Effects of lymphatic drainage therapy on autonomic nervous system, pain, edema and physical function in individual early stage knee osteoarthritis: a clinical controlled trial

Phase 3

Recruiting

• Conditions: Healthy participantsEarly stage knee osteoarthritis; early knee osteoarthritis; lymphatic drainage; autonomic nervous system; physical function

• Registration Number: TCTR20190424004
• Lead Sponsor: /A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-24
• Study Completion: 2020-04-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

Study I
1. Male or female age between 40-65 years
2. Recreationally active

Study II
1. Male or female age between 40-65 years
2. Diagnosed as knee osteoarthritis stage I or II, graded by using American College of Rheumatology (ACR) clinical classification

Exclusion Criteria

Study I
1. Renal dysfunction
2. Competitive athlete
3. Active cancer or malignant tumor
4. Body mass index (BMI) more than 24 kg/m2
5. Having cardiovascular or peripheral vascular disorder such as acute angina, heart attack and congestive heart failure which may not control cardiac load increasing
6. Having musculoskeletal disorder such as knee osteoarthritis which can affect lymph flow
7. Pain or any operation at the area which affects lymph flow such as abdominal operation and total knee arthroplasty
8. Having musculoskeletal, neurological, or cardiovascular problem that interferes with the study

Study II
1. Renal insufficiency
2. Rheumatoid arthritis (RA)
3. Abnormal skin sensation
4. Skin lesion on the knee joints
5. Active cancer or malignant tumor
6. Body mass index (BMI) more than 24 kg/m2
7. Having cardiovascular or peripheral vascular disorder such as acute angina, heart attack and congestive heart failure which may not control cardiac load increasing
8. Using anti-inflammation medication or intra-articular injection within the last 6 months
9. Pain or any operation at the area which affects lymph flow such as abdominal operation
10. Having musculoskeletal, neurological, or cardiovascular problem that interferes with study such as leg length discrepancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Heart rate variability (HRV) Pre and post intervention Polar H7 and Elite HRV smartphone application ,Salivary alpha amylase (sAA) Pre and post intervention Portable salivary amylase monitor, Range of motion (ROM) Pre and post intervention Straight raise leg (SLR) ,Hoffmann reflex (H-reflex) Pre and post intervention Electrical stimulator and surface electromyography ,Pain scale Pre and post intervention Visual Analog Scale (VAS) ,Pressure pain threshold test (PPT) Pre and post intervention Pressure pain threshold algometry,Displacement pain tissue (DPS) Pre and post intervention An algometer probe and synchronizing the end pressure with the light signal,Circumference Pre and post intervention Tape measure , Function activities Pre and post intervention Thai Knee Injury and Osteoarthritis Outcome Score (KOOS) ,Physical functional Pre and post intervention Six-minute walk test

Secondary Outcome Measures

Name	Time	Method
/A N/A N/A