'Do Patient Characteristics Associate With Poor Outcome With Femoral Acetabular Impingement Syndrome (FAIS) Following Physiotherapy-led Rehabilitation'

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-55
SponsorUniversity of Oxford

About this trial

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? The investigators know things like people's emotions such as 'feeling down' can affect pain. An experiment the investigators 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. The investigators 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 the investigators can find a reason why some people don't get better after strengthening their muscles.

Project design The investigators 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.

The investigators will invite 175 adults with hip impingement who have been referred for physiotherapy-led treatment to join this study. The participants 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 the participants will complete special questionnaires designed to explore emotions and causes of pain. The investigators will compare the results of the questionnaires which will give more information about the causes of pain and how people view their pain. This will give the investigators a better understanding why strengthening exercises may not be the best treatment.

Patient and public involvement (PPI) The investigators 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 the investigators 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 the investigators 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 the investigators further design the study so that the information available to the public is clear and concise.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Adult male or female participants with a formal diagnosis of FAIS who meet the inclusion criteria

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No intervention assigned. This is an observational study

    Other intervention

    No intervention assigned

Treatment groups

175 Participants
are divided into 1 treatment group
Group A: Patients diagnosed with femoral acetabular impingement syndrome1 intervention

Trial outcomes

Primary outcomes

1

International Hip Outcome Score33 (iHOT33)

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

Time frame
1 week maximum from enrolment to recording baseline iHOT33. This should ideally be done on the day of enrolment.
2

Average pain over 4 weeks

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.

Time frame
On the day of enrolment or within one week

Secondary outcomes

1

Neuropathic Pain Symptom Inventory (NPSI)

Neuropathic Pain Symptom Inventory (NPSI) is a self-administered validated screening tool designed to assess diverse symptoms of neuropathic pain. The NPSI has 5 clinical domains assessing superficial spontaneous pain, Deep spontaneous pain, Paroxysmal pain, Evoked Pain and Dysethesia/Parasthesia

Time frame
On the day of enrolment or within one week
2

• Douleur Neuropathique 4 -Interview

This is a validated questionnaire which can differentiate between neuropathic and non-neuropathic pain, which is self-administered, quick and easy to complete. It contains 7 questions with a cut off of ≥3 for assessing neuropathic pain.

Time frame
On the day of enrolment or within one week
3

Hospital Anxiety and Depression scale (HADS):

This is used as a screening tool in non-psychiatric hospital clinics. The HADS is used for multiple chronic pain conditions and has good concurrent validity and reliability. There are 7 items relating to anxiety and 7 items relating to depression with each item scored on a 4-point Likert scale from 0 to 3 with a maximum score for depression and anxiety of 21 respectively.

Time frame
on the day of enrolment or within one week
4

Widespread pain index (WPI)

The WPI is a questionnaire that fulfils three conditions, Widespread Pain Index, Symptom Severity Score where symptoms have been present for more than 3 months, and lastly, the patient does not have another disorder that may explain ongoing chronic pain. This measure constitutes the Fibromyalgianess Scale and can be applied to every disease .

Time frame
On the day of recruitment or within one week

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Oxford

Lead sponsor

Oxford University Hospitals NHS Trust

Collaborator

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