Effectiveness of Pressure Biofeedback-Assisted Deep Cervical Flexor Training With and Without Scapular Stabilization Exercises on Pain, Range of Motion and Neck Disability in Cervical Spondylosis
2026년 9월 7일 업데이트: Ibadat International University, Islamabad
This randomized controlled trial will evaluate the effectiveness of pressure biofeedback-assisted deep cervical flexor training with and without scapular stabilization exercises in patients with cervical spondylosis.
The study will compare the effects of the two treatment approaches on pain intensity, cervical range of motion and neck disability.
연구 개요
상태
상태
모병
정황
정황
개입 / 치료
개입 / 치료
상세 설명
Participants with radiologically confirmed cervical spondylosis will be recruited according to predefined inclusion and exclusion criteria. A total of 44 participants will be recruited, with 22 participants allocated to each group after accounting for an anticipated 10% loss to follow-up.
Participants will be randomly allocated using the sealed envelope method into two groups. Group A will receive pressure biofeedback-assisted deep cervical flexor training combined with scapular stabilization exercises and standard physiotherapy. Group B will receive pressure biofeedback-assisted deep cervical flexor training without scapular stabilization exercises, along with standard physiotherapy.
Treatment will be provided three times per week for four weeks, with each session lasting approximately 30-40 minutes. Outcomes will be assessed at baseline and after completion of the four-week intervention.
연구 유형
연구 유형
중재적
등록 (추정된)
등록
44
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Aqsa Anwar
- 전화번호: 0321-5172551
- 이메일: aqsaanwer.pt@gmail.com
연구 장소
-
-
Punjab Province
-
Rawalpindi, Punjab Province, 파키스탄
- 모병
- Hope Physiotherapy Clinic
-
연락하다:
- Nida Khan
- 전화번호: 0331-0404000
- 이메일: knida816@gmail.com
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Both genders aged 40-60 years.
- Presence of chronic neck pain for ≥3 months with NPRS ≥3.
- Radiologically confirmed cervical spondylosis, including cervical spine X-ray showing disc space narrowing and/or osteophyte formation.
- Ability to perform active cervical and shoulder movements without neurological deficits.
- Willingness to participate in the study and comply with the intervention protocol.
Exclusion Criteria:
- History of cervical spine surgery or trauma in the past 6 months.
- Severe neurological involvement, including cervical myelopathy or severe radiculopathy with motor weakness, gait disturbance, or bowel/bladder involvement.
- Inflammatory or systemic musculoskeletal disorders, e.g., rheumatoid arthritis or ankylosing spondylitis.
- Current participation in structured neck/shoulder rehabilitation programs.
- Uncontrolled medical conditions contraindicating exercise, e.g., uncontrolled hypertension or cardiovascular disease.
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: 하나의
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Group A: Pressure Biofeedback-Assisted Deep Cervical Flexor Training + Scapular Stabilization Exerci
|
Deep cervical flexor training will be performed using a pressure biofeedback unit to facilitate selective activation and improve the strength and endurance of the deep cervical flexor muscles, particularly the longus colli and longus capitis.
The participant will be positioned in supine lying with the hips and knees comfortably flexed, and the pressure biofeedback cuff will be placed beneath the cervical spine at approximately the C4-C5 level.
The cuff will be inflated to a baseline pressure of 20 mmHg.
The participant will be instructed to perform a gentle cranio-cervical flexion movement by slowly nodding the head and drawing the chin inward while maintaining contact of the head with the treatment surface.
The pressure will be gradually increased to the prescribed target while avoiding head lifting, excessive cervical flexion, jaw clenching, shoulder elevation, or compensatory activation of the superficial cervical muscles.
The target pressure will be 22 mmHg during the first week, 2
Scapular stabilization exercises will be performed progressively to improve scapular control, postural alignment, and the strength and endurance of the scapular stabilizing muscles.
During the first week, scapular retraction and depression exercises will be performed in sitting for 3 sets of 10 repetitions with a 5-second hold and 60 seconds rest between sets.
During the second week, scapular retraction will be progressed using light TheraBand resistance for 3 sets of 10 repetitions with controlled movement and 60 seconds rest between sets.
During the third week, wall slides and prone Y and T raises will be introduced and performed for 3 sets of 8-10 repetitions with controlled movement and 30-60 seconds rest between sets.
During the fourth week, scapular stabilization exercises will be progressed with shoulder flexion and abduction while maintaining appropriate scapular control, performed for 3 sets of 10 repetitions with 30-60 seconds rest between sets.
All exercises will be performe
Standard physiotherapy will include therapeutic exercises and postural management techniques aimed at reducing pain, improving cervical mobility, flexibility, and functional performance.
Cervical range-of-motion exercises including flexion, extension, lateral flexion, and rotation will be performed within a pain-free range for 10 repetitions in each direction.
Stretching exercises for the upper trapezius, levator scapulae, and pectoral muscles will be performed for 20-30 seconds for 3 repetitions.
Cervical isometric strengthening exercises including flexion, extension, and lateral flexion will be performed with a 5-10-second hold for 10 repetitions.
Postural education and ergonomic advice will also be provided, including instructions regarding proper sitting posture, appropriate head and neck positioning, and avoidance of prolonged static postures.
Standard physiotherapy will be provided for approximately 10-15 minutes per session, three times weekly for four consecutive weeks.
|
|
활성 비교기: Group B: Pressure Biofeedback-Assisted Deep Cervical Flexor Training + Standard Physiotherapy
|
Deep cervical flexor training will be performed using a pressure biofeedback unit to facilitate selective activation and improve the strength and endurance of the deep cervical flexor muscles, particularly the longus colli and longus capitis.
The participant will be positioned in supine lying with the hips and knees comfortably flexed, and the pressure biofeedback cuff will be placed beneath the cervical spine at approximately the C4-C5 level.
The cuff will be inflated to a baseline pressure of 20 mmHg.
The participant will be instructed to perform a gentle cranio-cervical flexion movement by slowly nodding the head and drawing the chin inward while maintaining contact of the head with the treatment surface.
The pressure will be gradually increased to the prescribed target while avoiding head lifting, excessive cervical flexion, jaw clenching, shoulder elevation, or compensatory activation of the superficial cervical muscles.
The target pressure will be 22 mmHg during the first week, 2
Standard physiotherapy will include therapeutic exercises and postural management techniques aimed at reducing pain, improving cervical mobility, flexibility, and functional performance.
Cervical range-of-motion exercises including flexion, extension, lateral flexion, and rotation will be performed within a pain-free range for 10 repetitions in each direction.
Stretching exercises for the upper trapezius, levator scapulae, and pectoral muscles will be performed for 20-30 seconds for 3 repetitions.
Cervical isometric strengthening exercises including flexion, extension, and lateral flexion will be performed with a 5-10-second hold for 10 repetitions.
Postural education and ergonomic advice will also be provided, including instructions regarding proper sitting posture, appropriate head and neck positioning, and avoidance of prolonged static postures.
Standard physiotherapy will be provided for approximately 10-15 minutes per session, three times weekly for four consecutive weeks.
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Neck Disability - Neck Disability Index (NDI)
기간: Baseline and after 4 weeks of treatment.
|
Measure: Functional disability related to neck pain measured using the Neck Disability Index.
|
Baseline and after 4 weeks of treatment.
|
|
Pain Intensity - Numeric Pain Rating Scale (NPRS)
기간: Baseline and after 4 weeks of treatment
|
Neck pain intensity measured using the 0-10 Numeric Pain Rating Scale
|
Baseline and after 4 weeks of treatment
|
|
Universal Goniometer
기간: Baseline and after 4 weeks of treatment.
|
Measure Cervical Range of Motion - Cervical flexion, extension, right/left lateral flexion and right/left rotation
|
Baseline and after 4 weeks of treatment.
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
The Neck Flexor Endurance Test
기간: Baseline and after 4 weeks of treatment
|
Measure cervical flexor muscle endurance
|
Baseline and after 4 weeks of treatment
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- • Tsiringakis G, Dimitriadis Z, Triantafylloy E, McLean S. Motor control training of deep neck flexors with pressure biofeedback improves pain and disability in patients with neck pain: a systematic review and meta-analysis. Musculoskeletal Science and Practice. 2020;50:102220. • Saleh MSM, Rehab NI, Sharaf MAF. Effect of deep cervical flexors training on neck proprioception, pain, muscle strength and dizziness in patients with cervical spondylosis: A randomized controlled trial. Phys Ther Rehabil. 2018;5(1):14. • Fatima I, Ashraf A, Khalid K. Effectiveness of thoracic manipulation versus scapular stabilization exercises on pain and functional disability in cervical spondylosis. Journal of Nursing and Allied Health. 2024;2(01). • Ashfaq R, Riaz H. Effect of Pressure biofeedback training on deep cervical flexors endurance in patients with mechanical neck pain: A randomized controlled trial. Pakistan Journal of Medical Sciences. 2021;37(2):550. • Modarresi S, et al. A systematic review and synthesis of psychometric properties of the numeric pain rating scale and the visual analog scale for use in people with neck pain. The Clinical Journal of Pain. 2022;38(2):132-148.
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 (실제)
연구 시작
2026년 6월 3일
기본 완료 (추정된)
기본 완료
2026년 9월 15일
연구 완료 (추정된)
연구 완료
2026년 9월 24일
연구 등록 날짜
최초 제출
최초 제출
2026년 9월 7일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 9월 7일
처음 게시됨 (실제)
처음 게시됨
2026년 9월 11일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 9월 11일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 7일
마지막으로 확인됨
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- IIUI/RERC/ADT/2026/06/342
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
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. .