Joint Injections for Osteoarthritic Knee Pain

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ClinicalTrials.gov Identifier: NCT00085722

Recruitment Status : Completed

First Posted : June 16, 2004

Last Update Posted : February 15, 2019

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborator:

National Center for Complementary and Integrative Health (NCCIH)

Information provided by (Responsible Party):

University of Wisconsin, Madison

Study Description

Brief Summary:

The purpose of this study is to determine whether prolotherapy (PrT), a therapy based on injection of a sugar solution in and around the knee, can decrease pain and disability from knee osteoarthritis (OA).

Condition or disease	Intervention/treatment	Phase
Osteoarthritis	Procedure: Dextrose Prolotherapy Procedure: Saline Prolotherapy Other: At-home physical therapy exercise group	Phase 1 Phase 2

Detailed Description:

OA is a common, debilitating condition for which there is no cure and no known cause. Prolotherapy (PrT) is an injection-based therapy for chronic musculoskeletal pain in which an irritant solution is injected at painful ligaments and tendons to produce stronger connective tissue and decrease pain. Although limited studies suggest PrT is effective may be effective for low back pain, its use has not been rigorously studied in human clinical trials for osteoarthritis.

Participants in this study will be randomly assigned to receive one of three treatments: standard PrT, injections with a saline placebo, or a pamphlet with recommendations for home knee physical therapy. Injections will be given at Weeks 1, 5, and 9; injection group subjects will have the option to receive an additional 2 sets of injections. All participants will be assessed for a total of 1 year. A set of disease-specific and general quality-of-life questionnaires will be used to assess participants' outcomes . A randomized subset of participants (N=38)will receive magnetic resonance imaging (MRI)of the knee at baseline and 52 weeks. At study completion, participants who did not receive PrT will have the option to receive up to five sessions of PrT at no cost. Data will be collected for this group (minus MRI) and will be analyzed separately. Enrollment is limited to residents of Southern Wisconsin.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	98 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	The Efficacy of Prolotherapy in Osteoarthritic Knee Pain
Study Start Date :	July 2004
Actual Primary Completion Date :	November 1, 2008
Actual Study Completion Date :	May 1, 2016

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Osteoarthritis

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Dextrose

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Dextrose Subjects in Group 1 receive PrT with 15% and 25% dextrose solution, as it is generally practiced in the US today.	Procedure: Dextrose Prolotherapy Injection procedure: 50% dextrose is diluted with .9% 'normal' saline and 1% lidocaine to achieve 15% dextrose for ligament injections and 25% dextrose for intra-articular injection. Other Name: Dextrose
Placebo Comparator: Normal saline Subjects in Group 2 will receive the same treatment as Group 1, except that a 0.9% 'normal' saline solution with no known benefit will be used instead of dextrose.	Procedure: Saline Prolotherapy 7 mL 9% 'normal' saline and 3mL 1% lidocaine Other Name: Saline
Exercise At-home physical therapy exercises as a non-injection control	Other: At-home physical therapy exercise group Subjects in the at-home physical therapy exercise group will receive a patient information pamphlet about knee osteoarthritis and conservative care instructions for standard at-home physical therapy exercises Other Name: Exercise

Outcome Measures

Primary Outcome Measures :

Quality of life, pain scores and disability at wks 0, 5, 9, 12, 24, 52 [ Time Frame: Participants will be followed for one year. ]

Secondary Outcome Measures :

Secondary outcomes include disease and general quality of life indicators (all subjects) and magnetic resonance image (in a subset of 37 subjects). [ Time Frame: Participants will be monitored for one year. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	40 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Pain from knee osteoarthritis that has impacted life for 3 months to 10 years
X-ray results indicating knee osteoarthritis

Exclusion Criteria:

Knee osteoarthritis surgical candidate
History of total knee joint repair
Prior use of PrT
Prior fracture of the knee joint
Joint injection of steroids or other drugs within the past 3 months
Rheumatoid or inflammatory arthritis
Chronic use of narcotic medication
Other chronic pain diagnoses
diabetes mellitus
Body mass index (BMI) greater than 45
Unresolved litigation
Pregnancy
Co-morbidity that may interfere with the study

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00085722

Locations

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United States, Wisconsin
Northeast Family Medical Center
Madison, Wisconsin, United States, 53704
University of Wisconsin General Clinical Research Center
Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

University of Wisconsin, Madison

National Center for Complementary and Integrative Health (NCCIH)

Investigators

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Principal Investigator:	David P. Rabago, MD	University of Wisconsin Dept of Family Medicine

More Information

Additional Information:

University of Wisconsin Department of Family Medicine Web Site This link exits the ClinicalTrials.gov site

Publications:

Rejeski WJ, Ettinger WH Jr, Shumaker S, Heuser MD, James P, Monu J, Burns R. The evaluation of pain in patients with knee osteoarthritis: the knee pain scale. J Rheumatol. 1995 Jun;22(6):1124-9.

Reeves KD, Hassanein K. Randomized, prospective, placebo-controlled double-blind study of dextrose prolotherapy for osteoarthritic thumb and finger (DIP, PIP, and trapeziometacarpal) joints: evidence of clinical efficacy. J Altern Complement Med. 2000 Aug;6(4):311-20. doi: 10.1089/10755530050120673.

Eberle E, Ottillinger B. Clinically relevant change and clinically relevant difference in knee osteoarthritis. Osteoarthritis Cartilage. 1999 Sep;7(5):502-3. doi: 10.1053/joca.1999.0246. No abstract available.

Klein RG, Eek BC, DeLong WB, Mooney V. A randomized double-blind trial of dextrose-glycerine-phenol injections for chronic, low back pain. J Spinal Disord. 1993 Feb;6(1):23-33.

Ongley MJ, Klein RG, Dorman TA, Eek BC, Hubert LJ. A new approach to the treatment of chronic low back pain. Lancet. 1987 Jul 18;2(8551):143-6. doi: 10.1016/s0140-6736(87)92340-3.

Dechow E, Davies RK, Carr AJ, Thompson PW. A randomized, double-blind, placebo-controlled trial of sclerosing injections in patients with chronic low back pain. Rheumatology (Oxford). 1999 Dec;38(12):1255-9. doi: 10.1093/rheumatology/38.12.1255.

Yelland MJ, Glasziou PP, Bogduk N, Schluter PJ, McKernon M. Prolotherapy injections, saline injections, and exercises for chronic low-back pain: a randomized trial. Spine (Phila Pa 1976). 2004 Jan 1;29(1):9-16; discussion 16. doi: 10.1097/01.BRS.0000105529.07222.5B.

Hackett GS, Hemwall GA, Montgomery GA. Ligament and Tendon Relaxation Treated by Prolotherapy. Fifth Ed. ed. Oak Park: Gustav A. Hemwall, 1993

Linetsky FS, FRafael M,. Pain Management, 2002:381-402.

Dorman TA. Prolotherapy: A survey. The Journal of Orthopaedic Medicine 1993;15(2):49-50

Reeves KD, Hassanein K. Randomized prospective double-blind placebo-controlled study of dextrose prolotherapy for knee osteoarthritis with or without ACL laxity. Altern Ther Health Med. 2000 Mar;6(2):68-74, 77-80.

Rogers WH, Wittink H, Wagner A, Cynn D, Carr DB. Assessing individual outcomes during outpatient multidisciplinary chronic pain treatment by means of an augmented SF-36. Pain Med. 2000 Mar;1(1):44-54. doi: 10.1046/j.1526-4637.2000.99102.x.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Rabago D, Patterson JJ, Mundt M, Zgierska A, Fortney L, Grettie J, Kijowski R. Dextrose and morrhuate sodium injections (prolotherapy) for knee osteoarthritis: a prospective open-label trial. J Altern Complement Med. 2014 May;20(5):383-91. doi: 10.1089/acm.2013.0225. Epub 2014 Mar 17.

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 May-Jun;11(3):229-37. doi: 10.1370/afm.1504. Erratum In: Ann Fam Med. 2013 Sep-Oct;11(5):480.

Rabago D, Zgierska A, Fortney L, Kijowski R, Mundt M, Ryan M, Grettie J, Patterson JJ. Hypertonic dextrose injections (prolotherapy) for knee osteoarthritis: results of a single-arm uncontrolled study with 1-year follow-up. J Altern Complement Med. 2012 Apr;18(4):408-14. doi: 10.1089/acm.2011.0030.

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Responsible Party:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00085722
Other Study ID Numbers:	H-2004-0112 K23AT001879-01 ( U.S. NIH Grant/Contract )
First Posted:	June 16, 2004 Key Record Dates
Last Update Posted:	February 15, 2019
Last Verified:	February 2019

Keywords provided by University of Wisconsin, Madison:


Injection Therapy

Additional relevant MeSH terms:

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Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

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