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

3 juin 2026 mis à jour par: 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).

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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).

Type d'étude

Interventionnel

Inscription (Estimé)

220

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur placebo: Group #1
Provider-directed care
Autre: Provider Directed Care
Provider directed care (i.e. Physical Therapy)
Comparateur actif: Group #2
Provider-directed care and Medical Massage Therapy
Autre: Provider Directed Care
Provider directed care (i.e. Physical Therapy)
Procédure: Medical Massage Therapy
Massage and educational treatment provided by a licensed massage therapist.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Modified Oswestry Low Back Pain Disability Index (M-ODI)
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

The Geneva Foundation

Collaborateurs

Uniformed Services University of the Health Sciences
Madigan Army Medical Center

Les enquêteurs

  • Chercheur principal: Ghena G. Grinshpun, PhD, MBA, MSF, PMP, Madigan Army Medical Center

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 juin 2026

Achèvement primaire (Estimé)

31 janvier 2027

Achèvement de l'étude (Estimé)

31 janvier 2027

Dates d'inscription aux études

Première soumission

1 mai 2026

Première soumission répondant aux critères de contrôle qualité

28 mai 2026

Première publication (Réel)

29 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

5 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

3 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 226029
  • HU00012520022 (Autre subvention/numéro de financement: Uniformed Services University of the Health Sciences (USUHS))

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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