Clinical trial NCT06310096: Role of Thoracolumbar Fascia Stretching on Pain Parameters With Non-Specific Chronic Low Back Pain
Official title: Role of Thoracolumbar Fascia Stretching on Pain Parameters With Non-Specific Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain
Low Back Pain
Keywords: thoracolumbar fascia
stretching
pain threshold
temporal summation
low back pain.
Lead sponsor: Atılım University
Sponsor class: OTHER
Collaborators: name: Kirsehir Ahi Evran Universitesi
First posted: 2024-03-15
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Detailed description: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Pain threshold
timeFrame: 12 weeks
measure: Temporal summation
timeFrame: 12 weeks
measure: NRS(Numerical rating scales)
timeFrame: 12 weeks
Secondary outcomes:
measure: Pain Sensitivity Scale (PSS)
timeFrame: 12 weeks
measure: Brief Pain Inventory (BPI)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Atılım University
Study officials:
affiliation: ATILIM UNİVERSİTY
name: Naime Uluğ, PhD.
role: PRINCIPAL_INVESTIGATOR
References: