To investigate the effects of two night splints on the pain and quality of life of people with plantar faciitis
Design
A clinical trial with a parallel-group design that included two intervention groups and a control group. 30 participants were allocated to three groups using the strata randomization method.
Settings and conduct
This study was a parallel-groups clinical trial. Participants were allocated into study groups using a stratified randomization method (gender was the stratification factor). Participants were recruited through a convenience sampling method and from outpatient clinic of the Alzahra Hospital, Isfahan, Iran. There was no blinding for participants and assessor.
Participants/Inclusion and exclusion criteria
The inclusion criteria were pain complain at the heel and stiffness and pain at the heel in morning. The exclusions were the history of surgery and fracture in the foot and leg and sensory loss in the foot.
Intervention groups
Intervention group used a neoprene splint for night stretching and a pair of silicon heel pad for daily use. Control group used a plastic ankle-foot splint for night stretching and a pair of silicon heel pad for daily use (the conventional orthotic management).
Main outcome variables
The main outcome measures included range of motion at the ankle and foot, pain intensity, and quality of life.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150210021034N5
Registration date:2020-02-06, 1398/11/17
Registration timing:retrospective
Last update:2020-02-06, 1398/11/17
Update count:0
Registration date
2020-02-06, 1398/11/17
Registrant information
Name
Ebrahim Sadeghi-Demneh
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 5235
Email address
sadeghi@rehab.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
2017-10-23, 1396/08/01
Actual recruitment end date
2018-05-22, 1397/03/01
Trial completion date
2018-05-31, 1397/03/10
Scientific title
The effects of two night splints on the pain and quality of life of people with plantar faciitis
Public title
Orthotic effects on the symptoms of plantar fasciitis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Pain complain at the heel ( score 3 and more based on visual analogue scale)
Stiffness and pain at the heel in morning
Exclusion criteria:
History of surgery and fracture in the foot and leg
Sensory loss in the foot
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization was stratified by gender to pursue equal distribution of the gender for all intervention and control groups. Randomization in each stratum was carried out by having a piece of paper that has the phrase "intervention 1 (heel stretching splint+heel pad)", "intervention 2 (toe stretching splint+heel pad)"and "control (heel pad only)" placed inside an envelope. The outside of the envelops were sequentially numbered. After participants have been enrolled in the study and consented, a sequence number envelope on the stack will be randomly drawn and opened to determine the study group that the participant will enter.
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
ُthical committee of Isfahan University of Medical Sciences, Isfahan, Iran
Street address
Hezar Jerib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2017-01-22, 1395/11/03
Ethics committee reference number
IR.MUI.REC.1395.3.726
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 intensity
Timepoint
The measurement was carried out before intervention and 4 weeks after intervention.
Method of measurement
Pain intensity was measured using visual analogue scale.
2
Description
Range of motion at the heel and metatarsophalengeal joints
Timepoint
The measurement was carried out before intervention and 4 weeks after intervention.
Method of measurement
The passive range of motion was measured using a digital goniometer.
3
Description
Quality of life
Timepoint
The measurement was carried out before intervention and 4 weeks after intervention.
Method of measurement
The quality of life was measured using the Persian version of SF-36 questionnaire.
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: an ankle-foot splint was used for night-time stretching of the plantar fascia and a pair of silicone heel pad for day-time use. The ankle-foot splint is a plastic-made device that extends from the dorsal aspect of the leg to the toes. This device is used during resting or sleeping time and fitted on the limb with three straps. This device maintains the ankle in the dorsiflexion position and thereby exerts a stretching force on the plantar fascia. The silicone heel pad is used to reduce the local pressure on the lesion area.
Category
Treatment - Devices
2
Description
Second intervention group: a neoprene ankle-foot support was used for night-time stretching the plantar fascia and a pair of silicone heel pad for day-time use. The ankle-foot support is made of a neoprene rubber that is put on like a sock. This device is used during resting or sleeping time and pulls the toes toward the shank using an adjustable strap. This device extends the toes and thereby exerts a stretching force on the plantar fascia. The silicone heel pad is used to reduce the local pressure on the lesion area.
Category
Treatment - Devices
3
Description
Control group: the use of silicone heel pad during day. A pair of silicone heel pad was used to reduce the pressure on the lesion area.