NCT06975345

Effects of a Protocol of Hip Flexor Stretching on Chronic Mechanical, Non-specific LBP.

Short, Medium and Long Term Effects of a Protocol of Hip Flexor Stretching, Exercise and Pain Managment Education, Function and Disability in Patients With Chronic, Mechanical, Non-specific Low Back Pain. Randomized Controlled Clinical Trial.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Wroclaw University of Health and Sport Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to compare the effectiveness of a stretching, exercise and education protocol versus usual care in improving pain, function and disability in patients with non-specific mechanical chronic low back pain (CLBP). The research hypothesis is: A combination of hip flexors stretching, exercise and education is more effective than usual care to improve pain, function and disability in patients with CLBP. Participants will be randomly allocated in one of the two treatment groups. Pain, function and disability will be assessed before starting treatment, after the end of the treatment and one month , three months and one year after the end of the treatment.

Detailed description

Study design: the study is a randomized controlled study that will be conducted in a physiotherapy center in Poland. Potential subjects will be identified in public and private health services by a medicine doctor who will be responsible for screening subjects for eligibility and enrolling into the study. Men and Women between 18 and 75 years old that will fulfill the criteria and will sign the informed consent will be randomly assigned to one of the two treatment groups. Randomization will be 1:1 ratio and the method to generate random allocation will be a random computer generated numbers table. Evaluator, outcome assessor, will be blinded to the participant's group assignment. The study has been approved by the research ethics committee of Wroclaw University of Health Sciences and Sports. The study will be conducted in accordance with ethical principles of the declaration of Helsinki (75th World Medical Association General Assembly , Helsinki, Finland, October 2024) Treatment Groups: Experimental group: Participants will receive a protocol of hip flexors stretching, exercise and education for chronic low back pain added to the standard of care in the Polish public health services prescribed by the medicine doctor. Control group: Participants will receive only the standard of care in the Polish public health services prescribed by a medicine doctor. The treatment period will consist of two weeks. Experimental group will receive 3 treatment sessions during this period of time. Control group will receive medication and counsels under medical doctor criteria. The patients will be assessed at baseline (t0), after the treatment period (t1), 1 month after the end of the treatment (t2), three months after the end of the treatment (t3), and one year after the end of the treatment (t4).The variables that will be collected will be: Pain (NPRS), function (ROM), disability (ODI) and other descriptive and sociodemographic variables. Statistical analysis will be performed to describe the sample, groups and comparison between groups.

Conditions

• Pain
• Musculoskeletal Manipulations
• Low Back Pain, Mechanical

Interventions

Type	Name	Description
OTHER	Multicomponent intervention. Hip flexors stretching, Strengthening exercises and education and medical treatment (Medication and medical counselling)	Hip flexors stretching (Adaptation from Evjenth and Hamberg) Strengthening Exercise * Deep squats * Flexo-extension of the ankle on a step over the head of metatarsal bones * Plank * Strengthening knee flexors and hip extensors * Lunges with a stick behind the patient back Education Pain relieving positions identified will be taught to the patient to use when they feel their pain. Identifying and learning to avoid pain positions or activities that increase pain. When the pain occur self stretching of hip flexors on the couch or the chair must be done
DRUG	Medical treatment.	A medical doctor will prescribe the treatment following the standard of care in Polish public health services. Treatment will consist of medication and counseling.

Timeline

• Start date: 2025-07-02
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2025-05-16
• Last updated: 2025-05-16

Locations

1 site across 1 country: Poland