Acute Lower Back PainNCT06852898
Comparative Clinical Trial: Manual Therapy With and Without Radial Extracorporeal Shockwave Therapy to Treat Acute Low Back Pain
A study testing Chiropractic Care and Radial Extracorporeal Shockwave Therapy (ESWT) - Radial Pulse Therapy in people with Acute Lower Back Pain, run by Northeast College of Health Sciences at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if the addition of radial pulse therapy to chiropractic care will help adult patients recover faster to an acute bout of low back pain. Radial pulse therapy is the application of acoustic waves that passes through the skin to tissues and cells in the body. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Acute Lower Back Pain
- What is being tested?
- Chiropractic Care and Radial Extracorporeal Shockwave Therapy (ESWT) - Radial Pulse Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2025to Jun 2028
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Biological sex of male or female
- Age Range: 18 to 40 years old
- Diagnosis of acute mechanical low back pain (< 3 months duration)
- Pain intensity > 3 on the 11 point NPRS with 0 "being no pain at all" to 10 "being worse pain possible" within the context of either "right now" or "at its worst during the past 7 days"
Who cannot join
- Subjects who are currently using over-the-counter nonsteroidal anti-inflammatory drugs (NSAIDs), like ibuprofen (Advil, Motrin) and naproxen (Aleve), or prescription NSAIDs to manage any medical condition.
- Subjects who used oral corticosteroids that are only available by prescription to manage any medical condition within the past 6 weeks.
- Subject who received a corticosteroid injection for any medical condition within the past 6 weeks.
- Subjects who are not willing to be randomly assigned to either of the treatment interventions.
- Subjects with open wounds to the lower and mid back that will prevent the application of radial ESWT.
- Subjects with hypermobility and/or instability of the lower and mid back, which are contraindications for manual therapy.
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- Subjects who have a case history of low back pain episodes, e.g., chronic or persistent occurrence of low back pain.
- Subjects who do not meet the differential diagnosis of acute mechanical low back pain, i.e., origin of their back pain is unknown or non-specific to a low back structure.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Seneca Falls Health Center at Northeast College of Health Sciences
Seneca Falls, New York, 13148
About this study
Official title: Manual Therapy With Radial Extracorporeal Shockwave Therapy (ESWT) Compared to Manual Therapy Alone for the Treatment of Acute Mechanical Low Back Pain: A Randomized Clinical Trial
The goal of this clinical trial is to learn if the addition of radial pulse therapy to chiropractic care will help adult patients recover faster to an acute bout of low back pain. Radial pulse therapy is the application of acoustic waves that passes through the skin to tissues and cells in the body. The main questions that the clinical trial aims to answer are:
- Does the addition of radial pulse therapy to chiropractic care result in better or earlier reduction in pain intensity?
- Does the addition of radial pulse therapy to chiropractic care result in better or earlier improvement in physical function?
Read more
Researchers will compare radial pulse therapy plus chiropractic care to chiropractic care alone to see if patients with acute low back pain recover faster with the addition of radial pulse therapy.
Participants will:
- Visit the clinic once a week for 5 weeks
- Receive chiropractic care with or without the addition of radial pulse therapy to the low back and hip regions of the body
- Report their pain intensity and perform a physical function test at each clinic visit
- Conditions
- Acute Lower Back Pain
- Being tested
- Chiropractic Care, Radial Extracorporeal Shockwave Therapy (ESWT) - Radial Pulse Therapy
- Keywords
- chiropractic care, acute low back pain, mechanical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chiropractic CareOther
Chiropractic Care is the active comparator arm / intervention. All subjects will receive chiropractic care.
Radial Extracorporeal Shockwave Therapy (ESWT) - Radial Pulse TherapyOther
This intervention is answering the question: Does on radial ESWT have additive therapeutic effects on the recovery of acute lower back pain symptoms - better or earlier reduction in pain intensity or improvement in physical function - than chiropractic care / manual therapy alone? Subjects will be randomly assigned to receive chiropractic care and ESWT or only chiropractic care.
| Study group | Role | What they receive |
|---|---|---|
| Chiropractic Care Only | Active comparator | 1. The treating clinician will use soft tissue palpation procedures applied to hips, pelvis / buttocks low back and mid back to identify taut and tender regions for manual therapy, e.g., trigger points that the clinician identified during soft tissue palpations.
2. The treating clinician will use soft tissue treatment procedures, e.g., applying precise pressure to trigger points and manual stretching techniques, to relieve taut and tender regions that were identified during soft tissue palpation procedures.
3. The treating clinician will perform high velocity, low amplitude (HVLA) spinal adjustments to restricted areas of the mid back, lower back, and hips regions. Receives: Other: Chiropractic Care |
| Chiropractic Care Plus Radial Pulse Therapy | Experimental | Chiropractic Care is the same as described for the active comparator arm. After receiving chiropractic care, the subject receives radial extracorporeal shockwave therapy (ESWT). The treating clinician places the ESWT probe over the treatment areas in the mid back, low back, and hip regions. At each clinic visit, there are up to six treatment areas for ESWT. At each treatment area, the subject receives 2000 radial pulses at frequency of 10 Hz (single pulse every 100 ms or 10 pulses per second). The intensity of the radial pulses are comfortable for the subjects. Duration of ESWT at each treatment area is 200 seconds or 3.33 minutes. Receives: Other: Chiropractic Care; Other: Radial Extracorporeal Shockwave Therapy (ESWT) - Radial Pulse Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity: Numeric Pain Rating Scale (NPRS)
Before the administration of treatment at each visit, subjects rate their pain on a scale of 0 to 10 with 0 being no pain at all and 10 being worse pain possible. The subjects provide NPRS scores within the context of right now, pain at its best in the past 7 days, and pain at its worst in the past 7 days. At the end of each treatment visit, subjects rate their pain right now on a scale of 0 to 10 with 0 being no pain at all and 10 being worse pain imaginable
Measured: From enrollment to the end of intervention at week 5.
Physical Function Assessment of a Squat Test
- Before and after the administration of treatment at each visit, subjects perform six squats - moving from a standing position to a squat position. Using an iPad Pro researchers record subjects performing the 3 consecutive squats from a front view and then 3 consecutive squats from a side view. There are 15 seconds between the six squats.
- Using the Kinetisense software on the iPad Pro, researchers generate a Clinical Biomechanics Report to measure squat performance.
- The overall score from clinical biomechanics report for the squat test is the primary outcome to assess physical function.
Measured: From enrollment to the end of intervention at week 5.
Secondary outcomes (1)
Clinical Biomechanics of Squat Performance
(1) Before and after the administration of treatment at each visit, subjects perform six squats - moving from a standing position to a squat position. Using an iPad Pro researchers record subjects performing the 3 consecutive squats from a front view and then 3 consecutive squats from a side view. There are 15 seconds between the six squats. (2) Using the Kinetisense software on the iPad Pro, researchers generate a Clinical Biomechanics Report to measure squat performance. (3) The secondary outcomes from Clinical Biomechanics Report are: (1) Thighs Reached Horizontal; (2) Knee Valgus; (3) Knee Over Toe; (4) Heels Raised; (5) Shoulder-Wrist Line; (6) Shoulder Lateral Tilt; (7) Shoulder Axis Rotation; and (8) Lumbopelvic Rounding.
Measured: From enrollment to the end of intervention at week 5.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study startJun 2025 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Why it stopped: No participants enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northeast College of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeanmarie R. Burke, PhD, Northeast College of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06852898
- Sponsor's protocol ID
- 24-08
- Status last verified
- Feb 2025
- First submitted
- 17 Feb 2025
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manual Therapy With Radial Extracorporeal Shockwave Therapy (ESWT) Compared to Manual Therapy Alone for the Treatment of Acute Mechanical Low Back Pain: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06852898
- Acronym / sponsor ID
- 24-08
- Conditions
- Acute Lower Back Pain
- Keywords
- chiropractic care, acute low back pain, mechanical
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northeast College of Health SciencesUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 28 Feb 2025 (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 learn if the addition of radial pulse therapy to chiropractic care will help adult patients recover faster to an acute bout of low back pain. Radial pulse therapy is the application of acoustic waves that passes through the skin to tissues and cells in the body. The main questions that the clinical trial aims to answer are:
- Does the addition of radial pulse therapy to chiropractic care result in better or earlier reduction in pain intensity?
- Does the addition of radial pulse therapy to chiropractic care result in better or earlier improvement in physical function?
Researchers will compare radial pulse therapy plus chiropractic care to chiropractic care alone to see if patients with acute low back pain recover faster with the addition of radial pulse therapy.
Participants will:
- Visit the clinic once a week for 5 weeks
- Receive chiropractic care with or without the addition of radial pulse therapy to the low back and hip regions of the body
- Report their pain intensity and perform a physical function test at each clinic visit
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chiropractic Care Only | Active comparator | Other: Chiropractic Care1. The treating clinician will use soft tissue palpation procedures applied to hips, pelvis / buttocks low back and mid back to identify taut and tender regions for manual therapy, e.g., trigger points that the clinician identified during soft tissue palpations. 2. The treating clinician will use soft tissue treatment procedures, e.g., applying precise pressure to trigger points and manual stretching techniques, to relieve taut and tender regions that were identified during soft tissue palpation procedures. 3. The treating clinician will perform high velocity, low amplitude (HVLA) spinal adjustments to restricted areas of the mid back, lower back, and hips regions. |
| Chiropractic Care Plus Radial Pulse Therapy | Experimental | Other: Chiropractic Care, Other: Radial Extracorporeal Shockwave Therapy (ESWT) - Radial Pulse TherapyChiropractic Care is the same as described for the active comparator arm. After receiving chiropractic care, the subject receives radial extracorporeal shockwave therapy (ESWT). The treating clinician places the ESWT probe over the treatment areas in the mid back, low back, and hip regions. At each clinic visit, there are up to six treatment areas for ESWT. At each treatment area, the subject receives 2000 radial pulses at frequency of 10 Hz (single pulse every 100 ms or 10 pulses per second). The intensity of the radial pulses are comfortable for the subjects. Duration of ESWT at each treatment area is 200 seconds or 3.33 minutes. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Biological sex of male or female
- Age Range: 18 to 40 years old
- Diagnosis of acute mechanical low back pain (< 3 months duration)
- Pain intensity > 3 on the 11 point NPRS with 0 "being no pain at all" to 10 "being worse pain possible" within the context of either "right now" or "at its worst during the past 7 days"
Key exclusion criteria (9 listed)
- Subjects who are currently using over-the-counter nonsteroidal anti-inflammatory drugs (NSAIDs), like ibuprofen (Advil, Motrin) and naproxen (Aleve), or prescription NSAIDs to manage any medical condition.
- Subjects who used oral corticosteroids that are only available by prescription to manage any medical condition within the past 6 weeks.
- Subject who received a corticosteroid injection for any medical condition within the past 6 weeks.
- Subjects who are not willing to be randomly assigned to either of the treatment interventions.
- Subjects with open wounds to the lower and mid back that will prevent the application of radial ESWT.
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 |
|---|---|---|
| Chiropractic CareChiropractic Care is the active comparator arm / intervention. All subjects will receive chiropractic care. | Other | Chiropractic Care Only, Chiropractic Care Plus Radial Pulse Therapy |
| Radial Extracorporeal Shockwave Therapy (ESWT) - Radial Pulse TherapyThis intervention is answering the question: Does on radial ESWT have additive therapeutic effects on the recovery of acute lower back pain symptoms - better or earlier reduction in pain intensity or improvement in physical function - than chiropractic care / manual therapy alone? Subjects will be randomly assigned to receive chiropractic care and ESWT or only chiropractic care. | Other | Chiropractic Care Plus Radial Pulse Therapy |
Primary outcome
Pain Intensity: Numeric Pain Rating Scale (NPRS)
Time frame: From enrollment to the end of intervention at week 5.
Before the administration of treatment at each visit, subjects rate their pain on a scale of 0 to 10 with 0 being no pain at all and 10 being worse pain possible. The subjects provide NPRS scores within the context of right now, pain at its best in the past 7 days, and pain at its worst in the past 7 days. At the end of each treatment visit, subjects rate their pain right now on a scale of 0 to 10 with 0 being no pain at all and 10 being worse pain imaginable
Physical Function Assessment of a Squat Test
Time frame: From enrollment to the end of intervention at week 5.
1. Before and after the administration of treatment at each visit, subjects perform six squats - moving from a standing position to a squat position. Using an iPad Pro researchers record subjects performing the 3 consecutive squats from a front view and then 3 consecutive squats from a side view. There are 15 seconds between the six squats. 2. Using the Kinetisense software on the iPad Pro, researchers generate a Clinical Biomechanics Report to measure squat performance. 3. The overall score from clinical biomechanics report for the squat test is the primary outcome to assess physical function.
1 secondary outcome
Clinical Biomechanics of Squat Performance
Time frame: From enrollment to the end of intervention at week 5.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chiropractic Care and Radial Extracorporeal Shockwave Therapy (ESWT) - Radial Pulse Therapy in people with Acute Lower Back Pain, run by Northeast College of Health Sciences 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 4 inclusion and 9 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: withdrawn, as of the sponsor's last update on 3 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity: Numeric Pain Rating Scale (NPRS) (time frame: From enrollment to the end of intervention at week 5.). The study lists 2 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 3 Jun 2026.