Comparative effectiveness of plantar massage and reflexology foot massage on pain, balance and functional reach among patients with peripheral neuropathy
To find out what is better in reducing neuropathic pain and increasing balance and functional reach between plantar massage and reflexology foot massage among patients with peripheral neuropathy
Design
A randomized clinical trial with two parallel intervention groups, a study of phase 3 with 18 people in each group, 36 in total.
Settings and conduct
Allied hospital Faisalabad
General hospital Samanabad
Participants/Inclusion and exclusion criteria
Both genders are between 35 and 60 years old. Diagnosed patients with grade II peripheral neuropathy. Ability to stand on both feet. Can perform the given instructions. There was no cardiac problem. No fracture, injury, or amputation of the lower or upper limb. Any neurological problem. No foot or toe ulcer. There is no peripheral thrombosis. Ambulation difficulties or using any walking devices were excluded. No vision impairment.
Intervention groups
Group A: Plantar massage group
Group B: Reflexology foot massage group
Main outcome variables
Pain
Balance
Functional reach
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240311061253N1
Registration date:2024-05-10, 1403/02/21
Registration timing:prospective
Last update:2024-05-10, 1403/02/21
Update count:0
Registration date
2024-05-10, 1403/02/21
Registrant information
Name
Rabeea Saeed
Name of organization / entity
The university of Faisalabad
Country
Pakistan
Phone
+92 303 0449224
Email address
2022-ms-pt-032@tuf.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-15, 1403/02/26
Expected recruitment end date
2024-09-26, 1403/07/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effectiveness of plantar massage and reflexology foot massage on pain, balance and functional reach among patients with peripheral neuropathy
Public title
Effect of plantar massage vs reflexology foot massage on peripheral neuropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 35 and 60 years
Diagnosed patient of grade II peripheral neuropathy
Ability to stand on both feet
Cooperative patients
Can perform given instructions
Volunteered to participate
Exclusion criteria:
Cardiac problem
upper limb or lower limb amputation at any level
foot or toe ulcer
severe visual impairment
any vestibular disorder
edema, peripheral thrombosis, burn, injury or fracture of lower extremity
ambulation difficulties or using any walking device
neurological disorders, including stroke, parkinson's disease, and dementia
Age
From 35 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random sampling was used for sample collection. The list of individuals was generated through online randomization generator. According to the list the participants were divided into both groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research and Ethics / Technical committee of The University of Faisalabad
Street address
House no. 68, street no. 1 defence paradise in front of sheikhon wala railway crossing
City
Faisalabad
Postal code
38000
Approval date
2024-02-15, 1402/11/26
Ethics committee reference number
TUF/DR/SA/MSPP/2024/397
Health conditions studied
1
Description of health condition studied
Peripheral neuropathy
ICD-10 code
G90.0
ICD-10 code description
Idiopathic peripheral autonomic neuropathy
Primary outcomes
1
Description
Pain
Timepoint
Pain was measured at 0 weeks before intervention and after the application of the intervention at 3 weeks.
Method of measurement
Self-report version of the Leeds assessment of signs and symptoms of neuropathic pain scale (S-LANSS)
2
Description
Balance
Timepoint
Balance was measured at 0 weeks before intervention and after the application of the intervention at 3 weeks.
Method of measurement
Balance was measured through Berg Balance Scale (BBS)
3
Description
Functional reach
Timepoint
Functional reach was measured at 0 weeks before intervention and after the application of the intervention at 3 weeks.
Method of measurement
Functional reach was measured through functional reach test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: plantar massage. Plantar massage will be given through sensory brush for 3 days per week dor 3 weeks. The brush will be held horizontal to the plantar aspect of the foot. Brushing will be done slowly, never back and forth on the same spot, and with enough pressure to cause the brush's bristles to bend. The goal is to trigger the feet's pressure touch receptors rapidly. Participants will be informed that the therapy might "tickle." Massage will be given for 5 minutes on each foot
Category
Treatment - Other
2
Description
Intervention group: Reflexology foot massage group. Three weeks of foot reflexology will be conducted, with two sessions each week lasting thirty minutes, 15 minutes for each foot. Applying the reflexology method will involve raising the participant's leg level to the practitioner's chest level. Effleurage massage will be given to the dorsal area, plantar region, tibialis anterior, peroneus longus-brevis, and gastro soleus muscles for five minutes. Effleurage will be utilized to stimulate the autonomic nervous system, and also the reflex mechanism of action, capillaries, and lymphatic function. Reflexology massage will be done according to the following application protocol: solar plexus and diaphragm reflexes, adrenal gland reflexes, the arm and shoulder reflexes, the spine reflexes, the hip, thigh and leg reflexes, the sciatic nerve reflexes, solar plexus and diaphragm reflexes. All of these are done for 7*2 on each foot.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Allied hospital Faisalabad
Full name of responsible person
Anbreena Rasool
Street address
West canal road, Faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 345 7936825
Email
anbreena.rasool@tuf.edu.pk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Anbreena Rasool
Street address
West canal road
City
Faisalabad
Postal code
38000
Phone
+92 345 7936825
Email
anbreena.rasool@tuf.edu.pk
Web page address
https://tuf.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 Faisalabad
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 Faisalabad
Full name of responsible person
Rabeea Saeed
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
House no. 68, street no. 1 defence paradise in front of sheikhon wala railway crossing
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 313 7709264
Email
2022-ms-pt-032@tuf.edu.pk
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Rabeea Saeed
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
House no. 68, street no. 1 defence paradise in front of sheikhon wala railway crossing
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 313 7709264
Email
2022-ms-pt-032@tuf.edu.pk
Web page address
Person responsible for updating data
Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Rabeea Saeed
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
House no. 68, street no. 1 defence paradise in front of sheikhon wala railway crossing
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 313 7709264
Email
2022-ms-pt-032@tuf.edu.pk
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Comparative effectiveness of plantar massage and the reflexology foot massage on pain, balance and functional reach among patients with peripheral neuropathy
When the data will become available and for how long
Starting 6 months after publication and it will remain available for everyone
To whom data/document is available
This will be available for everyone
Under which criteria data/document could be used
anbreena.rasool@tuf.edu.pk
From where data/document is obtainable
rabeeasaeed@gmail.com
+923030449224
What processes are involved for a request to access data/document
Any applicant will just need to contact for the data file at rabeeasaeed@gmail.com or at +923030449224