Clinical trial NCT06787209: Effects of a Hip Flexor and Extensor Muscle Training Program in Individuals with Chronic Mechanical Low Back Pain
Official title: Effects of a Hip Flexor and Extensor Muscle Training Program in Individuals with Chronic Mechanical Low Back Pain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Low-back Pain (cLBP)
Keywords: Chronic low back pain
hip flexors
Exercise therapy
lumbopelvic function
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
First posted: 2025-01-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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?
2. Are patients who have greater hip extension dysfunction going to benefit more from a specific program of stretching and strengthening of hip muscles?
3. 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?
4. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Hip flexors range of movement
timeFrame: From the enrollement to the end of the treatment at 4 weeks
measure: Hip flexors range of movement
timeFrame: From the enrollement to the end of the treatment at 4 weeks
Secondary outcomes:
measure: Pain
timeFrame: From enrollment through the end of the 4-week treatment, and again one month after.
measure: Oswestry Disability Index
timeFrame: From enrollment through the end of the 4-week treatment, and again one month after.
measure: Pelvis saggital movement
timeFrame: 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.
measure: Pain during pelvic tilting
timeFrame: 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.
Other outcomes:
measure: Force in Newtons by a Maximum voluntary isometric contraction (MVIC) test
timeFrame: From the enrollement to the end of the treatment at 4 weeks
measure: Dynamic Activation Assessment during walking
timeFrame: From the enrollement to the end of the treatment at 4 weeks
measure: Anthropometric Data (weight)
timeFrame: From the enrollement to the end of the treatment at 4 weeks
measure: Sleep Quality
timeFrame: From the enrollement to the end of the treatment at 4 weeks, and a month after.
measure: Kinesiophobia
timeFrame: From enrollment through the end of the 4-week treatment, and again one month after.
measure: Sensitization Questionnaire
timeFrame: From enrollment through the end of the 4-week treatment, and again one month after.
measure: Pain Catastrophizing Scale (PCS)
timeFrame: From the enrollement to the end of the treatment at 4 weeks, and a month after.
measure: COOP-WONCA Charts
timeFrame: From the enrollement to the end of the treatment at 4 weeks
measure: Mental Health Status
timeFrame: From enrollment through the end of the 4-week treatment, and again one month after.
measure: Emotional and Social Support
timeFrame: From enrollment through the end of the 4-week treatment, and again one month after.
measure: Dynamic Activation Assessment durign Pelvic tilt
timeFrame: From the enrollement to the end of the treatment at 4 weeks
measure: Walking speed
timeFrame: From the enrollement to the end of the treatment at 4 weeks
measure: Muscle activity during a Maximum voluntary isometric contraction (MVIC) test
timeFrame: From the enrollement to the end of the treatment at 4 weeks
measure: Anthropometric Data (Height)
timeFrame: At the begining of the enrollement
measure: Body composition, percentage of Fat mass
timeFrame: From the enrollement to the end of the treatment at 4 weeks
measure: waist circumference
timeFrame: From the enrollement to the end of the treatment at 4 weeks
measure: Body composition, percentage of muscle mass
timeFrame: From the enrollement to the end of the treatment at 4 weeks
Locations:
city: Zaragoza
country: Spain
facility: Centro Clinico de Fisioterapia OMT
Study officials:
References:
citation: 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.
citation: Jimenez-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.
citation: Zafereo 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.
citation: Vigotsky 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.