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Strengthening Exercise and Activities of Daily Living Instructions for Patients With Lumbar Disc Herniation

24. august 2021 oppdatert av: MD Imam Shahriar, Chittagong Medical College

Effectiveness of Strengthening Exercise Plus Activities of Daily Living Instructions in Reducing Pain in Patients With Lumbar Disc Herniation

Lumbar disc herniation (LDH) is one of the most common causes of mechanical low back pain (LBP) associated with radiating leg pain. Conservative treatment, including exercise, analgesic, and physical therapy, is regarded as the first-line treatment of LDH.

This randomized clinical trial was conducted to evaluate the effectiveness of back and hip strengthening exercises combined with activities of daily living instructions (ADLIs) to reduce pain intensity in patients with LDH.

Studieoversikt

Detaljert beskrivelse

A total of 70 patients with LDH were randomly allocated to either the intervention group (IG) or the control group (CG). Patients in IG received different back and hip strengthening exercises five days a week for six weeks. The patients in CG were treated with Naproxen (500 mg) and Baclofen (10 mg) tablet twice a day for three weeks, followed by hot moist compression for the next three weeks. In addition, the patients in both groups were instructed to follow the ADLIs during the intervention and at least 3 months after the intervention.

The straight leg raising (SLR) test and the Visual Analogue Scale (VAS) score were used to evaluate the patients' pain intensity. Outcomes were measured at baseline, at three weeks, and six weeks of the intervention. Patients were followed up after 3 months of the intervention.

Studietype

Intervensjonell

Registrering (Faktiske)

70

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Chittagong, Bangladesh
        • Chittagong medical College hospital

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 59 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Age: 18 - 59 years.
  • Clinically diagnosed LDH that was confirmed by MRI.
  • Duration of the pain: ≥ 3 months

Exclusion Criteria:

  • Painful spinal deformity
  • Cauda equina syndrome
  • Progressive neurological signs and/or muscle-wasting
  • History of spinal surgery, spine fracture, scoliosis, tuberculosis, and tumours.
  • Treated with epidural injections.
  • Pregnancy

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: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Intervention group (IG)
A total of 35 patients in IG received different back and hip strengthening exercises five times a week for six weeks. They were also instructed to follow the ADLIs to perform different tasks at home and in workplaces during the intervention and at least 3 months after the intervention.
Back and hip strengthening exercises. The intensity of exercises was based on the exercise tolerance and pain thresholds of the individual subjects.
  • Avoid forward bending.
  • Avoid heavy weightlifting.
  • Avoid prolong standing.
  • Avoid prolong sitting.
  • Use a plain firm bed.
  • Lie down in a supine position.
Aktiv komparator: Control group (CG)
The remaining 35 patients were allocated to CG. The patients in CG were treated with Naproxen (500 mg) and Baclofen (10 mg) tablet twice a day for three weeks, followed by hot moist compression for the next three weeks. Moreover, they were instructed to follow the ADLIs to perform different tasks at home and in workplaces during the intervention and at least 3 months after the intervention.
  • Avoid forward bending.
  • Avoid heavy weightlifting.
  • Avoid prolong standing.
  • Avoid prolong sitting.
  • Use a plain firm bed.
  • Lie down in a supine position.
Naproxen (500 mg) and Baclofen (10 mg) tablet twice a day for three weeks
Hot moist compression from week 4 to week 6.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Changes in perceived pain intensity
Tidsramme: Outcomes were evaluated at baseline, at three weeks, and six weeks of the intervention. Patients were followed up after 3 months of the intervention.
Visual analog scale (VAS) score: Patients were asked to rate their perceived pain on a 0-to-10-point scale, where 0 indicated no pain at all and 10 indicated the most severe imaginable pain.
Outcomes were evaluated at baseline, at three weeks, and six weeks of the intervention. Patients were followed up after 3 months of the intervention.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Changes in the range of hip flexion during straight leg raising test
Tidsramme: Outcomes were evaluated at baseline, at three weeks, and six weeks of the intervention. Patients were followed up after 3 months of the intervention.
The range of hip flexion during affected and unaffected straight leg raising without pain was measured by hand-held goniometry.
Outcomes were evaluated at baseline, at three weeks, and six weeks of the intervention. Patients were followed up after 3 months of the intervention.

Samarbeidspartnere og etterforskere

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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)

1. juli 2018

Primær fullføring (Faktiske)

15. september 2019

Studiet fullført (Faktiske)

30. september 2019

Datoer for studieregistrering

Først innsendt

22. august 2021

Først innsendt som oppfylte QC-kriteriene

24. august 2021

Først lagt ut (Faktiske)

25. august 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

25. august 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. august 2021

Sist bekreftet

1. august 2021

Mer informasjon

Begreper knyttet til denne studien

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

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