- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07730437
Effects of Clamshell Exercises in Addition to Standardized Physical Therapy in the Management of Patellofemoral Pain Syndrome
Effects of Clamshell Exercises in Addition to Standardized Physical Therapy in the Management of Patellofemoral Pain Syndrome. A Randomized Controlled Trial
This randomized controlled trial aims to evaluate whether adding clamshell exercises to standardized physical therapy provides greater improvements in pain and knee function than standardized physical therapy alone in individuals with patellofemoral pain syndrome (PFPS). PFPS is a common musculoskeletal condition characterized by pain around or behind the kneecap that is aggravated by activities such as stair climbing, squatting, running, and prolonged sitting.
Participants aged 18-45 years with clinically diagnosed PFPS will be randomly assigned to one of two groups. The control group will receive standardized physical therapy consisting of warm-up exercises, stretching, quadriceps and lower-limb strengthening exercises, and cool-down activities. The experimental group will receive the same standardized physical therapy program with the addition of clamshell exercises targeting the gluteus medius and hip external rotator muscles.
Both groups will participate in supervised treatment sessions lasting approximately 45 minutes, three times per week, for four weeks. Pain intensity will be measured using the Numeric Pain Rating Scale (NPRS), and knee function will be assessed using the Kujala Anterior Knee Pain Scale before and after the intervention. The findings of this study may help determine whether incorporating clamshell exercises into routine physiotherapy improves rehabilitation outcomes for patients with PFPS.
연구 개요
상태
상세 설명
Patellofemoral pain syndrome (PFPS) is one of the most common causes of anterior knee pain, affecting both physically active individuals and the general population. The condition is associated with pain during activities that increase patellofemoral joint loading, including squatting, stair climbing, running, jumping, and prolonged sitting. Altered lower-limb biomechanics, particularly weakness of the hip abductors and external rotators, may contribute to excessive femoral internal rotation and dynamic knee valgus, thereby increasing patellofemoral joint stress.
Conventional physiotherapy for PFPS typically includes stretching, quadriceps strengthening, and functional rehabilitation. Although these interventions are beneficial, many patients continue to experience persistent symptoms or recurrence. Recent evidence suggests that strengthening the hip musculature, particularly the gluteus medius, may improve lower-limb alignment and reduce patellofemoral joint stress. The clamshell exercise is a simple, low-cost exercise designed to activate the hip abductors and external rotators and may provide additional clinical benefit when combined with standard physiotherapy.
The purpose of this randomized controlled trial is to determine whether adding clamshell exercises to standardized physical therapy results in greater reductions in pain and improvements in knee function compared with standardized physical therapy alone in patients with PFPS.
Participants aged 18-45 years who meet the American Physical Therapy Association clinical diagnostic criteria for PFPS and have symptoms lasting at least three months with a pain score of 3 or higher on the Numeric Pain Rating Scale (NPRS) will be recruited. Participants with previous knee surgery, significant ligament or meniscal injuries, patellar dislocation, osteoarthritis, lumbar radiculopathy, hip pathology, systemic inflammatory arthritis, recent corticosteroid injection or surgery, neuromuscular disorders, pregnancy, or other exclusion criteria will not be eligible.
Approximately 40 participants will be enrolled using purposive sampling after accounting for potential loss to follow-up. Participants will be randomly allocated into one of two treatment groups:
Control Group: Standardized physical therapy. Experimental Group: Standardized physical therapy plus clamshell exercises.
Both groups will receive equal treatment duration of approximately 45 minutes per session, three sessions per week for four weeks. Standardized physical therapy includes warm-up activities, stretching of the hamstrings, quadriceps, gastrocnemius-soleus complex, and iliotibial band, quadriceps and lower-limb strengthening exercises, and cool-down stretching. The experimental group will additionally perform side-lying clamshell exercises (3 sets of 12-15 repetitions) during each treatment session.
Outcome assessments will be performed at baseline and after completion of the intervention. Pain intensity will be evaluated using the Numeric Pain Rating Scale (NPRS), while knee function will be assessed using the Kujala Anterior Knee Pain Scale. Statistical analyses will be conducted using SPSS version 27. Appropriate parametric or non-parametric tests will be selected based on data distribution, with statistical significance established at p < 0.05.
Ethical approval will be obtained from the Research Ethics Review Committee of Ibadat International University, Islamabad, and permission will be obtained from Alkhidmat Hospital, Peshawar. Written informed consent will be obtained from all participants before enrollment. Participant confidentiality will be maintained throughout the study, and participation will be voluntary with the right to withdraw at any stage without penalty.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
KPK
-
Charsadda, KPK, 파키스탄, 24420
- Tahir general Hospital Charsadda
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Adults aged 18 to 45 years. Male or female participants. Clinically diagnosed with patellofemoral pain syndrome (PFPS) according to the American Physical Therapy Association (APTA) clinical practice guidelines.
Presence of retropatellar or peripatellar pain. Reproduction of retropatellar or peripatellar pain during squatting or other functional activities that load the patellofemoral joint in knee flexion.
Symptoms present for at least 3 months. Pain intensity of ≥3 on the Numeric Pain Rating Scale (NPRS) during aggravating activities.
Able and willing to provide written informed consent and comply with the study procedures.
Exclusion Criteria:
- History of knee surgery, ligament injury, meniscal tear, patellar dislocation, or knee osteoarthritis.
Lumbar radiculopathy, hip pathology, or systemic inflammatory arthritis (e.g., rheumatoid arthritis).
Corticosteroid injection or knee surgery within the previous 3 months. Neuromuscular disorders affecting muscle function (e.g., stroke or Parkinson's disease).
Pregnancy or within 6 months postpartum. Family history of early degenerative joint disease. Any condition that, in the investigator's opinion, would interfere with safe participation or completion of the study.
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: Standardized Physical Therapy (Control)
Participants will receive standardized physical therapy consisting of warm-up exercises, stretching, quadriceps and lower-limb strengthening exercises, and cool-down activities.
Each treatment session will last approximately 35 minutes, three times per week for four weeks.
|
Standardized physical therapy consists of warm-up exercises, stretching of the hamstrings, quadriceps, gastrocnemius-soleus, and iliotibial band, quadriceps and lower-limb strengthening exercises (including static quadriceps exercises, straight leg raises, hip strengthening exercises, and mini-squats), followed by cool-down stretching.
The control group receives this intervention for approximately 35 minutes per session, three sessions per week for four weeks.
다른 이름들:
|
|
실험적: Standardized Physical Therapy + Clamshell Exercises
Participants will receive standardized physical therapy together with side-lying clamshell exercises targeting the gluteus medius and hip external rotator muscles.
Treatment sessions will last approximately 45 minutes, three times per week for four weeks.
The only additional intervention compared with the control group is the inclusion of clamshell exercises.
|
Participants perform side-lying clamshell exercises to strengthen the gluteus medius and hip external rotator muscles.
The exercise is performed as 3 sets of 12-15 repetitions under physiotherapist supervision.
This intervention is added to standardized physical therapy in the experimental group, resulting in a total treatment time of approximately 45 minutes per session, three sessions per week for four weeks.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Pain Intensity Measured by the Numeric Pain Rating Scale (NPRS)
기간: Baseline and Week 4 (end of intervention)
|
Pain intensity will be assessed using the 11-point Numeric Pain Rating Scale (NPRS), where 0 indicates no pain and 10 indicates the worst imaginable pain.
The primary outcome is the change in NPRS score from baseline to the end of the intervention.
|
Baseline and Week 4 (end of intervention)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Knee Function Measured by the Kujala Anterior Knee Pain Scale
기간: Baseline and Week 4 (end of intervention)
|
Knee function will be evaluated using the Kujala Anterior Knee Pain Scale, a validated patient-reported outcome measure assessing symptoms and functional limitations associated with patellofemoral pain syndrome.
The secondary outcome is the change in Kujala score from baseline to the end of the intervention.
|
Baseline and Week 4 (end of intervention)
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Dr Muhammad Nazim Farooq Dean, Phd, Ibadat International University, Islamabad
간행물 및 유용한 링크
일반 간행물
- Neal BS, Lack SD, Lankhorst NE, Raye A, Morrissey D, van Middelkoop M. Risk factors for patellofemoral pain: a systematic review and meta-analysis. Br J Sports Med. 2019;53(5):270-81. 2. Lack S, Barton C, Sohan O, Crossley K, Morrissey D. Proximal muscle rehabilitation is effective for patellofemoral pain: a systematic review with meta-analysis. Br J Sports Med.2015;49(21):1365-76. 3. Rathleff MS, Roos EM, Olesen JL, Rasmussen S. Exercise during school hours when added to patient education improves outcome for 2 years in adolescent patellofemoral pain: a cluster randomised trial. Br J Sports Med. 2015;49(6):406-12. 4. Bolgla LA, Boling MC. An update for the conservative management of patellofemoral pain syndrome: a systematic review of the literature from 2000 to 2010. Int J Sports Phys Ther. 2011;6(2):112-25. 5. Powers CM. The influence of abnormal hip mechanics on knee injury: a biomechanical perspective. J Orthop Sports Phys Ther. 2010;40(2):42-51. 6. Ferber R, Bolgla L, Earl-Boehm JE, Emery C, Hamstra-Wright K. Strengthening of the hip and core versus knee muscles for the treatment of patellofemoral pain: a multicenter randomized controlled trial. J Athl Train. 2015;50(4):366-77. 7. Khayambashi K, Fallah A, Movahedi A, Bagwell J, Powers C. Posterolateral hip muscle strengthening versus quadriceps strengthening for patellofemoral pain: a comparative control trial. Arch Phys Med Rehabil. 2014;95(5):900-7. 8. Santos TR, Oliveira BA, Ocarino JM, Holt KG, Fonseca ST. Effectiveness of hip muscle strengthening in patellofemoral pain syndrome patients: a systematic review. Braz J Phys Ther. 2015;19(3):167-76. 9. Kamel AM, Ghuiba K, Abd Allah DS, Fayaz NA, Abdelkader NA. Effect of adding short foot exercise to hip and knee focused exercises in treatment of patients with patellofemoral pain syndrome: a randomized controlled trial. J Orthop Surg Res. 2024;19(1):207. 10. Alammari A, Spence N, Narayan A, Karnad SD, Ottayil ZC. Effect of hip abductors and lateral rotators' mu
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- IIUI/RERC/ADT/2026/O2/229
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. .