Relationship of Core Stability on Pain and Functional Levels in Patients Diagnosed With Hip Osteoarthritis

NCT ID: NCT04771936

Last Updated: 2022-11-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-28
• Study Completion Date: 2022-06-30

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.

Conditions

Osteoarthritis, Hip

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control Group

The control group who shall be awaiting surgery and not receiving a regular physiotherapy exercise intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Conventional Exercise Group

The conventional exercise group shall be subject to a set of conventional exercises based on a program described by Deyle et al (2000).

Group Type: ACTIVE_COMPARATOR

Physiotherapy Exercises

Intervention Type: OTHER

All patients shall be randomly assigned to 3 groups: the control group who shall be awaiting surgery and not receiving a regular physiotherapy, the exercise group who shall be subject to a set of conventional exercises and a core exercise group who shall be performing the conventional exercises plus exercises aimed at the activation of core muscles. These exercises shall be carried out 3 times weekly for a period of 3 months. During the first 4 weeks, all sessions shall be supervised by a physiotherapist. From the 5th to the 8th week, patients shall attend 2 supervised sessions and complete the 3rd one at home. Between the 9th and the 12th week, patients shall then attend 1 supervised intervention and complete 2 sessions at home.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.

Conventional Exercise Group with added core exercises

This exercise group shall be subject to a set of conventional exercises based on a program described by Deyle et al (2000) and core exercises aimed at the activation of the core muscles as adapted from Imai et al (2010).

Group Type: EXPERIMENTAL

Physiotherapy Exercises

Intervention Type: OTHER

All patients shall be randomly assigned to 3 groups: the control group who shall be awaiting surgery and not receiving a regular physiotherapy, the exercise group who shall be subject to a set of conventional exercises and a core exercise group who shall be performing the conventional exercises plus exercises aimed at the activation of core muscles. These exercises shall be carried out 3 times weekly for a period of 3 months. During the first 4 weeks, all sessions shall be supervised by a physiotherapist. From the 5th to the 8th week, patients shall attend 2 supervised sessions and complete the 3rd one at home. Between the 9th and the 12th week, patients shall then attend 1 supervised intervention and complete 2 sessions at home.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.

Interventions

Physiotherapy Exercises

All patients shall be randomly assigned to 3 groups: the control group who shall be awaiting surgery and not receiving a regular physiotherapy, the exercise group who shall be subject to a set of conventional exercises and a core exercise group who shall be performing the conventional exercises plus exercises aimed at the activation of core muscles. These exercises shall be carried out 3 times weekly for a period of 3 months. During the first 4 weeks, all sessions shall be supervised by a physiotherapist. From the 5th to the 8th week, patients shall attend 2 supervised sessions and complete the 3rd one at home. Between the 9th and the 12th week, patients shall then attend 1 supervised intervention and complete 2 sessions at home.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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Malta

OTHER

Sponsor Role: lead

Responsible Party

Ilona Dalmas

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tonio Agius, PhD

Role: STUDY_DIRECTOR

Lecturer at University of Malta

Locations

Faculty of Health Sciences

Msida, , Malta

Countries

Malta

Other Identifiers

2395

Identifier Type: -

Identifier Source: org_study_id