- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06023498
Optimizing Impact of Manual Therapy on Lumbar Spinal Stenosis
Optimizing Impact of Manual Therapy and Exercise on Lumbar Spinal Stenosis With Neurogenic Claudication: A Multi-Site Feasibility Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Manual Therapy and Exercise (MTE)
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. |
The 20-minute manual therapy procedures will include:
|
Experimental: MTE Plus MTE Boosters
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. |
The 20-minute manual therapy procedures will include:
|
Experimental: MTE and Intramuscular Electroacupuncture (IMEA) Plus MTE and IM Boosters
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. |
The 20-minute manual therapy procedures will include:
As described previously
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
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
|
3 months (at completion of initial intervention) and 9 months (at completion of follow up period)
|
Rate of missing data
Time Frame: Baseline, 3 months, and 9 months
|
Percentage of study data that are not entered into data collection system
|
Baseline, 3 months, and 9 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY23020172
- R01AT012534 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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