Hypermobility, Joint, Hypermobility Syndrome, Knee Discomfort
Conditions
Keywords
Hypermobility, Knee pain, Treatment, Randomised controlled trial
Brief summary
Pain associated with knee joint hypermobility is common in the adult population, but evidence on treatment is sparse. This study investigates if high-load resistance training is superior to usual care in improving activity-related pain in young patients (18-45 years) with hypermobile joints and knee pain.
Detailed description
Knee joint hypermobility is common in the adult population. Patients with knee joint hypermobility and knee pain are typically managed with low intensity resistance training and proprioceptive training to reduce knee pain and improve function, but many patients do not respond well to these treatment strategies. High-load resistance training offers additional benefits to low intensity resistance training, including marked increase in muscle cross-sectional area, neural drive, and increased tendon stiffness, all important components of acquiring active knee joint stability during movement tasks and daily life. Therefore, the primary aim of this randomised controlled trial (RCT) is to investigate if high-load resistance training is superior to usual care in reducing activity-related pain in young patients (18-45 years) with hypermobile joints and knee pain.
Interventions
OTHERNeuromuscular training for the knee
The exercise programme includes exercises identified in literature to target muscles around the knee.
OTHERHigh-load strength training for the knee
The exercise programme includes exercises identified in literature to target muscles around the knee.
Sponsors
University of Southern Denmark
Independent Research Fund Denmark
Odense Patient Data Explorative Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
The patients will be kept blind to treatment allocation by being provided with minimal information about the content of the two exercise interventions and the study hypotheses; the patients will be informed that the study compares two different exercise protocols that both include safe exercises to reduce knee pain and increase knee function. An independent biostatistician blinded to group allocation will perform the primary RCT analysis. To reduce the risk of interpretation bias, blinded results from the analyses (group A compared with group B) will be presented to all authors, who will agree on two alternative written interpretations before the data manager unblinds the randomisation code.
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Persistent knee pain for ≥ 3 months (self-reported) * Knee pain ≥ 30mm during the last week using a 0-100 mm visual analogue scale (VAS; 0=no pain and 100=worst imaginable pain) (self-reported) * Generalised joint hypermobility assessed with the Five-Part Hypermobility Questionnaire (positive ≥ 2/5) (self-reported) * Local knee joint hypermobility using the passive hyperextension of the knee in standing (positive \> 10 degrees of hyperextension) and confirmed in supine lying (heel resting on 20 cm high block on the bench surface), with passive knee hyperextension (positive \> 10 degrees) (objectively measured)
Exclusion criteria
* Diagnosed with patellar tendinopathy * Pregnancy or childbirth within the past year (due to increased levels of relaxin that could affect joint stability) * Knee surgery within the past year * Participation in regular structured resistance training within the past six months * Inability to speak and understand Danish. * All types of Ehlers-Danlos syndrome * Other heritable connective tissue disorders such as Marfan syndrome, osteogenesis imperfecta, Loeys-Dietz syndrome, Stickler syndrome, skeletal dysplasias * Autoimmune rheumatic connective tissue disorders such as lupus, rheumatoid arthritis; Chromosomal conditions such as Fragile X syndrome, Kabuki syndrome, Down syndrome * Neuromuscular disorders that can cause joints to become unstable, such as multiple sclerosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale Nominated Activity | Baseline, 6 weeks, 12 weeks (primary endpoint), 12 months | The primary outcome is the Self-reported knee pain during an activity nominated by patients to be the most aggravating for their present knee pain (VAS nominated activity - VASNA, 0-100, 100 = worse). The primary endpoint is at 12-week follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee injury and Osteoarthritis Outcome Score (KOOS) | Baseline, 12 weeks, 12 months | Knee injury and Osteoarthritis Outcome Score is a validated knee-specific questionnaire used to assess patient-reported outcomes in the continuum from knee injury to osteoarthritis and is widely used for different types of knee pathology. (0-100, 100 = best) |
| Adverse events | Up to 12 months | Adverse events will be defined as any unintended, negative findings, symptom, or illnesses that occur during the study assessments or interventions, whether attributable to the project or not. |
| Dynamic knee strength | Baseline, 12 weeks | Dynamic leg strength will be established by a 5-repetition maximum leg press (single leg) by a standardised protocol. |
| Knee reposition sense | Baseline, 12 weeks | Sitting active knee joint reposition (proprioception) test will be performed using a HALO Digital Goniometer, to assess mean absolute angle error (AAE) |
| Single-Leg-Hop for Distance | Baseline, 12 weeks | The patients will be instructed to hop forward as far as possible and land steadily and stand still for at least three seconds. |
Countries
Denmark
Contacts
PRINCIPAL_INVESTIGATORBehnam Liaghat, PhD
University of Southern Denmark
STUDY_DIRECTORJonas B Thorlund, PhD
University of Southern Denmark
Outcome results
None listed