Chronic Low-back Pain (cLBP)NCT06787209
Effects of a Hip Flexor and Extensor Muscle Training Program in Individuals with Chronic Mechanical Low Back Pain
A study testing Program to improve lumbopelvic function. and generic health care in people with Chronic Low-back Pain (cLBP), run by Lucía Pilar Vicente Pina at 1 site in Spain.
Trial summary
The goal of this clinical trial is to evaluate the effect of a physiotherapy intervention program in the lumbopelvic area in chronic low back pain patients. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Low-back Pain (cLBP)
- What is being tested?
- Program to improve lumbopelvic function. and generic health care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2025to Mar 2026
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than 18 and less than 70 years.
- Low back pain lasting more than 3 months defined as: "Pain or discomfort localized below the costal margin and above the gluteal fold, with or without referred pain to the leg."
- Low back pain with a mechanical component.
- Signed informed consent prior to participation in the study.
Who cannot join
- A specific cause for their low back pain (trauma, spondylolisthesis, vertebral fractures, etc.), have undergone any surgical procedures on the spine or hip, or have other diseases or conditions (neurological issues, joint replacements, etc.).
- Cognitive impairment and inability to comprehend.
- Injections in the last 6 months or physiotherapy treatment in the last 3 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Centro Clinico de Fisioterapia OMT
Zaragoza, Zaragoza, 50009
Lucía Pilar Vicente Pina, +34 644 16 18 70, fisio@centroclinicoomt.es
César Hidalgo García
About this study
The goal of this clinical trial is to evaluate the effect of a physiotherapy intervention program in the lumbopelvic area in chronic low back pain patients. The main questions it aims to answer are:
- Is a specific stretching and strengthening program for the hip musculature beneficial for function and symptom reduction in patients with non-specific chronic low back ain?
- Are patients who have greater hip extension dysfunction going to benefit more from a specific program of stretching and strengthening of hip muscles?
- Are there more alteration in pelvis alignement and movement in standig position compared to seated position in those patiens with lesser hip range of movement?
- Are patiens with lesser hip range of movement going to show more dysfunction in the lumbopelvic region?
Read more
Participants will:
- Visit the physiotherapy clinic once a week to complete the therapeutic exercise session.
- Repeat the session in their houses if its possible between 3 or 4 times a week and record the number of days they repeat the session at home.
- Answer some questionaires at the begining of the intervention, after 4 weeks, a month and three months.
Read the detailed description
This study aims to enhance healthcare interventions for chronic low back pain, focusing specifically on patients whose pain may be linked to restricted hip extension mobility. Patients will be referred from the healthcare system to the physiotherapy center, where the principal investigator, Lucía Vicente, will randomize participants into either the intervention or control group. Each participant will complete an initial evaluation at the start of the intervention and again after 4 weeks. Additional questionnaires will be administered one and three months post-intervention. Pelvic movement changes will also be tracked before each in-person session. The program will focus on strengthening the pelvic muscles, particularly by targeting hip extensor strengthening and hip flexor stretching.
- Conditions
- Chronic Low-back Pain (cLBP)
- Being tested
- Program to improve lumbopelvic function., generic health care
- Keywords
- Chronic low back pain, hip flexors, Exercise therapy, lumbopelvic function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Program to improve lumbopelvic function.Behavioural
Each individual will receive a weekly session log at the start of the intervention, allowing them to record the total number of sessions performed between in-person visits and the perceived exertion.
In the strengthening phase, both compound and isolated exercises will be performed. These exercises will be of low intensity and maintained for prolonged periods until the patient reaches fatigue or can no longer perform the repetitions correctly. If the patient reaches 40 repetitions, the exercise will be progressed in difficulty. The patient will have one minute of rest after each set.
Each session will include a total of 4 sets focused on the gluteal muscles The speed of execution for each repetition will be between 4-6 seconds. After the strengthening phase, three unilateral static stretches targeting the hip flexors will be performed, each lasting one minute.
The entire program will be performed using bodyweight exercises and adapted exercises that can be done at home.
generic health careBehavioural
The patients will receive 10 physiotherapy sessions at the health center throughout 4 weeks.They will be taught active exercises and undergo passive therapies to address their low back pain. Each session will last approximately 30 minutes.
The intervention will therefore be variable depending on the assigned physiotherapist, as there is no standardized protocol for action.
| Study group | Role | What they receive |
|---|---|---|
| Public healthcare treatment | Active comparator | Participants will receive four weeks of convetional active treatment for chronic low back pain at the healthcare center. Receives: Behavioral: generic health care |
| Program to improve lumbopelvic function | Experimental | The program will consist of a mixed model of in-person and home-based sessions. In-person sessions will be once a week and supervised by a physiotherapist. After each session participants will be encourage to replicate that session at home as many times as possible. Each session will include a warm-up, a strengthening phase, and a stretching phase. The strengthening part will be performed using a low-load methodology, which is the best alternative for home-based training. Specifically, the training will focus on stretching the hip flexors and strengthening the hip extensors. Receives: Behavioral: Program to improve lumbopelvic function. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hip flexors range of movement
Range of motion of the hip flexors will be assessed using the Modified Thomas Test, also recording the body area where the sensation of stretch is felt, as well as the intensity.
Measured: From the enrollement to the end of the treatment at 4 weeks
Hip flexors range of movement
Range of motion of the hip flexors will be assessed using The modified Ober test, also recording the body area where the sensation of tension or stretch is felt, as well as the intensity.
Measured: From the enrollement to the end of the treatment at 4 weeks
Secondary outcomes (4)
Pain
Low back pain will be assessed using a visual analog scale (VAS). Information on average pain over the last 3 days, the maximum pain experienced, and the current pain level will be collected. The patient will mark their pain level with a line on scale ranging from 0 to 100 millimeters, where "0" represents no pain and "100" represents the worst imaginable pain, in relation to daytime pain (average VAS perceived over the last 3 days and at the present moment). Additionally, patients will be asked about the location and intensity of other symptoms using a Likert scale and a body map.
Measured: From enrollment through the end of the 4-week treatment, and again one month after.
Oswestry Disability Index
It is a questionnaire composed of 10 categories: (1) pain intensity, (2) self-care, (3) lifting objects, (4) walking, (5) sitting, (6) standing, (7) sleeping, (8) sexual life, (9) social life, and (10) traveling. Each category consists of 6 items scored from 0 to 5, with a score of 0 on the first statement and 5 on the last. A mark at the highest levels indicates that the person is in worse condition. The questionnaire includes an additional question about previous treatments. If more than one response is selected, the highest score is considered. If all 10 sections are completed, the score is calculated as follows: the maximum score for the 10 sections is 50 points. If all sections are completed, this number is converted into a percentage with a total of 100. The Spanish version of the questionnaire shows good reliability and validity with an ICC between 0.89-0.97 and was validated in Spanish.
Measured: From enrollment through the end of the 4-week treatment, and again one month after.
Pelvis saggital movement
The pelvic movement will be recorded in video format in the sagittal plane for each patient in both standing and sitting positions with 45° of hip flexion. In each measurement it will be registered the range of movemento of the pelvis. The movement consist of the total range of anterior and posterior rotation of the pelvis.
Measured: From the enrollement to the end of the treatment at 4 weeks. For participants enrolled in the program to improve lumbopelvic function, this assessment will also be performed after each physiotherapy session.
Pain during pelvic tilting
Pain during pelvic tilting will be assessed using a visual analog scale (VAS). The patient will mark their pain level with a line on scale ranging from 0 to 100 millimeters, where "0" represents no pain and "100" represents the worst imaginable pain. Additionally, patients will be asked about the location using a a body map and also the movement phase where the pain appears or is at its worst.
Measured: From the enrollement to the end of the treatment at 4 weeks. For participants enrolled in the program to improve lumbopelvic function, this assessment will also be performed after each physiotherapy session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study startMar 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Low-back Pain (cLBP)Studies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lucía Pilar Vicente Pina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lucía Pilar Vicente Pina, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06787209
- Sponsor's protocol ID
- PI24/303
- Status last verified
- Jan 2025
- First submitted
- 21 Oct 2024
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Iversen VM, Norum M, Schoenfeld BJ, Fimland MS. No Time to Lift? Designing Time-Efficient Training Programs for Strength and Hypertrophy: A Narrative Review. Sports Med. 2021 Oct;51(10):2079-2095. doi: 10.1007/s40279-021-01490-1. Epub 2021 Jun 14.
PubMed 34125411Jimenez-Del-Barrio S, Mingo-Gomez MT, Estebanez-de-Miguel E, Saiz-Cantero E, Del-Salvador-Miguelez AI, Ceballos-Laita L. Adaptations in pelvis, hip and knee kinematics during gait and muscle extensibility in low back pain patients: A cross-sectional study. J Back Musculoskelet Rehabil. 2020;33(1):49-56. doi: 10.3233/BMR-191528.
PubMed 31403939Zafereo J, Devanna R, Mulligan E, Wang-Price S. Hip stiffness patterns in lumbar flexion- or extension-based movement syndromes. Arch Phys Med Rehabil. 2015 Feb;96(2):292-7. doi: 10.1016/j.apmr.2014.09.023. Epub 2014 Oct 13.
PubMed 25312581Vigotsky AD, Lehman GJ, Contreras B, Beardsley C, Chung B, Feser EH. Acute effects of anterior thigh foam rolling on hip angle, knee angle, and rectus femoris length in the modified Thomas test. PeerJ. 2015 Sep 24;3:e1281. doi: 10.7717/peerj.1281. eCollection 2015.
PubMed 26421244
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Hip Flexor and Extensor Muscle Training Program in Individuals with Chronic Mechanical Low Back Pain
- ClinicalTrials.gov ID
- NCT06787209
- Acronym / sponsor ID
- PI24/303
- Conditions
- Chronic Low-back Pain (cLBP)
- Keywords
- Chronic low back pain, hip flexors, Exercise therapy, lumbopelvic function
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Lucía Pilar Vicente PinaUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 22 Jan 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 evaluate the effect of a physiotherapy intervention program in the lumbopelvic area in chronic low back pain patients. The main questions it aims to answer are:
- Is a specific stretching and strengthening program for the hip musculature beneficial for function and symptom reduction in patients with non-specific chronic low back ain?
- Are patients who have greater hip extension dysfunction going to benefit more from a specific program of stretching and strengthening of hip muscles?
- Are there more alteration in pelvis alignement and movement in standig position compared to seated position in those patiens with lesser hip range of movement?
- Are patiens with lesser hip range of movement going to show more dysfunction in the lumbopelvic region?
Participants will:
- Visit the physiotherapy clinic once a week to complete the therapeutic exercise session.
- Repeat the session in their houses if its possible between 3 or 4 times a week and record the number of days they repeat the session at home.
- Answer some questionaires at the begining of the intervention, after 4 weeks, a month and three months.
Detailed description
This study aims to enhance healthcare interventions for chronic low back pain, focusing specifically on patients whose pain may be linked to restricted hip extension mobility. Patients will be referred from the healthcare system to the physiotherapy center, where the principal investigator, Lucía Vicente, will randomize participants into either the intervention or control group. Each participant will complete an initial evaluation at the start of the intervention and again after 4 weeks. Additional questionnaires will be administered one and three months post-intervention. Pelvic movement changes will also be tracked before each in-person session. The program will focus on strengthening the pelvic muscles, particularly by targeting hip extensor strengthening and hip flexor stretching.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Public healthcare treatment | Active comparator | Behavioral: generic health careParticipants will receive four weeks of convetional active treatment for chronic low back pain at the healthcare center. |
| Program to improve lumbopelvic function | Experimental | Behavioral: Program to improve lumbopelvic function.The program will consist of a mixed model of in-person and home-based sessions. In-person sessions will be once a week and supervised by a physiotherapist. After each session participants will be encourage to replicate that session at home as many times as possible. Each session will include a warm-up, a strengthening phase, and a stretching phase. The strengthening part will be performed using a low-load methodology, which is the best alternative for home-based training. Specifically, the training will focus on stretching the hip flexors and strengthening the hip extensors. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age greater than 18 and less than 70 years.
- Low back pain lasting more than 3 months defined as: "Pain or discomfort localized below the costal margin and above the gluteal fold, with or without referred pain to the leg."
- Low back pain with a mechanical component.
- Signed informed consent prior to participation in the study.
Key exclusion criteria (3 listed)
- A specific cause for their low back pain (trauma, spondylolisthesis, vertebral fractures, etc.), have undergone any surgical procedures on the spine or hip, or have other diseases or conditions (neurological issues, joint replacements, etc.).
- Cognitive impairment and inability to comprehend.
- Injections in the last 6 months or physiotherapy treatment in the last 3 months.
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 |
|---|---|---|
| Program to improve lumbopelvic function.Each individual will receive a weekly session log at the start of the intervention, allowing them to record the total number of sessions performed between in-person visits and the perceived exertion. In the strengthening phase, both compound and isolated exercises will be performed. These exercises will be of low intensity and maintained for prolonged periods until the patient reaches fatigue or can no longer perform the repetitions correctly. If the patient reaches 40 repetitions, the exercise will be progressed in difficulty. The patient will have one minute of rest after each set. Each session will include a total of 4 sets focused on the gluteal muscles The speed of execution for each repetition will be between 4-6 seconds. After the strengthening phase, three unilateral static stretches targeting the hip flexors will be performed, each lasting one minute. The entire program will be performed using bodyweight exercises and adapted exercises that can be done at home. | Behavioural | Program to improve lumbopelvic function |
| generic health careThe patients will receive 10 physiotherapy sessions at the health center throughout 4 weeks.They will be taught active exercises and undergo passive therapies to address their low back pain. Each session will last approximately 30 minutes. The intervention will therefore be variable depending on the assigned physiotherapist, as there is no standardized protocol for action. | Behavioural | Public healthcare treatment |
Primary outcome
Hip flexors range of movement
Time frame: From the enrollement to the end of the treatment at 4 weeks
Range of motion of the hip flexors will be assessed using the Modified Thomas Test, also recording the body area where the sensation of stretch is felt, as well as the intensity.
Hip flexors range of movement
Time frame: From the enrollement to the end of the treatment at 4 weeks
Range of motion of the hip flexors will be assessed using The modified Ober test, also recording the body area where the sensation of tension or stretch is felt, as well as the intensity.
4 secondary outcomes
Pain
Time frame: From enrollment through the end of the 4-week treatment, and again one month after.
Oswestry Disability Index
Time frame: From enrollment through the end of the 4-week treatment, and again one month after.
Pelvis saggital movement
Time frame: From the enrollement to the end of the treatment at 4 weeks. For participants enrolled in the program to improve lumbopelvic function, this assessment will also be performed after each physiotherapy session.
Pain during pelvic tilting
Time frame: From the enrollement to the end of the treatment at 4 weeks. For participants enrolled in the program to improve lumbopelvic function, this assessment will also be performed after each physiotherapy session.
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 22 Jan 2025.
- Background: PubMed 34125411Iversen VM, Norum M, Schoenfeld BJ, Fimland MS. No Time to Lift? Designing Time-Efficient Training Programs for Strength and Hypertrophy: A Narrative Review. Sports Med. 2021 Oct;51(10):2079-2095. doi: 10.1007/s40279-021-01490-1. Epub 2021 Jun 14.
- Background: PubMed 31403939Jimenez-Del-Barrio S, Mingo-Gomez MT, Estebanez-de-Miguel E, Saiz-Cantero E, Del-Salvador-Miguelez AI, Ceballos-Laita L. Adaptations in pelvis, hip and knee kinematics during gait and muscle extensibility in low back pain patients: A cross-sectional study. J Back Musculoskelet Rehabil. 2020;33(1):49-56. doi: 10.3233/BMR-191528.
- Background: PubMed 25312581Zafereo J, Devanna R, Mulligan E, Wang-Price S. Hip stiffness patterns in lumbar flexion- or extension-based movement syndromes. Arch Phys Med Rehabil. 2015 Feb;96(2):292-7. doi: 10.1016/j.apmr.2014.09.023. Epub 2014 Oct 13.
- Background: PubMed 26421244Vigotsky AD, Lehman GJ, Contreras B, Beardsley C, Chung B, Feser EH. Acute effects of anterior thigh foam rolling on hip angle, knee angle, and rectus femoris length in the modified Thomas test. PeerJ. 2015 Sep 24;3:e1281. doi: 10.7717/peerj.1281. eCollection 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Program to improve lumbopelvic function. and generic health care in people with Chronic Low-back Pain (cLBP), run by Lucía Pilar Vicente Pina at 1 site in Spain.
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 3 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 22 Jan 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 Spain. 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 Lucía Pilar Vicente Pina (+34 619070688, l.vicente@unizar.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hip flexors range of movement (time frame: From the enrollement to the end of the treatment at 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06787209, which also lists 4 linked publications.
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 22 Jan 2025.