Comparing the effect of two common physiotherapy treatment methods with common physiotherapy with electromagnetic field on pain score and function index in patients with plantar fasciitis.
Design
The clinical trial has two intervention and control groups, including a total of 40 people, double-blind, randomized in a randomized block manner and using a table of random numbers.
Settings and conduct
In this study, a comparison of two non-surgical treatment methods for people with plantar fasciitis is performed at Sadat Private Physiotherapy Center. Before the treatment, all participants are evaluated in terms of foot function and foot pain score with FFI index and VAS scale, respectively. Also, immediately after the last session and 4 weeks after the end of the treatment, the level of foot function and the pain score of the participants will be evaluated. Double-blinding will be done in such a way that the patients and the evaluator will not know about the grouping of people.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age between 20 and 68 years; heel or sole pain for more than three months; heel or sole pain with a score of 5 or more according to the VAS scale in the morning and at the end of the day; Painful palpation with localized pressure at the origin of the plantar fascia.
Exclosion criteria: history of foot surgery; any damage; local steroid injection in the last 3 months; systemic inflammatory disease; metal implant; pregnancy; BMI more than 30; diabetes mellitus.
Intervention groups
The patients who refer to the physiotherapy center during the study are divided into two groups of 20 people; the first group receive 10 common physiotherapy sessions (control) and the second group receive 10 common physiotherapy sessions with magnet therapy (intervention).
Main outcome variables
pain score; foot function index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230712058753N1
Registration date:2023-08-01, 1402/05/10
Registration timing:registered_while_recruiting
Last update:2023-08-01, 1402/05/10
Update count:0
Registration date
2023-08-01, 1402/05/10
Registrant information
Name
Zeinab sadat Yajaddi Arani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5475 4747
Email address
zeinabsadat6266@rehab.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2023-09-21, 1402/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of pulsed electromagnetic field on pain and function index in people with plantar fasciitis
Public title
Evaluating the effect of magnet therapy on foot pain and function in people with plantar inflammation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People aged between 20 up to 68 years
Pain in the heel or sole of the foot for more than three months
The presence of pain in the heel or the sole of the foot with a score of 5 or more according to the VAS scale in the morning and at the end of the day
Painful palpation with local pressure at the origin of the plantar fascia on the medial tubercle of the heel
Exclusion criteria:
The presence of any injury, tear and previous local trauma in the heel and sole of the foot
History of foot surgery in the past
Local steroid injection in the last 3 months
The presence of severe and congenital abnormalities in the knee or ankle (such as severe knee braces, etc.)
Having diabetes, tumor, peripheral neuropathy with any cause, systemic inflammatory disease
The presence of a pacemaker or metal implant
The presence of other musculoskeletal disorders with any cause that causes clinical manifestations in the lower limbs or spine
Pregnancy
People with a body mass index greater than 30
Age
From 20 years old to 68 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two groups of 20 people in a random block manner using a table of random numbers by a person other than the therapist and evaluator.In this study, there are ten blocks of four, two people from the intervention group and two people from the control group will be randomly placed in each block of four.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to create double blinding, it will be so that the patients as well as the evaluator and statistical analyst do not know how to group people, and someone other than the therapist evaluates the patients.
In other words, the patients are in progress, and we have two treatment groups in this study, but they are unaware of which group they belong to, because in both groups, a magnet device is used, with the difference that in the control group, the device will not have an output and only the therapist is aware of it; Actually, because the device does not generate heat, the patient does not feel any special symptoms when the device is on and the current is established. Therefore, in this study, the patients and the evaluator (a person other than the therapist) are blinded.
Placebo
Used
Assignment
Parallel
Other design features
In this study, two non-surgical treatment methods are compared for people with plantar fasciitis.After starting the study, the patients referred by the orthopedic doctor, who refer to the physiotherapy center during the study period, are divided into two groups of 20 people by a random block method and using a table of random numbers by someone other than the therapist and the evaluator.It is worth mentioning that in this study we will have ten blocks of four, so that two people from the intervention group and two people from the control group will be randomly placed in each block of four.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Nursing, Rehabilitation and Management schools- Isfahan University of medical Sc
Street address
Hezar Jerib Avenue, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2023-05-24, 1402/03/03
Ethics committee reference number
IR.MUI.NUREMA.REC.1402.031
Health conditions studied
1
Description of health condition studied
Plantar fasciitis
ICD-10 code
M72.2
ICD-10 code description
Plantar fascial fibromatosis
Primary outcomes
1
Description
Pain: It is a dependent variable that is usually measured by a score, and it is a score that a person should give to the level of pain from zero to ten. In fact, a score of zero equals no pain and a score of ten equals severe unbearable pain.
Timepoint
Before starting the intervention; immediately after the last treatment session; Four weeks after completion of treatment.
Method of measurement
Visual Analogue Scale
2
Description
Foot Function Index: It is a questionnaire that is used in patients with foot problems, it has 23 items that are placed in three subgroups, and it examines the intensity of pain, disability and limitations of people. People should give each question a score between 0-10.
Timepoint
Before starting the intervention; immediately after the last treatment session; Four weeks after completion of treatment.
Method of measurement
Foot Function Index questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Control group: People only receive 10 sessions of common physiotherapy treatment. Each session includes 5 minutes of pulse ultrasound therapy (with 50% duty cycle, 1MHz frequency and 1.2W/cm2 intensity) and 20 minutes of TENS analgesic modality along (with 8Hz frequency, 300µs pulse width and motor intensity) with stretching exercises for the cuff muscles and plantar fascia and strengthening exercises for the anterior tibialis muscle.
Category
Rehabilitation
2
Description
Intervention group: In addition to receiving 10 sessions of common physiotherapy, people also receive 10 sessions of the electromagnetic field treatment program (with square wave shape and 30% duty cycle and 7.5Hz frequency and 100mT intensity) for 10 minutes.