Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000157572p
Ethics application status
Submitted, not yet approved
Date submitted
17/01/2024
Date registered
19/02/2024
Date last updated
19/02/2024
Date data sharing statement initially provided
19/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of manual therapy on selected biomechanical outcomes of gait in people with knee osteoarthritis
Scientific title
Effect of manual therapy on selected biomechanical outcomes of gait in people with knee osteoarthritis
Secondary ID [1] 310871 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
knee osteoarthritis 331912 0
Condition category
Condition code
Musculoskeletal 328645 328645 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 328699 328699 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The primary aim of this study is to explore whether a manual therapy intervention influences the biomechanical outcomes during gait in people with knee OA.

Manual therapy is defined as skilled therapist-applied manual procedures intended to modify the quality and range of motion of the target joint and associated soft tissue structures. The manual therapy protocol will not provide or prescribe aerobic, strengthening, or neuromuscular control exercises. The physiotherapist will deliver manual therapy interventions for all participants. The detailed description of the manual therapy intervention will be recorded to ensure consistency and reproducibility by another team. It includes manual therapy technique details such as name of the technique, rationale or goal, application method including patient and therapist position, location & direction of force, frequency, intensity, duration of the session. We will also record the assessment findings, including symptom irritability, baseline pain, range of motion quality, clinical notes, and the dosage provided/progressed for each intervention session. The compliance of the intervention will be audited in percentage by another research team member who is not involved in providing treatment sessions. We will also record the number of sessions completed by each participant.

Manual therapy for the knee will consist of:
1 Combination of the following treatment techniques for knee will be used for tailored intervention:
• Knee flexion physiological movement with adduction or abduction
• Knee extension physiological movement with adduction or abduction
• Medial and lateral rotation physiological movements
• Longitudinal movement caudal distraction
• Antero-posterior directed accessory movements of Grade I-IV to the tibia, tibiofemoral joint
• Posteroanterior directed accessory movements Grade I-IV to the tibia, tibiofemoral joint
• Tibio-femoral joint Medial and lateral rotation accessory movements
• Patellar gliding accessory movements Grade I-IV
• Manual stretch to quadriceps, hamstring, triceps surae muscle groups
2 Secondary (non-mandatory) interventions techniques prescribed when indicated by assessment findings:
• *Mobilisation with movement (MWM) consisted of a sustained manual glide of the tibia (either medial, lateral, anterior, posterior, or rotation) during active knee flexion and extension
*MWM testing is mandatory. It is only included as a treatment technique when indicated i.e., pain is significantly reduced with application of joint glide. MWM will be added as a non-mandatory intervention technique.

Manual therapy will be performed with the frequency of 2 sessions per week for 3 consecutive weeks. The duration for each session will be 45-60 minutes. The intensity of manual therapy will be chosen based on the assessment, clinical reasoning, and participant's tolerance. Necessary physical examination will be done to choose the treatment techniques as per recommendation of the Maitland’s peripheral manipulation textbook, and based on identified impairments (Hengeveld et al., 2005, Petty & Barnard, 2018). For example, if the knee has restricted extension, a PA or external rotation accessory movement will be selected. Each participant will receive a tailored MT intervention within one week of baseline II (4-week after the enrolment into the study). On post-intervention assessment at 8-week, participants will be educated about knee OA by providing information as suggested by Arthritis NZ and be advised to stay active as recommended by international guidelines.

Hengeveld, E., Banks, K., & Maitland, G. D. (2005). Maitland's peripheral manipulation (4th ed.).Elsevier/Butterworth Heinemann.
Petty, N. J., & Barnard, K. (2018). Principles of musculoskeletal treatment and management : a handbook fortherapists (Third edition ed.). Elsevier Edinburgh.
Intervention code [1] 327289 0
Rehabilitation
Intervention code [2] 327290 0
Treatment: Other
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336557 0
Peak knee adduction moment (KAM) will be used as a primary outcome measure.
Timepoint [1] 336557 0
Baseline I, baseline II at 4-week and post-intervention assessment at 8-week after enrolment into the study
Secondary outcome [1] 428800 0
Pain intensity while walking
Timepoint [1] 428800 0
Baseline I, baseline II at 4-week, post-intervention assessment at 8-week and
6-month after enrolment into the study
Secondary outcome [2] 428802 0
Pain interference, Physical Function, Quality of life (QOL)
Timepoint [2] 428802 0
Baseline I, baseline II at 4-week, post-intervention assessment at 8-week and
6-month after enrolment into the study
Secondary outcome [3] 428804 0
Fear and avoidance
Timepoint [3] 428804 0
Baseline I, baseline II at 4-week, post-intervention assessment at 8-week and
6-month after enrolment into the study
Secondary outcome [4] 428805 0
Physical function performance measure
Timepoint [4] 428805 0
Baseline I, baseline II at 4-week, post-intervention assessment at 8-week and
6-month after enrolment into the study
Secondary outcome [5] 428806 0
Physical function performance measure
Timepoint [5] 428806 0
Baseline I, baseline II at 4-week, post-intervention assessment at 8-week and
6-month after enrolment into the study
Secondary outcome [6] 428807 0
Physical function performance measure
Timepoint [6] 428807 0
Baseline I, baseline II at 4-week, post-intervention assessment at 8-week and
6-month after enrolment into the study
Secondary outcome [7] 428808 0
Physical function performance measure
Timepoint [7] 428808 0
Baseline I, baseline II at 4-week, post-intervention assessment at 8-week and
6-month after enrolment into the study
Secondary outcome [8] 428809 0
Patient assessment of overall change
Timepoint [8] 428809 0
post-intervention assessment at 8-week and 6-month after enrolment into the study
Secondary outcome [9] 430364 0
knee flexion moment (KFM)
Timepoint [9] 430364 0
Baseline I, baseline II at 4-week and post-intervention assessment at 8-week after enrolment into the study
Secondary outcome [10] 431393 0
Dynamic joint stiff ness (DJS)
Timepoint [10] 431393 0
Baseline I, baseline II at 4-week and post-intervention assessment at 8-week after enrolment into the study
Secondary outcome [11] 431394 0
Duration of single limb support (SLS) phase of the gait
Timepoint [11] 431394 0
Baseline I, baseline II at 4-week and post-intervention assessment at 8-week after enrolment into the study
Secondary outcome [12] 431395 0
Knee excursion in the sagittal plane throughout the stance phase of gait
Timepoint [12] 431395 0
Baseline I, baseline II at 4-week and post-intervention assessment at 8-week after enrolment into the study
Secondary outcome [13] 431396 0
Knee extensor moment (KEM)
Timepoint [13] 431396 0
Baseline I, baseline II at 4-week and post-intervention assessment at 8-week after enrolment into the study
Secondary outcome [14] 431397 0
Knee flexion angle at push-off
Timepoint [14] 431397 0
Baseline I, baseline II at 4-week and post-intervention assessment at 8-week after enrolment into the study

Eligibility
Key inclusion criteria
1. Unilateral tibiofemoral OA fulfilling the American College of Rheumatology clinical classification criteria for knee OA (knee pain >15 days in last month; the presence of at least 3 out 6 following criteria - age > 50 years, stiffness < 30 mins, crepitus, bony tenderness, bony enlargement, no palpable warmth)(Altman et al., 1986)

2. Reported knee pain while walking>3 on 11-point numeric pain-rating scale (NPRS) (0=no pain; 10=maximal pain).

3. Restricted overall range of motion (ROM) greater than or equal to 10 degrees in the involved knee as compared to non-involved knee.

4. Participant score should be less than 75 on Knee Injury and Osteoarthritis Outcome Score (KOOS4) symptoms subscales pain, symptoms, function of daily living and quality of life defined as the average score for the subscales pain, symptoms, function of daily living (ADL) and quality of life.

Altman, R., Asch, E., Bloch, D., Bole, G., Borenstein, D., Brandt, K., Christy, W., Cooke, T. D., Greenwald, R., Hochberg, M., Howell, D., Kaplan, D., Koopman, W., Longley, S., Mankin, H., McShane, D. J., Medsger, T., Meenan, R., Mikkelsen, W., . . . Wolfe, F. (1986). Development of criteria for the classification and reporting of osteoarthritis: Classification of osteoarthritis of the knee. Arthritis & Rheumatism, 29(8), 1039-1049. https://doi.org/10.1002/art.1780290816
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Any previous lower extremity fracture or surgery to either limb such as a history of hip or knee joint replacement or tibial osteotomy, and spine surgery.

2. Knee injury within 6 months requiring medical attention or physiotherapy treatment

3. Intra-articular corticosteroid injection within 6 months.

4. current or past (within 4 weeks) oral corticosteroid use.

5. Systemic inflammatory arthritic conditions; concurrent pain and/or pathology in the foot or ankle; neurological disorders e.g., stroke, parkinsons; concurrent musculoskeletal disorders e.g., back pain, neck pain, hip OA.

6. Diagnosed case of metabolic bone disease such as osteoporosis (lower bone density).

7. Participants referred to secondary care for an orthopaedic consultation to consider surgery for hip or knee OA, or on a waiting list for Total Knee Arthroplasty (TKA).

8. Intention to start or currently participating in a supervised physiotherapy program.

9. Currently using gait aid or orthotics such as foot insoles or knee-brace to ambulate.

10. Body mass index>35 due to difficulty in accurate marker placement for gait analysis.

11. A medical condition that precluded safe participation in manual therapy intervention such as osteoporosis requiring medication, prolonged use of oral steroid medication.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The primary aim of this study is to explore whether a manual therapy (MT) intervention influences the biomechanical outcomes during gait in people with knee OA. The secondary aim is to explore the relationship between biomechanical outcomes of gait and clinical outcomes (pain and function), following a MT intervention.

Statistical analyses will be completed using SPSS (IBM, version 21). Results will include descriptive statistics, assessment of normality of outcomes (Shapiro- Wilk test), missing data reporting and management. We will report mean ± standard deviation, mean differences (SD), 95 % CI, and p-value to describe each outcome measure.

• To evaluate our primary aim whether MT does influence the primary outcome measure (Peak KAM) from baseline I (time-point 1) to baseline II at 4-week (time-point 2) and post-intervention at 8-week (time-point 3), we will use a repeated measures ANOVA and a Tukey HSD post hoc test for normally distributed data or a comparable non-parametric test if the underlying assumptions not valid.
• We will evaluate changes in secondary biomechanical outcome measures from baseline I (time-point 1) to baseline II at 4-week (time-point 2) and post-intervention at 8-week (time-point 3) using repeated measures ANOVA and a Tukey HSD post hoc test for normally distributed data or a comparable non-parametric test if the underlying assumptions not valid.
• We will evaluate changes in clinical outcome measures from baseline I (time-point 1) to baseline II at 4-week (time-point 2), post-intervention (8-week) & follow-up at 6-month (time-point 3 & 4) using repeated measures ANOVA and a Tukey HSD post hoc test.
• To assess our secondary aim whether there is an association between selected biomechanical outcomes of gait change score (post-pre) and clinical outcomes change score (post-pre) following MT intervention at 8-week & 6-month (time-point 3 & 4), we will use repeated measure correlation (rmcorr) test (Bakdash & Marusich, 2017).
• We will perform one-way ANOVA to explore whether radiological severity of knee OA (K-L grade) influences the outcomes following a MT intervention at 8-week (time-point 3).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/03/2024
Actual
Date of last participant enrolment
Anticipated
15/05/2024
Actual
Date of last data collection
Anticipated
15/11/2024
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 25964 0
New Zealand
State/province [1] 25964 0
Otago

Funding & Sponsors
Funding source category [1] 315132 0
University
Name [1] 315132 0
School of Physiotherapy Research Fund Grant-in-aid, 2024 & Mark Steptoe Memorial Trust Research Grant-in-aid, 2024, School of Physiotherapy, University of Otago
Country [1] 315132 0
New Zealand
Primary sponsor type
Individual
Name
Dr Cathy Chapple (Primary supervisor of the applicant), School of Physiotherapy, University of Otago
Address
325 Great King Street, Dunedin- 9016
Country
New Zealand
Secondary sponsor category [1] 317148 0
None
Name [1] 317148 0
Address [1] 317148 0
Country [1] 317148 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314070 0
Health and Disability Ethics Committee
Ethics committee address [1] 314070 0
133 Molesworth Street Thorndon Wellington 6011
Ethics committee country [1] 314070 0
New Zealand
Date submitted for ethics approval [1] 314070 0
16/02/2024
Approval date [1] 314070 0
Ethics approval number [1] 314070 0

Summary
Brief summary
The primary aim of this study is to explore whether a manual therapy intervention influences the biomechanical outcomes during gait in people with knee OA. The secondary aim is to explore the relationship between biomechanical outcomes of gait and clinical outcomes (pain and function), following a manual therapy intervention.

Each participant will receive a tailored MT intervention for 3 weeks from a qualified physiotherapist within one week of baseline measurements. On post-intervention assessment at 8-week, participants will be educated about knee OA by providing information and advised to stay active as recommended by international guidelines.

All biomechanical outcomes during gait will be measured at 3 time-points (baseline I, baseline II at 4-week and post-intervention at 8-week). Clinical outcomes will be assessed at 4 time-points (baseline I, baseline II at 4-week, post-intervention at 8-week, and follow up at 6-month), except patient global assessment (8-week and 6-month).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130298 0
Mr Sarfaraz Alam
Address 130298 0
325 Great King Street, Centre for Health, Activity and Rehabilitation Research (CHARR), School of Physiotherapy, University of Otago, Dunedin- 9016
Country 130298 0
New Zealand
Phone 130298 0
+64 2902064380
Fax 130298 0
Email 130298 0
sarfaraz.alam@postgrad.otago.ac.nz
Contact person for public queries
Name 130299 0
Mr Sarfaraz Alam
Address 130299 0
325 Great King Street, Centre for Health, Activity and Rehabilitation Research (CHARR), School of Physiotherapy, University of Otago, Dunedin- 9016
Country 130299 0
New Zealand
Phone 130299 0
+64 2902064380
Fax 130299 0
Email 130299 0
sarfaraz.alam@postgrad.otago.ac.nz
Contact person for scientific queries
Name 130300 0
Mr Sarfaraz Alam
Address 130300 0
325 Great King Street, Centre for Health, Activity and Rehabilitation Research (CHARR), School of Physiotherapy, University of Otago, Dunedin- 9016
Country 130300 0
New Zealand
Phone 130300 0
+64 2902064380
Fax 130300 0
Email 130300 0
sarfaraz.alam@postgrad.otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23908Ethical approval    386810-(Uploaded-20-06-2024-08-15-56)-final approval Letter.pdf

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.