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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06428123
Other study ID # MSRSW/Batch-Fall22/708
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 1, 2023
Est. completion date October 1, 2024

Study information

Verified date May 2024
Source Superior University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 24
Est. completion date October 1, 2024
Est. primary completion date April 1, 2024
Accepts healthy volunteers No
Gender All
Age group 12 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Mirror Therapy on present Lower Limb
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.
Diagnostic Test:
Mental Imagery on present Lower Limb
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.

Locations

Country Name City State
Pakistan Azra Naheed Medical College, Superior University Lahore Punjab
Pakistan Ghurkee Hospital Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Superior University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
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Terminated NCT00771862 - Prevention of Phantom Limb and Stump Pain Using Ambulatory Continuous Peripheral Nerve Blocks: A Pilot Study Phase 4
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