| CTRI Number |
CTRI/2017/09/009735 [Registered on: 12/09/2017] Trial Registered Prospectively |
| Last Modified On: |
12/09/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Sugar Water injection Versus Steroid Injection in Knee pain |
|
Scientific Title of Study
|
Role of Dextrose Prolotherapy and Methyl Prednisolone Injections in Osteoarthritis Knee |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Apurba Barman |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences Bhubaneswar |
| Address |
Department of Physical Medicine & Rehabilitation
AIIMS Bhubaneswar
Sijua Patrapada Bhubaneswar
PO Dumuduma Khurda
Odisha
Khordha
ORISSA
751019
India |
| Phone |
9438884211 |
| Fax |
|
| Email |
apurvaa23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Apurba Barman |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences Bhubaneswar |
| Address |
Department of Physical Medicine & Rehabilitation
AIIMS Bhubaneswar
Sijua Patrapada Bhubaneswar
PO Dumuduma
Dist Khurda
Odisha
Khordha
ORISSA
751019
India |
| Phone |
9438884211 |
| Fax |
|
| Email |
apurvaa23@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Apurba Barman |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences Bhubaneswar |
| Address |
Department of Physical Medicine & Rehabilitation
AIIMS Bhubaneswar
Sijua Patrapada Bhubaneswar
PO Dumuduma
Dist Khurda
Odisha
Khordha
ORISSA
751019
India |
| Phone |
9438884211 |
| Fax |
|
| Email |
apurvaa23@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Medical Sciences Bhubaneswar |
|
|
Primary Sponsor
|
| Name |
Non funded |
| Address |
NA |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Apurba Barman |
All India Institute of Medical Sciences Bhubaneswar |
Room No 4
Minor OT PMR OPD Block
Department of Physical Medicine & Rehabilitation
Khordha
ORISSA |
9438884211
apurvaa23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences Bhubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Osteoarthritis Knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dextrose Prolotherapy Group |
In group I (Dextrose Prolotherapy Group), patients will receive dextrose prolotherapy in the affected one or both knees. 5ml of 25% Dextrose will be given intra-articularly with 25- gauge needle, and 15 ml of 15% Dextrose will be administered extra-articularly at 0, 4 & 8 weeks. Extra-articularly, patients will be delivered with peppering technique with maximum of 15 punctures subcutaneously with 15 % Dextrose over painful ligaments and tendons around the knee.
Patients will receive a pamphlet recommending home knee exercise and in-person instruction. All patients will be advised to do knee exercises for 30 minutes daily at home.
After the injection, participants will be offered acetaminophen tablets, as needed and will be advised on relative knee rest for 2 to 3 days with progressive resumption of routine activity & knee exercises during the study period. They will be discouraged from using nonsteroidal anti-inflammatory medications (NSAIDs) and from starting new therapies. Participants will be advised to maintain a log book record of receiving tab acetaminophen, other medications (if received) and adherence of exercise programs.
All patients will be assessed at 3 months and 6 months. Hence followed up will be till 6 months.
|
| Comparator Agent |
Steroid Injection Group |
In Group II (Steroid Injection Group), patients will receive single dose, 2ml (40mg) Methyl Prednisolone, mixed with 3ml (2%) Lignocaine (total 5ml) in affected knee at 0 week (1st Visit). However, patients will be also assessed at 4, 8 weeks. Patients will receive a pamphlet recommending home knee exercise and in-person instruction. All patients will be advised to do knee exercises for 30 minutes daily at home.
After the injection, participants will be offered acetaminophen tablets, as needed and will be advised on relative knee rest for 2 to 3 days with progressive resumption of routine activity & knee exercises during the study period. They will be discouraged from using nonsteroidal anti-inflammatory medications (NSAIDs) and from starting new therapies. Participants will be advised to maintain a log book record of receiving tab acetaminophen, other medications (if received) and adherence of exercise programs.
All patients will be assessed at 3 months and 6 months.Hence followed up will be till 6 months. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 40-65 years, who has
1. Persisting Knee Pain due to OA Knee (Grade II or III, according to radiological classification of knee OA defined by Kellgren and Lawrence)
2. Pain of at-least 40 mm on a 0-100mm VAS when asked “What is the average level of your Left/ Right knee pain over the last week?â€
3. Willing to participate in all assessment
4. If both knees involved, participants choose one or both knees to be treated.
|
|
| ExclusionCriteria |
| Details |
1. Severe OA Knee (Grade IV , according to Kellgren and Lawrence classification)
2. Inflammatory or post-infectious knee arthritis
3. History of prior knee replacement repair
4. Prior knee Prolotherapy
5. Prior fracture of the knee joint
6. Any Knee injection within 3 months
7. Daily use of opioid medication
8. Other chronic pain diagnoses
9. Diabetes mellitus
10. Body mass index (BMI) > 40 kg/m2
11. H/O Anticoagulation therapy
12. Pregnancy
13. Co-morbidity severe enough to prevent participation in the study protocol including at-home exercise or attendance at scheduled injection appointments.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Western Ontario McMaster University
Osteoarthritis Index (WOMAC),
Knee Injury and Osteoarthritis Outcome Score (KOOS)
VAS Scale
Goniometric ROM of affected Knee
|
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Injection procedure related pain (0, 2 days after injection)
Patient Satisfaction |
6 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/10/2017 |
| 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 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
1. Rabago D, Patterson JJ, Mundt M, Kijowski R, Grettie J, Segal NA, Zgierska A. Dextrose prolotherapy for knee osteoarthritis: a randomized controlled trial. Ann Fam Med. 2013;11(3):229-37
2. Hung CY, Hsiao MY, Chang KV, Han DS, Wang TG.J Comparative effectiveness of dextrose prolotherapy versus control injections and exercise in the management of osteoarthritis pain: a systematic review and meta-analysis. Pain Res. 2016 Oct 18; 9:847-857
3. Sit RW, Chung VCh, Reeves KD, Rabago D, Chan KK, Chan DC, Wu X, Ho RS, Wong SY.Hypertonic dextrose injections (prolotherapy) in the treatment of symptomatic knee osteoarthritis: A systematic review and meta-analysis. Sci Rep. 2016;6:25247 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Damage of the articular
cartilage and laxity of the joint lead to worsening of Osteoarthritis knee. Recently prolotherapy has been
shown to decrease looseness of joints and decrease degeneration of articular
cartilage in knee arthritis. However, use of prolotherapy has not been rigorously
studied in osteoarthritic knee. Only limited studies have been done in western
countries. There is scarcity of literature in
Indian Population. Considering this uncertainty in the use of Dextrose
prolotherapy in OA, we propose to conduct this study to find out whether
injection with Dextrose Prolotherapy improves knee symptoms in patients with OA
Knee compared to intra-articular steroid injection. We hypothesize that prolotherapy injections for knee OA will
be equally or more beneficial to the patients than steroids. The
purpose of this study is to determine whether injection
with Dextrose Prolotherapy, in and around the knee, can decrease pain
and disability from knee osteoarthritis. Our
secondary objective is to determine if Dextrose Prolotherapy provide better
symptom relief than intra-articular Steroid injection.
|