Role of Thoracolumbar Fascia Stretching on Pain Parameters With Non-Specific Chronic Low Back Pain

NCT ID: NCT06310096

Last Updated: 2024-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-09-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Role of Thoracolumbar Fascia Stretching on Pain Parameters with Non-Specific Chronic Low Back Pain

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

These findings demonstrate the significant impact of chronic pain on connective tissue health and highlight the importance of addressing this issue in the management of CLBP.

Chronic pain contributes to the persistence of chronic local connective tissue inflammation, resulting in fibrosis, connective tissue adhesions, and decreased mobility of the thoracolumbar fascia (TLF) in patients with chronic low back pain (CLBP).

Furthermore, an increase in TLF thickness, possibly due to structural changes in the connective tissue, is associated with pain severity.

Stretching the fascia is a crucial aspect of manual and movement therapies. The results of this study provide evidence for the effectiveness of TLF stretching in reducing pain and improving pain sensitivity in CLBP patients.

The language used was clear, objective, and value-neutral, avoiding biased, emotional, figurative, or ornamental language.

This study aimed to investigate the effect of TLF stretching on pain characteristics, including pain intensity, pressure pain threshold (PPT), temporal summation, pain sensitivity, and the impact of pain on activity in CLBP patients.

The study design was a randomized controlled trial and cross-sectional study.

Passive tone and impersonal construction were employed, and first-person perspectives were avoided unless necessary. High-level, standard language with consistent technical terms was used, and common sentence structure was adhered to.

The study was conducted from November 2023 to January 2024 and involved 30 participants with nonspecific chronic low back pain, aged 20-60 years, who were randomly assigned to either the study group (n=15; 7 men, 8 women) or the control group (n=15; 7 men, 8 women).

The study group received a 4-week TLF fascial stretching exercise (10 times per day) in addition to the conventional physiotherapy program, while the control group only received the conventional physiotherapy program. The study measured pain intensity using a 10-point numerical rating scale (NRS), pressure pain threshold (PPT), and temporal summation by an algometer (from TLF levels of lumbar 1 and 3 vertebrae (L1, L3) and 12th costa) as primary outcomes. Secondary outcomes comprised pain sensitivity assessed by the Pain Sensitivity Scale (PSS) and the effects of pain on activity measured by the Brief Pain Inventory (BPI).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain Low Back Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TLF fascial stretching exercise

The study group received a 4-week TLF fascial stretching exercise (10 times per day) in addition to the conventional physiotherapy program, while the control group only received a conventional physiotherapy program

Group Type ACTIVE_COMPARATOR

TLF fascial stretching exercise

Intervention Type OTHER

Relaxed lumbo-pelvic upright sitting with arms in neutral anatomical position (O'Sullivan et al., 2006). The subjects had to bend both knee flexed 90. The feet of the Participant lied flat on the ground. Trunk was in aligned position and the angle between upper body and lower body was 90. Seated position led to caudal tensioning of the pTLF via stretching of the gluteus maximus (GM)

Seated position with passive arms elevation Seated position with passive caudal stretching of TLF through thigh elevation. The subjects had to bend both hips while keeping their feet onto a stool (30 cm high) so to pull the GM and the TLF

conventional physiotherapy program

The study group received a 4-week TLF fascial stretching exercise (10 times per day) in addition to the conventional physiotherapy program, while the control group only received a conventional physiotherapy program.

Group Type ACTIVE_COMPARATOR

conventional physiotherapy program.

Intervention Type OTHER

hotpack, ultrasound ,Tens

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TLF fascial stretching exercise

Relaxed lumbo-pelvic upright sitting with arms in neutral anatomical position (O'Sullivan et al., 2006). The subjects had to bend both knee flexed 90. The feet of the Participant lied flat on the ground. Trunk was in aligned position and the angle between upper body and lower body was 90. Seated position led to caudal tensioning of the pTLF via stretching of the gluteus maximus (GM)

Seated position with passive arms elevation Seated position with passive caudal stretching of TLF through thigh elevation. The subjects had to bend both hips while keeping their feet onto a stool (30 cm high) so to pull the GM and the TLF

Intervention Type OTHER

conventional physiotherapy program.

hotpack, ultrasound ,Tens

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Those who are between the ages of 20-60 and agree to participate in the research,
* Those who have lower back pain for at least 3 months,
* Individuals who have no perception problems and can cooperate well,
* Individuals who attend regular checks and evaluations of the physiotherapy program.

Exclusion Criteria

* -Those who have had spinal surgery,
* Those who complain of low back pain due to inflammatory, tumoral, metabolic reasons,
* Orthopedic obstacles to treatment (pes planus, genu varum, genu valgum, scoliosis, etc.) or Those with neurological problems (Multiple Sclerosis, Stroke, etc.),
* Those who have had spine or lower extremity surgery,
* Those who have another musculoskeletal disorder affecting the lower extremity,
* They are pregnant.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kirsehir Ahi Evran Universitesi

OTHER

Sponsor Role collaborator

Atılım University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

NAİME ULUG

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Naime Uluğ, PhD.

Role: PRINCIPAL_INVESTIGATOR

ATILIM UNİVERSİTY

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Atılım University

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Naime Uluğ, PhD.

Role: CONTACT

+90 (312) 586 6110

seyde kodak, MSc

Role: CONTACT

+905511607016

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Naime Uluğ, PhD.

Role: primary

+905365434409

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

E-59394181-604.01-79277

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Non-Specific Chronic Low Back Pain Treatment Methods
NCT07057687 ACTIVE_NOT_RECRUITING NA