Effects of routine physical therapy with and without mirror therapy on phantom limb pain and psychosocial adjustment to amputation among prosthetic users
To determine the effectiveness of routine physical therapy with and without mirror therapy on phantom limb pain and psychosocial adjustment to amputation among prosthetic users.
Design
Single Blinded, Parallel Groups, Randomized Controlled Trial
Settings and conduct
setting was University of Lahore teaching hospital and study was single blinded
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
• Diagnosed patients with phantom limb pain having unilateral lower extremity limb traumatic amputation.
• Age 18-45 years.
• Both gender.
• Base line score 3 or more on 0-10 NPRS.
• Minimal one episode of phantom limb pain reported.
• Participant have sufficient cognitive and communication skills.
• Prosthetic user.
Exclusion Criteria:
• Any condition that restrict movement of opposite limb, pain or limited range of motion in intact limb.
• Any diagnosed psychological disorder that could restrains the ability to concentrate during therapy.
• Patients having residual limb pain.
• Infectious and systematic diseases.
• Patients having neuropathic pain other than phantom limb pain.
• Severe mental disorder, neglect syndrome, visual spatial hemi neglect, confusion, dizziness.
Intervention groups
Group-A received Mirror therapy in addition with Routine Physical therapy
Group-B received Routine Physical Therapy only
Main outcome variables
reduction of pain on NPRS scale and improvement on TAPES scale i.e. Psychosocial Adjustment, Prosthesis Satisfaction, Activity Restriction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200728048239N1
Registration date:2020-11-04, 1399/08/14
Registration timing:retrospective
Last update:2020-11-04, 1399/08/14
Update count:0
Registration date
2020-11-04, 1399/08/14
Registrant information
Name
Ayesha Noureen
Name of organization / entity
The university of Lahore
Country
Pakistan
Phone
+92 42 35963424
Email address
ayesha.noureen@uipt.uol.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-28, 1399/01/09
Expected recruitment end date
2020-05-15, 1399/02/26
Actual recruitment start date
2020-03-31, 1399/01/12
Actual recruitment end date
2020-05-19, 1399/02/30
Trial completion date
2020-08-08, 1399/05/18
Scientific title
Effects of routine physical therapy with and without mirror therapy on phantom limb pain and psychosocial adjustment to amputation among prosthetic users
Public title
Effects of routine physical therapy with and without mirror therapy on phantom limb pain and psychosocial adjustment to amputation among prosthetic users
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosed patients with phantom limb pain having unilateral lower extremity limb traumatic amputation.
Age 18-45 years
Both gender.
Base line score 3 or more on 0-10 NPRS.
Minimal one episode of phantom limb pain reported.
Participant have sufficient cognitive and communication skills.
Prosthetic user.
Exclusion criteria:
Any condition that restrict movement of opposite limb, pain or limited range of motion in intact limb.
Any diagnosed psychological disorder that could restrains the ability to concentrate during therapy
Patients having residual limb pain.
Infectious and systematic diseases.
Patients having neuropathic pain other than phantom limb pain.
Severe mental disorder, neglect syndrome, visual spatial hemi neglect, confusion, dizziness.
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
40
Actual sample size reached:
36
Randomization (investigator's opinion)
Randomized
Randomization description
we allocated numbers to participants in advance and then generated a table of random number based on these numbers. simple randomization was done with help of a random number table generated with excel. The first number was allocated to group-A and the second number was allocated to group-B and the same pattern was followed for the rest of the study participants for treatment allocation.
Blinding (investigator's opinion)
Single blinded
Blinding description
it was a single blinded study the assessor was blinded while ensuring confidentiality. An initial assessment of all patients was done by a trained physical therapist before allocation who was not allowed any access to allocation process and treatment. The treatment plan for both groups was executed by the researcher himself. Post trial assessment was performed by a physiotherapist having more than five years of experience in clinical field.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional review board/Faculty of Allied Health Sciences
Street address
1 km defense road Lahore
City
Lahore
Postal code
54000
Approval date
2020-03-05, 1398/12/15
Ethics committee reference number
IRB-UOL-FAHS/718-VIII/2020
Health conditions studied
1
Description of health condition studied
Phantom limb Pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Reduction of score on NPRS scale, improvement of score on TAPES scale i.e. psychosocial adjustment, prosthesis satisfaction, activity restriction
Timepoint
At baseline, at 2nd week and at 4th week
Method of measurement
NPRS (Numeric Pain Rating Scale) and TAPES (Trinity Amputation and prosthesis Evaluation Scale)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group
Category
Rehabilitation
2
Description
Control group
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
University Of Lahore Teaching Hospital
Full name of responsible person
Dr. Zain ul Abbas
Street address
1 km defense road Lahore
City
Lahore
Postal code
54000
Phone
+92 42 32560865
Email
zain.abbas@uipt.uol.edu.pk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Lahore
Full name of responsible person
Prof. Dr. Ashfaq Ahmad
Street address
1 km defense road Lahore
City
Lahore
Postal code
54000
Phone
+92 42 32300865
Email
ashfaq.ahmad@uipt.uol.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Lahore
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Dr. zain ul Abbas
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
1 km defense road Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 32300865
Email
zain.abbas@uipt.uol.edu.pk
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Dr. zain ul Abbas
Position
lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
1 km defense road Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 32300865
Email
zain.abbas@uipt.uol.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Dr. zain ul Abbas
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
1 km defense road Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 32300865
Email
zain.abbas@uipt.uol.edu.pk
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD