Lumbar Spinal StenosisNCT06023498
Optimizing Impact of Manual Therapy on Lumbar Spinal Stenosis
A study testing Manual Therapy and Exercise and Intramuscular Electroacupuncture in people with Lumbar Spinal Stenosis, run by University of Pittsburgh at 2 sites in United States.
Trial summary
Lumbar spinal stenosis, a common condition in older adults, can cause pain and difficulty walking (i.e., intermittent neurogenic claudication - INC). Patients with INC not infrequently undergo spinal surgery that fails to help them 1/3-1/2 the time. 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?
- Manual Therapy and Exercise and Intramuscular Electroacupuncture
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Jun 2024to 11 Mar 2026
- 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
- Intermittent neurogenic claudication (INC), defined as pain or discomfort with walking or prolonged standing that radiates beyond the spinal area and is relieved with sitting (ascertained using a structured interview)
- Average pain/discomfort severity > moderate
- Advanced imaging (e.g., MRI, CT scan, CT-myelogram) evidence of lumbar spinal stenosis (extracted from electronic medical record, or outside report provided by participant; advanced imaging will not be performed as part of our study procedures)
- Able to commit to 9 months of study participation
- English speaking
Who cannot join
- Red flags indicative of serious underlying illness requiring urgent care (e.g., fever, change in bowel/ bladder function, sudden severe change in pain, unintentional weight loss, new leg weakness)
- Walking capacity over 2 miles
- Other conditions that significantly impact mobility (e.g., painful conditions such as advanced hip/knee osteoarthritis with pain more severe than INC pain, Parkinson's disease, stroke, vascular claudication, angina pectoris, pulmonary disease, morbid obesity (i.e., BMI > 40).
- Prior lumbar surgery, because of its negative impact on spinal biomechanics;
- Positive screen for dementia (i.e., Folstein Mini-Mental State Examination);
- Acute medical or psychiatric illness, or active substance abuse that renders the patient incapable of being a reliable study participant;
- Prohibitive communication impairment (e.g., severe hearing or visual impairment)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Boston Medical Center
Boston, Massachusetts, 02118
Orlando VA Medical Center
Orlando, Florida, 32827
About this study
Official title: Optimizing Impact of Manual Therapy and Exercise on Lumbar Spinal Stenosis With Neurogenic Claudication: A Multi-Site Feasibility Study
Lumbar spinal stenosis, a common condition in older adults, can cause pain and difficulty walking (i.e., intermittent neurogenic claudication - INC). Patients with INC not infrequently undergo spinal surgery that fails to help them 1/3-1/2 the time. The purpose of this multi-site feasibility study is to prepare for the conduct of a randomized controlled trial to test the efficacy of manual therapy, exercise, and intramuscular electroacupuncture in reducing pain and improving walking ability for those with INC, and ultimately limiting the need for surgical referrals.
Read the detailed description
Decompressive laminectomy (DL), the most common spinal surgery in older adults, is performed to alleviate lumbar spinal stenosis (LSS) and reduce associated pain, paresthesias, and/or weakness when walking (i.e., intermittent neurogenic claudication - INC). The PI's recent prospective cohort study of 193 older veterans followed for 12 months following DL revealed that over 50% of participants did not experience significant functional improvement. Similar rates of failed surgery have been reported in non-veteran populations. Since the vast majority of DLs are performed electively, non-surgical treatment is recommended as an initial step. Two clinical trials have demonstrated modest efficacy of manual therapy and exercise (MTE) for people with INC that was sustained in one trial, but not in the other. Recent clinical practice guidelines recommend adding acupuncture as a non-surgical pain management strategy and highlight the need for high quality evidence to support this recommendation. The investigators' clinical experience and preliminary research data regarding the efficacy of electroacupuncture (specifically, intramuscular electroacupuncture [IMEA]) in these patients are promising. Ultimately, the study team wishes to conduct a randomized controlled clinical trial to optimize and sustain the efficacy of MTE by potentially a) increasing the robustness of the initial response via addition of IMEA and b) its durability via boosters. This two-site feasibility study will be conducted at Boston Medical Center and the Orlando VA Medical Center, chosen because of their sociodemographic diversity and prevalence of patients with multiple comorbidities, characteristics that will ultimately facilitate broad generalizability of study findings. The study team will evaluate the feasibility of recruiting, randomizing and retaining participants; fidelity of intervention delivery; participant adherence to prescribed interventions; and the accuracy and completeness of data collection procedures. Sixty participants (30 per site) with imaging-identified LSS and INC who have not had lumbar surgery, will be randomized to receive 1) MTE for 3 months (10 sessions over 12 weeks) followed by a 6-months observation period; 2) MTE for 3 months followed by monthly MTE booster sessions for 6-months; OR 3) MTE + IMEA for 3 months followed by monthly MTE + IMEA for 6-months. The primary outcome (Brigham Spinal Stenosis questionnaire) for the future efficacy trial will be measured at baseline, 3 months (primary endpoint), 6 and 9 months. The study also will measure community mobility (life space), emotional functioning (PHQ8 and GAD7), pain medications, and other key parameters relevant to older adults with LSS and INC (e.g., smoking, BMI, medical comorbidity). Fidelity will be optimized by delivering standardized provider training, conducting regular review of participant provider intervention sessions and documentation, and monthly all-site huddles. The study also will monitor participant attendance and home exercise compliance. If the study demonstrates feasibility (primary outcome for this study) of the proposed methods, the study team will be positioned to test a new model of care for patients with LSS and INC designed to optimize their function and quality of life and save substantial morbidity and healthcare resources.
- Conditions
- Lumbar Spinal Stenosis
- Being tested
- Manual Therapy and Exercise, Intramuscular Electroacupuncture
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Therapy and ExerciseOther
The 20-minute manual therapy procedures will include:
- Distraction-manipulation: manually assisted segmental lumbar traction manipulation using a specialized treatment table
- Neural mobilization: rhythmic stretches of the sciatic and femoral nerves75
- Hip, sacroiliac and lumbar facet mobilizations to improve joint mobility
- Soft tissue mobilization of lumbopelvic and lower extremity muscles using manual pressure over taut bands/myofascial trigger points and post-isometric (contract-relax) stretching techniques.
Intramuscular ElectroacupunctureOther
As described previously
| Study group | Role | What they receive |
|---|---|---|
| Manual Therapy and Exercise (MTE) | Experimental | Participants will be asked to attend 10 sessions of manual therapy that will be administered by a chiropractic physician and will consist of movements designed to enhance flexibility and muscle health. Session will last ~ 20 minutes.
The home exercise program (HEP) will consist of a light aerobic program (either walking with the lumbar spine in slight flexion while supported by a wheeled walker, going up and down a flight of stairs, using a treadmill, or using an exercise bicycle), neural mobilization self-stretches, individualized muscular stretches and core strengthening exercises. Participants will be encouraged to do the HEP 1-2 times per day, starting with 5 minutes and working up to 30 minutes.
During the subsequent 6 months, there will be no additional treatment administered. Participants will be asked to continue their HEP. Receives: Other: Manual Therapy and Exercise |
| MTE Plus MTE Boosters | Experimental | Participants will be asked to attend 10 sessions of manual therapy that will be administered by a chiropractic physician and will consist of movements designed to enhance flexibility and muscle health. Session will last ~ 20 minutes.
The home exercise program (HEP) will consist of a light aerobic program (either walking with the lumbar spine in slight flexion while supported by a wheeled walker, going up and down a flight of stairs, using a treadmill, or using an exercise bicycle), neural mobilization self-stretches, individualized muscular stretches and core strengthening exercises. Participants will be encouraged to do the HEP 1-2 times per day, starting with 5 minutes and working up to 30 minutes.
During the subsequent 6 months, participants will be asked to return for monthly MTE booster sessions, and they will be asked to continue their HEP. Receives: Other: Manual Therapy and Exercise |
| MTE and Intramuscular Electroacupuncture (IMEA) Plus MTE and IM Boosters | Experimental | Participants will be asked to attend 10 sessions of manual therapy that will be administered by a chiropractic physician and will consist of movements designed to enhance flexibility and muscle health. Session will last ~ 20 minutes.
Participants also will be asked to attend weekly intramuscular electroacupuncture (IMEA) sessions administered by a licensed acupuncturist. 30-gauge acupuncture needles will be placed in the muscles of the lower back and buttocks and gentle pulsing electrical stimulation will be delivered for 20 minutes.
The home exercise program (HEP) will be identical to that in the MTE and the MTE + Boosters groups.
During the subsequent 6 months, participants will be asked to return for monthly MTE and IMEA boosters. Participants also will be asked to continue their HEP. Receives: Other: Manual Therapy and Exercise; Other: Intramuscular Electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants recruited and retained after 9 months of participation
Number of participants recruited and retained at each site
Measured: Number of participants recruited at each of two study sites over a period of 12 months (duration of recruitment period) - assessed at 12 months after recruitment starts; number of participants retained at each site after 9 months of study participation
Median number of intervention sessions attended
Median number of intervention sessions attended at each site
Measured: 3 months (at completion of initial intervention) and 9 months (at completion of follow up period)
Rate of missing data
Percentage of study data that are not entered into data collection system
Measured: Baseline, 3 months, and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start11 Jun 2024
- Primary completion11 Mar 2026
- Study completion11 Mar 2026
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.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Randomized controlled clinical trial - feasibility study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Medical Center, VA Pittsburgh Healthcare System, Syracuse VA Medical Center, Orlando VA Medical Center, National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Debra Weiner, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06023498
- Sponsor's protocol ID
- STUDY24010020
- Other IDs
- R01AT012534
- Status last verified
- Apr 2026
- First submitted
- 14 Aug 2023
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Impact of Manual Therapy and Exercise on Lumbar Spinal Stenosis With Neurogenic Claudication: A Multi-Site Feasibility Study
- ClinicalTrials.gov ID
- NCT06023498
- Acronym / sponsor ID
- STUDY24010020
- Conditions
- Lumbar Spinal Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Boston Medical Center, VA Pittsburgh Healthcare System, Syracuse VA Medical Center, Orlando VA Medical Center, National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 11 Jun 2024 (actual)
- Primary completion
- 11 Mar 2026 (actual)
- Study completion
- 11 Mar 2026 (actual)
- First posted
- 5 Sep 2023 (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.
Lumbar spinal stenosis, a common condition in older adults, can cause pain and difficulty walking (i.e., intermittent neurogenic claudication - INC). Patients with INC not infrequently undergo spinal surgery that fails to help them 1/3-1/2 the time. The purpose of this multi-site feasibility study is to prepare for the conduct of a randomized controlled trial to test the efficacy of manual therapy, exercise, and intramuscular electroacupuncture in reducing pain and improving walking ability for those with INC, and ultimately limiting the need for surgical referrals.
Detailed description
Decompressive laminectomy (DL), the most common spinal surgery in older adults, is performed to alleviate lumbar spinal stenosis (LSS) and reduce associated pain, paresthesias, and/or weakness when walking (i.e., intermittent neurogenic claudication - INC). The PI's recent prospective cohort study of 193 older veterans followed for 12 months following DL revealed that over 50% of participants did not experience significant functional improvement. Similar rates of failed surgery have been reported in non-veteran populations. Since the vast majority of DLs are performed electively, non-surgical treatment is recommended as an initial step. Two clinical trials have demonstrated modest efficacy of manual therapy and exercise (MTE) for people with INC that was sustained in one trial, but not in the other. Recent clinical practice guidelines recommend adding acupuncture as a non-surgical pain management strategy and highlight the need for high quality evidence to support this recommendation. The investigators' clinical experience and preliminary research data regarding the efficacy of electroacupuncture (specifically, intramuscular electroacupuncture [IMEA]) in these patients are promising. Ultimately, the study team wishes to conduct a randomized controlled clinical trial to optimize and sustain the efficacy of MTE by potentially a) increasing the robustness of the initial response via addition of IMEA and b) its durability via boosters. This two-site feasibility study will be conducted at Boston Medical Center and the Orlando VA Medical Center, chosen because of their sociodemographic diversity and prevalence of patients with multiple comorbidities, characteristics that will ultimately facilitate broad generalizability of study findings. The study team will evaluate the feasibility of recruiting, randomizing and retaining participants; fidelity of intervention delivery; participant adherence to prescribed interventions; and the accuracy and completeness of data collection procedures. Sixty participants (30 per site) with imaging-identified LSS and INC who have not had lumbar surgery, will be randomized to receive 1) MTE for 3 months (10 sessions over 12 weeks) followed by a 6-months observation period; 2) MTE for 3 months followed by monthly MTE booster sessions for 6-months; OR 3) MTE + IMEA for 3 months followed by monthly MTE + IMEA for 6-months. The primary outcome (Brigham Spinal Stenosis questionnaire) for the future efficacy trial will be measured at baseline, 3 months (primary endpoint), 6 and 9 months. The study also will measure community mobility (life space), emotional functioning (PHQ8 and GAD7), pain medications, and other key parameters relevant to older adults with LSS and INC (e.g., smoking, BMI, medical comorbidity). Fidelity will be optimized by delivering standardized provider training, conducting regular review of participant provider intervention sessions and documentation, and monthly all-site huddles. The study also will monitor participant attendance and home exercise compliance. If the study demonstrates feasibility (primary outcome for this study) of the proposed methods, the study team will be positioned to test a new model of care for patients with LSS and INC designed to optimize their function and quality of life and save substantial morbidity and healthcare resources.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized controlled clinical trial - feasibility study
| Arm | Type | Receives |
|---|---|---|
| Manual Therapy and Exercise (MTE) | Experimental | Other: Manual Therapy and ExerciseParticipants will be asked to attend 10 sessions of manual therapy that will be administered by a chiropractic physician and will consist of movements designed to enhance flexibility and muscle health. Session will last ~ 20 minutes. The home exercise program (HEP) will consist of a light aerobic program (either walking with the lumbar spine in slight flexion while supported by a wheeled walker, going up and down a flight of stairs, using a treadmill, or using an exercise bicycle), neural mobilization self-stretches, individualized muscular stretches and core strengthening exercises. Participants will be encouraged to do the HEP 1-2 times per day, starting with 5 minutes and working up to 30 minutes. During the subsequent 6 months, there will be no additional treatment administered. Participants will be asked to continue their HEP. |
| MTE Plus MTE Boosters | Experimental | Other: Manual Therapy and ExerciseParticipants will be asked to attend 10 sessions of manual therapy that will be administered by a chiropractic physician and will consist of movements designed to enhance flexibility and muscle health. Session will last ~ 20 minutes. The home exercise program (HEP) will consist of a light aerobic program (either walking with the lumbar spine in slight flexion while supported by a wheeled walker, going up and down a flight of stairs, using a treadmill, or using an exercise bicycle), neural mobilization self-stretches, individualized muscular stretches and core strengthening exercises. Participants will be encouraged to do the HEP 1-2 times per day, starting with 5 minutes and working up to 30 minutes. During the subsequent 6 months, participants will be asked to return for monthly MTE booster sessions, and they will be asked to continue their HEP. |
| MTE and Intramuscular Electroacupuncture (IMEA) Plus MTE and IM Boosters | Experimental | Other: Manual Therapy and Exercise, Other: Intramuscular ElectroacupunctureParticipants will be asked to attend 10 sessions of manual therapy that will be administered by a chiropractic physician and will consist of movements designed to enhance flexibility and muscle health. Session will last ~ 20 minutes. Participants also will be asked to attend weekly intramuscular electroacupuncture (IMEA) sessions administered by a licensed acupuncturist. 30-gauge acupuncture needles will be placed in the muscles of the lower back and buttocks and gentle pulsing electrical stimulation will be delivered for 20 minutes. The home exercise program (HEP) will be identical to that in the MTE and the MTE + Boosters groups. During the subsequent 6 months, participants will be asked to return for monthly MTE and IMEA boosters. Participants also will be asked to continue their HEP. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Intermittent neurogenic claudication (INC), defined as pain or discomfort with walking or prolonged standing that radiates beyond the spinal area and is relieved with sitting (ascertained using a structured interview)
Key exclusion criteria (7 listed)
- Red flags indicative of serious underlying illness requiring urgent care (e.g., fever, change in bowel/ bladder function, sudden severe change in pain, unintentional weight loss, new leg weakness)
- Walking capacity over 2 miles
- Other conditions that significantly impact mobility (e.g., painful conditions such as advanced hip/knee osteoarthritis with pain more severe than INC pain, Parkinson's disease, stroke, vascular claudication, angina pectoris, pulmonary disease, morbid obesity (i.e., BMI > 40).
- Prior lumbar surgery, because of its negative impact on spinal biomechanics;
- Positive screen for dementia (i.e., Folstein Mini-Mental State Examination);
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 |
|---|---|---|
| Manual Therapy and ExerciseThe 20-minute manual therapy procedures will include: * Distraction-manipulation: manually assisted segmental lumbar traction manipulation using a specialized treatment table * Neural mobilization: rhythmic stretches of the sciatic and femoral nerves75 * Hip, sacroiliac and lumbar facet mobilizations to improve joint mobility * Soft tissue mobilization of lumbopelvic and lower extremity muscles using manual pressure over taut bands/myofascial trigger points and post-isometric (contract-relax) stretching techniques. | Other | MTE Plus MTE Boosters, MTE and Intramuscular Electroacupuncture (IMEA) Plus MTE and IM Boosters, Manual Therapy and Exercise (MTE) |
| Intramuscular ElectroacupunctureAs described previously | Other | MTE and Intramuscular Electroacupuncture (IMEA) Plus MTE and IM Boosters |
Primary outcome
Number of participants recruited and retained after 9 months of participation
Time frame: Number of participants recruited at each of two study sites over a period of 12 months (duration of recruitment period) - assessed at 12 months after recruitment starts; number of participants retained at each site after 9 months of study participation
Number of participants recruited and retained at each site
Median number of intervention sessions attended
Time frame: 3 months (at completion of initial intervention) and 9 months (at completion of follow up period)
Median number of intervention sessions attended at each site
Rate of missing data
Time frame: Baseline, 3 months, and 9 months
Percentage of study data that are not entered into data collection system
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 7 Apr 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Therapy and Exercise and Intramuscular Electroacupuncture in people with Lumbar Spinal Stenosis, run by University of Pittsburgh at 2 sites 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 7 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 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Number of participants recruited and retained after 9 months of participation (time frame: Number of participants recruited at each of two study sites over a period of 12 months (duration of recruitment period) - assessed at 12 months after recruitment starts; number of participants retained at each site after 9 months of study participation). The study lists 3 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 7 Apr 2026.