The effect of combined pelvic floor treatments on sexual function, pelvic floor muscle strength and endurance in women with chronic low back pain at two different levels of fear of pain
The effect of combined pelvic floor treatments on sexual function, strength and pelvic floor muscle endurance in two groups of women with nonspecific chronic low back pain at two different levels of fear of pain
Design
Clinical Trial, with parallel groups, double-blinded, simple-randomization with random numbers table
Settings and conduct
Volunteers with nonspecific chronic low back pain at IRAN Mehr Physiotherapy Center in shahrood entered the study after completing the consent and demographic form. Then randomly divided into4 groups: high fear of pain and control, low fear of pain and control. The treatment plan includes 10 sessions of combined electromyographic biofeedback, functional electrical stimulation and progressive pelvic floor exercises once a week for a total of three months
Participants/Inclusion and exclusion criteria
Inclusion criteria;
Age between 20 and 50 years
Having recurrent low back pain for 12 weeks or more
VAS less than 3
Sexual dysfunction based on FSFI questionnaire score lower than 26.55
Exclusion criteria;
Any symptoms of serious spine involvement
Pregnancy
Psychological and mental diseases
Neurological diseases
Respiratory and metabolic diseases
Gynecological Diseases
Intervention groups
First group؛High fear of pain treated with 10 sessions of combined pelvic floor rehabilitation ( electromyographic biofeedback, functional electrical stimulation) with neuro track device and progressive pelvic floor muscle training
Second group؛Low fear of pain treated with 10 sessions of combined pelvic floor rehabilitation (electromyographic biofeedback, functional electrical stimulation) by neuro track device and progressive pelvic floor muscle training
control groups without intervention
Main outcome variables
Pelvic floor muscle strength؛ Pelvic floor muscles endurance؛ Female sexual function index questionnaire score؛ Fear of pain Questionnaire score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190416043289N2
Registration date:2020-01-26, 1398/11/06
Registration timing:registered_while_recruiting
Last update:2020-01-26, 1398/11/06
Update count:0
Registration date
2020-01-26, 1398/11/06
Registrant information
Name
MARZIEH MORTEZANEJAD
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3334 0867
Email address
mariptma62@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-04-20, 1399/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of combined pelvic floor treatments on sexual function, pelvic floor muscle strength and endurance in women with chronic low back pain at two different levels of fear of pain
Public title
Pelvic floor treatment on pelvic floor muscle strength
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20 and 50 years
Recurrent low back pain for 12 weeks or more
VAS less than 3
Female sexual dysfunction based on FSFI questionnaire score lower than 26.55
Exclusion criteria:
Serious spine involvement
Symptoms of the cauda equina syndrome
Pregnancy
Neurological disorders
Mental disorders
Respiratory and metabolic diseases
Gynecological Diseases
Age
From 20 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with a random number table such that each person is given a code and they are written in a table. we select one place from the table in a blinded manner, then we select 12 numbers smaller than the selected number in the same row. The same would be true for the second treatment and control group
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher will be blind to the intervention using the research assistant and he/she is absent in the treatment room
The outcome evaluator will vary with the researcher and research data be given him with code and is unaware of the participants' intervention
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Headquarters of Semnan University of Medical Sciences,Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2019-12-24, 1398/10/03
Ethics committee reference number
IR.SEMUMS.REC.1398.241
Health conditions studied
1
Description of health condition studied
Chronic low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Strength of pelvic floor muscles
Timepoint
Before and after the end of intervention
Method of measurement
Perinometer setting
2
Description
Endurance of pelvic floor muscles
Timepoint
Before and after the end of intervention
Method of measurement
perinometer setting
3
Description
Score of PASS questionnaire
Timepoint
Before and after the end of intervention
Method of measurement
Questionnaire
4
Description
Score of FSFI ( sexual funcion index)questionnaire
Timepoint
Before and after the end of intervention
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: high fear of pain group include biofeedback myoelectric,progressive exercise of pelvice floor muscles,functional electrical stimulation of pelvice floor muscles
Category
Treatment - Devices
2
Description
Intervention group: low fear of pain group include biofeedback myoelectric,progressive exercise of pelvice floor muscles,functional electrical stimulation pelvice floor muscles