Hyaluronic Acid Injection Combined With Rehabilitation for Frozen Shoulder (HA - AC)
Clinical Outcomes of Ultrasound-Guided Intra-Articular Hyaluronic Acid Injection Combined With Rehabilitation in Adhesive Capsulitis: A Randomized Controlled Trial
This randomized controlled trial evaluates the clinical efficacy of ultrasound-guided intra-articular hyaluronic acid injection combined with rehabilitation in patients with adhesive capsulitis (frozen shoulder).
Participants were randomly assigned to either an injection plus rehabilitation group or a rehabilitation-only group. The injection group received ultrasound-guided intra-articular hyaluronic acid once weekly for three weeks, along with a standardized rehabilitation program for six weeks. The control group received the same rehabilitation program without injection.
Clinical outcomes were assessed at multiple time points, including baseline, 4, 6, 8, and 12 weeks. The primary outcome was the change in the Shoulder Pain and Disability Index (SPADI) total score. Secondary outcomes included SPADI pain and disability subscales, as well as shoulder range of motion.
The trial was registered retrospectively at ClinicalTrials.gov (NCT07570095) after study completion due to administrative oversight.
The study was conducted in accordance with the protocol approved by the Tri-Service General Hospital Institutional Review Board (approval no. C202205160) prior to enrollment. The IRB-approved protocol specified the eligibility criteria and outcome measures reported in this record; discrepancies in the initial registry entry have been corrected in this amendment.
연구 개요
상세 설명
Adhesive capsulitis is a common musculoskeletal disorder characterized by progressive pain and restricted range of motion of the shoulder joint, leading to significant functional impairment. Although rehabilitation remains the cornerstone of treatment, the additional benefit of intra-articular hyaluronic acid injection remains controversial.
This randomized controlled trial aimed to evaluate the clinical efficacy of ultrasound-guided intra-articular injection of non-cross-linked hyaluronic acid combined with a structured rehabilitation program in patients with adhesive capsulitis.
Participants were randomly assigned to two groups: an injection plus rehabilitation group and a rehabilitation-only group. The injection group received ultrasound-guided intra-articular hyaluronic acid injections once weekly for three consecutive weeks. Both groups underwent a standardized rehabilitation program twice weekly for six weeks, including range of motion exercises, stretching, and strengthening under the supervision of a physical therapist.
Clinical outcomes were assessed at multiple time points, including baseline, 4, 6, 8, and 12 weeks. The primary outcome measure was the change in the Shoulder Pain and Disability Index (SPADI) total score over time. Secondary outcomes included SPADI pain and disability subscales, as well as shoulder external rotation range of motion.
The trial was registered retrospectively at ClinicalTrials.gov (NCT07570095) after study completion due to administrative oversight.
The study was conducted in accordance with the protocol approved by the Tri-Service General Hospital Institutional Review Board (approval no. C202205160) prior to enrollment. The IRB-approved protocol specified the eligibility criteria and outcome measures reported in this record; discrepancies in the initial registry entry have been corrected in this amendment.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Taipei
-
Taipei, Taipei, 대만, 114
- Tri-Service General Hospital
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Adults aged 40 to 70 years.
- Clinical diagnosis of frozen-phase primary adhesive capsulitis characterized by predominant stiffness as the chief complaint, with symptom duration of at least 3 months, minimal resting pain, and absence of nocturnal pain.
- Limitation of both active and passive shoulder range of motion, particularly in external rotation.
- Ability to understand the study procedures and provide informed consent.
Exclusion Criteria:
- Prior shoulder surgery or fracture on the affected side.
- Rotator cuff tear confirmed by imaging.
- Glenohumeral osteoarthritis or inflammatory joint disease.
- Neurological disorders affecting shoulder function.
- Previous intra-articular injection within the past 3 months.
- Contraindications to hyaluronic acid injection.
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: Hyaluronic Acid Injection + Rehabilitation
Participants receive ultrasound-guided intra-articular injection of non-cross-linked hyaluronic acid (10 mg/mL, once weekly for 3 consecutive weeks) combined with a standardized rehabilitation program consisting of joint mobilization, stretching, and strengthening exercises, performed twice weekly for 6 weeks.
|
Non-cross-linked hyaluronic acid (10 mg/mL) administered via ultrasound-guided intra-articular injection into the affected shoulder joint once weekly for 3 weeks.
Supervised physical therapy program including joint mobilization, stretching, and strengthening exercises, conducted twice weekly for 6 weeks.
|
|
활성 비교기: Rehabilitation Alone
Participants receive a standardized rehabilitation program including joint mobilization, stretching, and strengthening exercises, performed twice weekly for 6 weeks without hyaluronic acid injection.
|
Supervised physical therapy program including joint mobilization, stretching, and strengthening exercises, conducted twice weekly for 6 weeks.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Shoulder Pain and Disability Index (SPADI) Total Score
기간: Baseline, 4 weeks, 6 weeks, 8 weeks, and 12 weeks
|
The SPADI is a validated questionnaire assessing shoulder pain and functional disability, with total scores ranging from 0 to 100.
Higher scores indicate greater impairment.
|
Baseline, 4 weeks, 6 weeks, 8 weeks, and 12 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
SPADI Item - Wearing a Pullover Shirt
기간: Baseline, 4, 6, 8, and 12 weeks
|
Item-level SPADI score for wearing a pullover shirt (requires combined abduction and external rotation), rated 0-10 (0=no difficulty, 10=worst difficulty).
|
Baseline, 4, 6, 8, and 12 weeks
|
|
SPADI Item - Putting on Pants or Shorts
기간: Time Frame: Baseline, 4, 6, 8, and 12 weeks
|
Item-level SPADI score for putting on pants or shorts (requires internal rotation and extension), rated 0-10.
|
Time Frame: Baseline, 4, 6, 8, and 12 weeks
|
|
SPADI Item - Pain on Arm Traction
기간: Time Frame: Baseline, 4, 6, 8, and 12 weeks
|
Item-level SPADI pain score during arm traction of the affected side (reflects capsular tension), rated 0-10.
|
Time Frame: Baseline, 4, 6, 8, and 12 weeks
|
|
Shoulder Range of Motion
기간: Baseline, 4, 6, 8, and 12 weeks
|
Active and passive range of motion of the shoulder (flexion, abduction, external rotation) measured by gravity goniometer by a blinded assessor.
|
Baseline, 4, 6, 8, and 12 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 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. .
Hyaluronic Acid (HA)에 대한 임상 시험
-
National Cancer Centre, SingaporeSingapore General Hospital; Singhealth Duke-NUS Oncology Academic Clinical Programme (ONCO...완전한
-
Yu-Hsiang WuVanderbilt University Medical Center; National Institute on Deafness and Other Communication...완전한