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

NCT06975345 | Not Yet Recruiting

• 1 other identifier: AWFWroclawUNIZAR.PhDAlek
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Musculoskeletal Manipulations; Low Back Pain, Mechanical

Keywords

manual therapy,; spine,; low back pain,; Chronic Low Back Pain,; Muscle Stretching Exercises,; Range of Motion, Articular,; Body composition,; Numeric Pain Rating Scale (NPRS)

Outcome Measures

Primary Outcomes (1)

• Numeric Pain Rating Scale (NPRS)

  Numeric Pain Rating Scale (NPRS) The NPRS will be used to ask the patient about the level of pain that he/she feels considering from 0 to 10, where 0 represents the absence of pain and 10 represents the most intense pain, used to measure the pain experienced by the patient. The participant will answer the NPRS, responding to the average, maximum and minimum pain experienced throughout its duration.

  Baseline, to complete the treatments, on average 2 weeks, 1, 3 and 12 months after the end of treatment

Secondary Outcomes (10)

• Lumbar Range of Motion

  Baseline, to complete the treatments, on average 2 weeks, 1 month after the end of treatment.

• ROM in Thomas test

  Baseline,to complete the treatments, on average 2 weeks, 1 month after the end of treatment

• Clinical Measure of extension.

  Baseline, to complete the treatments, on average 2 weeks, 1 month after the end of treatment.

• Anatomical distribution of pain

  Baseline, to complete the treatments, on average 2 weeks, 1, 3 and 12 months after the end of treatment

• ROM in Straight Leg Raise Test

  Baseline, to complete the treatments, on average 2 weeks, 1 month after the end of treatment.

Study Arms (2)

Experimental group

EXPERIMENTAL

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.

Other: Multicomponent intervention. Hip flexors stretching, Strengthening exercises and education and medical treatment (Medication and medical counselling); Drug: Medical treatment.

Control group

ACTIVE COMPARATOR

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

Drug: Medical treatment.

Interventions

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

Experimental group

Medical treatment. 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; Experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wroclaw University of Health and Sport Sciences: lead
• Universidad de Zaragoza: collaborator
• Universitat Internacional de Catalunya: collaborator

Study Sites (1)

Rehasport Wroclaw

Wroclaw, Lower Silesian Voivodeship, 54-615, Poland

Location

MeSH Terms

Conditions

Pain; Low Back Pain

Interventions

Educational Status; Dosage Forms

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Back Pain

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Central Study Contacts

Aleksander Kucza

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 16, 2025
• Study Start: July 2, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 16, 2025

Record last verified: 2025-04

Locations

PL (1)