- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07915817
Effects of Myofascial Techniques on Chronic Low Back Pain
Myofascial Approaches in Chronic Low Back Pain: Effects of Local Application and Superficial Back Line Techniques on Clinical Outcomes
Participants with chronic low back pain will be randomly allocated to three groups: conservative treatment, conservative treatment plus local myofascial release, or conservative treatment plus superficial back line myofascial release. All groups will receive treatment three times weekly for six weeks. The conservative treatment program will include stretching, strengthening, and postural exercises. Myofascial release will be performed using a roller bar, with controlled rhythmic pressure applied for 30-60 seconds per region, totaling 10-15 minutes per session, according to individual tolerance. Age, height, weight, and body mass index will be recorded. Outcomes will include pain intensity (Visual Analog Scale), pressure pain threshold (digital algometer), range of motion (goniometer), static and dynamic balance (Biodex Balance System), and functional disability (Oswestry Disability Index). All outcomes will be assessed before and after the intervention.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Chronic low back pain is a common musculoskeletal condition that can negatively affect physical function, postural control, mobility, and quality of life. In addition to conventional exercise-based interventions, myofascial release techniques have been used to address soft tissue restrictions and improve musculoskeletal function. However, the effects of applying myofascial release locally to the lumbar region compared with applying it along the Superficial Back Line have not been sufficiently clarified in individuals with chronic low back pain.
The aim of this study is to investigate and compare the effects of local lumbar myofascial release and Superficial Back Line myofascial release, when combined with conservative treatment, on pain intensity, pressure pain threshold, lumbar range of motion, static and dynamic balance, and functional disability in individuals with chronic low back pain.
Participants diagnosed with chronic low back pain will be randomly allocated to one of three intervention groups: (1) conservative treatment alone, (2) conservative treatment combined with local lumbar myofascial release, and (3) conservative treatment combined with myofascial release applied along the Superficial Back Line. All interventions will be administered three times per week for six consecutive weeks, resulting in a total of 18 treatment sessions.
The conservative treatment program will be applied to all three groups and will consist of stretching, strengthening, and postural exercises designed to address the physical limitations associated with chronic low back pain. Participants in the second group will additionally receive local myofascial release targeting the lumbar region. Participants in the third group will receive myofascial release along the Superficial Back Line, targeting the posterior myofascial structures according to the intervention protocol.
Myofascial release will be performed using a roller bar. Controlled and rhythmic pressure will be applied for approximately 60 seconds per treatment region. The total duration of the myofascial release application will be approximately 10-15 minutes per session, depending on the treatment protocol and individual participant tolerance.
Demographic and anthropometric characteristics, including age, height, and body weight, will be recorded, and body mass index will be calculated.
Clinical outcomes will be evaluated before and after the six-week intervention period. Pain intensity will be assessed using the Visual Analog Scale (VAS), while pressure pain threshold will be measured using a digital algometer. Lumbar range of motion will be evaluated using a goniometer. Static and dynamic balance will be assessed using the Biodex Balance System. Functional disability related to low back pain will be evaluated using the Oswestry Disability Index (ODI).
The changes in clinical outcomes within each group and the differences between the three intervention groups will be analyzed to determine whether adding local lumbar myofascial release or Superficial Back Line myofascial release to conservative treatment provides additional benefits. The study will also compare the effects of the two myofascial approaches to determine whether the location and extent of myofascial application influence clinical outcomes in individuals with chronic low back pain.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria
- Aged 18-65 years.
- Presence of mechanically induced low back pain.
- Willingness to participate in the study.
- No neurological, rheumatological, or advanced degenerative spinal pathology.
- No lumbar surgery within the previous three months.
- No history of serious systemic diseases, such as advanced cardiovascular, neurological, or metabolic disorders.
- Sufficient cognitive ability to understand and follow the treatment procedures. Exclusion Criteria
- Pregnancy.
- Active infection or malignancy.
- Severe osteoporosis.
- Spinal instability.
- History of lumbar surgery.
- Severe neurological deficits, such as substantial motor loss or progressive neurological symptoms.
- Ongoing intensive physical therapy or manual therapy.
- Psychiatric or cognitive disorders that may prevent participation in the study.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Sham-komparator: Conservative treatment
Patients attended treatment sessions specifically for low back pain, receiving conservative treatment as indicated. |
Patients attended treatment sessions specifically for low back pain, receiving conservative treatment as indicated. |
|
Eksperimentell: Local Myofascial Release
Myofascial release targeting only the lumbar region will be performed in addition to conservative treatment. |
Patients attended treatment sessions specifically for low back pain, receiving conservative treatment as indicated. Myofascial release targeting only the lumbar region will be performed in addition to conservative treatment. |
|
Eksperimentell: Superficial Back Line Myofascial Release
Myofascial release will be applied along the entire superficial back line in addition to conservative treatment. |
Patients attended treatment sessions specifically for low back pain, receiving conservative treatment as indicated. Myofascial release will be applied along the entire superficial back line in addition to conservative treatment. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Pain Intensity from Baseline to Week 6
Tidsramme: Baseline and Week 6
|
Pain intensity will be assessed using the Visual Analog Scale (VAS). Participants will rate their pain intensity on a 10-cm line, with 0 indicating no pain and 10 indicating the worst imaginable pain. The change in pain intensity from baseline to the end of the intervention will be evaluated. |
Baseline and Week 6
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Balance Performance from Baseline to Week 6
Tidsramme: Baseline and Week 6
|
Balance performance will be assessed using [Biodex Blance System]. Changes in balance performance from baseline to the end of the intervention will be evaluated. |
Baseline and Week 6
|
|
Change in Functional Disability from Baseline to Week 6
Tidsramme: Baseline and Week 6
|
Functional disability will be assessed using [Oswerty Disability Index]. Changes in functional disability scores from baseline to the end of the intervention will be evaluated. |
Baseline and Week 6
|
|
Change in Lumbar Range of Motion from Baseline to Week 6
Tidsramme: Baseline and Week 6
|
Lumbar range of motion will be assessed using [goniometer]. Changes in lumbar range of motion from baseline to the end of the intervention will be evaluated in degrees. |
Baseline and Week 6
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
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