Investigating Medical Massage Therapy for Patients With Sub-Acute Lower Back Pain

Обзор

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).

Подробное описание

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).

Вмешательства

• Процедура Medical Massage Therapy
  Massage and educational treatment provided by a licensed massage therapist.
• Другое Provider Directed Care
  Provider directed care (i.e. Physical Therapy)

Первичные конечные точки

• Modified Oswestry Low Back Pain Disability Index (M-ODI) [Срок оценки: 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 [Срок оценки: Week 1-12 Visits, and Final Follow-up Visit (up to 16 weeks after Baseline Visit)]
• Work Productivity and Activity Impairment Questionnaire (WPAI-LBP) [Срок оценки: 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) [Срок оценки: Baseline Visit, Week 1-12 Visits, and Final Follow-up Visit (up to 16 weeks after Baseline Visit)]
• Global Pain Scale (GPS) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: Week 1-12 Visits, and Final Follow-up Visit (up to 16 weeks after Baseline Visit)]
• Military Specific Duty Status [Срок оценки: Baseline Visit, Week 1-12 Visits, and Final Follow-up Visit (up to 16 weeks after Baseline Visit)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Madigan Army Medical Center — Joint Base Lewis McChord

Идентификаторы

NCT: NCT07615816 · 226029 · HU00012520022

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗