, 2024
Last Update Submitted That Met QC Criteria
May 20, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MSRSW/Batch-Fall22/708
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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