NCT Number: NCT06975345
The goal of this clinical trial is to compare the effectiveness of a stretching, exercise and education protocol versus usual care in improving pain, function and disability in patients with non-specific mechanical chronic low back pain (CLBP). The research hypothesis is: A combination of hip flexors stretching, exercise and education is more effective than usual care to improve pain, function and disability in patients with CLBP.
Participants will be randomly allocated in one of the two treatment groups. Pain, function and disability will be assessed before starting treatment, after the end of the treatment and one month , three months and one year after the end of the treatment.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Not applicable
Wroclaw, Lower Silesian Voivodeship, 54-615, Poland
Adam Paluszak, PhD
SUB_INVESTIGATOR
Agnieszka Chwałczyńska, dr hab.
CONTACT
Aleksander Kucza, master
CONTACT
Aleksander Kucza, master of physiotheraphy
PRINCIPAL_INVESTIGATOR
Study design: the study is a randomized controlled study that will be conducted in a physiotherapy center in Poland. Potential subjects will be identified in public and private health services by a medicine doctor who will be responsible for screening subjects for eligibility and enrolling into the study.
Men and Women between 18 and 75 years old that will fulfill the criteria and will sign the informed consent will be randomly assigned to one of the two treatment groups. Randomization will be 1:1 ratio and the method to generate random allocation will be a random computer generated numbers table.
Evaluator, outcome assessor, will be blinded to the participant's group assignment.
The study has been approved by the research ethics committee of Wroclaw University of Health Sciences and Sports. The study will be conducted in accordance with ethical principles of the declaration of Helsinki (75th World Medical Association General Assembly , Helsinki, Finland, October 2024)
Treatment Groups:
Experimental group: Participants will receive a protocol of hip flexors stretching, exercise and education for chronic low back pain added to the standard of care in the Polish public health services prescribed by the medicine doctor.
Control group: Participants will receive only the standard of care in the Polish public health services prescribed by a medicine doctor.
The treatment period will consist of two weeks. Experimental group will receive 3 treatment sessions during this period of time. Control group will receive medication and counsels under medical doctor criteria.
The patients will be assessed at baseline (t0), after the treatment period (t1), 1 month after the end of the treatment (t2), three months after the end of the treatment (t3), and one year after the end of the treatment (t4).The variables that will be collected will be: Pain (NPRS), function (ROM), disability (ODI) and other descriptive and sociodemographic variables.
Statistical analysis will be performed to describe the sample, groups and comparison between groups.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Hip flexors stretching (Adaptation from Evjenth and Hamberg)
Strengthening Exercise
Education Pain relieving positions identified will be taught to the patient to use when they feel their pain.
Identifying and learning to avoid pain positions or activities that increase pain.
When the pain occur self stretching of hip flexors on the couch or the chair must be done
A medical doctor will prescribe the treatment following the standard of care in Polish public health services. Treatment will consist of medication and counseling.
Time frame: Baseline, to complete the treatments, on average 2 weeks, 1, 3 and 12 months after the end of treatment
Numeric Pain Rating Scale (NPRS) The NPRS will be used to ask the patient about the level of pain that he/she feels considering from 0 to 10, where 0 represents the absence of pain and 10 represents the most intense pain, used to measure the pain experienced by the patient. The participant will answer the NPRS, responding to the average, maximum and minimum pain experienced throughout its duration.
Time frame: Baseline, to complete the treatments, on average 2 weeks, 1 month after the end of treatment.
The MyoMotion( Noraxon, USA) is a device used to measure degrees of range of motion (ROM) in the lumbar spine. It consists of accelerometers and a program. The range of flexion, extension, will be measured in degrees.
Time frame: Baseline,to complete the treatments, on average 2 weeks, 1 month after the end of treatment
The MyoMotion( Noraxon, USA) is a device used to measure degrees of range of motion (ROM) in the lumbar spine. It consists of accelerometers and a program. The range of flexion, extension, will be measured in degrees.
Time frame: Baseline, to complete the treatments, on average 2 weeks, 1 month after the end of treatment.
To assess a patient's ability to extend their spine, a clinical method will be used and recorded. This method involves asking the patient how far they can reach while looking at a measuring tape.
Time frame: Baseline, to complete the treatments, on average 2 weeks, 1, 3 and 12 months after the end of treatment
Patients will draw on a body silhouette the region where they feel pain.
Time frame: Baseline, to complete the treatments, on average 2 weeks, 1 month after the end of treatment.
Range of motion (ROM) in a straight leg raise (SLR) test that measures the hip's flexibility while putting tension on the sciatic nerve. The test helps diagnose nerve root compression in the lower lumbar spine. Measures range of motion of the hip.
Time frame: Baseline, to complete the treatments, on average 2 weeks, 1, 3 and 12 months after the end of treatment
The SF-36 questionnaire includes 8 multi-item subscales assessing social functioning, mental health, vitality, physical functioning, role limitations due to physical problems, role limitations due to emotional problems, pain, and general health perception. The total score ranges from 0 to 100, with a higher score indicating a better health-related quality of life.
Time frame: Baseline, to complete the treatments, on average 2 weeks, 1, 3 and 12 months after the end of treatment
The Tampa Scale of Kinesiophobia (TSK) is a 17-item self-report questionnaire that measures fear of movement or re-injury. It's used to identify people with chronic pain who have high levels of fear of movement.
Time frame: Baseline,to complete the treatments, on average 2 weeks, 1, 3 and 12 months after the end of treatment
Oswestry Disability Index ( ODI) a questionnaire that measures how much disability someone has in their daily lives. It's used to assess low back pain. It assesses 10 activities of daily living, including pain, walking, sleeping, and social life. The ODI score ranges from 0-100, with 0 being the best and 100 being the worst.
Time frame: Baseline, to complete the treatments, on average 2 weeks, 1, 3 and 12 months after the end of treatment
Measured using the short version of the International Physical Activity Questionnaire (IPAQ). Questionnaire contains 7 questions about all types of physical activity related to everyday life, work and leisure. Results are reported in categories depending on the variable 'MET minutes a week'. MET minutes represent the amount of energy expended carrying out physical activity. High physical activity (one hour or more of physical activity per day), moderate physical activity (half an hour of physical activity per day) or low physical activity (not meeting any of the criteria for either moderate or high levels of physical activity).
Time frame: Baseline
Body mass (Body composition analyzer BC 418 MA by Tanita), body height (height gauge SECA 217), based on them, determination of the BMI index and BMI percentile using percentile grids developed based on the OLAF program. Analysis of general and segmental parameters:
FatP - body fat mass in %, FatM - body fat mass in kg, FFM - body fat-free mass, TBW - body water quantity in kg and %. FFF index - based on the values of body fat and fat-free tissue, the general and segmental fat-free index is calculated.
Contact information is provided by the study sponsor or research team.
Aleksander Kucza
CONTACT
Wroclaw University of Health and Sport Sciences
Other
Short, Medium and Long Term Effects of a Protocol of Hip Flexor Stretching, Exercise and Pain Managment Education, Function and Disability in Patients With Chronic, Mechanical, Non-specific Low Back Pain. Randomized Controlled Clinical Trial.
Acronym: HipFlexinCLBP
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