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Investigating Medical Massage Therapy for Patients With Sub-Acute Lower Back Pain (Zeel LBP)

3. června 2026 aktualizováno: The Geneva Foundation

The goal of this clinical trial is to determine if a weekly regimen of Medical Massage Therapy (MMT) with provider-directed care shortens the duration of Medically Restricted Duty Days (MRDD) periods in Active-Duty Service Members with Subacute Lower Back Pain (LBP) compared to provider-directed care alone.

The main question the study aims to answer is, when used as an adjunct to provider-directed care, a consistent program of MMT provided by a qualified practitioner, will shorten the duration of MRDD periods, reduce pain, and decrease unnecessary healthcare utilization in patients with Subacute LBP compared to provider-directed care alone. Researchers will study this hypothesis through the comparison of Group #1 (provider-directed care alone) and Group #2 (provider-directed care and MMT).

Participants randomized into the two study groups will be following a 12-week study design (+/- 2 weeks) comprised of their compliance to their provider-directed care, the study intervention (if randomized to Group #2) and study case report forms (CRFs); with a final follow up visit (up to 4 weeks following their final treatment visit).

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

Musculoskeletal injuries (MSKI) affect approximately 800,000 service members (SMs) annually and result in 25 million days of limited duty. These conditions account for 34% of medical evacuations from theatre, and are the primary reasons for medical separation. Low back pain (LBP) is the leading cause of MSKI amongst active-duty service members (ADSMs) with a lifetime prevalence rate of up to 80%. The burden of disease for LBP is reaching $100 billion annually in the United States and new methods for prevention and treatment are necessary.

At the present time, there is no "gold standard" for LBP management and strong evidence as to what is most beneficial is lacking. One of the most promising medical options for LBP is massage therapy (MT), given that no special equipment is needed, it can be delivered anywhere, it is non-habit forming, and the likelihood for serious harm is low. Massage therapy is unique in that it can naturally enhance local blood flow, thereby providing vital oxygen and nutrients to areas damaged by MSKI to promote healing, offers relaxation and normalization of soft tissue which reduces pain, lessens swelling, clears local pain mediators, improves cognitive/psychosocial complications (e.g., depression, anxiety, etc.), aids in sleep quality, and provides a positive hormone release. To date, however, there has not been a large randomized control trial (RCT) performed on patients with subacute LBP to demonstrate healing and preventing patients from becoming chronically injured.

To address this limitation, we will enroll a total of 200 patients to assess the efficacy of medical massage therapy (MMT) combined with standard of care (SoC) in ADSMs with subacute LBP (intervention) as compared to SoC only (control). Five specific aims have been designed to understand if weekly MMT can reduce medically restricted duty days (MRDD) (Aim #1), decrease pain/disability and improve sleep quality (Aim #2), and lessen the need for prescription medications (Aim #3). Data will be aggregated at the end of the study through survey tools and self-reported information to understand the economic impact of (Aim #4) and to understand which patient phenotypes are optimal for future care (Aim #5).

Typ studie

Intervenční

Zápis (Odhadovaný)

220

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Inclusion Criteria:

  • Active-duty service member
  • 18-64 (inclusive) years of age
  • Medical evidence of subacute low back pain (as indicated by complications lasting 1-3 months)
  • Willingness to comply with treatment and follow-up schedule
  • Ability and willingness to provide written informed consent

Exclusion Criteria:

  • Current dx of any of the following:
  • Presence of significant comorbid pain (e.g., polytrauma)
  • Cancer - active/ongoing treatment for
  • Active Infections, including skin lesions and rashes
  • Flu or other severe cold virus or COVID
  • Severe depression or anxiety
  • Symptomatic Inflammatory/Autoimmune diseases such as Rheumatoid
  • Arthritis and Ankylosing Spondylitis. Acute exacerbation and not in remission
  • High Grade Spondylolisthesis (Grade III and Grade IV)
  • Fibromyalgia
  • Severe Osteoporosis (BMD with T-score of -2.5 or lower, along with the presence of one or more fragility fractures)
  • Neurogenic conditions
  • Spinal Stenosis with active neurogenic claudication
  • Cauda Equina Syndrome - acute
  • Radiating pain below the knee or in the presence of true Neurological signs (numbness/weakness)
  • Historical dx of any of the following:
  • Spinal Cord injuries with persisting neurogenic sensory or motor loss
  • Lumbar spine back surgery within the past year
  • Received spinal interventions (e.g., surgery, nerve ablations, steroid injections, etc.) within the past 6 months
  • Current use of blood thinners/anticoagulants
  • Is enrolled or plans to enroll in another clinical trial during this study that would affect the patient's safety or results of this trial
  • [Females only] Currently pregnant (self-reported) or plans to become pregnant during the study intervention period

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Komparátor placeba: Group #1
Provider-directed care
Jiný: Provider Directed Care
Provider directed care (i.e. Physical Therapy)
Aktivní komparátor: Group #2
Provider-directed care and Medical Massage Therapy
Jiný: Provider Directed Care
Provider directed care (i.e. Physical Therapy)
Postup: Medical Massage Therapy
Massage and educational treatment provided by a licensed massage therapist.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Modified Oswestry Low Back Pain Disability Index (M-ODI)
Časové okno: Baseline Visit, Week 1 Visit, Week 6 Visit, Week 12 Visit, and Final Follow-up Visit (up to 16 weeks after Baseline Visit)
The M-ODI is the most commonly used aid for evaluating disability due to LBP This free instrument delivers medical provider information related to functional limitation and pain management.
Baseline Visit, Week 1 Visit, Week 6 Visit, Week 12 Visit, and Final Follow-up Visit (up to 16 weeks after Baseline Visit)
Satisfaction and Treatment History Self-Reported Data
Časové okno: Week 1-12 Visits, and Final Follow-up Visit (up to 16 weeks after Baseline Visit)
Participants will self-report differences in healthcare utilization and prescription medication fulfillment, as well as satisfaction with care.
Week 1-12 Visits, and Final Follow-up Visit (up to 16 weeks after Baseline Visit)
Work Productivity and Activity Impairment Questionnaire (WPAI-LBP)
Časové okno: Baseline Visit, Week 1-12 Visits, and Final Follow-up Visit (up to 16 weeks after Baseline Visit)
The Work Productivity and Activity Impairment (WPAI) Low Back Pain (LBP) questionnaire is an instrument used to assess the impact of low back pain on a person's ability to work and perform daily activities. The questionnaire focuses on absenteeism (missing work), presenteeism (reduced productivity at work), and limitations in non-work activities due to low back pain.
Baseline Visit, Week 1-12 Visits, and Final Follow-up Visit (up to 16 weeks after Baseline Visit)
Defense and Veterans Pain Rating Scale (DVPRS)
Časové okno: Baseline Visit, Week 1-12 Visits, and Final Follow-up Visit (up to 16 weeks after Baseline Visit)
The Defense and Veterans Pain Rating Scale (DVPRS 2.0) is a pain assessment tool that utilizes a numerical rating scale enhanced by functional word descriptors, color coding, and pictorial facial expressions matched to pain levels.
Baseline Visit, Week 1-12 Visits, and Final Follow-up Visit (up to 16 weeks after Baseline Visit)
Global Pain Scale (GPS)
Časové okno: Baseline Visit, Week 1 Visit, Week 6 Visit, Week 12 Visit, and Final Follow-up Visit (up to 16 weeks after Baseline Visit)
The GPS is a comprehensive assessment of pain evaluating pain, emotions, clinical outcomes, and daily activities,. This may be a valuable tool for evaluation and treatment planning for interventional pain management physicians.
Baseline Visit, Week 1 Visit, Week 6 Visit, Week 12 Visit, and Final Follow-up Visit (up to 16 weeks after Baseline Visit)
Global Rating of Change Score (GRoC)
Časové okno: Week 1 Visit, Week 6 Visit, Week 12 Visit, and Final Follow-up Visit (up to 16 weeks after Baseline Visit)
The GRoC is a frequently used outcome measure that has ben used to independently score self-perceived improvement in a patient and has been used as an anchor method to determine minimal clinically important change scores. The GRoC is a single-item, recall-based questionnaire of well-being that is based on progress since an initial treatment encounter.
Week 1 Visit, Week 6 Visit, Week 12 Visit, and Final Follow-up Visit (up to 16 weeks after Baseline Visit)
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Časové okno: Baseline Visit, Week 1 Visit, Week 6 Visit, Week 12 Visit, and Final Follow-up Visit (up to 16 weeks after Baseline Visit)
The PROMIS-29 v2.0 profile assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain.
Baseline Visit, Week 1 Visit, Week 6 Visit, Week 12 Visit, and Final Follow-up Visit (up to 16 weeks after Baseline Visit)
Physical Therapy Appointment History
Časové okno: Week 1-12 Visits, and Final Follow-up Visit (up to 16 weeks after Baseline Visit)
How many PT appointments since last study visit, which body part(s) treated, what treatment modalities were performed?
Week 1-12 Visits, and Final Follow-up Visit (up to 16 weeks after Baseline Visit)
Military Specific Duty Status
Časové okno: Baseline Visit, Week 1-12 Visits, and Final Follow-up Visit (up to 16 weeks after Baseline Visit)
Baseline Visit, Week 1-12 Visits, and Final Follow-up Visit (up to 16 weeks after Baseline Visit)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

The Geneva Foundation

Spolupracovníci

Uniformed Services University of the Health Sciences
Madigan Army Medical Center

Vyšetřovatelé

  • Vrchní vyšetřovatel: Ghena G. Grinshpun, PhD, MBA, MSF, PMP, Madigan Army Medical Center

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. června 2026

Primární dokončení (Odhadovaný)

31. ledna 2027

Dokončení studie (Odhadovaný)

31. ledna 2027

Termíny zápisu do studia

První předloženo

1. května 2026

První předloženo, které splnilo kritéria kontroly kvality

28. května 2026

První zveřejněno (Aktuální)

29. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

5. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

3. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 226029
  • HU00012520022 (Jiné číslo grantu/financování: Uniformed Services University of the Health Sciences (USUHS))

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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