PainNCT06310096
Role of Thoracolumbar Fascia Stretching on Pain Parameters With Non-Specific Chronic Low Back Pain
A study testing TLF fascial stretching exercise and conventional physiotherapy program. in people with Pain and Low Back Pain, run by Atılım University at 1 site in Turkey (Türkiye).
Trial summary
Role of Thoracolumbar Fascia Stretching on Pain Parameters with Non-Specific Chronic Low Back Pain Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Low Back Pain
- What is being tested?
- TLF fascial stretching exercise and conventional physiotherapy program.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 11 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- -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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Atılım University
Ankara
Naime Uluğ, PhD., +905365434409, naime.ulug@atilim.edu.tr
About this study
Role of Thoracolumbar Fascia Stretching on Pain Parameters with Non-Specific Chronic Low Back Pain
Read the 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).
- Conditions
- Pain, Low Back Pain
- Being tested
- TLF fascial stretching exercise, conventional physiotherapy program.
- Keywords
- thoracolumbar fascia, stretching, pain threshold, temporal summation, low back pain.
- Medical subject headings
- Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLF fascial stretching exerciseOther
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.Other
hotpack, ultrasound ,Tens
| Study group | Role | What they receive |
|---|---|---|
| TLF fascial stretching exercise | Active comparator | 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 Receives: Other: TLF fascial stretching exercise |
| conventional physiotherapy program | Active comparator | 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. Receives: Other: conventional physiotherapy program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain threshold
Pain threshold levels were analysed with algometer.
Measured: 12 weeks
Temporal summation
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.
Measured: 12 weeks
NRS(Numerical rating scales)
We used a 10-point numerical rating scale (NRS) to assess the patient's current pain.
Measured: 12 weeks
Secondary outcomes (2)
Pain Sensitivity Scale (PSS)
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.
Measured: 12 weeks
Brief Pain Inventory (BPI)
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start1 Jan 2024
- Primary completion15 Aug 2024 (estimated)
- Study completion11 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atılım University
- Sponsor type
- University, hospital or other
- Collaborators
- Kirsehir Ahi Evran Universitesi
- Responsible party
- Principal investigator, NAİME ULUG, Atılım University
- Investigators
- Naime Uluğ, PhD., Principal investigator, ATILIM UNİVERSİTY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06310096
- Sponsor's protocol ID
- E-59394181-604.01-79277
- Status last verified
- Jul 2024
- First submitted
- 6 Feb 2024
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Thoracolumbar Fascia Stretching on Pain Parameters With Non-Specific Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT06310096
- Acronym / sponsor ID
- E-59394181-604.01-79277
- Conditions
- Pain, Low Back Pain
- Keywords
- thoracolumbar fascia, stretching, pain threshold, temporal summation, low back pain.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Atılım UniversityUniversity, hospital or other
- Collaborators
- Kirsehir Ahi Evran Universitesi
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 15 Aug 2024 (estimated)
- Study completion
- 11 Sep 2024 (estimated)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TLF fascial stretching exercise | Active comparator | Other: TLF fascial stretching exerciseThe 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 |
| conventional physiotherapy program | Active comparator | Other: 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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- -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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TLF fascial stretching exerciseRelaxed 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 | Other | TLF fascial stretching exercise |
| conventional physiotherapy program.hotpack, ultrasound ,Tens | Other | conventional physiotherapy program |
Primary outcome
Pain threshold
Time frame: 12 weeks
Pain threshold levels were analysed with algometer.
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.
NRS(Numerical rating scales)
Time frame: 12 weeks
We used a 10-point numerical rating scale (NRS) to assess the patient's current pain.
2 secondary outcomes
Pain Sensitivity Scale (PSS)
Time frame: 12 weeks
Brief Pain Inventory (BPI)
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naime Uluğ, PhD. principal investigator
ATILIM UNİVERSİTY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TLF fascial stretching exercise and conventional physiotherapy program. in people with Pain and Low Back Pain, run by Atılım University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Naime Uluğ, PhD. (+90 (312) 586 6110, naime.ulug@atilim.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain threshold (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.