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

NCT ID: NCT06975345

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-02
• Study Completion Date: 2027-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study 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.

Group Type: EXPERIMENTAL

Multicomponent intervention. Hip flexors stretching, Strengthening exercises and education and medical treatment (Medication and medical counselling)

Intervention Type: OTHER

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

Medical treatment.

Intervention Type: DRUG

A medical doctor will prescribe the treatment following the standard of care in Polish public health services. Treatment will consist of medication and counseling.

Control group

Participants will receive only the standard of care in the Polish public health services prescribed by a medicine doctor.

Group Type: ACTIVE_COMPARATOR

Medical treatment.

Intervention Type: DRUG

A medical doctor will prescribe the treatment following the standard of care in Polish public health services. Treatment will consist of medication and counseling.

Interventions

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

Intervention Type: OTHER

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age 18-75 years
• Medical diagnosis of chronic, mechanical, non-specific pain in the lumbar spine (M54, M51) - chronic low back pain.
• Obtaining written consent to conduct research
• Must be able to swallow tablets

Exclusion Criteria

• Pregnancy
• Pacemaker
• Active cancer
• To consent to conduct research
• Difficulty communicating
• The presence of a metal plate in the head and metal screws in the body
• Condition after operations in the area of the lumbar spine
• Condition after fractures in the lumbar spine
• Contraindications to manual therapy or exercise
• Has participated in a lumbar spine exercise or manual therapy program in the last three months
• Present clear signs of having suffered a significant lumbar injury
• Inability to maintain standing or a supine or prone position
• No possibility to perform the stretching of hip flexors

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad de Zaragoza

OTHER

Sponsor Role: collaborator

Universitat Internacional de Catalunya

OTHER

Sponsor Role: collaborator

Wroclaw University of Health and Sport Sciences

OTHER

Sponsor Role: lead

Responsible Party

Aleksander Kucza

MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Rehasport Wroclaw

Wroclaw, Lower Silesian Voivodeship, Poland

Countries

Poland

Central Contacts

Aleksander Kucza

Role: CONTACT

Facility Contacts

Agnieszka Chwałczyńska, dr hab.

Role: primary

agnieszka.chwalczynska@awf.wroc.pl

0048601204500

Aleksander Kucza, master

Role: backup

alekkucza@gmail.com

0048607337612

Other Identifiers

AWFWroclawUNIZAR.PhDAlek

Identifier Type: -

Identifier Source: org_study_id