- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07691151
Targeted Cervical Versus Integrated Trunk and Diaphragmatic Muscle Retraining for Chronic Mechanical Neck Pain (INT-CMNP)
Comparison of Targeted Cervical Versus Integrated Trunk and Diaphragmatic Muscle Retraining on Pain and Disability in Chronic Neck Pain: A Randomized Clinical Trial
Persistent pain, functional disability, cervical motor control deficit, and abnormal posture are associated with chronic mechanical neck pain. This study aimed to evaluate the efficacy of an integrated physiotherapy program of cervical motor control training, lumbopelvic stabilization, diaphragmatic breathing exercises, and pressure biofeedback versus conventional cervical physiotherapy in patients with chronic mechanical neck pain through a randomized controlled trial.
40 eligible participants were randomly assigned to the experimental or control group. The two groups were all given supervised physiotherapy three times a week for 6 weeks plus a standardized home exercise program. The main aim was to investigate the efficacy of the interventions on pain intensity and neck related disability. Secondary outcomes were CROM, DCFE, head position, and patient perceived recovery. Outcome measures were conducted at both baseline and the end of the six-week intervention.
연구 개요
상세 설명
Chronic mechanical neck pain is one of the most prevalent musculoskeletal conditions and is related to ongoing pain, diminished cervical movement, poor neck muscle control, poor posture, and diminished functional ability. Conventional physiotherapy emphasizes the mobility, strengthening, stretching and postural correction of the cervical region. Recent research indicates that cervical motor control, trunk stabilization and respiratory training may be beneficial when integrated into a rehabilitation program, as multiple aspects of spinal stability and motor control can be targeted.
The study was designed as a single center, parallel-group, assessor-blinded randomized controlled trial, to compare the effectiveness of integrated physiotherapy program to conventional cervical physiotherapy in subjects with chronic mechanical neck pain.
Participants were recruited from the outpatient physiotherapy department of Thumbay Physical Therapy and Rehabilitation Hospital, Ajman, UAE, where they met the inclusion criteria for having mechanical neck pain with a duration of at least three months. After obtaining informed consent, participants were allocated by a computer-generated random sequence in a 1:1 ratio to either the experimental or control group, with allocation concealed.
The experimental group received an integrated rehabilitation program that included cervical motor control training with pressure biofeedback, lumbopelvic stabilization exercises, diaphragmatic breathing exercises and traditional physiotherapy interventions as clinically needed. The control group received conventional cervical physiotherapy which included cervical range of motion exercises, isometric strengthening, stretching, scapulothoracic strengthening, proprioceptive training, postural exercises, and other standard physiotherapy treatment. Both groups underwent supervised treatment three times a week for six weeks and an identical home exercise program during the intervention.
The primary outcome measures included intensity of pain (Numeric Pain Rating Scale [NPRS]) and neck-related disability (Neck Disability Index [NDI]). Secondary outcome measures were the cervical range of motion, deep cervical flexor endurance, craniovertebral angle for head posture and the Global Rating of Change (GROC). Assessment of outcomes was conducted at baseline and at the end of the six-week interventions by an assessor who was not aware of the allocation of the interventions.
This study aimed to evaluate the effectiveness of an integrated physiotherapy approach including cervical motor control training, lumbopelvic stabilization, diaphragmatic breathing exercises, and pressure biofeedback in comparison to a conventional cervical physiotherapy approach for reduction of pain, disability, and cervical function and postural control in patients with chronic mechanical neck pain.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Ajman Emirate
-
Ajman, Ajman Emirate, 아랍 에미리트
- Thumbay Physical Therapy & Rehabilitation Hospital
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Age in the range 18-60 years.
- CNMP (lasting more than 3 months).
- NPRS score ≥ 3.
- Head Impact Test (HIT-6) score < 50.
- Absence of clinical signs of cervical radiculopathy.
- Capacity to comprehend study procedures, follow directions for exercising and sign informed consent in writing.
- Diaphragmatic function impairment by the DNS diaphragm test with asymmetric or inadequate rib expansion laterally, high elevation of upper chest or shoulder girdle and diminished truncal stabilization during inhalation.
Exclusion Criteria:
- Participants were excluded if they had cervical radiculopathy, cervical myelopathy, previous cervical spine surgery, spinal fracture, inflammatory arthritis, malignancy, neurological disorders, pregnancy, or any other serious spinal pathology that would make it difficult for the participant to participate in the rehabilitation programme. People with cognitive deficits or any medical condition which hampered their safe involvement in the exercise programme were also excluded.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Integrated Physiotherapy
Participants were treated with a comprehensive physiotherapy intervention that included cervical motor control exercises with pressure biofeedback, lumbopelvic stabilization exercises, diaphragmatic breathing exercises, and additional physiotherapy interventions as clinically necessary.
Three times per week for 6 weeks.
In addition, a standardized home exercise program was performed during the intervention.
|
Participants were given an integrated physiotherapy program which comprised motor control training for the cervical spine with pressure biofeedback, lumbopelvic stabilization exercises, diaphragmatic breathing exercises, and a standardized home exercise program.
Three treatment sessions per week for six weeks were conducted under supervision.
|
|
활성 비교기: Conventional Physiotherapy
All participants underwent conventional cervical physio, which included cervical range of motion exercises, cervical isometric strengthening, upper trapezius and levator scapulae and pectoral muscles stretching, scapulothoracic strengthening, proprioceptive training, postural correction exercises and intermittent cervical traction as clinically indicated.
Treatment was given three times a week for 6 weeks.
A standardized home exercise program was also performed by the participants during the intervention period.
|
Conventional cervical physiotherapy included cervical range-of-motion exercises, isometric strengthening, stretching, scapulothoracic strengthening, proprioceptive training, postural exercises, and a standardized home exercise program.
Supervised treatment was provided three times per week for six weeks.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Neck Disability
기간: Baseline and 6 weeks
|
Neck-related disability will be assessed using the NDI.
Higher scores indicate greater disability.
|
Baseline and 6 weeks
|
|
Pain Intensity
기간: Baseline and 6 weeks
|
Pain intensity will be assessed using the NPRS.
The NPRS is an 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain).
Lower scores indicate reduced pain intensity.
|
Baseline and 6 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Cervical Range of Motion
기간: Baseline and 6 weeks
|
Cervical range of motion will be measured in flexion, extension, rotation, and lateral flexion using standard clinical assessment procedures.
|
Baseline and 6 weeks
|
|
Deep Cervical Flexor Endurance
기간: Baseline and 6 weeks
|
Deep cervical flexor muscle endurance will be assessed using a standardized endurance test.
|
Baseline and 6 weeks
|
|
Head Posture
기간: Baseline and 6 weeks
|
Forward head posture will be assessed by measuring the craniovertebral angle.
|
Baseline and 6 weeks
|
|
Global Rating of Change
기간: 6 weeks
|
Participant-perceived overall improvement will be assessed using the GROC scale.
|
6 weeks
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- COHSSTD32Jan2026
- RB-COHS-STD-32-Jan-2026 (기타 식별자: Gulf Medical University, Ajman)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .