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

Not Applicable

Not yet recruiting

• Conditions: Chronic Low-back Pain (cLBP)

• Registration Number: NCT06787209
• Lead Sponsor: Lucía Pilar Vicente Pina

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.

Study Timeline

• Study First Submitted: 2024-10-21
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-16
• Last Update Submitted: 2025-01-16
• Study First Posted: 2025-01-22
• Last Update Posted: 2025-01-22
• Study Start: 2025-03
• Primary Completion: 2025-12
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Hip flexors range of movement	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.

Secondary Outcome Measures

Name	Time	Method
Pain	From enrollment through the end of the 4-week treatment, and again one month after.	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.
Oswestry Disability Index	From enrollment through the end of the 4-week treatment, and again one month after.	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.
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.	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.
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.	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.

Trial Locations

Locations (1)

Centro Clinico de Fisioterapia OMT; 🇪🇸 Zaragoza, Spain