- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00865358
Yoga for Chronic Low Back Pain
4 december 2012 uppdaterad av: Boston Medical Center
Yoga for Chronic Low Back Pain in a Predominantly Minority Population: A Pilot Randomized Controlled Trial
Chronic low back pain is the most common cause of pain in the United States.
Common treatments such as medication, physical therapy, and surgery often do not provide adequate relief.
Yoga has shown promise for improving low back pain in studies of predominantly middle class white individuals.
We will assess the feasibility and collect preliminary data on yoga for chronic low back pain in predominantly minority individuals in a community health center setting in a low income neighborhood of Boston, Massachusetts.
We hypothesize that offering yoga for this population is feasible and will show promising efficacy and safety data.
Studieöversikt
Detaljerad beskrivning
Promising therapies for chronic low back pain such as yoga need to be studied because conventional treatments such as medication, physical therapy, and surgery frequently do not provide lasting relief.
We will use a standardized yoga protocol, developed specifically for this trial by a consensus panel of yoga experts, in a pilot randomized controlled trial for subjects with chronic low back pain.
We will recruit 30 predominantly English-speaking minority adults from Boston Medical Center (BMC) and its affiliated clinics with low back pain lasting >12 weeks and an average pain level in the previous week of 4 or more on a scale of 0 to 10 (0 = no pain, 10 = worst possible pain).
Subjects will be randomized to a yoga class once per week for 12 weeks (Group 1) or a wait-list control group (Group 2).
All subjects will receive their usual medical care and an educational booklet designed for low back pain patients.
Primary outcomes are 12 week pain intensity and functional status measured by the Roland Morris Disability scale.
Secondary outcomes include analgesic use, health-related quality of life (SF-36), global improvement, subject satisfaction, adverse events, compliance, work status, and health expenditures.
Group 2 will be offered yoga classes at 26 weeks.
To refine estimates of effect size and further confirm safety of the protocol, we will also collect data from Group 2 during their yoga classes.
This pilot will provide preliminary feasibility and efficacy data to plan a future adequately powered randomized controlled trial of yoga for chronic low back pain in predominantly minority subjects.
Studietyp
Interventionell
Inskrivning (Faktisk)
30
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Massachusetts
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Dorchester, Massachusetts, Förenta staterna, 02124
- Codman Square Health Center
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Dorchester, Massachusetts, Förenta staterna, 02122
- Dorchester Multi-Service Center
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 64 år (Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: Yoga Group
A standardized hatha yoga protocol delivered in 12 weekly classes.
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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
Andra namn:
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Inget ingripande: Usual care
Participants continue to receive their usual medical care for their back pain
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
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Pain intensity
Tidsram: Previous 7 days
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Previous 7 days
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Back related function (Modified Roland Morris Disability Scale)
Tidsram: previous 7 days
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previous 7 days
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Biverkningar
Tidsram: 12 veckor
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12 veckor
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Pain medication use
Tidsram: previous 7 days
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previous 7 days
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Global improvement
Tidsram: previous 12 weeks
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previous 12 weeks
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Health Related Quality of Life (SF-36)
Tidsram: previous 7 days
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previous 7 days
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Robert B Saper, MD MPH, Boston Medical Center
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 februari 2007
Primärt slutförande (Faktisk)
1 juli 2007
Avslutad studie (Faktisk)
1 januari 2008
Studieregistreringsdatum
Först inskickad
27 februari 2009
Först inskickad som uppfyllde QC-kriterierna
18 mars 2009
Första postat (Uppskatta)
19 mars 2009
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
5 december 2012
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
4 december 2012
Senast verifierad
1 december 2012
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- AT002915
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