Effects of a Hip Flexor and Extensor Muscle Training Program in Individuals with Chronic Mechanical Low Back Pain

NCT ID: NCT06787209

Last Updated: 2025-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-31

Study Completion Date

2026-03-31

Brief Summary

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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

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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

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Chronic Low-back Pain (cLBP)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Public healthcare treatment

Participants will receive four weeks of convetional active treatment for chronic low back pain at the healthcare center.

Group Type ACTIVE_COMPARATOR

generic health care

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

Program to improve lumbopelvic function.

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

generic health care

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lucía Pilar Vicente Pina

OTHER

Sponsor Role lead

Responsible Party

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Lucía Pilar Vicente Pina

Trainee Researcher at the Department of Physiatry and Nursing

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Centro Clinico de Fisioterapia OMT

Zaragoza, Zaragoza, Spain

Site Status

Countries

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Spain

Central Contacts

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Lucía Pilar Vicente Pina

Role: CONTACT

+34 619070688

Facility Contacts

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Lucía Pilar Vicente Pina

Role: primary

+34 644 16 18 70

César Hidalgo García

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 34125411 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31403939 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25312581 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26421244 (View on PubMed)

Other Identifiers

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PI24/303

Identifier Type: -

Identifier Source: org_study_id

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