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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Low-back Pain
• Intervention / Treatment: Other: Swimming programme; Other: Standard Physiotherapy care

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Kent
    • Canterbury, Kent, United Kingdom, CT1 3NG
      • David Stephensen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Swimming programme; Participants allocated to the swimming programme will be invited to complete three short questionnaires to assess general health, back pain, and swimming ability and experience, see Appendix H, I and J. Both the swimming and physiotherapy groups will complete the three outcome measures, the Oswestry low back pain disability index (ODI), the pain self-efficacy questionnaire (PSEQ), and the EQ-5D-3L, before the intervention, after the last appointment and 6 months later. Data will be collected to report participant characteristics: including age, gender, and length of time with LBP. A follow up participant feedback questionnaire will be distributed to the participants in the swimming arm on completion of the programme and 6 months later.	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.
Active Comparator: Standard Physiotherapy care; The participants in the physiotherapy arm will attend the physiotherapy department in the hospital. Treatment delivered by the physiotherapist could include exercise, advice, education, and manual therapy; they will be offered up to 6 sessions. Some appointments will be delivered in a cubicle and others in the physiotherapy gym. The time between appointments varied from person to person.	Other: Standard Physiotherapy care; Treatment delivered by the physiotherapist could include exercise, advice, education, and manual therapy; they will be offered up to 6 sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
EQ-5D-3L	Measure of health related quality of life	Baseline, 3 weeks and 6 months

Collaborators and Investigators

• Sponsor: Canterbury Christ Church University
• Collaborators: East Kent Hospitals University NHS Foundation Trust
• Investigators: Study Chair: Hayley Mills, PhD, Canterbury Christ Church University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): October 1, 2022
• Study Completion (Actual): October 1, 2022

Study Registration Dates

• First Submitted: May 16, 2024
• First Submitted That Met QC Criteria: May 16, 2024
• First Posted (Actual): May 21, 2024

Study Record Updates

• Last Update Posted (Actual): May 21, 2024
• Last Update Submitted That Met QC Criteria: May 16, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Rehabilitation; Physiotherapy; Swimming
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 264307

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan but we are happy to share data with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No