이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Trial to Test the Efficacy of Using Magnetic Fields to Stimulate the Back to Treat Chronic Lower Back Pain.

2026년 6월 11일 업데이트: Joe X. Zhang

A Single-Blind Randomized Clinical Trial to Evaluate the Efficacy of High Vector Electrokinetics (HiVE), A Form of Peripheral Magnetic Stimulation, In Treatment of Chronic Back Pain

The goal of this study is to see if a new way to treat back pain without the use of medications is effective. We plan use Transcranial Magnetic Stimulation (TMS), a wand-like device, to excite the nerves of people with lower back pain to see if we can decrease pain and improve quality of life.

This study will have two groups and randomly assign participants to a group. One group will have their back nerves stimulated with the TMS device and the other group will not.

Participants will also need to do back exercises at home once a day, and complete questionnaires at each visit before and after each treatment. The total time commitment will be 5 to10 visits with one visit occurring each weekday and each visit lasting up to 30 minutes.

연구 개요

상세 설명

The purpose of this research study is to learn about magnetic nerve stimulation and if it can help treat back pain. We believe that magnetic nerve stimulation may improve pain symptoms. Nerve stimulation using electricity and needles is a relatively common medical procedure. This study will use magnetic fields to stimulate nerves to see if it has the same or better effect at decreasing back pain than just doing light workouts. This treatment has been used to treat back pain in the past but the frequency level we are testing has not been well-studied before. This means that the HiVE treatment protocol is still considered to be experimental for the treatment of lower back pain.

Participation in this study will include 5-10 visits one visit per day on weekdays with each session lasting up to 30 minutes and will include TMS treatment (2-3 minutes) and completion of questionnaires (12-30 minutes) before and after treatment. Individuals in the sham group will be offered open label trail of the actual stimulation if the participants desires.

There will be 88 people taking part in the study over a period of 6 months and the overall pain scores as well as a functional activity score will be used to determine effectiveness between treatment and sham groups.

연구 유형

중재적

등록 (추정된)

88

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

    • California
      • Edwards Air Force Base, California, 미국, 93524
        • 모병
        • 412 Medical Group

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  • Diagnosed with chronic low back pain (greater than or equal to 12 weeks) with or without concurrent neck pain.
  • Low back pain in the paraspinal region (L1-S2) by asking the patient to point to their area of pain.
  • 18 - 64 years old (on the day of informed consent)
  • Willing and able to attend all study visits.
  • No medication changes for at least 30 days before study enrollment (self-report)
  • Eligible for care at participating military treatment facilities
  • Able to read and understand English.
  • Negative pregnancy test for women capable of pregnancy.

Exclusion Criteria:

  • Diagnosed with low back pain of less than 12 weeks duration
  • History of back fractures or surgical repair of the back
  • History of depression with vagus nerve stimulation
  • Any type of transcranial magnetic stimulation (TMS), or rPMS treatment prior to study enrollment.
  • Currently using any other adjunctive treatments for chronic back pain such as low-level laser treatment, ultrasound, dry needling, chiropractor manipulations, cervical collars, TENS units, or other stimulation, eastern medicine regimens including Qi Gong or Tai Chi. (Exception: strength building physical therapy, non-neuropathic pain modifiers, and non-anticonvulsant routine pain medicine regimens such as NSAIDS and Acetaminophen are allowed).Scheduled for nerve ablation, dry needling, trigger point injections, nerve block, therapeutic ultrasound, other stimulation, or similar adjunct treatments during the study period.
  • Diagnosed with a specific low back pain: osteoarthritis, rheumatoid arthritis, phantom limb pain, central pain syndrome, spinal cord damage, myofascial pain syndrome, or other more specific diagnosis (at investigators discretion).
  • Unstable or poorly controlled mental health diagnosis (e.g., current changes in medication or medical management).
  • Dermal or subdermal implants (e.g., aneurysm clips, shunts, stimulators, ferro magnetic implants, stents, or electrodes, or pacemakers) or any other metal object within or near the site of stimulation which cannot be safely removed.
  • Clinically significant abnormality or clinically significant unstable medical condition that, in the investigator's judgment, might pose a potential safety risk to the subject or limit interpretation of the trial results.
  • Any condition which, in the judgment of the investigator, would prevent the patient from completing study procedures.
  • Pregnancy
  • Younger than 18 years old (on the day of informed consent)
  • Older than 64 years old (on the day of informed consent)
  • NOT willing or able to attend all study visits.
  • Medication changes for back pain less than 30 days prior to study enrollment (self-report)
  • NOT eligible for care at participating military treatment facilities
  • NOT able to read and understand English.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 크로스오버 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Treatment Arm
Individuals in this arm receive magnetic stimulation to the area of the lower back where they have pain from sessions 1 through 5. We begin stimulation operation at 20% advancing in 5% increments to maximum of 35% machine power which in our case is approximately 0.3 tesla to 0.58 tesla of power (a typical outpatient MRI is 1.5 to 3 tesla). The power of the unit will be titrated up to the maximum 35% based on patient tolerance by asking participants to "Tell me if you feel a painful muscle contraction". Patients receiving active therapy would be able to feel the stimulus usually described as a vibration sensation. If patients report painful muscle contractions, stop and go back by 5%. Doing this helps ensure that we would not cause any potentially painful muscle contractions and avoid confounding our test data. The first treatment will start at 20% power then increase by 5% until the titrated power level is identified, subsequent treatments will start at the power level last used.
Our stimulation protocol is ssing approximately 0.3 tesla to 0.58 tesla of magnetic power using a variable stimulation frequency between 11ms and 14ms with center value of 13ms between pulses. This translates to estimated values of lower bounds of 71.43 Hz, central value of 83 Hz, and maximum value of 99 Hz .
다른 이름들:
  • rPMS
  • magnetic stimulation
  • repetitive magnetic stimulation
  • repetitive peripheral magnetic stimulation
All patients will receive a home exercise guide and recommended to perform the stated number of repetitions of those exercises. Exercises include Neutral Curl Up with Straight Leg, Plank on Elbow, and Bird Dog positions.
다른 이름들:
  • back pain exercises
  • home physical therapy
  • Neutral Curl Up with Straight Leg
  • Plank on Elbow
  • Bird Dog
가짜 비교기: Sham Arm

The investigators will configure the rPMS device to not utilize any power, then place the treatment wand over the participant's back pain area and hit the start button like they do in the treatment arm. When the power setting is set to zero, the magnetic wand will not generate any power but will still make the customary computer-generated tones as it does in normal operation. The device is set to play a completed tone once 2 minutes and 30 seconds have elapsed just as it does in the normal treatment. The investigator will then replace the wand back to the storage position and notify the patient that the session is completed.

Following completion of 5 sessions, the sham group will be offered to receive up to 5 sessions of real rPMS stimulation. The data from the sham treatment and real rPMS treatment for these patients will be tracked separately.

All patients will receive a home exercise guide and recommended to perform the stated number of repetitions of those exercises. Exercises include Neutral Curl Up with Straight Leg, Plank on Elbow, and Bird Dog positions.
다른 이름들:
  • back pain exercises
  • home physical therapy
  • Neutral Curl Up with Straight Leg
  • Plank on Elbow
  • Bird Dog

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Visual Analog Scale
기간: VAS numbers are obtained at: Baseline, pre-intervention. Immediately before each intervention Immediately after each intervention
Visual Analog Scale or VAS is a common self reported pain measurement scale from 0 - 100 with 0 being pain free and 100 being most pain possible.
VAS numbers are obtained at: Baseline, pre-intervention. Immediately before each intervention Immediately after each intervention

2차 결과 측정

결과 측정
측정값 설명
기간
ODI
기간: Scores are obtained at: Baseline, pre-intervention. Immediately after intervention session 2 Immediately after intervention session 5 Immediately after intervention session 10 for those that elect to opt in for open label portion of study
Oswestry Disability Index (ODI) is a set of questions used to identify participant's functional status as related to activities of daily living.
Scores are obtained at: Baseline, pre-intervention. Immediately after intervention session 2 Immediately after intervention session 5 Immediately after intervention session 10 for those that elect to opt in for open label portion of study

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

  • 연구 책임자: Joe Zhang, MD, United States Air Force

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 7월 1일

기본 완료 (추정된)

2026년 11월 1일

연구 완료 (추정된)

2027년 2월 1일

연구 등록 날짜

최초 제출

2026년 5월 27일

QC 기준을 충족하는 최초 제출

2026년 6월 11일

처음 게시됨 (실제)

2026년 6월 17일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 17일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 11일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • FDG20240078H
  • 23S005 (기타 보조금/기금 번호: 711 HPW Studies and Analysis Branch)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

IPD 계획 설명

measured variables such as VAS and ODI scales for the study along with power tolerated by de-identified individuals using participant ID only can be shared.

IPD 공유 기간

Will be available at the conclusion of data collection (estimated Nov 2026) and be available for up to 2 years (Nov 2028)

IPD 공유 액세스 기준

De-identified data can be made available upon request. Data is stored on secured government systems and cannot be actively reviewed without permission and assistance from investigation team. A formal request needs to be coordinated with the research team to be able to gain access to the data sheets.

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF
  • CSR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

peripheral magnetic stimulation에 대한 임상 시험

구독하다