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

March 12, 2024 updated by: NAİME ULUG, Atılım University
Role of Thoracolumbar Fascia Stretching on Pain Parameters with Non-Specific Chronic Low Back Pain

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Other: 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
Active Comparator: 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.
Other: conventional physiotherapy program.
hotpack, ultrasound ,Tens

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain threshold
Time Frame: 12 weeks
Pain threshold levels were analysed with algometer.
12 weeks
Temporal summation
Time Frame: 12 weeks

With a cotton-tipped applicator, the points T12, L1 and L3 were tapped with a frequency of 1 cm/second. This is usually the site of cutaneous allodynia and trigger points. Three strokes were given at a predetermined interval. After each tap, patients were asked to rate the level of pain caused by the cotton-tipped applicator on a scale from 1 to 10.

The primary outcome was pain level, which was scored from 1 to 10. Patients gave their responses verbally and these responses were recorded by the researcher.
12 weeks
NRS(Numerical rating scales)
Time Frame: 12 weeks
We used a 10-point numerical rating scale (NRS) to assess the patient's current pain.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Sensitivity Scale (PSS)
Time Frame: 12 weeks
In the questionnaire consisting of 17 questions, the patient's sensitivity to pain is measured with the pain sensitivity questionnaire. In the questionnaire with a 10-point Likert scale, the patient rates the pain experienced according to the questions asked.
12 weeks
Brief Pain Inventory (BPI)
Time Frame: 12 weeks
The Brief Pain Inventory (BPI) scale is used to measure the effects of pain on activity, mood, walking, human relationships, sleep and enjoyment of life. It is graded on a 10-point Likert scale, with an increase in the total score indicating the negative effect of pain on the parameters.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Atılım University

Collaborators

Kirsehir Ahi Evran Universitesi

Investigators

  • Principal Investigator: Naime Uluğ, PhD., Atilim University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

March 11, 2024

Study Completion (Estimated)

March 11, 2024

Study Registration Dates

First Submitted

February 6, 2024

First Submitted That Met QC Criteria

March 12, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-59394181-604.01-79277

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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