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Optimizing Impact of Manual Therapy on Lumbar Spinal Stenosis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 50 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06023498
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of Pittsburgh
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, U.S. Fed, NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Lumbar Spinal Stenosis
Additional Details

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.

Arms & Interventions

Arms

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.

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.

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.

Interventions

Other: - Manual Therapy and Exercise

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.

Other: - Intramuscular Electroacupuncture

As described previously

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Orlando VA Medical Center, Orlando, Florida

Status

Recruiting

Address

Orlando VA Medical Center

Orlando, Florida, 32827

Site Contact

Charles Penza, PhD

[email protected]

407-631-3190

Boston Medical Center, Boston, Massachusetts

Status

Recruiting

Address

Boston Medical Center

Boston, Massachusetts, 02118

Site Contact

Eric Roseen, PhD

[email protected]

617-536-1161

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