Determining the effect of exercise therapy on improving back pain
Design
A clinical trial with a control group with parallel groups without blinding, randomized, letter cards were used for randomization, 50 patients were included in the study and were followed up for 3 months.
Settings and conduct
This study will be conducted at the Yasai Pain Clinic in Fasa, patients under 20 years old and over 60 years old and patients who do not agree to participate in the study will be excluded from the study. they announce
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 20 to 60 years, with VAS back pain intensity higher than 3
Exclusion criteria: no uncontrollable underlying disease and back pain without specific symptoms
Intervention groups
In this study, the effect of exercise on improving disabilities caused by back pain will be investigated.
Including two groups, the first group will receive only medicine and the second group will receive medicine and exercise
Main outcome variables
the amount of primary disability; the level of patient satisfaction; The rate of improvement of the patient's pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220830055833N1
Registration date:2022-09-12, 1401/06/21
Registration timing:retrospective
Last update:2022-09-12, 1401/06/21
Update count:0
Registration date
2022-09-12, 1401/06/21
Registrant information
Name
Maryam Marzbanfard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5334 3202
Email address
m.marzbanfard95@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-30, 1401/06/08
Expected recruitment end date
2022-09-07, 1401/06/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of exercise therapy on pain and disability indicators of patients with non-specific back pain in patients referred to the pain clinic
Public title
The effect of exercise therapy on pain and disability in patients with low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 20 to 60 years
Severity of back pain with VAS criteria higher than 3
Exclusion criteria:
Not having an uncontrollable underlying disease
Presence of back pain without specific symptoms
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we prepare cards for the sample size of 50 people, we write the letter A on 25 of the cards and the letter B on the other 25. We put these in a closed envelope. Then we ask the patient to choose one of the cards at the time of visit. If the patient gets card A, he will be in the intervention group, and if he gets card B, he will be in the control group.
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
Ethics committee of Fasa University of Medical Sciences
Street address
Ibn Sina Square
City
Fasa
Province
Fars
Postal code
7461453493
Approval date
2022-08-30, 1401/06/08
Ethics committee reference number
IR.FUMS.REC.1401.076
Health conditions studied
1
Description of health condition studied
Back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Pain score in Oswestry Disability Index
Timepoint
Examining the improvement of patient's pain 6 weeks after doing sports exercises
Method of measurement
Oswestry Disability Index Questionnaire
Secondary outcomes
1
Description
Patient satisfaction score from 0 to 10
Timepoint
Pain score after 6 weeks of exercise
Method of measurement
Patients were asked to rate their satisfaction with exercise from 0 to 10
Intervention groups
1
Description
Intervention group: The intervention group of 25 patients with back pain will be followed up by giving Williams and McKenzie exercises. Exercises are performed during two stages of 6 weeks, in which the first 6 weeks are 6 days a week and the second 6 weeks are 3 days a week, every other day for a total of 12 weeks, and the patients visit the pain clinic monthly. This group also uses uniflex tablets once a day, wishca cream three times a day and meloxicam tablets 15 mg every 12 hours in case of pain. Uniflex tablets contain calcium carbonate, methylsulfonylmethane, vitamin D and K, magnesium and zinc. Methylsulfonylmethane is anti-inflammatory and antioxidant, and it has been shown that it has cartilage-building and collagen-building effects, which is useful for our study considering the cause of wear and tear, which is cartilage breakdown.
Category
Rehabilitation
2
Description
Control group:The control group also uses uniflex tablets once a day, wishca cream three times a day and meloxicam tablets 15 mg every 12 hours in case of pain. Uniflex tablets contain calcium carbonate, methylsulfonylmethane, vitamin D and K, magnesium and zinc. Methylsulfonylmethane is anti-inflammatory and antioxidant, and it has been shown that it has cartilage-building and collagen-building effects, which is useful for our study considering the cause of wear and tear, which is cartilage breakdown.Community Verified icon
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dastghib Yasai Pain Clinic
Full name of responsible person
Maryam Marzbanfard
Street address
Ibn Sina Square
City
Fasa
Province
Fars
Postal code
7461453493
Phone
+98 71 5334 3202
Email
m.marzbanfard95@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Bordbar Zare
Street address
Ibn Sina Square
City
Fasa
Province
Fars
Postal code
7461453463
Phone
+98 71 5334 3202
Email
m.marzbanfard95@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?