Physiotherapy for Sciatica: Is Earlier Better?
| ISRCTN | ISRCTN25018352 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25018352 |
| ClinicalTrials.gov number | NCT02618278 |
| Secondary identifying numbers | 19794 |
- Submission date
- 10/12/2015
- Registration date
- 10/12/2015
- Last edited
- 25/04/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Sciatica is the name given to pain in the lower back or legs, caused by the compression (squeezing) or irritation of the sciatic nerve. The sciatic nerve is the longest nerve in the body, running from the spine at the level of the lower back through the hips and buttocks and down each leg. One of the most common causes causes of sciatica occurs when the sciatic nerve is compressed (squashed) or irritated by one of the discs which separate the bones in the spine (vertebrae) sticking out (herniating). Typically, most people only experience sciatica on one side of the body, and the pain can range from mild to so severe that it is physically disabling. In most people, the condition can improve on its own however physiotherapy is widely used in order to speed up recovery. A Physiotherapist is able to help devise a management programme with the patient in order to improve function, help pain management and optimise the bodys' natural healing response. The length of time between referral from the GP and physiotherapy can vary greatly in different parts of the UK however this is thought to be because of local clinical commissioning group decisions rather than medical recommendations. The aim of this study is to compare the benefits of early physiotherapy (within 2 weeks of referral) to the standard wait time (of around 6 weeks) in the treatment of patients with sciatica. The study also aims to find out whether it would be possible to conduct a larger trial in the future.
Who can participate?
Adults between 18 and 70 years old with sciatica in one leg.
What does the study involve?
Participants are randomly allocated to one of two groups. Participants in the first group are referred to see a physiotherapist within 2 weeks of seeing their GP. Each participant is interviewed by the physiotherapist and their physiotherapy regimen is tailored to their individual needs. Participants in the second group a referred to see a physiotherapist around 6 weeks after seeing their GP, as is usual practice. After 6 months, participants in both groups are interviewed in order to find out whether they feel that they have reached the goals that they set in the initial meeting with the physiotherapist. The amount of participants that took part and how many continued to the end of the study is then recorded, so that the investigators can decide whether a larger study would be appropriate.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Northern General Hospital (UK)
When is the study starting and how long is it expected to run for?
February 2016 to August 2017
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Mr Michael Reddington
Contact information
Public
School of Health and Related Research
Regents Court
30 Regent Street
Sheffield
S1 4DA
United Kingdom
 ORCID ID |
0000-0001-8139-2103 |
|---|
Study information
| Study design | Mixed methods randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Physiotherapy management Of LumbAr Radicular syndrome: does early intervention improve outcomes? the POLAR study |
| Study acronym | POLAR |
| Study objectives | The aim of this study to investigate the effects of early intervention physiotherapy for people with sciatica, and to determine the feasibility of performing a full-scale trial. |
| Ethics approval(s) | East of Scotland Research Ethics Service, 20/08/2015, ref: 15/ES/0130 |
| Health condition(s) or problem(s) studied | Topic: Musculoskeletal disorders; Subtopic: Musculoskeletal (all Subtopics); Disease: Musculoskeletal |
| Intervention | Participants are randomly allocated to one of two groups. Group 1: Participants receive an individual, goal-orientated physiotherapy management package within 2 weeks G.P referral for physiotherapy. Group 2: Participants receive the same individual, goal-orientated physiotherapy management as the intervention arm but at 6 weeks post G.P referral, as is usual care. Participants in both groups are followed up at 6 months post-randomisation. |
| Intervention type | Other |
| Primary outcome measure | 1. Recruitment rate is determined at 26 weeks 2. Attrition rate is determined at 26 weeks |
| Secondary outcome measures | 1. Feasibility measures for a future, full-scale trial include attrition rates, recruitment rate, acceptability of the intervention to patient and clinician, patient adherence to the intervention and will be measured with monthly report and analysis 2. Oswestry Disability Index will be used to assess self-rated disability at baseline, 6 weeks, 12 weeks and 26 weeks 3. Pain will be measured using the VAS pain scale for back and leg pain at baseline, 6 weeks, 12 weeks and 26 weeks 4. General health status will be measured using the EQ5D-5L tool at baseline, 6 weeks, 12 weeks and 26 weeks |
| Overall study start date | 01/02/2016 |
| Completion date | 01/02/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 80; UK Sample Size: 80; Description: 80 patients will be recruited from primary care G.P practices and randomised into 2 groups. |
| Total final enrolment | 80 |
| Key inclusion criteria | 1. Aged between 18 and 70 years of age 2. Presence of unilateral lumbar radicular syndrome (defined as pain and or sensory disturbance and or weakness in a dermatomal and/or myotmal distribution) |
| Key exclusion criteria | 1. Bilateral lumbar radicular syndrome (LRS) 2. Patients with ‘red flag’ signs and symptoms of potential serious pathology 3. Cancer at the time of the study 4. Proven vascular claudication 5. Cauda Equina Syndrome (CES) 6. Spinal fracture within the last 3 months 7. Chronic regional pain syndromes 8. Recent lower limb fracture 9. CVA with physical and/or psychiatric disability 10. Poor English skills (necessitating the use of an interpreter and invalidating outcomes measures-ODI as well as increasing costs) 11. Other significant comorbidities preventing regular attendance at physiotherapy clinics 12. Patients with significant mental health problems for which treatment adherence may be difficult or psychologically disabling (at the discretion of the referring G.P) |
| Date of first enrolment | 01/02/2016 |
| Date of final enrolment | 06/11/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Sheffield Teaching Hospitals NHS Trust
Herries Road
Sheffield
S5 7AU
United Kingdom
Sponsor information
Hospital/treatment centre
South Yorkshire Cardiothoracic Unit
Sheffield Teaching Hospitals NHS Trust
Herries Road
Sheffield
S5 7AU
England
United Kingdom
"ROR" |
https://ror.org/05r409z22 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/07/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Planned publication of study results in a peer reviewed journal, as well as presentation at relevant conferences. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 03/03/2017 | Yes | No | |
| Results article | results | 28/07/2018 | 25/04/2019 | Yes | No |
| HRA research summary | 26/07/2023 | No | No |
Editorial Notes
25/04/2019: Publication reference and total final enrolment added.
06/03/2017: Publication reference added.
10/11/2016: The recruitment end date has been updated from 01/08/2017 to 06/11/2016.
