- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05173948
The Effectiveness of Kinesio Taping in Patients With Chronic Low Back Pain
29. december 2021 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret 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
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
40
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
North West
-
Tabuk, North West, Saudi Arabien, 71491
- University of Tabuk
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 60 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Han
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
|
Eksperimentel: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
15. juni 2019
Primær færdiggørelse (Faktiske)
30. juni 2020
Studieafslutning (Faktiske)
30. august 2020
Datoer for studieregistrering
Først indsendt
23. november 2021
Først indsendt, der opfyldte QC-kriterier
29. december 2021
Først opslået (Faktiske)
30. december 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
30. december 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. december 2021
Sidst verificeret
1. december 2021
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- UT-79-11-2019
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .