Is targeted physiotherapy effective in improving outcomes, quality of life and return to activity in patients that are at risk of deteriorating symptoms and early osteoarthritis following anterior cruciate ligament reconstruction.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616000564459
• Date of registration: 02/05/2016
• Prospective Registration: Yes
• Primary sponsor: Professor Kay Crossley
• Public title: Is targeted physiotherapy effective in improving outcomes, quality of life and return to activity in patients that are at risk of deteriorating symptoms and early osteoarthritis following anterior cruciate ligament reconstruction.
• Scientific title: An exploration of the feasibility of a randomised clinical trial for physiotherapy intervention in patients at high risk of early-onset knee osteoarthritis and symptomatic decline following anterior cruciate ligament reconstruction.
• Date of first enrolment: 24/01/2017
• Target sample size: 24
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12616000564459.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Miss Brooke Howells

• Name: Miss Brooke Howells

Key inclusion & exclusion criteria

Inclusion criteria: (i) aged 18-50 years; (ii) primary arthroscopic ACLR with a hamstring-tendon autograft 6 months prior; (iii) evidence of poor knee function at 12 months as defined by:
< 87.5 on KOOS-QoL score AND meeting one the following three criteria:

1. <22 on the one leg rise task OR
2. <88% LSI on single leg hop for distance
3. <87 on the AKP scale

Please note that patients will be recruited at 6 months post ACLR into a recruitment pool. From this point we will monitor their activity level from 6 -12 months as it has been shown significant bone and cartilage changes occur in this time point, and it has been suggested that those that participate early in cutting/impact activities may have greater changes. At 12 months, each patient who had agreed to be contacted for eligibility at 12 months will be re contacted, The patients will then be invited to attend an eligibility testing session at BodySystem clinic, of which the KOOS- QoL, one leg rise, single hop for distance and AKP scale will be administered by a physiotherapist who will not be involved in the treatment intervention. If eligible they will book an appointment for physiotherapy 1:1 session, to begin as soon as possible.
Note: The patients will be informed on the possibility at 6 months that they may not be eligible for the study.
Exclusion criteria: (i) previous injury/symptoms in the ACL injured knee; (ii) >5 years between ACL injury and reconstruction; (iii) subsequent injury (for which medical treatment was sought) or follow-up surgery to the ACLR knee; (v) another condition influencing daily function; (iv) inability to understand written and spoken English.

Age minimum: 18 Years
Age maximum: 50 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Musculoskeletal - Other muscular and skeletal disorders

anterior cruciate ligament reconstruction;
anterior cruciate ligament reconstruction

Physical Medicine / Rehabilitation - Physiotherapy

Intervention(s)

The targeted physiotherapy intervention group will complete eight 1:1 physiotherapy sessions (duration = 30 minutes) over 16 weeks, (1 x week for 4 weeks, then every 3 weeks for 12 weeks). These sessions will be conducted at BodySystem sports medicine clinic by two experienced physiotherapists (>5 years clinical experience in treating lower limb musculoskeletal conditions). This will occur immediately following a baseline assessment session with investigator BH at 12 months post ACLR.

Physiotherapy in this pilot RCT will have a distinct focus on functional retraining split into “progressive phases”. These phases are similar to a neuromuscular retraining intervention that has led to clinically meaningful changes in self-reported QoL in knee injury populations (articular cartilage lesions) with ongoing functional deficits following a similar period of routine rehabilitation.

There are 7 main "tasks" or exercises:
1. Balance
2. Functional strength
3. One Leg Rise
4. Posterior chain strength
5. Power
6. Multidirectional Movement
7. Sport Specific/Cardiovascular exercise
Each task, will have progressive phases within it. For example, "one leg rise" will start at phase one of a bilateral sit to stand, then once the pass criteria is met (x 30 to 90 degrees, nil pain or response in the knee), they move to an assisted one leg rise, then to an unassisted one leg rise, then to a single leg squat, then to a star excursion exercise.
The 7th category of "sport specific/cardiovascular exercise," is also phased. For example, they may not have began running, so phase 1 starts at walking/bike/swimming, then once they have passed the criteria (range of strength, control and balance tests) they may move to running.
See attached document for

Primary Outcome(s)

Knee-related QoL
- via KOOS and ACL-QoL
[Baseline (= prior to first intervention session) will be compared to 16 weeks (following last intervention session) ]

Secondary Outcome(s)

Tegner Activity Scale


[Baseline (= prior to first intervention session) will be compared to 16 weeks (following last intervention session) ]

Anterior Knee Pain Scale (AKPS)[Baseline (= prior to first intervention session) will be compared to 16 weeks (following last intervention session) ]

Swelling, as measured by the physiotherapist using the stroke test.
Scoring methods: Zero - 3+
Zero = no wave produced on downstroke.
Trace: small wave on medial side with downstroke. 1+ = large bulge on medial side with downstroke.
2+ = effusion spontaneously returns to medial side after upstroke.
3+ = so much fluid that it is not possible to move the effusion out of the medial side of the knee.
[Baseline (= prior to first intervention session) will be compared to 16 weeks (following last intervention session) ]

Anterior cruciate ligament return to sport after injury scale (ACL-RSI) [Baseline (= prior to first intervention session) will be compared to 16 weeks (following last intervention session) ]

International Physical Activity Questionnaire (IPAQ) [Baseline (= prior to first intervention session) will be compared to 16 weeks (following last intervention session) ]

One leg rise test[Baseline (= prior to first intervention session) will be compared to 16 weeks (following last intervention session) ]

Perceived global change score
Participants will rate their perceived change following treatment on a 5-point ordinal scale (much improved, improved, no change, worse and much worse. [Baseline (= prior to first intervention session) will be compared to 16 weeks (following last intervention session) ]

Single Leg Balance[Baseline (= prior to first intervention session) will be compared to 16 weeks (following last intervention session) ]

Side hop test. Reported as maximum number of hops each limb in 30 seconds. Patient to hop sideways over 40cm taped lines. [Baseline (= prior to first intervention session) will be compared to 16 weeks (following last intervention session) ]

triple crossover hop for distance, reported in cm each limb [Baseline (= prior to first intervention session) will be compared to 16 weeks (following last intervention session) ]

International Knee Documentation Committee (IKDC) subjective knee evaluation form
[Baseline (= prior to first intervention session) will be compared to 16 weeks (following last intervention session) ]

Marx Activity Scale [Baseline = 6 months post ACLR
Monthly from 6 - 12 months post ACLR
]

Quadriceps Circumference
Measured with measuring tape, 10cm above the centre of the knee cap[Baseline (= prior to first intervention session) will be compared to 16 weeks (following last intervention session) ]

Self Efficacy of knee function scale [Baseline (= prior to first intervention session) will be compared to 16 weeks (following last intervention session) ]

strength gluteals - assessed by hand held dynamometry:
- hip abduction (side-lying)
- hip external and internal rotation (prone)
- hip extension (prone)
Also using belt to stabilise and assist the therapist.
[Baseline (= prior to first intervention session) will be compared to 16 weeks (following last intervention session) ]

strength of hamstrings assessed by hand held dynamometry prone, at 15 degrees and 45 degrees. [Baseline (= prior to first intervention session) will be compared to 16 weeks (following last intervention session) ]

Tampa Scale for Kinesiophobia[Baseline (= prior to first intervention session) will be compared to 16 weeks (following last intervention session) ]

Video of single leg squat (SLS) and single leg drop jump (SLDJ).

The quality of these movements will be assessed by experienced clinician researchers, and rated by the following functional alignment criteria:
For the SLS: Rated as good, fair or poor.
For a subject to be rated “good” they must achieve 7/8 of the following criteria.
For a subject to be rated “fair” they must achieve 5/8 of the following criteria.
For a subject to be rated "poor" achieve <5/8 of the following criteria

– Maintain balance
– Perform the movement smoothly
– Squat must be to at least 60 degrees
– No trunk movement (lateral deviation, rotation, lateral flexion, forward flexion)
– No pelvic movement (shunt or lateral deviation, rotation, or tilt)
– No hip adduction or internal rotation
– No knee valgus
– Centre of knee remains over centre of foot

For the SLDJ:
- See attached functional alignment criteria scoring method document [Baseline (= prior to first intervention session) will be compared to 16 weeks (following last intervention session) ]

Crepitus:
measured by the baseline assessor through active flexion/extension as the feeling of grinding/cracking/vibrations with the hand over the patella. [Baseline (= prior to first intervention session) will be compared to 16 weeks (following last intervention session) ]

Range of Motion:
Flexion: measured supine with long arm goniometer
Extension: measured by prone leg hang [Baseline (= prior to first intervention session) will be compared to 16 weeks (following last intervention session) ]

strength of calf assessed by maximum number of single leg heel raises on each leg (with full height, good form and technique). [Baseline (= prior to first intervention session) will be compared to 16 weeks (following last intervention session)]

Single leg hop for distance, reported in cm each limb [Baseline (= prior to first intervention session) will be compared to 16 weeks (following last intervention session) ]

strength of core assessed by side plank endurance (maximum number of seconds able to hold in correct position up to 1 minute). Compared to the other side and normative/acceptable values. [Baseline (= prior to first intervention session) will be compared to 16 weeks (following last intervention session) ]

Strength of quadriceps - seated knee extension isometric hand held dynamometer at 30 degrees. (therapist assisted via external belt stabilisation).
[Baseline (= prior to first intervention session) will be compared to 16 weeks (following last intervention session) ]

Secondary ID(s)

Nil Known

Source(s) of Monetary Support

Physiotherapy Research Foundation

Secondary Sponsor(s)

Adam Culvenor

Brooke Howells

Ethics review

Status: Approved
Approval date:
Contact:

La Trobe University Human Ethics Committee