NCT06310096

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 6, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 15, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2024

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2024

Completed
Last Updated

August 1, 2024

Status Verified

July 1, 2024

Enrollment Period

8 months

First QC Date

February 6, 2024

Last Update Submit

July 31, 2024

Conditions

Keywords

thoracolumbar fasciastretchingpain thresholdtemporal summationlow back pain.

Outcome Measures

Primary Outcomes (3)

  • Pain threshold

    Pain threshold levels were analysed with algometer.

    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.

    12 weeks

  • NRS(Numerical rating scales)

    We used a 10-point numerical rating scale (NRS) to assess the patient's current pain.

    12 weeks

Secondary Outcomes (2)

  • Pain Sensitivity Scale (PSS)

    12 weeks

  • Brief Pain Inventory (BPI)

    12 weeks

Study Arms (2)

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

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.

Other: conventional physiotherapy program.

Interventions

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

TLF fascial stretching exercise

hotpack, ultrasound ,Tens

conventional physiotherapy program

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atılım University

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

PainLow Back Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBack Pain

Study Officials

  • Naime Uluğ, PhD.

    ATILIM UNİVERSİTY

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

February 6, 2024

First Posted

March 15, 2024

Study Start

January 1, 2024

Primary Completion

August 15, 2024

Study Completion

September 11, 2024

Last Updated

August 1, 2024

Record last verified: 2024-07

Locations