Lumbar Spinal StenosisNCT03167736
Dry Needling and Spinal Manipulation vs. Conventional PT for Lumbar Spinal Stenosis
A study testing electric dry needling, manipulation and conventional physical therapy in people with Lumbar Spinal Stenosis, run by Alabama Physical Therapy & Acupuncture at 1 site in United States.
Trial summary
The purpose of this research is to compare two different approaches for treating patients with lumbar spinal stenosis: electric dry needling and thrust manipulation versus impairment-based manual therapy, stretching, strengthening and electrothermal modalities. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Lumbar Spinal Stenosis
- What is being tested?
- electric dry needling, manipulation and conventional physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2017to 15 Mar 2020
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult over the age of 50 years old that is able to read, write and speak English
- Symptoms of neurogenic claudication (pain in the buttock, thigh, or leg during ambulation that improves with rest) or radicular leg symptoms with associated neurological deficits on the physical examination for at least 12 weeks.
- Confirmatory imaging (i.e. magnetic resonance imaging (MRI), computed tomography (CT), myelography, ultrasound or X-ray of either central or lateral (foraminal) lumbar spinal stenosis at one or more levels in the lumbar spine.
Who cannot join
- Report of red flags to manual physical therapy to include: severe hypertension, infection, ankylosing spondylitis, neoplasm, uncontrolled diabetes, peripheral neuropathy, heart disease, stroke, chronic, ischemia, edema, severe varicosities, tumor, metabolic disease, prolonged steroid use, fracture, RA, osteoporosis, severe vascular disease, malignancy, etc.
- Severe vascular, pulmonary, or coronary artery disease limiting participation in exercise, to include a walking program (including presence of absolute contraindications to submaximal exercise testing)
- Severe degenerative stenosis with intractable pain and progressive neurological dysfunction
- Lumbar spinal stenosis not caused by degeneration
- Radiographic evidence of instability, degenerative spondylolisthesis, fracture or scoliosis of more than 15°
- Lumbar herniated disc diagnosis during the last 12 months.
Show all 9Show fewer
- Previous lumbar surgery for lumbar spinal stenosis or instability (i.e. previous lumbar fusion, lumbar microdiscectomy, lumbar foraminotomy, lumbar laminectomy, etc.)
- Psychiatric disorder or cognitively impaired.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Addition of Electric Dry Needling and Spinal Manipulation to Impairment-based Manual Therapy, Stretching, Strengthening and Electrothermal Modalities for Patients With Lumbar Spinal Stenosis: a Multi-randomized Clinical Trial
The purpose of this research is to compare two different approaches for treating patients with lumbar spinal stenosis: electric dry needling and thrust manipulation versus impairment-based manual therapy, stretching, strengthening and electrothermal modalities. Physical therapists commonly use all of these techniques to treat lumbar spinal stenosis. This study is attempting to find out if one treatment strategy is more effective than the other.
Read the detailed description
Patients with lumbar spinal stenosis will be randomized to receive 1-2 treatment sessions per week for 6 weeks (up to 12 sessions total) of either: (1) electric dry needling and thrust manipulation or (2) impairment-based manual therapy, stretching, strengthening and electrothermal modalities
- Conditions
- Lumbar Spinal Stenosis
- Being tested
- electric dry needling, manipulation, conventional physical therapy
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electric dry needling, manipulationOther
HVLA thrust manipulation to lumbar spine. Dry needling to lumbar/sacral paraspinal muscles and gluteus medium/minimus muscles. Treatment may include dry needling of the piriformis muscle, quadrates lumborum muscle and perineurial needling of sciatic/tibial nerve. Up to 12 treatment sessions over 6 weeks.
conventional physical therapyOther
Impairment-based manual therapy, stretching, strengthening and electrothermal modalities targeting the lumbar/sacral spine and hips. Up to 12 treatment sessions over 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Electric dry needling, manipulation | Experimental | Not described Receives: Other: electric dry needling, manipulation |
| conventional physical therapy | Active comparator | Not described Receives: Other: conventional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in low back pain (NPRS) (Rating Score)
Baseline score must exceed 2/10 to be included in the study.
Measured: baseline, 2-weeks, 6-weeks and 3-months
Change in Oswestry Disability Index
The Oswestry Disability Index (ODI) includes 10 questions, each worth 0-5 points with maximum score of 50 points possible. The greater the score, the worse the disability. Baseline score must exceed 10/50 points to be included in the study.
Measured: baseline, 2-weeks, 6-weeks and 3-months
Secondary outcomes (3)
Change in Roland Morris Disability Index
The Roland Morris Disability Index (RMDI) is measured on a 0-24 scale. Greater scores indicate increased disability.
Measured: baseline, 2-weeks, 6-weeks and 3-months
Change in Global Rating of Change Score
Measured: 2-weeks, 6-weeks and 3-months
Change in Medication Intake (Frequency of medication intake in last week)
Measured: baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start15 Jun 2017
- Primary completion15 Mar 2020
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spinal StenosisStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alabama Physical Therapy & Acupuncture
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Rey Juan Carlos
- Responsible party
- Principal investigator, James Dunning, DPT, MSc, FAAOMPT, Alabama Physical Therapy & Acupuncture
- Investigators
- James Dunning, DPT, Principal investigator, American Academy of Manipulative Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03167736
- Sponsor's protocol ID
- AAMT0011
- Status last verified
- Jun 2024
- First submitted
- 24 May 2017
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Addition of Electric Dry Needling and Spinal Manipulation to Impairment-based Manual Therapy, Stretching, Strengthening and Electrothermal Modalities for Patients With Lumbar Spinal Stenosis: a Multi-randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03167736
- Acronym / sponsor ID
- AAMT0011
- Conditions
- Lumbar Spinal Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Alabama Physical Therapy & AcupunctureUniversity, hospital or other
- Collaborators
- Universidad Rey Juan Carlos
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 30 May 2017 (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 purpose of this research is to compare two different approaches for treating patients with lumbar spinal stenosis: electric dry needling and thrust manipulation versus impairment-based manual therapy, stretching, strengthening and electrothermal modalities. Physical therapists commonly use all of these techniques to treat lumbar spinal stenosis. This study is attempting to find out if one treatment strategy is more effective than the other.
Detailed description
Patients with lumbar spinal stenosis will be randomized to receive 1-2 treatment sessions per week for 6 weeks (up to 12 sessions total) of either: (1) electric dry needling and thrust manipulation or (2) impairment-based manual therapy, stretching, strengthening and electrothermal modalities
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electric dry needling, manipulation | Experimental | Other: electric dry needling, manipulation |
| conventional physical therapy | Active comparator | Other: conventional physical therapy |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult over the age of 50 years old that is able to read, write and speak English
- Symptoms of neurogenic claudication (pain in the buttock, thigh, or leg during ambulation that improves with rest) or radicular leg symptoms with associated neurological deficits on the physical examination for at least 12 weeks.
- Confirmatory imaging (i.e. magnetic resonance imaging (MRI), computed tomography (CT), myelography, ultrasound or X-ray of either central or lateral (foraminal) lumbar spinal stenosis at one or more levels in the lumbar spine.
Key exclusion criteria (9 listed)
- Report of red flags to manual physical therapy to include: severe hypertension, infection, ankylosing spondylitis, neoplasm, uncontrolled diabetes, peripheral neuropathy, heart disease, stroke, chronic, ischemia, edema, severe varicosities, tumor, metabolic disease, prolonged steroid use, fracture, RA, osteoporosis, severe vascular disease, malignancy, etc.
- Severe vascular, pulmonary, or coronary artery disease limiting participation in exercise, to include a walking program (including presence of absolute contraindications to submaximal exercise testing)
- Severe degenerative stenosis with intractable pain and progressive neurological dysfunction
- Lumbar spinal stenosis not caused by degeneration
- Radiographic evidence of instability, degenerative spondylolisthesis, fracture or scoliosis of more than 15°
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 |
|---|---|---|
| electric dry needling, manipulationHVLA thrust manipulation to lumbar spine. Dry needling to lumbar/sacral paraspinal muscles and gluteus medium/minimus muscles. Treatment may include dry needling of the piriformis muscle, quadrates lumborum muscle and perineurial needling of sciatic/tibial nerve. Up to 12 treatment sessions over 6 weeks. | Other | Electric dry needling, manipulation |
| conventional physical therapyImpairment-based manual therapy, stretching, strengthening and electrothermal modalities targeting the lumbar/sacral spine and hips. Up to 12 treatment sessions over 6 weeks. | Other | conventional physical therapy |
Primary outcome
Change in low back pain (NPRS) (Rating Score)
Time frame: baseline, 2-weeks, 6-weeks and 3-months
Baseline score must exceed 2/10 to be included in the study.
Change in Oswestry Disability Index
Time frame: baseline, 2-weeks, 6-weeks and 3-months
The Oswestry Disability Index (ODI) includes 10 questions, each worth 0-5 points with maximum score of 50 points possible. The greater the score, the worse the disability. Baseline score must exceed 10/50 points to be included in the study.
3 secondary outcomes
Change in Roland Morris Disability Index
Time frame: baseline, 2-weeks, 6-weeks and 3-months
Change in Global Rating of Change Score
Time frame: 2-weeks, 6-weeks and 3-months
Change in Medication Intake (Frequency of medication intake in last week)
Time frame: baseline, 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Individual participant dataSharing planned: Undecided
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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.
James Dunning, DPT principal investigator
American Academy of Manipulative Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electric dry needling, manipulation and conventional physical therapy in people with Lumbar Spinal Stenosis, run by Alabama Physical Therapy & Acupuncture 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 3 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: finished, as of the sponsor's last update on 12 Jun 2024. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in low back pain (NPRS) (Rating Score) (time frame: baseline, 2-weeks, 6-weeks and 3-months). 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 12 Jun 2024.