Lower Back PainZeel LBPNCT07615816
Investigating Medical Massage Therapy for Patients With Sub-Acute Lower Back Pain
A study testing Medical Massage Therapy and Provider Directed Care in people with Lower Back Pain and Subacute Lower Back Pain, run by The Geneva Foundation at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Lower Back Pain, Subacute Lower Back Pain, Medical Massage Therapy
- What is being tested?
- Medical Massage Therapy and Provider Directed Care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2026to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brad M. Isaacson, PhD, MBA, MSF, PMP contact
United States1 site, 1 recruiting
- Recruiting
Madigan Army Medical Center
Joint Base Lewis McChord, Washington, 98431
Janel Son, MPH, 253-968-3288, json@genevausa.org
Ghena Grinshpun, DO, german.grinshpun.civ@health.mil
About this study
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).
Read the detailed description
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).
- Being tested
- Medical Massage Therapy, Provider Directed Care
- Keywords
- Medical Massage Therapy, Active Duty Service Members, Subacute Lower Back Pain, Lower Back Pain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical Massage TherapyProcedure or surgery
Massage and educational treatment provided by a licensed massage therapist.
Provider Directed CareOther
Provider directed care (i.e. Physical Therapy)
| Study group | Role | What they receive |
|---|---|---|
| Group #1 | Placebo comparator | Provider-directed care Receives: Other: Provider Directed Care |
| Group #2 | Active comparator | Provider-directed care and Medical Massage Therapy Receives: Procedure: Medical Massage Therapy; Other: Provider Directed Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Oswestry Low Back Pain Disability Index (M-ODI)
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.
Measured: 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
Participants will self-report differences in healthcare utilization and prescription medication fulfillment, as well as satisfaction with care.
Measured: Week 1-12 Visits, and Final Follow-up Visit (up to 16 weeks after Baseline Visit)
Work Productivity and Activity Impairment Questionnaire (WPAI-LBP)
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.
Measured: 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)
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.
Measured: Baseline Visit, Week 1-12 Visits, and Final Follow-up Visit (up to 16 weeks after Baseline Visit)
Global Pain Scale (GPS)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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
How many PT appointments since last study visit, which body part(s) treated, what treatment modalities were performed?
Measured: Week 1-12 Visits, and Final Follow-up Visit (up to 16 weeks after Baseline Visit)
Military Specific Duty Status
Measured: Baseline Visit, Week 1-12 Visits, and Final Follow-up Visit (up to 16 weeks after Baseline Visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start1 Jun 2026
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two treatment groups: provider-directed care, or provider-directed care plus medical massage therapy.
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Geneva Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Uniformed Services University of the Health Sciences, Madigan Army Medical Center
- Responsible party
- Sponsor
- Investigators
- Ghena G. Grinshpun, PhD, MBA, MSF, PMP, Principal investigator, Madigan Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07615816
- Sponsor's protocol ID
- 226029
- Other IDs
- HU00012520022
- Acronym
- Zeel LBP
- Status last verified
- Jun 2026
- First submitted
- 1 May 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Medical Massage Therapy for Patients With Sub-Acute Lower Back Pain
- ClinicalTrials.gov ID
- NCT07615816
- Acronym / sponsor ID
- Zeel LBP / 226029
- Keywords
- Medical Massage Therapy, Active Duty Service Members, Subacute Lower Back Pain, Lower Back Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- The Geneva FoundationUniversity, hospital or other
- Collaborators
- Uniformed Services University of the Health Sciences, Madigan Army Medical Center
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two treatment groups: provider-directed care, or provider-directed care plus medical massage therapy.
| Arm | Type | Receives |
|---|---|---|
| Group #1 | Placebo comparator | Other: Provider Directed CareProvider-directed care |
| Group #2 | Active comparator | Procedure: Medical Massage Therapy, Other: Provider Directed CareProvider-directed care and Medical Massage Therapy |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical Massage TherapyMassage and educational treatment provided by a licensed massage therapist. | Procedure or surgery | Group #2 |
| Provider Directed CareProvider directed care (i.e. Physical Therapy) | Other | Group #1, Group #2 |
Primary outcome
Modified Oswestry Low Back Pain Disability Index (M-ODI)
Time frame: 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.
Satisfaction and Treatment History Self-Reported Data
Time frame: 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.
Work Productivity and Activity Impairment Questionnaire (WPAI-LBP)
Time frame: 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.
Defense and Veterans Pain Rating Scale (DVPRS)
Time frame: 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.
Global Pain Scale (GPS)
Time frame: 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.
Global Rating of Change Score (GRoC)
Time frame: 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.
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Time frame: 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.
Physical Therapy Appointment History
Time frame: 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?
Military Specific Duty Status
Time frame: Baseline Visit, Week 1-12 Visits, and Final Follow-up Visit (up to 16 weeks after Baseline Visit)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brad M. Isaacson, PhD, MBA, MSF, PMP contact
Ghena G. Grinshpun, PhD, MBA, MSF, PMP principal investigator
Madigan Army Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical Massage Therapy and Provider Directed Care in people with Lower Back Pain and Subacute Lower Back Pain, run by The Geneva Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Janel Son, MPH (253-968-3288, json@genevausa.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Oswestry Low Back Pain Disability Index (M-ODI) (time frame: Baseline Visit, Week 1 Visit, Week 6 Visit, Week 12 Visit, and Final Follow-up Visit (up to 16 weeks after Baseline Visit)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.