PainHipFlexinCLBPNCT06975345
Effects of a Protocol of Hip Flexor Stretching on Chronic Mechanical, Non-specific LBP.
A study testing Multicomponent intervention. Hip flexors stretching, Strengthening exercises and education and medical treatment (Medication and medical counselling) and Medical treatment. in people with Pain and Musculoskeletal Manipulations, run by Wroclaw University of Health and Sport Sciences at 1 site in Poland.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain, Musculoskeletal Manipulations, Low Back Pain, Mechanical
- What is being tested?
- Multicomponent intervention. Hip flexors stretching, Strengthening exercises and education and medical treatment (Medication and medical counselling) and Medical treatment.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 2 Jul 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years
- Medical diagnosis of chronic, mechanical, non-specific pain in the lumbar spine (M54, M51) - chronic low back pain.
- Obtaining written consent to conduct research
- Must be able to swallow tablets
Who cannot join
- Pregnancy
- Pacemaker
- Active cancer
- To consent to conduct research
- Difficulty communicating
- The presence of a metal plate in the head and metal screws in the body
Show all 13Show fewer
- Condition after operations in the area of the lumbar spine
- Condition after fractures in the lumbar spine
- Contraindications to manual therapy or exercise
- Has participated in a lumbar spine exercise or manual therapy program in the last three months
- Present clear signs of having suffered a significant lumbar injury
- Inability to maintain standing or a supine or prone position
- No possibility to perform the stretching of hip flexors
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Aleksander Kucza contact
Poland1 site
Rehasport Wroclaw
Wroclaw, Lower Silesian Voivodeship, 54-615
Agnieszka Chwałczyńska, dr hab., 0048601204500, agnieszka.chwalczynska@awf.wroc.pl
Aleksander Kucza, master, 0048607337612, alekkucza@gmail.com
About this study
Official title: 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.
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.
Read the detailed description
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.
- Being tested
- Multicomponent intervention. Hip flexors stretching, Strengthening exercises and education and medical treatment (Medication and medical counselling), Medical treatment.
- Keywords
- manual therapy,, spine,, low back pain,, Chronic Low Back Pain,, Muscle Stretching Exercises,, Range of Motion, Articular,, Body composition,, Numeric Pain Rating Scale (NPRS)
- Medical subject headings
- Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent intervention. Hip flexors stretching, Strengthening exercises and education and medical treatment (Medication and medical counselling)Other
Hip flexors stretching (Adaptation from Evjenth and Hamberg)
Strengthening Exercise
- Deep squats
- Flexo-extension of the ankle on a step over the head of metatarsal bones
- Plank
- Strengthening knee flexors and hip extensors
- Lunges with a stick behind the patient back
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
Medical treatment.Drug
A medical doctor will prescribe the treatment following the standard of care in Polish public health services. Treatment will consist of medication and counseling.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 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. Receives: Other: Multicomponent intervention. Hip flexors stretching, Strengthening exercises and education and medical treatment (Medication and medical counselling); Drug: Medical treatment. |
| Control group | Active comparator | Participants will receive only the standard of care in the Polish public health services prescribed by a medicine doctor. Receives: Drug: Medical treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale (NPRS)
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.
Measured: Baseline, to complete the treatments, on average 2 weeks, 1, 3 and 12 months after the end of treatment
Secondary outcomes (10)
Lumbar Range of Motion
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.
Measured: Baseline, to complete the treatments, on average 2 weeks, 1 month after the end of treatment.
ROM in Thomas test
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.
Measured: Baseline,to complete the treatments, on average 2 weeks, 1 month after the end of treatment
Clinical Measure of extension.
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.
Measured: Baseline, to complete the treatments, on average 2 weeks, 1 month after the end of treatment.
Anatomical distribution of pain
Patients will draw on a body silhouette the region where they feel pain.
Measured: Baseline, to complete the treatments, on average 2 weeks, 1, 3 and 12 months after the end of treatment
ROM in Straight Leg Raise Test
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.
Measured: Baseline, to complete the treatments, on average 2 weeks, 1 month after the end of treatment.
Quality of Life level
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.
Measured: Baseline, to complete the treatments, on average 2 weeks, 1, 3 and 12 months after the end of treatment
Kinesiophobia
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.
Measured: Baseline, to complete the treatments, on average 2 weeks, 1, 3 and 12 months after the end of treatment
Degree of Functional Disability
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.
Measured: Baseline,to complete the treatments, on average 2 weeks, 1, 3 and 12 months after the end of treatment
Physical activity level
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).
Measured: Baseline, to complete the treatments, on average 2 weeks, 1, 3 and 12 months after the end of treatment
Body composition analysis
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start2 Jul 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wroclaw University of Health and Sport Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Zaragoza, Universitat Internacional de Catalunya
- Responsible party
- Principal investigator, Aleksander Kucza, Wroclaw University of Health and Sport Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06975345
- Sponsor's protocol ID
- AWFWroclawUNIZAR.PhDAlek
- Acronym
- HipFlexinCLBP
- Status last verified
- Apr 2025
- First submitted
- 25 Apr 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06975345
- Acronym / sponsor ID
- HipFlexinCLBP / AWFWroclawUNIZAR.PhDAlek
- Keywords
- manual therapy,, spine,, low back pain,, Chronic Low Back Pain,, Muscle Stretching Exercises,, Range of Motion, Articular,, Body composition,, Numeric Pain Rating Scale (NPRS)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Wroclaw University of Health and Sport SciencesUniversity, hospital or other
- Collaborators
- Universidad de Zaragoza, Universitat Internacional de Catalunya
- Study start
- 2 Jul 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Multicomponent intervention. Hip flexors stretching, Strengthening exercises and education and medical treatment (Medication and medical counselling), Drug: Medical treatment.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 | Active comparator | Drug: Medical treatment.Participants will receive only the standard of care in the Polish public health services prescribed by a medicine doctor. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-75 years
- Medical diagnosis of chronic, mechanical, non-specific pain in the lumbar spine (M54, M51) - chronic low back pain.
- Obtaining written consent to conduct research
- Must be able to swallow tablets
Key exclusion criteria (13 listed)
- Pregnancy
- Pacemaker
- Active cancer
- To consent to conduct research
- Difficulty communicating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multicomponent intervention. Hip flexors stretching, Strengthening exercises and education and medical treatment (Medication and medical counselling)Hip flexors stretching (Adaptation from Evjenth and Hamberg) Strengthening Exercise * Deep squats * Flexo-extension of the ankle on a step over the head of metatarsal bones * Plank * Strengthening knee flexors and hip extensors * Lunges with a stick behind the patient back 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 | Other | Experimental group |
| Medical treatment.A medical doctor will prescribe the treatment following the standard of care in Polish public health services. Treatment will consist of medication and counseling. | Drug | Control group, Experimental group |
Primary outcome
Numeric Pain Rating Scale (NPRS)
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.
10 secondary outcomes
Lumbar Range of Motion
Time frame: Baseline, to complete the treatments, on average 2 weeks, 1 month after the end of treatment.
ROM in Thomas test
Time frame: Baseline,to complete the treatments, on average 2 weeks, 1 month after the end of treatment
Clinical Measure of extension.
Time frame: Baseline, to complete the treatments, on average 2 weeks, 1 month after the end of treatment.
Anatomical distribution of pain
Time frame: Baseline, to complete the treatments, on average 2 weeks, 1, 3 and 12 months after the end of treatment
ROM in Straight Leg Raise Test
Time frame: Baseline, to complete the treatments, on average 2 weeks, 1 month after the end of treatment.
Quality of Life level
Time frame: Baseline, to complete the treatments, on average 2 weeks, 1, 3 and 12 months after the end of treatment
Kinesiophobia
Time frame: Baseline, to complete the treatments, on average 2 weeks, 1, 3 and 12 months after the end of treatment
Degree of Functional Disability
Time frame: Baseline,to complete the treatments, on average 2 weeks, 1, 3 and 12 months after the end of treatment
Physical activity level
Time frame: Baseline, to complete the treatments, on average 2 weeks, 1, 3 and 12 months after the end of treatment
Body composition analysis
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aleksander Kucza contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent intervention. Hip flexors stretching, Strengthening exercises and education and medical treatment (Medication and medical counselling) and Medical treatment. in people with Pain and Musculoskeletal Manipulations, run by Wroclaw University of Health and Sport Sciences at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aleksander Kucza, or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (NPRS) (time frame: Baseline, to complete the treatments, on average 2 weeks, 1, 3 and 12 months after the end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.