Clinical trial NCT04771936: Relationship of Core Stability on Pain and Functional Levels in Patients Diagnosed With Hip Osteoarthritis
Official title: Relationship of Core Stability on Pain and Functional Levels in Patients Diagnosed With Hip Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Hip
Keywords: Hip
Osteoarthritis
Exercise
Core Stability
Lead sponsor: University of Malta
Sponsor class: OTHER
First posted: 2021-02-25
Enrollment: 51
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with a diagnosis of OA hip who are awaiting a total hip replacement will be recruited in this study. Both male and female subjects age 40 years and over will be included in the study.
Primary purpose: TREATMENT

Brief summary: Osteoarthritis (OA) is a common disease that occurs more commonly amongst the elderly and is caused by the destruction of the joint cartilage. It is considered to be one of the most common joint disorders worldwide and a main cause of disability amongst older adults. After the knee, the hip is considered to be the second most commonly affected joint by OA. One of the functional capacities affected by OA is muscle strength with studies looking into knee OA documenting a decrement of this measure. It is reported that the muscle strength of the quadriceps, hamstrings and other musculature around the hip is significantly impaired in patients with knee OA compared to age-matched controls.

Evidence for quadriceps muscle weakness in knee OA is consistent and programs based on quadriceps strengthening exercises as a core component in the management of knee OA are now evidence-based. Lower extremity muscle weakness is also apparent in hip OA. However, compared to the knee, there is less literature on muscle strength in hip OA with guidelines for therapeutic exercise prescription being more expert rather than evidence-based. Therefore, one of the major questions that arises here is whether muscle weakness as observed in knee OA is evident in hip OA, and if so, which muscles are most affected.

A concept which has been found to help diminish the effect of decreased muscle strength in the above mentioned muscle groups is optimal core stability. Core stability contributes to strength, endurance, flexibility and motor control all of which optimise the stability of the spine during both dynamic and static tasks in daily normal biomechanical function in patients with a diagnosis of OA knees. Despite such evidence, no studies to the knowledge of the researcher have looked into the effects of core stability on pain and functional levels in patients with a diagnosis of OA hip. A lack of literature in relation to this aspect is due to the unavailability of a gold standard for measuring core stability.

Therefore, the objective of this study will be multifold with an investigation into which muscles in the lower limb are predominantly weaker, whether there is core muscle weakness in patients with hip OA, looking for any correlation between both these factors and whether an exercise programme leads to changes on functional activity and pain levels.

Detailed description: Osteoarthritis (OA) is a common disease that occurs more commonly amongst the elderly and is caused by the destruction of the joint cartilage. It is considered to be one of the most common joint disorders worldwide and a main cause of disability amongst older adults. After the knee, the hip is considered to be the second most commonly affected joint by OA.

One of the functional capacities affected by OA is muscle strength with studies looking into knee OA documenting a decrement of this measure. The muscle strength of the quadriceps, hamstrings and other musculature around the hip is significantly impaired in patients with knee OA compared to age-matched controls.

Evidence for quadriceps muscle weakness in knee OA is consistent and programs based on quadriceps strengthening exercises as a core component in the management of knee OA are now evidence-based. Lower extremity muscle weakness is also apparent in hip OA. However, compared to the knee, there is less literature on muscle strength in hip OA with guidelines for therapeutic exercise prescription being more expert rather than evidence-based. Therefore, one of the major questions that arises here is whether muscle weakness as observed in knee OA is evident in hip OA, and if so, which muscles are most affected.

A concept which has been found to help diminish the effect of decreased muscle strength in the above mentioned muscle groups is optimal core stability. Core stability contributes to strength, endurance, flexibility and motor control all of which optimise the stability of the spine during both dynamic and static tasks in daily normal biomechanical function in patients with a diagnosis of OA knees. Despite such evidence, no studies to the knowledge of the researcher have looked into the effects of core stability on pain and functional levels in patients with a diagnosis of OA hip. Lack of literature in relation to this aspect is due to the unavailability of a gold standard for measuring core stability.

Therefore, the objective of this study will be multifold with an investigation into which muscles in the lower limb are predominantly weaker, whether there is core muscle weakness in patients with hip OA, looking for any correlation between both these factors and whether an exercise programme leads to changes on functional activity and pain levels.

All the patients who give consent to participate shall be randomly assigned to three groups being the control group who shall be awaiting surgery and not receiving a regular physiotherapy exercise intervention, the exercise group who shall be subject to a set of conventional exercises based and a core exercise group who shall be performing the conventional exercises plus exercises aimed at the activation of the core muscles. These exercises shall be carried out three times weekly for a period of three months. During the first four weeks, all sessions shall be supervised by a physiotherapist who shall monitor and increase the duration or difficulty of exercises according to patients' progression. From the 5th to the 8th week, patients shall attend two supervised sessions and complete the third one at home. Between the 9th and the 12th week, patients shall then attend one supervised intervention and complete two exercise sessions at home. All patients shall be given a copy of the exercise sheet with instructions for use at home. Anonymisation shall be ensured with every patient through assignment of a random code for every individual. Patients assigned to the control group shall be given a chance to enrol into the program upon completion of the study if they wish to do so.

Eligibility criteria: Inclusion Criteria:

* Patients awaiting a total hip replacement
* Anyone above the age of 40 years

Exclusion Criteria:

* Patients with neurologic conditions affecting mobility
* Patients with cognitive impairments
* Patients not willing to comply

Primary outcomes:
measure: Change in pain levels assessed using the Numerical Pain Rating Scale (NPRS)
timeFrame: Week 0 and week 12
measure: Change in functional Levels assessed using the WOMAC Scale
timeFrame: Week 0 and week 12
measure: Change in functional Levels assessed using the 6 MWT
timeFrame: Week 0 and week 12
measure: Change in lower limb muscle strength
timeFrame: Week 0 and week 12
measure: Change in core Muscle Strength using a pressure biofeedback unit (PBU)
timeFrame: Week 0 and week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Imsida
country: Malta
facility: Faculty of Health Sciences
Study officials:
affiliation: Lecturer at University of Malta
name: Tonio Agius, PhD
role: STUDY_DIRECTOR
References: