See the published version of this preprint at BMC Musculoskeletal Disorders.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
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Research article
Brooke Patterson
La Trobe University School of Allied Health
Corresponding Author
ORCiD: https://orcid.org/0000-0002-6570-5429
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background: Guided rehabilitation beyond 6-months is rare following anterior cruciate ligament reconstruction (ACLR), despite high prevalence of unacceptable symptoms and quality of life (QoL). Our primary aim was to determine the feasibility of a randomised controlled trial (RCT) evaluating a physiotherapist-guided intervention for individuals 1-year post-ACLR with persistent symptoms. Our secondary aim was to determine if a worthwhile treatment effect could be observed for the lower-limb focussed intervention (compared to the trunk-focussed intervention), for improvement in knee-related QoL, symptoms, and function.
Design: Participant- and assessor-blinded, pilot feasibility RCT.
Methods: Participant eligibility criteria: i) 12-15 months post-ACLR; ii) <87.5/100 on the Knee injury and Osteoarthritis Outcome Score (KOOS) QoL subscale; and either a one-leg rise test <22 repetitions, single-hop <90% limb symmetry; or Anterior Knee Pain Scale <87/100. Participants were randomised to lower-limb or trunk-focussed focussed exercise and education.. Both interventions involved 8 face-to-face physiotherapy sessions over 16-weeks. Feasibility was assessed by eligibility rate (>1 in 3 screened), recruitment rate (> 4 participants/month), retention (<20% drop-out), physiotherapy attendance and unsupervised exercise adherence (>80%). Between-group differences for knee-related QoL (KOOS-QoL, ACL-QoL), symptoms (KOOS-Pain, KOOS-Symptoms), and function (KOOS-Sport, functional performance tests) were used to verify that the worthwhile effect (greater than the minimal detectable change for each measure) was contained within the 95% confidence interval.
Results: 47% of those screened were eligible, and 27 participants (3 participants/month; 48% men, 34±12 years) were randomised. Two did not commence treatment, and two were lost to follow-up (16% drop-out). Physiotherapy attendance was >80% for both groups but reported adherence to unsupervised exercise was low (<55%). Both interventions had potentially worthwhile effects for KOOS-QoL and ACL-QoL, while the lower-limb focussed intervention had potentially greater effects for KOOS-Sport, KOOS-Pain, and functional performance.
Conclusions: A larger-scale RCT is warranted. All feasibility criteria were met, or reasonable recommendations could be made to achieve the criteria in future trials. Strategies to increase recruitment rate and exercise adherence are required. The potential worthwhile effects for knee-related QoL, symptoms, and function indicates a fully-powered RCT may detect a clinically meaningful effect.
Trial Registration: Prospectively registered (ACTRN12616000564459).
Keywords
anterior cruciate ligament, rehabilitation, physiotherapy
Figure 1
This is a list of supplementary files associated with this preprint. Click to download.
- AdditionalFile1CONSORTchecklist.pdf
Additional File 1 CONSORT Checklist
- AdditionalFile4Participantfeedback.pdf
Additional File 4 Feedback from study participants on exercise program content, structure and delivery methods.pdf
- AdditionalFile3TASKWebsite.docx
- AdditionalFile5Secondaryoutcomesadditionaldetail.pdf
Additional File 5 Secondary outcomes additional detail.pdf
- AdditionalFile2Physiotherapymanual.pdf
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CURRENT STATUS: Published
View the published article at BMC Musculoskeletal Disorders.
Version 3
Posted 07 Jan, 2021
No community comments so far
Submission checks complete
On 24 Dec, 2020
Editorial decision: Accept
On 22 Dec, 2020
Editor assigned
On 22 Dec, 2020
Editor invited
On 22 Dec, 2020
No comments provided
Review #2 received
Received 15 Dec, 2020
Review #1 received
Received 29 Nov, 2020
Reviewer #2 agreed
On 24 Nov, 2020
Reviewers invited
Invitations sent on 24 Nov, 2020
Reviewer #1 agreed
On 24 Nov, 2020
Editor assigned
On 15 Nov, 2020
Submission checks complete
On 15 Nov, 2020
Editor invited
On 15 Nov, 2020
No comments provided
Editorial decision: Major revision
On 11 Sep, 2020
Review #3 received
Received 10 Sep, 2020
Review #2 received
Received 30 Aug, 2020
Reviewer #3 agreed
On 13 Aug, 2020
Review #1 received
Received 13 Aug, 2020
Reviewer #2 agreed
On 11 Aug, 2020
Reviewers invited
Invitations sent on 10 Aug, 2020
Reviewer #1 agreed
On 10 Aug, 2020
Editor assigned
On 10 Jul, 2020
Submission checks complete
On 09 Jul, 2020
Editor invited
On 09 Jul, 2020
First submitted
On 08 Jul, 2020
Metrics
Comments: 0
PDF Downloads: ...
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See the published version of this preprint at BMC Musculoskeletal Disorders.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research article
Brooke Patterson
La Trobe University School of Allied Health
Corresponding Author
ORCiD: https://orcid.org/0000-0002-6570-5429
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
View the published article at BMC Musculoskeletal Disorders.
Version 3
Posted 07 Jan, 2021
No community comments so far
Submission checks complete
On 24 Dec, 2020
Editorial decision: Accept
On 22 Dec, 2020
Editor assigned
On 22 Dec, 2020
Editor invited
On 22 Dec, 2020
No comments provided
Review #2 received
Received 15 Dec, 2020
Review #1 received
Received 29 Nov, 2020
Reviewer #2 agreed
On 24 Nov, 2020
Reviewers invited
Invitations sent on 24 Nov, 2020
Reviewer #1 agreed
On 24 Nov, 2020
Editor assigned
On 15 Nov, 2020
Submission checks complete
On 15 Nov, 2020
Editor invited
On 15 Nov, 2020
No comments provided
Editorial decision: Major revision
On 11 Sep, 2020
Review #3 received
Received 10 Sep, 2020
Review #2 received
Received 30 Aug, 2020
Reviewer #3 agreed
On 13 Aug, 2020
Review #1 received
Received 13 Aug, 2020
Reviewer #2 agreed
On 11 Aug, 2020
Reviewers invited
Invitations sent on 10 Aug, 2020
Reviewer #1 agreed
On 10 Aug, 2020
Editor assigned
On 10 Jul, 2020
Submission checks complete
On 09 Jul, 2020
Editor invited
On 09 Jul, 2020
First submitted
On 08 Jul, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at BMC Musculoskeletal Disorders.
Background: Guided rehabilitation beyond 6-months is rare following anterior cruciate ligament reconstruction (ACLR), despite high prevalence of unacceptable symptoms and quality of life (QoL). Our primary aim was to determine the feasibility of a randomised controlled trial (RCT) evaluating a physiotherapist-guided intervention for individuals 1-year post-ACLR with persistent symptoms. Our secondary aim was to determine if a worthwhile treatment effect could be observed for the lower-limb focussed intervention (compared to the trunk-focussed intervention), for improvement in knee-related QoL, symptoms, and function.
Design: Participant- and assessor-blinded, pilot feasibility RCT.
Methods: Participant eligibility criteria: i) 12-15 months post-ACLR; ii) <87.5/100 on the Knee injury and Osteoarthritis Outcome Score (KOOS) QoL subscale; and either a one-leg rise test <22 repetitions, single-hop <90% limb symmetry; or Anterior Knee Pain Scale <87/100. Participants were randomised to lower-limb or trunk-focussed focussed exercise and education.. Both interventions involved 8 face-to-face physiotherapy sessions over 16-weeks. Feasibility was assessed by eligibility rate (>1 in 3 screened), recruitment rate (> 4 participants/month), retention (<20% drop-out), physiotherapy attendance and unsupervised exercise adherence (>80%). Between-group differences for knee-related QoL (KOOS-QoL, ACL-QoL), symptoms (KOOS-Pain, KOOS-Symptoms), and function (KOOS-Sport, functional performance tests) were used to verify that the worthwhile effect (greater than the minimal detectable change for each measure) was contained within the 95% confidence interval.
Results: 47% of those screened were eligible, and 27 participants (3 participants/month; 48% men, 34±12 years) were randomised. Two did not commence treatment, and two were lost to follow-up (16% drop-out). Physiotherapy attendance was >80% for both groups but reported adherence to unsupervised exercise was low (<55%). Both interventions had potentially worthwhile effects for KOOS-QoL and ACL-QoL, while the lower-limb focussed intervention had potentially greater effects for KOOS-Sport, KOOS-Pain, and functional performance.
Conclusions: A larger-scale RCT is warranted. All feasibility criteria were met, or reasonable recommendations could be made to achieve the criteria in future trials. Strategies to increase recruitment rate and exercise adherence are required. The potential worthwhile effects for knee-related QoL, symptoms, and function indicates a fully-powered RCT may detect a clinically meaningful effect.
Trial Registration: Prospectively registered (ACTRN12616000564459).
Figure 1
This is a list of supplementary files associated with this preprint. Click to download.
- AdditionalFile1CONSORTchecklist.pdf
Additional File 1 CONSORT Checklist
- AdditionalFile4Participantfeedback.pdf
Additional File 4 Feedback from study participants on exercise program content, structure and delivery methods.pdf
- AdditionalFile3TASKWebsite.docx
- AdditionalFile5Secondaryoutcomesadditionaldetail.pdf
Additional File 5 Secondary outcomes additional detail.pdf
- AdditionalFile2Physiotherapymanual.pdf
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