Swimming Versus Standard Physiotherapy Care as Rehabilitation Modalities for Persistent Low Back Pain: Feasibility Study

Chronic Low-back Pain Clinical Trial

Official title:

Swimming Versus Standard Physiotherapy Care as Rehabilitation Modalities for Persistent Low Back Pain: A Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06423755
• Other study ID #: 264307
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: October 1, 2022

Study information

• Verified date: May 2024
• Source: Canterbury Christ Church University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study four: A small scale RCT will be conducted to pilot the swimming lessons developed in study three, to compare the lessons to standard physiotherapy care and to assess the feasibility of conducting a large RCT in the future. The results from this feasibility study will give the researcher some initial feedback on the swimming lessons and will inform and support the development of an RCT in the future; if the initial findings are positive. This will include whether an RCT can be carried out and evaluating recruitment and retention rates, willingness to be randomised, adverse events, outcomes, acceptability and cost analysis.

Description:

Low back pain is very common; globally it is the number one cause of disability. National guidelines recommend exercise for the management of back pain; swimming is frequently advised despite little supporting evidence. Swimming is considered to be low impact and might target conditions associated with back pain such as obesity, inactivity, and depression. Swimming lessons are not funded by the NHS, many adults cannot swim and there are no guidelines regarding what type of swimming program to recommend. This multi-phase mixed methods research project aims to develop a swimming class to be used as a form of rehabilitation for persistent low back pain. There are many barriers to exercise and this can affect uptake and adherence; Study 1 will be an online survey finding out what stops and what encourages people with back pain to go swimming. Some people already use swimming to manage back pain; in Study 2, individuals who use swimming to manage back pain will be interviewed to explore their experience including discussion about swimming stroke and adaptations. The swimming class will be developed in Study 3 using the data from Study 1 and 2 and by consulting physiotherapists, swimming teachers, and patients, through a series of surveys, known as the Delphi method. Study 4 will be a feasibility study; comparing the swimming class developed in Study 3 over 3 weeks to standard physiotherapy care. Data will be collected on the running of the study, outcomes including function and quality of life, with further follow up at on completion of the trial and 6 months. These studies will be carried out at East Kent Hospitals NHS Trust and the Hotel Burstin swimming pool; people with back pain for more than 3 months would be eligible to take part.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The inclusion criteria for the study were that participants should have experienced CLBP for more than three months, be at least 18 years old and have a small amount of swimming experience.

Exclusion Criteria:

• Exclusion criteria for the study included the following: unable to read or speak English, allergy to chlorine, severe fear of the water, pregnancy, ear infection, already a competent regular swimmer, visual impairment not correctable with glasses, medical contraindication to aquatic exercise or precaution that cannot be resolved. The following back conditions were excluded; red flag conditions (cauda equina syndrome, cancer or tumour related back pain, spinal infection, spinal cord compression, back pain from visceral source), inflammatory back pain, fractures of the spine during the last 6 months, severe spinal stenosis, nerve root compromise causing neurological deficit or constant pain in the leg, back surgery in the last 6 months, and fitted with a spinal cord stimulator.

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain

Intervention

Other:
• Swimming programme
A session plan will be followed, which included aims, objectives, learning outcomes and suggested core aquatic skills and swimming activities under each section. The session will consist of a session brief, a warmup, core aquatic skills, swimming strokes (front crawl, backstroke, breaststroke, and hybrid strokes), a cool down and a session debrief; following the guidance developed in study three.
• Standard Physiotherapy care
Treatment delivered by the physiotherapist could include exercise, advice, education, and manual therapy; they will be offered up to 6 sessions.

Locations

Country	Name	City	State
United Kingdom	David Stephensen	Canterbury	Kent

Sponsors (2)

Lead Sponsor	Collaborator
Canterbury Christ Church University	East Kent Hospitals University NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Oakes H, de Vivo M, Mills H, Stephensen D. Recommending swimming to people with low back pain: A scoping review. J Bodyw Mov Ther. 2023 Oct;36:274-281. doi: 10.1016/j.jbmt.2023.05.012. Epub 2023 Aug 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Self efficacy questionnaire	10 questions scored on a Likert scale asking the participant how confident they are to do an activity despite the pain.	Baseline, 3 weeks and 6 months
Secondary	Oswestry low back pain disability index	This questionnaire is composed of 10 questions with 6 response statements to assess disability	Baseline, 3 weeks and 6 months
Secondary	EQ-5D-3L	Measure of health related quality of life	Baseline, 3 weeks and 6 months