Condition category
Musculoskeletal Diseases
Date applied
24/07/2015
Date assigned
28/07/2015
Last edited
21/08/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Hip osteoarthritis (OA) is a very common condition that causes pain and can affect ability to do day to day activities. There have been several studies on treatments for OA including joint injections. However, little is known about the best treatments for patients with moderate to severe hip OA. This trial aims to find out whether best current treatment in addition to a single steroid and local anaesthetic injection is effective at reducing pain in patients with hip OA when compared to best current treatment and a single local anaesthetic injection, or best current treatment alone.

Who can participate?
Participants recruited from primary care referrals to orthopaedics, rheumatology and two musculoskeletal services in Staffordshire. Patients aged 40 years and over and who have experienced pain from hip OA for at least 6 weeks.

What does the study involve?
Participants are randomly allocated into one of three groups. Those in group 1 are given the best current treatment plus a single steroid and local anaesthetic injection. The steroid is a drug called Triamcinolone Acetonide. This drug is widely used to treat joint pain and arthritis. Participants in group 2 are given the best current treatment and a local anaesthetic injection. Participants n group 3 are given only the best current treatment. All participants are then asked to complete up to 5 questionnaires over the next 6 months. Interviews are also conducted with trial participants who consent to take part in the qualitative study about their experience of the trial and living with hip pain.

What are the possible benefits and risks of participating?
It is considered that there are minimal risks to participants associated with the trial interventions as both the injections are being given in accordance with routine care. The duration of the clinic is longer than for usual care and patients attending clinic are asked not to drive themselves because they will be unable to drive themselves afterwards if they receive an injection. Participants will be asked to completed up to 5 questionnaires and there is some burden with regards to the time taken to complete them. However, the questionnaires have been designed to be as simple and clear to read as possible. A small sample of participants will take part in qualitative interviews. It is possible that participants may become upset when talking about their lives but the interviewer will be sensitive to this. In terms of potential benefit to research participants. The treatments in this trial are already used in the management of osteoarthritis, but we cannot guarantee that one is better than the another and it is possible that neither treatment works for some patients. This trial will allow us to compare the benefits of each treatment in a large group of patients. The results from this trial may help us to decide how best to treat people with hip osteoarthritis in the future.

Where is the study run from?
Keele Clinical Trials Unit, Arthritis Research UK Primary Care Centre, Keele University (UK)

When is the study starting and how long is it expected to run for?
August 2014 to December 2017

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr Edward Roddy
e.roddy@keele.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Andrea Cherrington

ORCID ID

Contact details

Arthritis Research UK Primary Care Centre
Research Institute for Primary Care & Health Sciences
Keele University
Staffordshire
ST5 5BG
United Kingdom

Additional identifiers

EudraCT number

2014-003412-37

ClinicalTrials.gov number

Protocol/serial number

323/12

Study information

Scientific title

For patients with painful hip OA; comparing 1) best current treatment plus an ultrasound-guided intra-articular hip injection of corticosteroid (triamcinolone acetonide 40mg) with 1% lidocaine hydrochloride with either 2) best current treatment alone or 3) best current treatment plus an ultrasound-guided intra-articular hip injection of 1% lidocaine hydrochloride. a randomised, clinical, single-blind, three-arm, parallel group pragmatic trial in patients with hip OA with a linked qualitative study

Acronym

HIT - the Hip Injection Trial

Study hypothesis

This trial aims to find out whether best current treatment in addition to a single steroid and local anaesthetic injection is effective at reducing pain in patients with hip OA when compared to best current treatment and a single local anaesthetic injection, or best current treatment alone.

Ethics approval

NRES Committee North West - Greater Manchester South, 15/07/2015, ref: 15/NW/0546

Study design

A randomised, clinical, single-blind, three-arm, parallel group pragmatic trial in patients with hip OA with a linked qualitative study.

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Osteoarthritis of the hip

Intervention

1. Best current treatment only
2. Best current treatment plus an ultrasound-guided intra-articular hip injection of corticosteroid (triamcinolone acetonide 40mg) with 1% lidocaine hydrochloride
3. Best current treatment plus an ultrasound-guided intra-articular hip injection of 1% lidocaine hydrochloride alone

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

Pain - Numerical Rating Scale score for current pain (Dworkin 2005)

Measured at baseline, 2 weeks, 2 months, 4 months and 6 months.

Secondary outcome measures

1. Joint Function - Western Ontario and McMaster University Arthritis Index (WOMAC v3.1), measured at baseline, 2 months, 4 months and 6 months
2. Participant’ self-reported global impression of change, measured at 2 weeks, 2 months, 4 months and 6 months
3. General health (SF-12), measured at baseline, 2 months, 4 months and 6 months
4. Sleep disturbance (Likert type scale), measured at baseline, 2 months, 4 months and 6 months
5. Pain self-efficacy, measured at baseline, 2 months, 4 months and 6 months
6. Modified Brief Illness Perceptions Questionnaire, measured at baseline, 2 months, and 6 months
7. Satisfaction and experience, measured at baseline, 2 months and 6 months
measured at baseline, 2 months, 4 months and 6 months
8. Health status - EQ5D-5L, measured at baseline, 2 weeks, 2 months, 4 months and 6 months
9. Employment status, measured at baseline and 6 months
10. Performance at work, measured at baseline, 2 months, 4 months and 6 months
11. Absenteeism from work, measured at baseline, 2 months and 6 months
12. Health care utilisation, measured at 2 months and 6 months
13. Participant -incurred costs, measured at 2 months and 6 months
14. Other hip injections received, measured 2 months and 6 months
15. Self-reported adverse events, measured at 2 weeks, 2 months and 6 months
16. Adherence to best current treatment advice, measured at 2 months, 4 months and 6 months

Overall trial start date

01/08/2014

Overall trial end date

01/12/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male or female aged ≥ 40 years
2. A clinical diagnosis of unilateral or bilateral hip OA, and confirmed on plain radiography within the last 24 months, as made by a trained clinician in the musculoskeletal service
3. Moderate to severe current hip pain
4. Symptom duration of episode of at least 6 weeks
5. Hip pain occurring on most days of the last month
6. Informed written consent provided by the patient

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

348

Participant exclusion criteria

1. Hip pain due to other disorders (e.g. trochanteric bursitis, avascular necrosis, pain referred from back)
2. Intra-articular corticosteroid injection into the affected hip or ipsilateral trochanteric bursa injection within the preceding 3 months
3. Any previous surgery on the affected hip
4. Clinical suspicion of local or systemic sepsis or infection
5. Current or previous infection of the affected hip
6. Significant trauma to the affected hip requiring immobilisation in the previous 3 months
7. Unwillingness to undergo study interventions
8. Unable to understand and complete self-report questionnaires written (or spoken) in English
9. Significant illness (known or suspected) including, but not limited to:
9.1. Inflammatory joint disease (e.g. rheumatoid arthritis, seronegative spondyloarthropathy (ankylosing spondylitis, psoriatic arthritis, reactive arthritis, inflammatory-bowel disease associated inflammatory arthritis))
9.2. Polymyalgia rheumatica or other condition requiring regular oral steroid use
9.3. Malignancy (where malignancy is thought to be causing hip pain e.g. suspected bony metastases)
9.4. Any other severe medical illness which in the opinion of the local Principal Investigator (or other authorised clinical delegate) precludes trial participation
10. Pregnant or lactating females
11. Receiving anticoagulants (warfarin, dabigatran, rivaroxaban, apixaban or low molecular weight heparin)
12. Any history of hypersensitivity to triamcinolone acetonide or 1% lidocaine hydrochloride or any of their excipients (1N Hydrochloric Acid QS, 1N Sodium Hydroxide QS, Benzyl alcohol. Polysorbate 80, Sodium carboxymethylcellulose and Sodium chloride)
13. Contraindications to use of local anaesthetic: Complete heart block and hypovolaemia

Recruitment start date

01/10/2015

Recruitment end date

01/04/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Keele Clinical Trials Unit (CTU)
Arthritis Research UK Primary Care Centre Keele University
Newcastle-under-Lyme, Staffordshire
ST5 5BG
United Kingdom

Sponsor information

Organisation

Keele University

Sponsor details

Keele University Science & Business Park
IC1 Building
Staffordshire
ST5 5BG
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Research results will be published in scientific journals and the relevant manuscripts made available in the public domain as required by the funder (NIHR RfPB). We will also provide information for appropriate public forums. Once the results of the trial have been published participants will be sent a summary of the findings.

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes