An interventional study of Program to improve lumbopelvic function. and generic health care in Chronic Low-back Pain (cLBP), sponsored by Lucía Pilar Vicente Pina. Not yet recruiting at 1 site in Spain. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-01-22.
Sponsored by Lucía Pilar Vicente Pina · Not applicable, Interventional, and Treatment
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:
Participants will:
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.
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's planned enrollment of 50 is below the median of 60 across 1,941 interventional studies indexed under Back Pain.
Browse Back Pain studies →This is the only study on the registry with Lucía Pilar Vicente Pina as lead sponsor.
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Exclusion Criteria:
Participants will receive four weeks of convetional active treatment for chronic low back pain at the healthcare center.
Behavioral: generic health care
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.
Behavioral: 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.
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.
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.
Time frame: 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.
Time frame: From the enrollement to the end of the treatment at 4 weeks
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.
Time frame: 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.
Time frame: 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.
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
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.
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.
Force in Newtons by a Maximum voluntary isometric contraction (MVIC) test
A maximum voluntary isometric contraction (MVIC) test will be performed for the biceps femoris, gluteus maximus and tensor fasciae latae using a load cell.
Time frame: From the enrollement to the end of the treatment at 4 weeks
Dynamic Activation Assessment during walking
To assess dynamic activation, a gait test will be used. The gait test will involve walking on a treadmill for one minute at a comfortable speed, chosen by each patient. Two repetitions will be performed. Additionally, each subject will have an adaptation period to ensure they feel comfortable during the test. To assess activation, internal oblique, lumbar multifidus, gluteus maximus, and tensor fasciae lataewill be recorded simultaneously. The total percentage of activation for each muscle during the central 30 seconds of the test will be calculated. In addition, the speed achieved by each participant will also be recorded.
Time frame: From the enrollement to the end of the treatment at 4 weeks
Anthropometric Data (weight)
Weight in kq using the Tanita TBF-300, Amsterdam, Belgium
Time frame: From the enrollement to the end of the treatment at 4 weeks
Sleep Quality
The MOS Sleep Scale (Sleep Scale from the Medical Outcomes Study) will be used, which has proven to be a valid and reliable tool.
Time frame: From the enrollement to the end of the treatment at 4 weeks, and a month after.
Kinesiophobia
The Tampa Scale for Kinesiophobia-11 (TSK-11) is a self-administered questionnaire recommended by the clinical guidelines for neuropathic pain assessment to measure fear of movement. It consists of 11 items assessing two factors: Activity Avoidance and Fear of Harm. Each item is rated on a 4-point Likert scale ranging from strongly disagree to strongly agree. High scores indicate a greater degree of kinesiophobia.
Time frame: From enrollment through the end of the 4-week treatment, and again one month after.
Sensitization Questionnaire
This instrument measures symptoms related to central sensitization syndromes. Part A assesses 25 common symptoms related to central sensitization syndromes, with a total score ranging from 0 to 100. Part B (not scored) asks if the participant has been diagnosed with one or more specific conditions, including seven different central sensitization syndromes.
Time frame: From enrollment through the end of the 4-week treatment, and again one month after.
Pain Catastrophizing Scale (PCS)
The PCS is a 13-item self-administered scale and one of the most widely used to assess pain catastrophizing. It comprises three dimensions: a) rumination, b) magnification, and c) helplessness. The theoretical range of the scale is between 13 and 62, with lower scores indicating low catastrophizing and higher scores indicating severe catastrophizing.
Time frame: From the enrollement to the end of the treatment at 4 weeks, and a month after.
COOP-WONCA Charts
These charts assess health-related quality of life or perceived health. The questionnaire consists of 6 charts on health status and a total of 7 questions with five possible answers.
Time frame: From the enrollement to the end of the treatment at 4 weeks
Mental Health Status
Assessed using the validated Spanish version of the GHQ-12 (General Health Questionnaire), which evaluates overall psychological well-being to detect non-psychotic psychiatric problems.The total score ranges from 0 to 12, with higher scores indicating poorer mental health. A cutoff score above 3 suggests psychological distress.
Time frame: From enrollment through the end of the 4-week treatment, and again one month after.
Emotional and Social Support
Assessed using the DUKE-UNC-11 (Duke-UNC Functional Social Support Questionnaire).The total score ranges from 11 to 55, categorizing the individual's perceived social support as "low" (below 32) or "normal" (32 or above)
Time frame: From enrollment through the end of the 4-week treatment, and again one month after.
Dynamic Activation Assessment durign Pelvic tilt
To assess dynamic activation, a pelvic mobility test will be used. To assess activation, internal oblique, lumbar multifidus, gluteus maximus, and tensor fasciae lataewill be recorded simultaneously. The pelvic mobility test will be the same one used to analyze biomechanical variables. It will consist of an assessment in both standing and seated positions at 45° flexion, during which the electromyographic activity of the aforementioned muscles will be recorded simultaneously. The percentage of muscle activation during anterior and posterior pelvic tilts will be calculated in both standing and seated positions.
Time frame: From the enrollement to the end of the treatment at 4 weeks
Walking speed
The gait test will involve walking on a treadmill for one minute at a comfortable speed chosen by each patient. Two repetitions will be performed. Additionally, each subject will have an adaptation period to ensure they feel comfortable during the test. The speed achieved by each participant will be recorded, as lower speeds are associated with protective mechanisms.
Time frame: From the enrollement to the end of the treatment at 4 weeks
Muscle activity during a Maximum voluntary isometric contraction (MVIC) test
A maximum voluntary isometric contraction (MVIC) test will be performed for the biceps femoris, gluteus maximus, lumbar multifidus, internal oblique , and tensor fasciae latae using a wireless surface electromyography (EMG) system (Trigno Avanti, Delsys, Natick, USA). The electrode placement will follow the SENIAM recommendations. Each test will be performed for 3 seconds with 20 secons rest. The percentage of activation and peak activation will be recorded for each test.
Time frame: From the enrollement to the end of the treatment at 4 weeks
Anthropometric Data (Height)
Height in centimeters using a stadiometer.
Time frame: At the begining of the enrollement
Body composition, percentage of Fat mass
Fat mass wil be assessed using the Tanita bioelectrical impedance analyzer, with results expressed as a percentage relative to total body mass.
Time frame: From the enrollement to the end of the treatment at 4 weeks
waist circumference
waist circumference using a non-extensible plastic tape (TECSYMP Instruments: 0-2 m).
Time frame: From the enrollement to the end of the treatment at 4 weeks
Body composition, percentage of muscle mass
Muscle mass wil be assessed using the Tanita bioelectrical impedance analyzer, with results expressed as a percentage relative to total body mass.
Time frame: From the enrollement to the end of the treatment at 4 weeks
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