Comparison of physical exercises with physical exercises and psychological exercises on pain, range of motion, lower extremity strength. Quality of life and Kinesiophobia in the elderly with chronic back pain
The main purpose of the research is to compare physical therapy exercises and the combination of physical exercises with psychological exercises on pain, range of motion, lower limb strength, quality of life and kinesiophobia in the elderly with chronic back pain.
Design
Clinical trial with two exercises groups, with parallel groups, double-blind, randomized, phase 2 on 30 patients. A random generator software will be used for randomization.
Settings and conduct
The present research will be conducted at Bu-Ali Sina University for eight weeks, three sessions per week. Due to the nature of exercise therapy and assessment, blinding of practitioners will not be possible, but participants and one of the researchers who will measure assessments before and immediately after eight weeks will be blinded to group allocation.
Participants/Inclusion and exclusion criteria
Inclusion criteria include elderly people 60-80 years old; history of low back pain for more than three months; back pain in the range of 2.5 out of 10 on the Numerical Pain Rating Scale (NPRS); independence in daily activities; no use of assistive devices; no history of illness. cardiovascular and respiratory problems, and exclusion criteria included having any respiratory disease; pregnancy or history of surgery in the lumbar region; inability to exercise; occurrence of pain during the exercise protocol; obvious abnormality; body mass index (BMI) more than 30; non-cooperation and withdrawing from the research; absence in two consecutive sessions and three alternating training sessions.
Intensity of pain; range of motion of the spine; lower limb strength; quality of life; kinesiophibia
General information
Reason for update
Acronym
DNS
IRCT registration information
IRCT registration number:IRCT20211018052801N2
Registration date:2024-09-17, 1403/06/27
Registration timing:prospective
Last update:2024-09-17, 1403/06/27
Update count:0
Registration date
2024-09-17, 1403/06/27
Registrant information
Name
Marziyeh Ziya
Name of organization / entity
Bu-Ali Sina University of Hamedan
Country
Iran (Islamic Republic of)
Phone
+98 71 3825 5617
Email address
m.zia@phe.basu.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-20, 1403/06/30
Expected recruitment end date
2024-10-21, 1403/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of physical exercises with physical exercises and psychological exercises on pain, range of motion, lower extremity strength. Quality of life and Kinesiophobia in the elderly with chronic back pain
Public title
Effect of physical exercises and psychological exercises in chronic back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Low back pain in the range of 2-5 out of 10 on the Numerical Pain Rating Scale (NPRS)
History of back pain for more than three months
Non-use of auxiliary equipment
No history of cardiovascular diseases and respiratory problems
No history of fractures and severe injuries in the lower limbs and spine
Non-participation in therapeutic interventions during the last 4 weeks
Voluntary participation in research
Independence in daily activities
Exclusion criteria:
Having any respiratory disease, pregnancy or history of surgery in the lumbar region
Inability to exercise
Occurrence of pain during the training protocol
Obvious abnormality that is problematic for the implementation of research
Body mass index (BMI) greater than 30
Age
From 60 years old to 80 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be divided into two groups, Feldenkrais and DNS combined exercises group and DNS exercise group by Random Number Generator. This method ensures that each participant has an equal chance of being assigned to either group, reducing selection bias.
Blinding (investigator's opinion)
Double blinded
Blinding description
Due to the nature of the therapeutic exercise and evaluation, athletes will not be able to do it, but the participants and one of the researchers who will evaluate will measure after eight weeks, they will be assigned to groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Bu-Ali Sina university oh Hamedan
Street address
Bu-Ali Sina university oh Hamedan, Shahid Ahmadi Roshan Avenue, Hamedan
City
Hamedan
Province
Hamadan
Postal code
6517838695
Approval date
2024-08-28, 1403/06/07
Ethics committee reference number
IR.BASU.REC.1403.011
Health conditions studied
1
Description of health condition studied
Low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Pain
Timepoint
Pre-test at the beginning of the study (3 to 5 days before the start of the intervention) and post-test at the end of the intervention (three to five days after the last training session)
Method of measurement
Using Visual Analogue Scale of pain intensity
2
Description
Lumbar range of motion
Timepoint
Pre-test at the beginning of the study (3 to 5 days before the start of the intervention) and post-test at the end of the intervention (three to five days after the last training session)
Method of measurement
Modified -Modified Schober's Test
3
Description
Lower limp strength
Timepoint
Pre-test at the beginning of the study (3 to 5 days before the start of the intervention) and post-test at the end of the intervention (three to five days after the last training session)
Method of measurement
30 Seconds Sit To Stand Test
4
Description
Quality of life
Timepoint
Pre-test at the beginning of the study (3 to 5 days before the start of the intervention) and post-test at the end of the intervention (three to five days after the last training session)
Method of measurement
36-Item Short Form Survey Instrument
5
Description
Kinesiophobia
Timepoint
Pre-test at the beginning of the study (3 to 5 days before the start of the intervention) and post-test at the end of the intervention (three to five days after the last training session)
Method of measurement
Tempa scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Combined Feldenkrais and dynamic neuromuscular stabilization exercises.