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

NCT06787209 | Not Yet Recruiting

• 1 other identifier: PI24/303
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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:

• 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.

Conditions

Chronic Low-back Pain (cLBP)

Keywords

Chronic low back pain; hip flexors; Exercise therapy; lumbopelvic function

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  From the enrollement to the end of the treatment at 4 weeks

Secondary Outcomes (4)

• Pain

  From enrollment through the end of the 4-week treatment, and again one month after.

• Oswestry Disability Index

  From enrollment through the end of the 4-week treatment, and again one month after.

• Pelvis saggital movement

  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

  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 (17)

• Force in Newtons by a Maximum voluntary isometric contraction (MVIC) test

  From the enrollement to the end of the treatment at 4 weeks

• Dynamic Activation Assessment during walking

  From the enrollement to the end of the treatment at 4 weeks

• Anthropometric Data (weight)

  From the enrollement to the end of the treatment at 4 weeks

Study Arms (2)

Public healthcare treatment

ACTIVE COMPARATOR

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

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.

Behavioral: Program to improve lumbopelvic function.

Interventions

Program to improve lumbopelvic function. 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.

Program to improve lumbopelvic function

generic health care 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.

Public healthcare treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lucía Pilar Vicente Pina: lead

Study Sites (1)

Centro Clinico de Fisioterapia OMT

Zaragoza, Zaragoza, 50009, Spain

Location

Related Publications (4)

• 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.

  PMID: 34125411 BACKGROUND

• 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.

  PMID: 31403939 BACKGROUND

• 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.

  PMID: 25312581 BACKGROUND

• 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.

  PMID: 26421244 BACKGROUND

Central Study Contacts

Lucía Pilar Vicente Pina

CONTACT

+34 619070688; l.vicente@unizar.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Trainee Researcher at the Department of Physiatry and Nursing

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: January 22, 2025
• Study Start: March 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: January 22, 2025

Record last verified: 2025-01

Locations

ES (1)