Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000230257
Ethics application status
Approved
Date submitted
2/02/2018
Date registered
12/02/2018
Date last updated
28/05/2019
Date data sharing statement initially provided
28/05/2019
Date results provided
28/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Is manual therapy for stiff knees using lessons learned from 4D motion analysis more effective than traditional manual therapy?
Scientific title
Effect of PosteroAnterior versus AnteroPosterior manual therapy mobilisation on range of movement in stiff knees. A pilot study for a randomised controlled trial.
Secondary ID [1] 292846 0
Nil known
Universal Trial Number (UTN)
Trial acronym
PAVAP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stiff Knees 306447 0
Condition category
Condition code
Physical Medicine / Rehabilitation 305535 305535 0 0
Physiotherapy
Musculoskeletal 305566 305566 0 0
Other muscular and skeletal disorders
Musculoskeletal 305567 305567 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Knee Mobilization to increase knee flexion ROM. Grade 3 Posterior-Anterior (PA) joint glide with medial rotation performed on stiff knee performed at a dosage of 3 x 30 oscillations. Participants will undergo 4 face-to-face physiotherapy treatment sessions (1 x 1 hour and 1 x 30 minutes during the first week, and 2 x 30 minutes during the second week). This intervention will be delivered by either a registered physiotherapist or a student physiotherapist under the supervision of a registered physiotherapist.

Participants will also be given a home exercise program of a self-mobilization in the direction of treatment (PA). This will will be performed with the patient in supine, a towel roll positioned in the knee crease and a towel around the ankle, pulling the knee into maximal passive flexion and oscillating for 10 seconds. Participants will be asked to perform this 2o times, twice a day and will be asked to complete a logbook to assess adherence to the home exercise program.
Intervention code [1] 300215 0
Rehabilitation
Intervention code [2] 300232 0
Treatment: Other
Comparator / control treatment
Knee Mobilization to increase knee flexion ROM. Grade 3 Anterior-Posterior (AP) joint glide with medial rotation performed on stiff knee performed at a dosage of 3 x 30 oscillations. Participants will undergo 4 face-to-face physiotherapy treatment sessions (1 x 1 hour and 1 x 30 minutes during the first week, and 2 x 30 minutes during the second week). This intervention will be delivered by either a registered physiotherapist or a student physiotherapist under the supervision of a registered physiotherapist.

Participants will also be given a home exercise program of a self-mobilization in the direction of treatment (AP). This will will be performed with the patient in supine and a towel around the upper calf, pulling the knee into maximal passive flexion and oscillating for 10 seconds. Participants will be asked to perform this 20 times, twice a day and will be asked to complete a logbook to assess adherence to the home exercise program.
Control group
Active

Outcomes
Primary outcome [1] 304667 0
Knee flexion range of motion (ROM) using a digital goniometer (Dualler IQ, JTech medical, Utah).
Timepoint [1] 304667 0
Measure before and after each treatment.
Secondary outcome [1] 342724 0
Knee pain rated using the Numeric Rating Scale (NRS).
Timepoint [1] 342724 0
Before and after each treatment
Secondary outcome [2] 342725 0
Patient perceived function and knee-related quality of life using the Knee Specific Outcome Score (KOOS).
Timepoint [2] 342725 0
Before the initial treatment and after the final treatment.
Secondary outcome [3] 342726 0
Patient perceived function using the Patient Specific Functional Scale (PSFS).
Timepoint [3] 342726 0
Before the initial treatment and after the final treatment.

Eligibility
Key inclusion criteria
- Individuals with restricted knee flexion ROM
- Aged >18
- Stiffness duration of at least 7 days
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Knee pain > 8/10 on Numeric Rating Scale
- Chronic Regional Pain Syndrome (CRPS)
- Anxiety related to manual therapy
- Total Knee Replacement on the affected side
- Inflammatory Arthritis
- Anterior or posterior cruciate ligament graft surgery.
- Knee reconstruction or previous ligament rupture on the affected side
- Acute locked meniscus
- Initiation of opioid analgaesia or corticosteroid injection within the past 7 days.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using random number generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Pilot study for a Randomized Controlled Trial
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Advice will be sought from the University of Canberra consulting biostatistician. Analysis will be conducted by the honours student, under the guidance of the supervisor.

The baseline data for the participants in the study will be explored and described by descriptive statistics. To examine for any differences between the two interventions groups prior to intervention, the gender ratio between groups will be analysed using Chi-square statistics and age distribution analysed with a t-test. Outcomes measures at baseline (Pain, KOOS, PSFS) will be explored by descriptive statistics (mean and standard deviation) and t-test.

The effect of intervention on primary outcome measures of flexion and pain will be examined for within and between group effects using a linear mixed model analysis of variance. Fixed factors include the group, visit number, and sex. Random factors included the participant identification number. Outcomes will be described by estimated marginal means and variance by standard error. Confidence intervals of 95% will be reported.

Differences will be considered significant at p > or = 0.05, and confidence intervals set at 95%.

In this study, intention to treat analysis will be completed using imputation of the last observation carried forward. In this method, no participant who is randomized is omitted.

In this pilot study there will be no interim analysis conducted.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/02/2018
Actual
6/05/2018
Date of last participant enrolment
Anticipated
13/07/2018
Actual
30/07/2018
Date of last data collection
Anticipated
27/07/2018
Actual
30/08/2018
Sample size
Target
40
Accrual to date
Final
29
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment postcode(s) [1] 18753 0
2617 - Bruce
Recruitment postcode(s) [2] 18754 0
2901 - Tuggeranong

Funding & Sponsors
Funding source category [1] 297480 0
University
Name [1] 297480 0
University of Canberra
Country [1] 297480 0
Australia
Primary sponsor type
University
Name
University of Canberra
Address
University Dr,
Bruce ACT 2617
Country
Australia
Secondary sponsor category [1] 296475 0
Commercial sector/Industry
Name [1] 296475 0
Southside Physiotherapy
Address [1] 296475 0
146 Scollay St,
Greenway ACT 2900
Country [1] 296475 0
Australia
Other collaborator category [1] 279924 0
Other Collaborative groups
Name [1] 279924 0
Trauma and Orthopaedic Research Unit
Address [1] 279924 0
Trauma & Orthopaedic Research Unit
Canberra Hospital,
Yamba Drive,
Garran. ACT 2607
Country [1] 279924 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298582 0
Human Research Ethics Committee of the University of Canberra
Ethics committee address [1] 298582 0
Ethics committee country [1] 298582 0
Australia
Date submitted for ethics approval [1] 298582 0
07/11/2017
Approval date [1] 298582 0
06/12/2017
Ethics approval number [1] 298582 0
HREC 17-292

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2407 2407 0 0
/AnzctrAttachments/373623-17-292_Scarvell_Approved_Letter.pdf (Ethics approval)
Attachments [2] 2408 2408 0 0
/AnzctrAttachments/373623-PAVAP Protocol v 1.0_ 2018-01-31.docx (Protocol)

Contacts
Principal investigator
Name 77550 0
Prof Jennie Scarvell
Address 77550 0
Faculty of Health,
University of Canberra
University Dr,
Bruce ACT 2617
Country 77550 0
Australia
Phone 77550 0
+61 2 6201 2796
Fax 77550 0
Email 77550 0
[email protected]
Contact person for public queries
Name 77551 0
Jennie Scarvell
Address 77551 0
Faculty of Health,
University of Canberra
University Dr,
Bruce ACT 2617
Country 77551 0
Australia
Phone 77551 0
+61 2 6201 2796
Fax 77551 0
Email 77551 0
[email protected]
Contact person for scientific queries
Name 77552 0
Jennie Scarvell
Address 77552 0
Faculty of Health,
University of Canberra
University Dr,
Bruce ACT 2617
Country 77552 0
Australia
Phone 77552 0
+61 2 6201 2796
Fax 77552 0
Email 77552 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethics approval did not include the sharing of participant data except in grouped and de-identified form.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.