- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05173948
The Effectiveness of Kinesio Taping in Patients With Chronic Low Back Pain
29. desember 2021 oppdatert av: Shahul Hameed Pakkir Mohamed, University of Tabuk
Effectiveness of Kinesio Taping and Conventional Physical Therapy in the Management of Chronic Low Back Pain
The objective of this study is to determine the effectiveness of Kinesio taping (KT) with Conventional Physical therapy (CPT) - Transcutaneous Electrical Nerve Stimulation (TENS) and Supervised Exercise therapy and CPT in the management of CLBP.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Chronic low back pain (CLBP) is one of the most common causes of chronic disability which leads to major social and economic consequences.
The role and effectiveness of the Kinesio taping (KT) and Conventional Physical therapy (CPT) are evident from the existing literature but no comparison was found on the combination of other physical therapy techniques such as supervised exercise therapy and Transcutaneous Electrical Nerve Stimulation (TENS) with CLBP in the Kingdom of Saudi Arabia
Studietype
Intervensjonell
Registrering (Faktiske)
40
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
North West
-
Tabuk, North West, Saudi-Arabia, 71491
- University of Tabuk
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 60 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Mann
Beskrivelse
Inclusion Criteria:
- Pain caused by mechanical/nonspecific low back pain.
- Degeneration of the spine and intervertebral disc.
- The visual analog scale of pain 4 and above
- Low back pain for at least three months
Exclusion Criteria:
- Physical therapy treatment is taken in the past 6 months period
- Previous spinal surgery with fixation
- Structural anomalies
- Spinal cord compression
- Severe osteoporosis
- Acute infections
- Severe cardiovascular or metabolic diseases
- Pregnant women
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Kinesio taping and Conventional Physical therapy
Kinesio taping with Transcutaneous Electrical Nerve Stimulation and Supervised Exercise therapy
|
Kinesio taping: The tape is measured from the sacrum to the 12th thoracic vertebra with forwarding flexion of the trunk.
The base is affixed to the insertion in the resting position.
The muscle is elongated and the base anchored with skin displacement.
The tape is then affixed with 10% stretch paravertebrally over the muscle bundles up to T12.
The tape is rubbed with the muscle in the elongated state.
Transcutaneous electrical nerve stimulation device settings, such as the frequency of 80 Hz, the pulse width of 100 µs, and symmetrical biphasic waveform.
Four mediums sized (2 × 2 cm) carbon-impregnated rubber cutaneous electrodes were placed bilaterally in a standard dermatomal pattern over the most painful lumbar region.
The current intensity was increased up to the patient's perception of paraesthesia.
The supervised exercise therapy management consisted of stretching exercises for the back, iliopsoas, gluteal and hamstring muscles, and strengthening exercises for the abdominal and back muscles.
Three sets of stretching exercises, each involving a 30-sec hold and 30-sec of rest repeated three times, were performed in three sessions per week over four weeks.
One set of strengthening exercises, consisting of 10 repetitions with a 5-sec hold, was performed in three sessions per week over four weeks.
|
|
Eksperimentell: Conventional Physical therapy
Transcutaneous Electrical Nerve Stimulation and Supervised Exercise therapy
|
Transcutaneous electrical nerve stimulation device settings, such as the frequency of 80 Hz, the pulse width of 100 µs, and symmetrical biphasic waveform.
Four mediums sized (2 × 2 cm) carbon-impregnated rubber cutaneous electrodes were placed bilaterally in a standard dermatomal pattern over the most painful lumbar region.
The current intensity was increased up to the patient's perception of paraesthesia.
The supervised exercise therapy management consisted of stretching exercises for the back, iliopsoas, gluteal and hamstring muscles, and strengthening exercises for the abdominal and back muscles.
Three sets of stretching exercises, each involving a 30-sec hold and 30-sec of rest repeated three times, were performed in three sessions per week over four weeks.
One set of strengthening exercises, consisting of 10 repetitions with a 5-sec hold, was performed in three sessions per week over four weeks.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Numerical Pain Rating Scale
Tidsramme: Six weeks
|
Pain, for the Average pain intensity over the last week was measured on a numerical pain rating scale, where 0 represented no pain and 10 represented the worst pain possible
|
Six weeks
|
|
Modified Oswestry low back pain disability questionnaire
Tidsramme: Six weeks
|
Disability were measured using the Modified Oswestry Disability Index (MODI) which is a self-rating questionnaire used to evaluate functional physical disability
|
Six weeks
|
|
Lumbar range of motion-Modified Schober test
Tidsramme: Six weeks
|
Lumbar flexion range of motion were measured by using modified Schober method
|
Six weeks
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
15. juni 2019
Primær fullføring (Faktiske)
30. juni 2020
Studiet fullført (Faktiske)
30. august 2020
Datoer for studieregistrering
Først innsendt
23. november 2021
Først innsendt som oppfylte QC-kriteriene
29. desember 2021
Først lagt ut (Faktiske)
30. desember 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
30. desember 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
29. desember 2021
Sist bekreftet
1. desember 2021
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- UT-79-11-2019
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .