AzTrials
AzTrials

OsteoarthritisPhase 1/2NCT00085722

Joint Injections for Osteoarthritic Knee Pain

A Phase 1/2 study testing Dextrose Prolotherapy, Saline Prolotherapy and At-home physical therapy exercise group in people with Osteoarthritis, run by University of Wisconsin, Madison at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 40 to 70 years
Conditions the study is for
Osteoarthritis
What is being tested?
Dextrose Prolotherapy, Saline Prolotherapy and At-home physical therapy exercise group
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
98 participants
Where
2 sitesUnited States
Study dates
Jul 2004to 1 May 2016
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Northeast Family Medical Center

    Madison, Wisconsin, 53704

  • University of Wisconsin General Clinical Research Center

    Madison, Wisconsin, 53792

Other trials in United States

About this study

Official title: The Efficacy of Prolotherapy in Osteoarthritic Knee Pain

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).

Read the 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.

Conditions
Osteoarthritis
Being tested
Dextrose Prolotherapy, Saline Prolotherapy, At-home physical therapy exercise group
Keywords
Injection Therapy
Medical subject headings
Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dextrose ProlotherapyProcedure or surgery

    Also called Dextrose

    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.

  • Saline ProlotherapyProcedure or surgery

    Also called Saline

    7 mL 9% 'normal' saline and 3mL 1% lidocaine

  • At-home physical therapy exercise groupOther

    Also called Exercise

    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

Study groups in NCT00085722
Study groupRoleWhat they receive
DextroseExperimentalSubjects in Group 1 receive PrT with 15% and 25% dextrose solution, as it is generally practiced in the US today.
Receives: Procedure: Dextrose Prolotherapy
Normal salinePlacebo comparatorSubjects 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.
Receives: Procedure: Saline Prolotherapy
ExerciseOtherAt-home physical therapy exercises as a non-injection control
Receives: Other: At-home physical therapy exercise group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quality of life, pain scores and disability at wks 0, 5, 9, 12, 24, 52

    Measured: Participants will be followed for one year.

Secondary outcomes (1)

  1. Secondary outcomes include disease and general quality of life indicators (all subjects) and magnetic resonance image (in a subset of 37 subjects).

    Measured: Participants will be monitored for one year.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2004 (estimated)
  2. Study startJul 2004
  3. Primary completion1 Nov 2008
  4. Study completion1 May 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
98 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00085722
Sponsor's protocol ID
H-2004-0112
Other IDs
K23AT001879-01
Status last verified
Feb 2019
First submitted
14 Jun 2004
Last updated
15 Feb 2019
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 7674241

  • 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.

    PubMed 10976977

  • 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.

    PubMed 10489324

  • 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.

    PubMed 8439713

  • 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.

    PubMed 2439856

  • 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.

    PubMed 10587555

  • 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.

    PubMed 14699269

  • 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.

    PubMed 10710805

  • 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.

    PubMed 15101963

  • 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.

    PubMed 24635447

  • 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.

    PubMed 23690322

  • 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.

    PubMed 22515800

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Dextrose Prolotherapy, Saline Prolotherapy and At-home physical therapy exercise group in people with Osteoarthritis, run by University of Wisconsin, Madison at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of life, pain scores and disability at wks 0, 5, 9, 12, 24, 52 (time frame: Participants will be followed for one year.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00085722, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in