Yoga for Chronic Low Back Pain
Yoga for Chronic Low Back Pain in a Predominantly Minority Population: A Pilot Randomized Controlled Trial
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Undersøgelsestype
Tilmelding (Faktiske)
Tilmelding
Fase
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
Massachusetts
-
Dorchester, Massachusetts, Forenede Stater, 02124
- Codman Square Health Center
-
Dorchester, Massachusetts, Forenede Stater, 02122
- Dorchester Multi-Service Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 18-64 years old. The rationale for including adults only less than 65 years old is that the causes of low back pain in older persons are more likely to be multifactorial (e.g., degenerative disk disease, spinal canal stenosis, fractures) and less likely to be the non-specific muscular type that our yoga protocol was designed to address. A study of yoga for low back pain in individuals > 65 years old is important. However, the ideal design would likely benefit from a yoga protocol specifically designed for this purpose.
- Current non-specific low back pain lasting at least 12 weeks. Non-specific refers to predominantly muscular and ligamentous causes for the low back pain, and the absence of clear symptoms and signs of other causes of low back pain (e.g., herniated disk). This will be ascertained during the eligibility screening process using the Eligibility Screening Instrument (see Sect. S). This instrument was adapted from eligibility screening tools used in multiple published trials of CAM therapies for chronic low back pain by Karen Sherman PhD and Daniel Cherkin PhD. The instrument uses subject self-report to exclude specific causes of chronic low back pain that are exclusion criteria for the study.
- Average pain intensity during the week prior to enrollment is 4 or greater on a 0 to 10 numerical pain scale (0=no pain, 10=worst possible pain).
- Compliant with filling out a 2 week daily pain score dairy during the eligibility screening processes.
- Ability to comprehend, read, and write English at a level necessary to understand the yoga class instructions and complete data collection forms. Given that this is the first pilot for the yoga protocol and the first trial of yoga for low back pain for predominantly minority adults at BMC and affiliated clinics, we have decided to enhance feasibility by focusing on English speakers first. Our goal is ultimately to study and offer this intervention in other languages commonly spoken by BMC patients (e.g., Spanish). We fully anticipate that this trial will provide the necessary experience to return to the IRB in the near future with a proposal for a pilot trial of Spanish speakers with chronic low back pain.
- Individuals with sufficient English language ability from all ethnic groups can enroll. However, since this pilot study is specifically targeting minorities with chronic low back pain, we will purposefully allocate 80% (24 of 30) of the openings in the study to minority subjects (ascertained by self-report).
- Consent to participate.
Exclusion Criteria:
- Age > 64 years old.
- Yoga use in the previous 12 months.
- Inability to understand English at a level necessary to follow yoga class instructions.
- Pregnancy - although back pain in pregnancy is common and may be amenable to yoga, the causes of the pain are likely different than non specific chronic low back pain in nonpregnant adults.
- Change in pain medications four weeks or fewer prior to enrollment.
- Other back pain treatments (e.g., physical therapy, epidural steroid injection, chiropractic, acupuncture) anticipated to begin in the next 6 months or initiated less than four weeks prior to enrollment.
- Ongoing or planned litigation related to back pain. Ongoing or planned workers' compensation, disability, or personal injury claims related to back pain. Litigation or claims that have been resolved or settled are not exclusion criteria.
- Back pain by self-report due to specific non-muscular pathologies (e.g., infection, malignancy, fracture); severe or progressive neurological deficits; active substance or alcohol abuse; serious underlying systemic or co-morbid disease that precludes physical or cognitive ability to perform the yoga protocol (see Inclusion Criteria #2 above).
- Suicidal thoughts detected through the eligibility interview. Those who report suicidal thoughts will immediately be referred to their PCP and/or the BMC Department of Psychiatry.
- Lack of consent to participate.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: Yoga Group
A standardized hatha yoga protocol delivered in 12 weekly classes.
|
Reproducible standardized 12 week series of hatha yoga classes specifically developed for patients with chronic low back pain and little or no experience with yoga
Andre navne:
|
|
Ingen indgriben: Usual care
Participants continue to receive their usual medical care for their back pain
|
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Pain intensity
Tidsramme: Previous 7 days
|
Previous 7 days
|
|
Back related function (Modified Roland Morris Disability Scale)
Tidsramme: previous 7 days
|
previous 7 days
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Uønskede hændelser
Tidsramme: 12 uger
|
12 uger
|
|
Pain medication use
Tidsramme: previous 7 days
|
previous 7 days
|
|
Global improvement
Tidsramme: previous 12 weeks
|
previous 12 weeks
|
|
Health Related Quality of Life (SF-36)
Tidsramme: previous 7 days
|
previous 7 days
|
Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Efterforskere
Efterforskere
- Ledende efterforsker: Robert B Saper, MD MPH, Boston Medical Center
Datoer for undersøgelser
Studer store datoer
Studiestart
Studiestart
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
Studieafslutning (Faktiske)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- AT002915
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 .