| CTRI Number |
CTRI/2013/02/003402 [Registered on: 18/02/2013] Trial Registered Prospectively |
| Last Modified On: |
06/02/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
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Type of Study
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Other (Specify) [Elastic taping] |
| Study Design |
Randomized, Crossover Trial |
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Public Title of Study
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A Study to evaluate the Efficacy and Tolerability of ActiTape in Patients with Pain in Knee Joint due to Mild to Moderate Osteoarthritis |
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Scientific Title of Study
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An Exploratory, Randomized, Open Label, Controlled, Cross over Study to Investigate the Efficacy and Tolerability of ActiTape in Patients with Pain in Knee Joint due to Mild to Moderate Osteoarthritis |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NW/ 120706 / AT/ OA Version: 1.0 Date: 07.01.2013 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
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| Name |
Dr Navneet Sonawane |
| Designation |
Manager-Clinical operation |
| Affiliation |
Vedic Lifesciences Pvt Ltd |
| Address |
Vediclifesciences Pvt Ltd
118,B Morya House
Opp new link road, Andheri west
Mumbai
MAHARASHTRA
400053
India |
| Phone |
02242025706 |
| Fax |
66941179 |
| Email |
navneet.s@vediclifesciences.com |
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Details of Contact Person
Public Query
|
| Name |
Dr Navneet Sonawane |
| Designation |
Manager-Clinical operation |
| Affiliation |
Vedic Lifesciences Pvt Ltd |
| Address |
118,B Morya House
Opp new link road, Andheri west
Mumbai
MAHARASHTRA
400053
India |
| Phone |
02242025706 |
| Fax |
66941179 |
| Email |
navneet.s@vediclifesciences.com |
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Source of Monetary or Material Support
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| Vedic Lifescienes Pvt Ltd |
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Primary Sponsor
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| Name |
Nutriworks Limited |
| Address |
Unit 6C, Gold King Industrial Building
35-41 Tai Lin Pai Road, Kowloon
Hong Kong
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| Type of Sponsor |
Other [Nutraceutical company] |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Narayan Karne |
karne Multipseciality Hospital |
Near Laxminarayn Theater, Satara road, Swargate, Pune. Pin: 411037
Pune
MAHARASHTRA |
9822036724
020-24265148
njk@hotmail.com |
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INDEPENDENT ETHICS COMMITTEE (Dhanashree Hospital)-Dr. Karne |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
Mild to Moderate Knee Osteoarthritis, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
Actitape |
ActiTape or knee guard group in ratio of 1:1 at Baseline. Patients would continue using ActiTape or knee guard for a period of 6 days. This would be followed by a wash-out for 1 day, after which the groups of patients would be crossed over to receive the other therapy for another 6 days. Screening variables will be assessed at Day -5 and informed consent will be recorded. Physical examination, recording of medical history and safety monitoring will be performed on all visits. Efficacy assessments will be conducted on Days 0, 3 and 6 in the Treatment Period 1 and on Days 8, 11 and 14 in Treatment Period 2. |
| Comparator Agent |
Kneeaid |
ActiTape or knee guard group in ratio of 1:1 at Baseline. Patients would continue using ActiTape or knee guard for a period of 6 days. This would be followed by a wash-out for 1 day, after which the groups of patients would be crossed over to receive the other therapy for another 6 days. Screening variables will be assessed at Day -5 and informed consent will be recorded. Physical examination, recording of medical history and safety monitoring will be performed on all visits. Efficacy assessments will be conducted on Days 0, 3 and 6 in the Treatment Period 1 and on Days 8, 11 and 14 in Treatment Period 2. |
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Inclusion Criteria
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| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Ambulatory adult patients of either sex aged 30-65 years.
2. Patients with moderate OA of the knee, which can be clinically, categorized as ARA functional Class II and III and with radiological confirmation of Kellgren Lawrence Grade II and III.
3. Patient’s functional assessment of overall pain score should be ≥ 50 mm on a 100 mm VAS for pain at baseline visit.
4. Patients receiving a stable dose of oral calcium or chondrogenic supplements for at least past 1 month and/or a stable dose of NSAIDs for the past 1 week will be eligible for inclusion
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| ExclusionCriteria |
| Details |
1. Patients of any form of arthritis other than osteoarthritis.
2. Arthroscopy of either knee in the past year.
3. Administration of intra-articular or oral steroids in the past 3 month or intra articular hyaluronic acid in the last 9 months or parenteral use of NSAIDs.
4. Patients requiring immediate surgery for knee.
5. Pregnant / lactating women and women who are planning to get pregnant
6. Recent ( 3 months) participation in a clinical study
7. History of major chronic hepatic, cardiovascular, neurological or immunosuppressive conditions or the presence of any infections
8. Patients with a risk of Deep Vein Thrombosis (DVT) as depicted by a score of ≥3 on the Well’s questionnaire
9. Patients with localized trauma to the lower limb
10. Dermatological conditions affecting the lower limb
11. History of skin irritation on application of bandages/tapes
12. A psychiatric condition, chronic alcohol or drug abuse problem as evidenced by withdrawal symptoms
13. Patients otherwise judged by the investigator to be inappropriate for inclusion in the study
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Not Applicable |
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Blinding/Masking
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Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
1.Pain - Visual analogue scale (VAS)
2.Time up-and-go test,
Patients’ and Investigator global assessment
3.Unilateral anterior reach test.
4.Medial step-down test |
At Day 0,Day 3,Day 6,Visit 5,Day 8,Day 11 and Day 14
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Secondary Outcome
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| Outcome |
TimePoints |
| none |
none |
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Target Sample Size
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Total Sample Size="14"
Sample Size from India="14"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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Phase 2 |
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Date of First Enrollment (India)
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25/02/2013 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
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Years="0"
Months="2"
Days="0" |
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Recruitment Status of Trial (Global)
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Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
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None |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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The study will be conducted in two phases. First phase will be of 6 days followed by 7 days wash out and then eligible patient will entr into second phase of study which is of again 7 days treatment to assess the efficacy and tolerability of ActiTape in Patients with pain in knee joint due to mild to moderate osteoarthritis. Below is a visist soecific schedule:
Screening (Day -5, Visit 1)
Informed consent
- Patients would be thoroughly explained in their local language, the entire design of the study and the activities to be performed throughout the study. Patients’ written, dated and signed informed consent would be obtained
- Patients will be administered the Well’s questionnaire for assessing their DVT risk status and those with a DVT probability score of ≥3, will be excluded from the study
- Patients will be screened as per ARA functional classification of OA based upon clinical examination and investigator’s judgement.
- Pain VAS assessments for the signal knee joint to exclude patients with a pain VAS score higher than 50 mm on a 100 mm VAS.
- Medical history will be recorded and a thorough physical examination will be conducted.
- Patients will be sent for digital radiographs of the affected joint.
Visit 2, Day 0, Treatment Period 1 (Baseline)
- Based on the results of the digital radiographs, patients will be classified as per Kellgren Lawrence classification and only Grade II and III patients will be considered eligible.
- Pain VAS measurements will be repeated on Day 0 to check for the inclusion criterion of higher than 50 mm pain on a 100 mm VAS.
- After confirming the Kellgren Lawrence and VAS score of the patients, the patients would be randomized in a 1:1 ratio to receive either ActiTape or the knee guard.
- Recording of medical history, conducting a thorough physical examination.
- Unilateral anterior reach, medial step down and time up and go tests will also be performed at Baseline (To be done before the Application of Tape or using Knee guard)
- Safety monitoring to be performed
- Training for ActiTape or knee guard application. Prior to first instance of application of the ActiTape, every patient will be given a thorough demonstration of the correct method of application and removal of the tape. Post demonstration, the patient will be expected to apply AtciTape independently. ActiTape will be removed by detaching the ends slightly and by rolling the tape off against the skin instead of pulling the tape off. This prevents any excessive strain on the skin surface. For convenience, any edible or massage oil can be applied over the tape to loosen the adherence of the tape. The tape can then be removed easily.
Visit 3, Day 3, Treatment Period 1
- Recording of pain VAS
- Performing timed up and go, medial step down and anterior reach test (To be carried out before changing ActiTape or with wearing the Knee guard)
- Safety monitoring
- Recording of medical history, conducting a thorough physical examination
- Changing the ActiTape for patients randomized to this treatment.
Visit 4, Day 6, Treatment Period 1
- Recording of pain VAS
- Performing timed up and go, medial step down and anterior reach test (To be carried out before removing ActiTape or with wearing the Knee guard)
- Safety monitoring
- Recording of medical history, conducting a thorough physical examination
- Remove ActiTape and return of ActiTape OR Knee guard
Day 7 (wash out)
The patients will not receive any treatment.
Visit 5, Day 8, Treatment Period 2
- Recording of medical history, conducting a thorough physical examination.
- Recording of pain VAS scoring and performing unilateral anterior reach, medial step down and time up and go tests (To be done before the Application of Tape or using Knee guard)Safety monitoring to be performed
- Crossover to the next treatment
- Training for ActiTape or knee guard application.
Visit 6, Day 11, Treatment Period 2
- Recording of pain VAS
- Performing timed up and go, medial step down and anterior reach test (To be carried out before changing ActiTape or with wearing the Knee guard)
- Safety monitoring
- Recording of medical history, conducting a thorough physical examination
- Changing the ActiTape for patients randomized to this treatment.
Visit 7, Day 11, Treatment Period 2
- Recording of pain VAS
- Performing timed up and go, medial step down and anterior reach test (To be carried out before changing ActiTape or with wearing the Knee guard)
- Safety monitoring
- Recording of medical history, conducting a thorough physical examination
- Remove ActiTape and return of ActiTape. The knee guards being used by the patients will be given to them at the end of Treatment Period 2
- Patient and Investigator overall assessment
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