ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 1205

Effectiveness of Low-Dose Radiation Therapy on Symptoms in Knee Osteoarthritis: First Results of a Triple Blinded, Randomized Controlled Trial

E.A.M. Mahler1, M.J.M Minten1, M.M. Leseman-Hoogenboom2, P.M.P. Poortmans2, S.S. Boks3, J.W.J. Bijlsma4, F.H.J. van den Hoogen1,5, A.A. Den Broeder1,5 and C.H.M. van den Ende1,5, 1Rheumatology, Sint Maartenskliniek, Nijmegen, Netherlands, 2Radiation Therapy, Radboud university medical centre, Nijmegen, Netherlands, 3Radiology, Sint Maartenskliniek, Nijmegen, Netherlands, 4Rheumatology and Clinical Immunology, University Medical Centre Utrecht, Utrecht, Netherlands, 5Rheumatology, Radboud university medical centre, Nijmegen, Netherlands

Meeting: 2017 ACR/ARHP Annual Meeting

Date of first publication: September 18, 2017

Keywords: , , ,

Session Information

Date: Monday, November 6, 2017

Title: Osteoarthritis – Clinical Aspects Poster I: Clinical Trials and Interventions

Session Type: ACR Poster Session B

Session Time: 9:00AM-11:00AM

Background/Purpose:
Previous research in animal osteoarthritis (OA) has shown that low-dose radiation therapy (LD-RT) exerts anti-inflammatory effects, but a systematic review concluded that the evidence for its effectiveness in clinical practice is insufficient. Therefore, we wanted primarily to evaluate the effectiveness of LD-RT on symptoms in knee OA patients. In addition, the effects of LD-RT on inflammatory aspects were examined.

Methods:
Knee OA patients, aged ≥ 50 years, fulfilling clinical ACR criteria, with a pain score ≥ 5 on a numeric rating scale (0-10), not responding to analgesics and exercise therapy, were included in this triple blinded, sham controlled, randomized clinical trial (RCT). The local Medical Research Ethics Committee, approved the study design (study number 2014-275). Patients were randomly allocated 1:1 to the experimental (6x 1Gy LD-RT in two weeks) or sham (6x 0 Gy in two weeks) intervention.
The primary outcome was the proportion of responders according to the OMERACT-OARSI responder criteria, 3 months post-intervention. Secondary outcomes were changes in inflammatory aspects assessed by both ultrasound (mean synovial effusion and synovial thickness measured at suprapatellar and both medial and lateral parapatellar recesses) and serum inflammatory markers (erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP)). Chi squared tests or t-tests were used to compare differences in proportions and differences in changes to continuous variables, respectively.

Results:
Preliminary results enclose the evaluation of 53 patients out of 55 participating patients; 51% was female, mean age 65 years (SD 9) and median body mass index 27 (IQR 24-31) kg/m2. A total of 21 out of 53 patients (39.6%) met the OMERACT-OARSI responder criteria at 3 months post-intervention; of whom 10/25 (40%) were assigned to the intervention group and 11/28 (39%) to the sham group. A greater increase in mean synovial thickness in the intervention group than in the sham group was observed (difference intervention minus sham group: 0.07 mm, 95% CI -0.00-0.14). No differences between the two groups in any of the other secondary measures were observed.

Conclusion:
Our preliminary results suggest that LD-RT is not effective in reducing symptoms in knee OA patients and has no impact on inflammatory aspects on the short-term. We therefore suggest not using LD-RT for symptom relief in knee OA.

Dutch Trial Register: NTR4574

Trail register number Central Committee on Research Involving Human Subjects (CCMO): : NL48752.091.14


Table 1 Baseline characteristics of 53 knee OA patients

 

Intervention group
(n=25)

Sham group
(n=28)

Sociodemographic characteristics

 

Age, years

61.7 (8.9)

67.9 (9.3)*

 

Women, n (%)

14 (56.0)

13 (46.4)

 

Body mass index, kg/m2, median (IQR)

28.6 (25.6 – 30.1)

25.8 (24.1 – 30.7)

 

Duration of symptoms ≤ 5 years

15 (60.0)

14 (51.9)

 

NRS pain (0-10)

5.8 (1.6)

5.4 (1.6)

 

Kellgren and Lawrence ≥ 1, n (%)

10 (40.0)

11 (39.2)

Clinical parameters included in the primary outcome

 

WOMAC pain (0-100)

58.9 (14.7)

61.3 (16.9)

 

WOMAC function (0-100)

61.4 (16.2)

61.8 (18.8)

 

NRS PGA (0-10)

5.6 (2.1)

4.6 (2.4)

Inflammatory parameters included in the secondary outcomes

 

 

Synovial thickness (mm)

0.21 (0.08)

0.23 (0.15)

 

Synovial effusion (mm)

0.61 (0.25)

0.51 (0.21)

 

ESR (mm/h), above upper limit, n (%)

9 (36.0)

4 (14.3)

 

CRP (mg/l), above upper limit, n (%)

4 (16)

7 (25)

Values are mean (SD) unless stated otherwise; IQR: interquartile range
NRS: numeric rating scale; PGA: patient global assessment; WOMAC pain, function and stiffness, Western Ontario and McMaster University Osteoarthritis Index scale; ESR: Erythrocyte sedimentation rate; CRP: C-reactive protein
Higher scores indicate more NRS pain, worse PGA, better scores for WOMAC pain and function
*: p < 0.02


 

Table 2 Outcomes: changes (SD) per group and differences (95% CI) between groups between baseline and 3 months post-intervention

 

Change (SD) in
intervention group

Change (SD)
in sham group

Difference (95% CI) between intervention and sham groups

Clinical parameters included in the primary outcome

 

WOMAC pain (range 0-100)

7.7 (12.3)

10.4 (13.3)

-2.6 (-9.7-4.5)

 

WOMAC function (range 0-100)

7.6 (9.3)

5.9 (12.5)

1.7 (-4.4-7.8))

 

PGA (range 0-10)

-1.0 (1.8)

-0.9 (2.6)

-0.10 (-1.4-1.2)

Inflammatory parameters included in the secondary outcomes

 

Synovial thickness (mm)

0.08 (0.13)

0.01 (0.12)

0.07 (-0.00-0.14) *

 

Synovial effusion (mm)

0.05 (0.18)

0.00 (0.11)

0.04 (-0.04-0.13)

 

ESR (mm/h)

-0.2 (3.2)

2.0 (7.9)

-2.2 (-5.6-1.2)

 

CRP (mg/l)

0.0 (4.3)

0.6 (5.2)

-0.5 (-3.2-2.2)

ESR: Erythrocyte sedimentation rate; CRP: C-reactive protein
Positive changes indicate less pain, better function, worse PGA, increase in synovial thickness, effusion, ESR, CRP
Positive differences indicate less pain, better function, worse PGA, increase in synovial thickness, effusion, ESR, CRP of intervention group compared to sham group
*: p < 0.05

 

Disclosure: E. A. M. Mahler, None; M. J. M. Minten, None; M. M. Leseman-Hoogenboom, None; P. M. P. Poortmans, None; S. S. Boks, None; J. W. J. Bijlsma, None; F. H. J. van den Hoogen, None; A. A. Den Broeder, None; C. H. M. van den Ende, None.

To cite this abstract in AMA style:

Mahler EAM, Minten MJM, Leseman-Hoogenboom MM, Poortmans PMP, Boks SS, Bijlsma JWJ, van den Hoogen FHJ, Den Broeder AA, van den Ende CHM. Effectiveness of Low-Dose Radiation Therapy on Symptoms in Knee Osteoarthritis: First Results of a Triple Blinded, Randomized Controlled Trial [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/effectiveness-of-low-dose-radiation-therapy-on-symptoms-in-knee-osteoarthritis-first-results-of-a-triple-blinded-randomized-controlled-trial/. Accessed .

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