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A Comparison of Two Thoracic Manipulation Techniques to Improve Neck Pain

2018년 3월 9일 업데이트: Tarang Jain, Northern Arizona University

A Comparison of Two Thoracic Manipulation Techniques to Improve Neck Pain: A Randomized Control Trial

The purpose of this study is to compare the short-term effects of two different thoracic spine thrust manipulation techniques on neck range-of-motion, pain, and self-reported disability in individuals experiencing neck pain.

연구 개요

상세 설명

The study will be conducted at the Musculoskeletal clinical facility in the Dept. of Physical Therapy and Athletic Training, Northern Arizona University, Flagstaff AZ. The investigators aim to test a maximum of 76 participants in this study. A phone screening will determine initial eligibility. If the participant meets the inclusion criteria and is not excluded after the phone screen, an appointment will be scheduled. Final eligibility will be determined in the initial session after the participant completes the outcome measures and is evaluated by a licensed physical therapist.

Participants will be involved in the study over a 4 week period. Each participant will be asked to attend 4 sessions, with one week in between each session as follows: Week 0 = baseline assessment and treatment 1; Week 1= treatment 2; Week 2 = treatment 3; and week 4 = follow-up assessment.

After completion of the baseline assessment, qualified participants will be randomly assigned to either a supine or prone thoracic spine thrust manipulation intervention.

연구 유형

중재적

등록 (예상)

76

단계

  • 해당 없음

연락처 및 위치

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

연구 장소

    • Arizona
      • Flagstaff, Arizona, 미국, 86011
        • Northern Arizona University

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

20년 (성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Between 20 and 50 years of age (inclusive)
  • Primary complaint of neck pain with or without symptoms that spread down into one arm
  • Overall rating of neck pain intensity is at least 3/10; the overall rating is the average of the participant's rating of current, least, and worst pain experienced over the previous 24 hours on separate numeric pain rating scales where 0 corresponds to "no pain" and 10 corresponds to "worst possible pain"
  • Neck Disability Index (NDI) score > 10 points (measure of self-reported disability with a 0 to 50-point scale where higher scores indicate higher levels of disability)
  • Proficient in speaking and reading English to complete outcome questionnaires

Exclusion Criteria:

  • Neck pain related to a motor vehicle accident or other trauma within the previous 6 weeks
  • Neck pain that spreads down into both arms
  • Low back pain or thoracic origin of pain
  • Nerve root involvement; defined as the presence of two or more neurological findings (e.g., decreased strength, diminished deep tendon reflex, or decreased sensation) at the same nerve root level
  • Diagnosis of cervical spinal stenosis (narrowing of the central canal that contains the spinal cord)
  • History of spinal tumors, spinal infection, cervical spine fracture, or previous neck surgery
  • Pending legal action related to current episode of neck pain
  • Contraindications to thoracic spine thrust manipulation

    1. serious pathologies or conditions (tumor, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis, history of prolonged steroid use)
    2. hyperreflexia
    3. unsteadiness during gait
    4. nystagmus
    5. loss of visual acuity
    6. impaired sensation of the face
    7. altered taste
    8. the presence of pathological reflexes
    9. pregnancy or considering pregnancy

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: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Supine thoracic spine manipulation
Supine thoracic spine thrust manipulation (lying face-up on the treatment table) will be given 2 times at 3 treatment sessions (Weeks 0, 1, and 2)
The participant will be positioned so that small amplitude quick stretch can be applied to the least mobile area of the thoracic spine that is identified during the spinal segmental mobility testing. The thoracic spine thrust manipulation will be applied at an appropriate range of motion as identified by the clinician.
활성 비교기: Seated thoracic spine manipulation
Seated thoracic spine thrust manipulation will be given 2 times at 3 treatment sessions (Weeks 0, 1, and 2).
The participant will be positioned so that small amplitude quick stretch can be applied to the least mobile area of the thoracic spine that is identified during the spinal segmental mobility testing. The thoracic spine thrust manipulation will be applied at an appropriate range of motion as identified by the clinician.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Numerical Pain Rating Scale (NPRS)
기간: Change in NPRS scores at different time points (Baseline (Week 0) during initial visit before 1st treatment, Week 1, Week 2, and Week 3)
Each participant's neck pain intensity will be assessed by use of the Numeric Pain Rating Scale (NPRS of 0-10)
Change in NPRS scores at different time points (Baseline (Week 0) during initial visit before 1st treatment, Week 1, Week 2, and Week 3)
Neck Range of Motion
기간: Change in Neck ROM at different time points (Baseline (Week 0) during initial visit before 1st treatment, Week 1, Week 2, and Week 3)
Cervical range of motion measured with the Goniometer
Change in Neck ROM at different time points (Baseline (Week 0) during initial visit before 1st treatment, Week 1, Week 2, and Week 3)
Neck Disability Index (NDI)
기간: Change in NDI at different time points (Baseline (Week 0) during initial visit before 1st treatment, Week 1, Week 2, and Week 3)
The Neck Disability Index (NDI) is a self-reported measure of disability consisting of a 0-50 point scale where higher scores indicate higher levels of disability
Change in NDI at different time points (Baseline (Week 0) during initial visit before 1st treatment, Week 1, Week 2, and Week 3)
Shortened version of the Disabilities of the Arm, Shoulder, and Hand questionnaire (Quick DASH)
기간: Change in QuickDASH scores at different time points (Baseline (Week 0) during initial visit before 1st treatment, Week 1, Week 2, and Week 3)
The shortened version of the Disabilities of the Arm, Shoulder, and Hand (Quick DASH) questionnaire is a self-report measure of function that can assess how neck pain may be impacting daily activities that require use of the upper limb
Change in QuickDASH scores at different time points (Baseline (Week 0) during initial visit before 1st treatment, Week 1, Week 2, and Week 3)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: John Heick, PT, PhD, DPT, Northern Arizona University

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

2016년 11월 1일

기본 완료 (예상)

2018년 11월 1일

연구 완료 (예상)

2018년 11월 1일

연구 등록 날짜

최초 제출

2016년 11월 17일

QC 기준을 충족하는 최초 제출

2016년 11월 22일

처음 게시됨 (추정)

2016년 11월 23일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 3월 13일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 3월 9일

마지막으로 확인됨

2018년 3월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 962801-1

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

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. .

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