Are Baseline Factors Associated With Persistent Pain in People With Femoral Acetabular Impingement Syndrome After a Physiotherapy-led Rehabilitation Programme?
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 175
- 试验地点
- 1
- 主要终点
- International Hip Outcome Score33 (iHOT33)
研究概览
简要总结
Background:
The hip joint is a ball and socket joint where the ball inserts into the socket. The ball shape is round but sometimes the ball has a bony bump on it. When the ball moves in the socket, the bump can hit the edge of the socket causing pain in movements like squatting or kicking a ball. Repeated hitting of the bump in the socket can cause hip pain, damage, and arthritis. This is called hip impingement and is found in 10-15% of young adults.
Does Physiotherapy treatment work? Exercises from a physiotherapist make the muscles stronger around the hip joint which alters the way the ball moves. This stops the bump hitting the socket and this can help reduce the pain. However, an experiment found only 32% of people doing exercises got better.
So, why after strengthening the muscles are some people still in pain? Is there another source of pain?
Other causes of pain? We know things like people's emotions such as 'feeling down' can affect pain. An experiment I did found neuropathic pain in people with hip impingement. This pain is caused by a disease of the nerves that provide information about your body. This can be a cause of pain even if your muscles are strong. In both situations, strengthening your muscles may not be the best choice. We need to know more about types of pain in people with hip impingement to give better treatment.
Aim To look at causes of hip impingement in people before they have physiotherapy treatment, to see if we can find a reason why some people don't get better after strengthening their muscles.
Project design I will review the research to see if people with hip impingement may feel for example, sad, anxious or scared of moving their hip, which could be a reason why some people don't get better after doing their strengthening exercises.
I will invite 175 adults with hip impingement who have been referred for physiotherapy to join this study. They will have 2 research appointments, 30-60 minutes each. The first one before the start of their physiotherapy treatment, the second one will be 4 months after starting their physiotherapy treatment. At both appointments they will complete special questionnaires designed to explore emotions and causes of pain. I will compare the results of the questionnaires which will give me more information about the causes of pain and how people view their pain. This will give me a better understanding why strengthening exercises may not be the best treatment.
Patient and public involvement (PPI) I presented this project to 23 members of the public (who help researchers with their projects) at our monthly meeting. They thought this project was a good idea, especially talking about things like anxiety and depression. This will form part of the questionnaires.
Patients told me about their thoughts of having pain following treatment for hip pain. They felt further knowledge into why they had pain and help with mental and emotional support was important to them. They told me about their concerns over the lack of information about what treatment can and cannot achieve. They were reluctant to suggest treatment.
Three patients would like to help me further design my study so that the information available to the public is clear and concise.
详细描述
STUDY DESIGN The study flow is shown in Appendix A which summarises the study. Patients will be invited to participate in this observational prospective cohort study.
Setting: Participants will be screened from 4 tertiary hospital sites recognised for the management and treatment for FAIS. The hospital locations were chosen to cover a diverse population ranging from urban to rural locations, offering a broad range of backgrounds and culture according to the ONS Census of Population. Across hospital involvement will reduce spectrum and selection bias. All participants will be approached prior to attending their PLR with a diagnosis of FAIS at the specialist orthopaedic hip clinics. However, alternative centres are available should the situation change at any of these between application and study onset.
Participants: will be recruited from relevant hip clinics and from the hospital that they are attending. They will be approached by a research assistant including a study information pack after identified by a clinician. Participants who have a formal diagnosis of FAIS by an orthopaedic doctor/registrars or physiotherapists will be screened for eligibility.
Consent: Patients with mental capacity who have a proven understanding of the English language will be approached. The consent form, questionnaires and information pack will be accessible on-line via a QR code linked to a free secure web-based data collection platform (REDCap). An information pack including a letter of invitation, Patient Information Sheet explaining the nature of the study and an informed consent form will be included in paper form. If participants would prefer, a printed copy of the questionnaires will be issued, and the results manually inputted.
• Outcome measures: Baseline physical hip characteristics will be collected from MRI or Xray findings: Cam size (alpha angle), OA (Kellgren Lawrence staging of OA), and radiological co-morbidities on MRI (e.g., gluteal tendinopathy) Pain Phenotyping • Douleur Neuropathique 4, Widespread Pain Index, Neuropathic Pain Symptom Inventory Psychometric measurements, Tampa scale of Kinesiophobia (TSK-11), Hospital Anxiety and Depression scale (HADS), Pain Catastrophising Scale (PCS), Credibility/Expectancy Questionnaire (CEC), Treatment Expectation Questionnaire (TEX-Q), Quality of Life: International Hip Outcome Tool (iHOT33). • Visual analogue scale for pain, Hip range of movement The two additional outcome measures in the form of questionnaires (CEQ and TEX-Q) have been included based on feedback from the PPIE group. For participants unable to access the QR code, a paper copy of the questionnaires will be provided with a self-addressed stamped envelope.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Participants aged between 18 and 55 years
- •Diagnosis of symptomatic FAIS following a formal clinical assessment
- •Appropriate imaging: MRI/Arthrogram, and /or Xray and/or CT (secondary care pathway for diagnosis but this is optional).
- •Awaiting PLR
- •No previous surgery to the index hip
- •Have capacity to give informed consent
- •English as a spoken language
排除标准
- •• Presence of hip dysplasia, femoral stress fracture, synovitis or other inflammatory arthropathy (psoriatic arthropathy)
- •Kellgren-Lawrence grading of Osteoarthritis ≥2 (to exclude moderate OA which could be a confounding influence on pain)
- •Avascular necrosis of the femoral head
- •Previous surgery to index hip
- •Previous physiotherapy treatment to the index hip in the past 6 months
- •Current pregnancy
- •Perthes disease
- •Involved in a current research study involving the hip
研究组 & 干预措施
Patients diagnosed with femoral acetabular impingement syndrome
Adult male or female participants with a formal diagnosis of FAIS who meet the inclusion criteria:
- Participants aged between 18 and 55 years
- Diagnosis of symptomatic FAIS following a formal clinical assessment
- Appropriate imaging: MRI/Arthrogram, and /or Xray and/or CT (secondary care pathway for diagnosis but this is optional).
- Awaiting PLR
- No previous surgery to the index hip
- Have capacity to give informed consent
- English as a spoken language Exclusion Criteria
The participant may not enter the study if ANY of the following apply:
- Presence of hip dysplasia, femoral stress fracture, synovitis or other inflammatory arthropathy (psoriatic arthropathy)
- Kellgren-Lawrence grading of Osteoarthritis ≥2 (to exclude moderate OA)
- Avascular necrosis of the femoral head
- Previous surgery to index hip
- Previous physiotherapy treatment to the index hip in the past 6 months
- Current pregnancy
- Perthes disease
- Involved in a current research study involving the hip
干预措施: No intervention assigned. This is an observational study (Other)
结局指标
主要结局
International Hip Outcome Score33 (iHOT33)
时间窗: 1 week maximum from enrolment to recording baseline iHOT33. This should ideally be done on the day of enrolment.
this is a validated hip quality of life questionnaire for FAIS. The iHOT33 provides a 100-point score with 100 representing no pain and perfect function, and a lower scores indicating pain and poorer function. The iHOT33 has a minimal clinically important difference of 6.1 points
Average pain over 4 weeks
时间窗: On the day of enrolment or within one week
Is a unidimensional measure of pain intensity and is a widely used outcome for pain in the adult population for conditions such as chronic pain, rheumatic diseases etc. It is measured on a 100 mm line with an anchor point at 0 mm for 'no pain' and 100 mm representing severe pain. The participant is asked to mark on the 100 mm line their current pain intensity. The pain score is calculated using a ruler to measure along the 100 mm line where the mark on the scale lies.
次要结局
- Neuropathic Pain Symptom Inventory (NPSI)(On the day of enrolment or within one week)
- • Douleur Neuropathique 4 -Interview(On the day of enrolment or within one week)
- Hospital Anxiety and Depression scale (HADS):(on the day of enrolment or within one week)
- Widespread pain index (WPI)(On the day of recruitment or within one week)
- Pain Catastrophising Scale (PCS)(On the day or enrolment or within one week.)
- Tampa Scale of Kinesiophobia (TSK11)(This is a commonly used self-reported questionnaire quantifying the fear of movement or re-injury. The TSK shows a high level of internal consistency and demonstrated moderate construct validity. Concurrent validity is moderate ranging from r =0.33-0.59)
- Credibility/Expectancy Questionnaire (CEQ)(On the day of enrolment or within one week.)
- Treatment Expectation Questionnaire (TEX-Q)(On the day of enrolment or within one week)