Phantom Limb PainNCT06428123
Comparison of Efficacy of Mirror Therapy vs Mental Imagery in Reduction of Phantom Limb Pain in AKAP
A study testing Mirror Therapy on present Lower Limb and Mental Imagery on present Lower Limb in people with Phantom Limb Pain, run by Superior University at 2 sites in Pakistan.
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). Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Phantom Limb Pain
- What is being tested?
- Mirror Therapy on present Lower Limb and Mental Imagery on present Lower Limb
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesPakistan
- Study dates
- 1 Nov 2023to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Azra Naheed Medical College, Superior University
Lahore, Punjab Province
Ghurkee Hospital
Lahore, Punjab Province
About this study
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
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
- Being tested
- Mirror Therapy on present Lower Limb, Mental Imagery on present Lower Limb
- Medical subject headings
- Phantom Limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirror Therapy on present Lower LimbBehavioural
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.
Mental Imagery on present Lower LimbDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Mirror Therapy | Experimental | Not described Receives: Behavioral: Mirror Therapy on present Lower Limb |
| Mental Imagery | Other | Not described Receives: Diagnostic Test: Mental Imagery on present Lower Limb |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start1 Nov 2023
- Primary completion1 Apr 2024
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phantom Limb PainStudies of the same condition, open and under way.
- More trials run by Superior UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06428123
- Sponsor's protocol ID
- MSRSW/Batch-Fall22/708
- Status last verified
- May 2024
- First submitted
- 20 May 2024
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06428123
- Acronym / sponsor ID
- MSRSW/Batch-Fall22/708
- Conditions
- Phantom Limb Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 24 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mirror Therapy | Experimental | Behavioral: Mirror Therapy on present Lower Limb |
| Mental Imagery | Other | Diagnostic Test: Mental Imagery on present Lower Limb |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mirror Therapy on present Lower LimbPatients 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. | Behavioural | Mirror Therapy |
| Mental Imagery on present Lower LimbMental 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. | Diagnostic test | Mental Imagery |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- Individual participant dataSharing planned: No
Related trials for Phantom Limb Pain
RecruitingObservational study
Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain
Amputation, Amputation of Lower Limb
RecruitingObservational study
Early Postoperative Pain Following a Limb Amputation
Amputation, Surgical, Pain Management
Recruiting
Uses of Phantom Sensations Induced by Global and Local Modifications of the Prosthetic Socket as Somatosensory Feedback During Walking in Lower Limb Amputees
Lower Limb Amputation
Not yet recruitingPhase 4
Role of Perineural Catheter in Pain Control and Opioid Consumption After Major Amputation of Lower Limb
Lower Limb Surgery, Pain
Recruiting
TENS for Restoring Somatotopic Sensory Feedback in Lower Limb Amputees and Improving Phantom Limb Perception
Lower Limb Amputation Above Knee, Lower Limb Amputation Below Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mirror Therapy on present Lower Limb and Mental Imagery on present Lower Limb in people with Phantom Limb Pain, run by Superior University at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Numeric Rating (NRS) (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2024.