Randomized Clinical Trial
Copyright ©The Author(s) 2018. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Orthop. Sep 18, 2018; 9(9): 165-172
Published online Sep 18, 2018. doi: 10.5312/wjo.v9.i9.165
Corticosteroid injection alone vs additional physiotherapy treatment in early stage frozen shoulders
Tim Kraal, Inger Sierevelt, Derek van Deurzen, Michel PJ van den Bekerom, Lijkele Beimers
Tim Kraal, Inger Sierevelt, Lijkele Beimers, Department of Orthopedic Surgery, Slotervaart Center of Orthopedic Research and Education, Amsterdam 1066 EC, The Netherlands
Derek van Deurzen, Michel PJ van den Bekerom, Department of Orthopedic Surgery, Shoulder and Elbow Unit, OLVG Hospital, Amsterdam 1091 AC, The Netherlands
Author contributions: Kraal T is the initiator of this study and wrote the study protocol and a large part of this manuscript; Sierevelt I is involved as a clinical epidemiologist and research coordinator; Sierevelt I is responsible for the statistical analysis and correct presentation of the results; van Deurzen D and van den Bekerom MPJ both included patients at their center, and were both responsible for follow up at this location; Beimers L is responsible for inclusions at the other center and responsible as supervisor for the protocol and progress of the study; all authors were involved in the writing and revising of this manuscript.
Institutional review board statement: Approval for a prospective randomized clinical trial (D-FROST; Dutch frozen shoulder study) was obtained by the MC Slotervaart Hospital Medical Ethics Committee (NL47325.048.13).
Clinical trial registration statement: The trial was registered in the Dutch Trial Register (NTR4587).
Conflict-of-interest statement: All authors declare that they have no conflict of interest to declare.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Lijkele Beimers, MD, PhD, Staff Physician, Orthopedic Surgeon, Department of Orthopedic Surgery, Slotervaart Center of Orthopedic Research and Education, MC Slotervaart, Louwesweg 6, Amsterdam 1066 EC, The Netherlands. lijkele.beimers@slz.nl
Telephone: +31-20-5125116
Received: April 7, 2018
Peer-review started: April 7, 2018
First decision: June 14, 2018
Revised: July 1, 2018
Accepted: August 2, 2018
Article in press: August 3, 2018
Published online: September 18, 2018
Processing time: 162 Days and 20.2 Hours
ARTICLE HIGHLIGHTS
Research background

Frozen shoulder (FS) is a common cause of shoulder pain and disability. A contracted capsule with a decreased capsular volume leads to a typical loss of passive external rotation seen in FS. Physiotherapy and corticosteroid injections are the most widely used treatment modalities in FS, in both primary and secondary healthcare settings.

Research motivation

Corticosteroid injections demonstrated a positive effect on shoulder pain and range of motion (ROM), at least in the short term. However, the role of physiotherapy in the treatment of FS is more uncertain. For example, supervised neglect, consisting of supportive therapy and exercises within pain limits, has also been advocated as an appropriate treatment for FS.

Research objectives

The objective of this randomized controlled trial was therefore to investigate the additional value of physiotherapy treatment (PT) after an intra-articular corticosteroid injection in the management of early stage idiopathic FSs. It is hypothesized that additional physiotherapy is superior to corticosteroid injection alone with respect to ROM and shoulder function.

Research methods

A two center prospective randomized controlled trial was undertaken. Patients with painful early-stage idiopathic FS were eligible for inclusion. After written consent, patients were randomly allocated into two groups. All patients received an ultrasound-guided intra-articular corticosteroid injection. One group underwent additional PT and the other group did not (non-PT). The primary outcome measure was the SPADI. Secondary outcomes were pain (NPRS), ROM, quality of life (RAND-36 score), and patient satisfaction. Follow-up was scheduled after 6, 12 and 26 wk.

Research results

Twenty-one patients were included, 11 patients in the non-PT and ten in the PT group. Both treatment groups showed a significant improvement at 26 wk for SPADI score. At the 6 wk follow-up, median SPADI score was significantly decreased in the PT group (14 IQR: 6-38) vs the non-PT group (63 IQR: 45-76) (P = 0.01). Significant differences in all three ROM directions were observed after 6 wk in favor of the PT group (P ≤ 0.02 for all directions). At 26 wk, both groups did not differ significantly with respect to any of the outcome parameters. No complications were reported in both groups.

Research conclusions

Intra-articular corticosteroid infiltration is effective in the treatment of FS. Additional PT can improve shoulder function and shorten the duration of functional limitations during the recovery of early-stage FS patients up to the first three months. The physiotherapy intensity should be guided on tissue irritability. Future research should focus on the different populations other than idiopathic FSs, like post-operative or post-traumatic FSs. Furthermore, a small subset of patients is not satisfactorily treated with conservative treatment as an injection and physiotherapy. It would be very interesting to investigate if these patients with a prolonged and refractory course of disease could be identified at an early time point.

Research perspectives

It would be very interesting to investigate if these patients with a prolonged and refractory course of disease could be identified at an early time point.