- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07847034
Comparative Effects of Multiple Angle Isometrics vs Standard Isometric Exercise in Lateral Epicondylitis
Comparative Effects of Multiple Angle Isometrics vs Standard Isometric Exercise in Lateral Epicondylitis:A Randomized Controlled Trial
Lateral Epicondylitis is one of the most common musculoskeletal conditions affecting 1-3% of population.Various terminologies are used to describe the disease like tendinitis of extensor carpi radialis brevis muscle (ECRB), periostitis and radial epicondylitis, lateral epicondylitis is still the most used terminology in literature. Research shows that LE mainly targets population which is active with poor nutrition habits and biomechanical faults thus affecting their job and social life. Pain is seen to be activity dependent and is triggered via excessive muscle activity.
연구 개요
상태
상세 설명
Lateral epicondylitis (tennis elbow) is a frequent musculoskeletal condition, which involves pain, decreased grip strength and functional impairments due to a degeneration of the common extensor tendon. Despite the fact that isometric exercises are widely applied in the conservative treatment of lateral epicondylitis for their analgesic and strengthening properties, the most effective way of isometric training is not known. Multiple Angle Isometric (MAI) exercises are designed to engage a larger number of muscle fibres, increase neuromuscular activation and strengthen muscles across their entire range of motion than single angle isometric exercises.
The objective of this randomized controlled trial is to determine the effectiveness of the Multiple Angle Isometric (MAI) exercise to reduce pain, strengthen the wrist extensor muscles and increase upper limb function in patients with lateral epicondylitis when compared with the Standard Isometric (SI) exercise. The total number of participants is 36 with acute and sub acute lateral epicondylitis and will be sampled by non-probability purposive sampling and divided into two intervention groups by random allocation. All subjects will then be given the same initial treatment (hot pack and Transcutaneous Electrical Nerve Stimulation [TENS]) and then their respective exercise protocols. The intervention will take place three times a week for four weeks.
The Numeric Pain Rating Scale (NPRS) will be used to assess pain intensity, Camry digital hand dynamometer to assess wrist extensor grip strength, and the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire will be used to assess functional disability. Measurements will be taken pre- and post- and post-4 weeks after completion of the intervention. This study's results will give physiotherapists evidence for comparative effectiveness of the Multiple Angle Isometric and Standard Isometric exercise protocols to choose the most effective rehabilitation approach for lateral epicondylitis and optimal patient outcomes.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Punjab Province
-
Islamabad, Punjab Province, 파키스탄, 4000
- Akbar Niazi Teaching Hospital
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
- Inclusion Criteria:
- Adults aged 25-35 years.
- Clinically diagnosed with acute or subacute lateral epicondylitis.
- Patients with ≥3 out of the following 5 positive clinical tests:
- Pain on palpation over the lateral epicondyle.
- Cozen's test positive.
- Mill's test positive.
- Maudsley's test positive.
- Acute or subacute clinical presentation.
- Willing to participate and provide written informed consent.
- Exclusion Criteria:
- Cervical spine disorders.
- Chronic lateral epicondylitis.
- Elbow deformity (fracture, previous surgery, contracture, etc.).
- Diabetes mellitus.
- Steroid injection at the lateral epicondyle within the previous 3 months.
- Rheumatoid arthritis or other neurological or muscular disorders.
- Previous elbow injury.
- Arthritic changes or calcifications around the elbow joint on radiographs. Malignancy.
- Pregnancy.
- Corticosteroid injection to the lateral epicondyle within the previous 6 weeks.
공부 계획
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 |
|---|---|
|
실험적: Group A-Multiple Angle Isometrics (MAI)
Participants will be given baseline treatment with a hot pack and Transcutaneous Electrical Nerve Stimulation (TENS), then the exercises will be therapist-supervised multiple angle isometric wrist extensors at neutral, 15° and 30° wrist extension. There will be 3 sets of 10 repetitions for each exercise with 6-second hold (Weeks 1-2) followed by 12-second hold (Weeks 3-4) with 1-minute rest between sets, 3 times per week, 4 weeks total. |
Baseline treatment with a hot pack and Transcutaneous Electrical Nerve Stimulation (TENS), then the exercises will be therapist-supervised multiple angle isometric wrist extensors at neutral, 15° and 30° wrist extension. There will be 3 sets of 10 repetitions for each exercise with 6-second hold (Weeks 1-2) followed by 12-second hold (Weeks 3-4) with 1-minute rest between sets, 3 times per week, 4 weeks total. |
|
활성 비교기: Group B - Standard Isometric Exercise
Participants will get the same baseline treatment (hot pack and TENS) and then do therapist supervised standard isometric wrist extensor exercises at a single (neutral) wrist position, with the same dosage and frequency (3 sets × 10 repetitions, 6-second hold during Weeks 1-2, 12-second hold during Weeks 3-4, 3 sessions per week for 4 weeks). |
Baseline treatment (hot pack and TENS) and then do therapist supervised standard isometric wrist extensor exercises at a single (neutral) wrist position, with the same dosage and frequency (3 sets × 10 repetitions, 6-second hold during Weeks 1-2, 12-second hold during Weeks 3-4, 3 sessions per week for 4 weeks). |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Numeric Pain Rating Scale (NPRS)
기간: Baseline, Week2 , Week 4
|
Assesses pain intensity using an 11-point numerical scale (0-10). |
Baseline, Week2 , Week 4
|
|
Grip Strength (Camry Digital Hand Dynamometer)
기간: Baseline, 2 Week, 4 Week
|
Assess wrist extensor grip strength using a digital hand dynamometer. |
Baseline, 2 Week, 4 Week
|
|
Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
기간: Baseline, 2 Week, 4 Week
|
Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a standardized tool that relies on patient-reported outcomes to evaluate function and disability in the upper limbs. It includes 30 questions designed to assess how symptoms affect daily tasks and physical abilities. Scores are calculated on a scale from 0 to 100, where higher values reflect more severe disability. |
Baseline, 2 Week, 4 Week
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Maria Fatima Mughees, DPT, Akbar Niazi Teaching Hospital
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. .